药物洗脱支架与裸金属支架治疗急性冠脉综合征
Referencias
References to studies included in this review
References to studies excluded from this review
References to studies awaiting assessment
Additional references
References to other published versions of this review
Characteristics of studies
Characteristics of included studies [ordered by study ID]
| Study characteristics | ||
| Methods | Parallel‐design randomised clinical trial in Switzerland, Denmark, Serbia, UK, the Netherlands, and Israel | |
| Participants | 1161 participants with symptom onset within 24 hours and ST‐segment elevation of at least 1 mm in 2 or more contiguous leads, true posterior MI, or new left bundle branch block were eligible for randomisation in the presence of at least 1 culprit lesion within the infarct vessel. There was no limit regarding the number of treated lesions, vessels, or complexity. Male:female = 918:243 Mean age = 60.5 years Exclusion criteria: presence of mechanical complications of acute MI, known allergy to any study medication, use of vitamin K antagonists, planned surgery unless dual antiplatelet therapy could be maintained throughout the perisurgical period, history of bleeding diathesis or known coagulopathy, pregnancy, participation in another trial before reaching the primary endpoint, inability to provide informed consent, and non‐cardiac comorbid conditions with life expectancy of less than 1 year. | |
| Interventions | Experimental group: stents eluting Biolimus from a biodegradable polylactic acid polymer (BioMatrix, Biosensors Europe SA). Control group 1: bare‐metal stents of otherwise identical design (Gazelle, Biosensors Europe SA). Co‐intervention: acetylsalicylic acid (250 mg) was administered before the procedure. In centres where prasugrel was available, an initial dose of 60 mg (including participants preloaded with clopidogrel) was administered followed up with a 10 mg daily dose. If prasugrel was not available or contraindicated, clopidogrel was administered at a loading dose of 600 mg, followed up with a dose of 75 mg twice daily for 7 days, followed up with a maintenance dose of 75 mg once daily. Dual antiplatelet therapy was prescribed for a duration of at least 1 year in all participants. Unfractionated heparin was routinely administered with a minimal dose of 5000 IU or a dose of 70 to 100 IU/kg to maintain an activated clotting time of 250 seconds. Bivalirudin was administered at a dose of 0.75 mg/kg intravenously followed up with an infusion of 1.75 mg/kg per hour during the duration of the procedure. The use of glycoprotein IIb/IIIa inhibitors was left to the discretion of the operator. | |
| Outcomes | Death, myocardial infarction, biomarkers, TVR, TLR, device success, lesion success, procedural success, stent thrombosis, transient ischaemic attack, ischaemic stroke | |
| Notes | NCT00962416 (prospectively) | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Computer‐generated web‐based system |
| Allocation concealment (selection bias) | Low risk | Computer‐generated web‐based system |
| Blinding of participants and personnel (performance bias) | High risk | Participants and personnel were not blinded to the allocation. |
| Blinding of outcome assessment (detection bias) | Low risk | An independent data and safety monitoring board blinded to treatment groups periodically reviewed all event information and compared safety outcomes between groups. |
| Incomplete outcome data (attrition bias) | Low risk | Less than 5% dropped out, and dropout was judged to be equal in both groups. |
| Selective reporting (reporting bias) | Low risk | All outcomes stated in the pre‐published protocol were reported. |
| Other bias | High risk | The trial was funded by the Swiss National Science Foundation (grant 33CM30‐124112) and an unrestricted research grant from Biosensors Europe SA. |
| Study characteristics | ||
| Methods | Parallel‐design randomised clinical trial in Iran | |
| Participants | 384 participants with ST‐segment elevation myocardial infarction. Male:female = not reported Mean age = not reported Exclusion criteria: none stated. | |
| Interventions | Experimental group: drug‐eluting stent Control group: bare‐metal stent Co‐intervention: none stated. | |
| Outcomes | Death, MI, TVR | |
| Notes | Abstract only. We contacted the authors at [email protected] on 23 April 2017 regarding all bias domains, additional data, and request for full publication, but have received no reply. | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Not described |
| Allocation concealment (selection bias) | Unclear risk | Not described |
| Blinding of participants and personnel (performance bias) | Unclear risk | Not described |
| Blinding of outcome assessment (detection bias) | Unclear risk | Not described |
| Incomplete outcome data (attrition bias) | Unclear risk | The number of dropouts was unclear. |
| Selective reporting (reporting bias) | Unclear risk | There was no pre‐published protocol, and the trial did not report on our primary outcomes. |
| Other bias | Unclear risk | It was unclear how the trial was funded. |
| Study characteristics | ||
| Methods | Parallel‐design randomised clinical trial in the Netherlands and Italy | |
| Participants | 100 participants presenting in the first 12 h after the onset of STEMI (diagnosed by the presence of anginal symptoms associated with electrocardiographic ST‐segment elevation of 1 mm in 2 contiguous leads or new left bundle branch block) and undergoing primary PCI, with angiographic evidence of a single culprit lesion in the target vessel, after successful thrombus aspiration (defined by no angiographically evident flow‐limiting residual thrombus at the site of [sub]occlusion, and Thrombolysis In Myocardial Infarction (TIMI) flow grade 1) were deemed eligible for inclusion. Male:female = 83:17 Mean age = 57.9 years Exclusion criteria: contraindications to study medications (acetylsalicylic acid, clopidogrel, paclitaxel), life expectancy 12 months, lesion length 25 mm, reference vessel diameter 2.5 mm and 4.0 mm, severe triple vessel disease, left main stenosis 50%, and a combination of type C coronary lesion and diabetes mellitus (in which DES was favoured). | |
| Interventions | Experimental group: DES (Taxus Liberté, Boston Scientific, Natick, MA) as a stainless steel stent platform coated with a permanent polymer that allows the release of paclitaxel (1 g/mm2). The total strut thickness including stent and polymer is 132 µm. Control group: BMS (Genius MAGIC stent, Eurocor) cobalt chromium stent platform with a strut thickness of 60 µm. Co‐intervention: pre‐dilation with a standard balloon (balloon‐to‐artery ratio 0.8:1). All participants received routinely in the ambulance or at the first medical contact a loading dose of acetylsalicylic acid (325 to 500 mg) and of clopidogrel (600 mg). Heparin was administered before and during the procedure to maintain an activated clotting time 250 s. Additional administration of glycoprotein IIb/IIIa inhibitors was recommended, but was left to the physician’s discretion. After fulfilling angiographic inclusion criteria, patients underwent mandated thrombus aspiration of the culprit lesion with a manual thrombus aspiration device. | |
| Outcomes | Angiographic in‐segment late luminal loss (expressed in millimetres) as determined by quantitative coronary analysis (QCA), binary restenosis using QCA, stent malapposition and re‐endothelialisation assessed by optical coherence tomography, coronary endothelial dysfunction after acetylcholine infusion, and clinical outcomes (death, MI, repeated revascularisation procedures). | |
| Notes | The trial had a third arm receiving paclitaxel drug‐eluting balloon dilatation before BMS implantation. We were unable to include this arm due to multi‐intervention. NCT00856765 ‐ prospectively We contacted the authors at [email protected] on 21 March 2017 regarding blinding, dropouts, and additional data, but have received no reply. | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Automatically generated by a computer |
| Allocation concealment (selection bias) | Low risk | Opaque, sealed envelopes |
| Blinding of participants and personnel (performance bias) | Unclear risk | Not described |
| Blinding of outcome assessment (detection bias) | Unclear risk | Outcome assessors were only described as blinded for images (QCA analyses) and not for our primary outcomes. |
| Incomplete outcome data (attrition bias) | Unclear risk | The number of dropouts was unclear. |
| Selective reporting (reporting bias) | Low risk | The authors reported on all outcomes described on ClinicalTrials.gov, and the outcomes were submitted before the trial was started. |
| Other bias | High risk | The trial was funded by Eurocor GmbH. |
| Study characteristics | ||
| Methods | Parallel‐design randomised clinical trial in the Netherlands | |
| Participants | 907 patients 18 years of age or older with STEMI were eligible if they presented within 12 h of onset of symptoms. Male:female = 668:202 Mean age = 60.5 years Exclusion criteria: patients who were on oral anticoagulation and patients who had received thrombolytic therapy or treatment with a glycoprotein IIb/IIIa inhibitor in the previous 24 h were not eligible. Other exclusion criteria were contraindications for DES, contraindications for clopidogrel or glycoprotein IIb/IIIa inhibitors, comorbid conditions with a predictable fatal outcome in the short run, cardiogenic shock, and inability to give informed consent. | |
| Interventions | Experimental group: sirolimus‐eluting stents (Cypher, Cordis Corporation, Bridgewater, NJ). Control group: BMS (type was left to the discretion of the operator). Co‐intervention: all participants received aspirin (300 mg chewed or 500 mg intravenously), clopidogrel (600 mg), and a fixed bolus of intravenous unfractionated heparin (5000 IU) in the ambulance. Before angiography, all participants received an additional intravenous bolus of heparin (5000 IU). After primary PCI, aspirin 80 mg per day was given indefinitely, and clopidogrel was prescribed (75 mg/day) for at least 1 month after BMS and 6 to 12 months after sirolimus‐eluting stents. Participants allocated to abciximab received a 0.25 mg/kg bolus after stent placement followed by an infusion of 0.125 g/kg/min for 12 h. | |
| Outcomes | Death, MI, revascularisation, stroke, bleeding | |
| Notes | Participants included in this trial were randomised to another trial comparing abciximab with no abciximab (clinical trial number NCT00986050). We contacted the authors at [email protected] on 23 April 2017 regarding allocation concealment, specific data on cardiovascular mortality, and additional data, but have received no reply. | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Computer‐generated allocation |
| Allocation concealment (selection bias) | Unclear risk | Not described |
| Blinding of participants and personnel (performance bias) | High risk | Participants and personnel were not blinded. |
| Blinding of outcome assessment (detection bias) | Low risk | All events were adjudicated by a clinical endpoints committee under blinded conditions. |
| Incomplete outcome data (attrition bias) | Unclear risk | More than 5% dropped out at 5 years, however not at 1‐year follow‐up (4.1%). |
| Selective reporting (reporting bias) | High risk | The protocol was published retrospectively. |
| Other bias | High risk | The trial was funded by Johnson & Johnson (Cordis), Guidant, Abbott, and the Friends of the Heart Foundation. |
| Study characteristics | ||
| Methods | Randomised clinical trial with a factorial (2x2) design in Denmark | |
| Participants | 626 participants with chest pain of 30‐minute duration who had a cumulated ST‐segment elevation of 4 mm in at least 2 contiguous leads of the ECG, provided that they were 18 years of age and had a high‐grade stenosis or occlusion of a coronary artery without excessive tortuosity or calcification prohibiting advancement of a filter wire to the distal vascular bed of the vessel. We did not distinguish between patients who were admitted directly to the tertiary unit with laboratory facilities or via a referring hospital as long as they presented to the catheterisation laboratory within 12 hours from symptom onset. Male:female = 458:168 Mean age = 62.2 years Exclusion criteria: previous MI in the target vessel area, development of cardiogenic shock before enrolment, culprit lesions in an unprotected left main coronary artery, gastrointestinal bleeding within 1 month, pregnancy, known renal failure, life expectancy 1 year, and linguistic problems. | |
| Interventions | Experimental group: drug‐eluting stents (47% were sirolimus‐eluting (Cordis, Bridgewater, NJ), 40% were paclitaxel‐eluting (Boston Scientific, Natick, MA), and 13% were zotarolimus‐eluting stents (Medtronic, USA). Control group: BMS, 38% were made of cobalt alloy (Vision, Abbott and Driver, Medtronic); 39% were stainless steel stents from Boston Scientific; and 23% were miscellaneous stainless steel stents from Biotronik (Seoul, South Korea), Cordis, Guidant (Diegem, Belgium), Jomed (Helsingborg, Sweden), and Terumo (Tokyo, Japan). Co‐intervention: participants were examined during and after the index procedure with ST‐segment monitoring, cardiac markers, and echocardiography. At discharge, participants received a daily dose of a statin, clopidogrel (for 12 months), and aspirin (indefinitely). A beta‐blocker was administered in the absence of contraindications, and an angiotensin‐converting enzyme inhibitor was given in case of reduced (45%) left ventricular ejection fraction. | |
| Outcomes | ST‐segment resolution, late loss (difference between minimal lumen diameter in stented segment immediately after and at 8 months' follow‐up), restenosis, maximal elevations, wall motion index, minimal lumen diameter, frequency of binary restenosis, occurence of stent thrombosis, and MACE | |
| Notes | Clinical trial number NCT00192868. The participants in the trial were additionally randomised to distal protection or no distal protection, however this was done at random, and did not break the protocol for drug‐eluting stents versus bare‐metal stents. | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Computerised assignment |
| Allocation concealment (selection bias) | Low risk | Central telephone system |
| Blinding of participants and personnel (performance bias) | High risk | Unblinded |
| Blinding of outcome assessment (detection bias) | Low risk | The angiographic analyses were performed by blinded investigators, and the Clinical Events Committee adjudicated the serious events without knowledge of the treatment sequence. |
| Incomplete outcome data (attrition bias) | Unclear risk | More than 5% dropped out on re‐angiography. |
| Selective reporting (reporting bias) | High risk | The primary outcome were changed. |
| Other bias | High risk | The trial was funded by Cordis/Johnson & Johnson, Medtronic, Abbott, and Boston Scientific companies. |
| Study characteristics | ||
| Methods | Parallel‐design randomised clinical trial in Brazil | |
| Participants | 40 people with acute coronary syndrome. Male:female = unclear Mean age = unclear Exclusion criteria: not described. | |
| Interventions | Experimental group: drug‐eluting stent (Cypher). Control group 1: bare‐metal stent (Driver). Co‐intervention: not described. | |
| Outcomes | Modification in vessel, lumen and plaque area and in the composition of the plaque in the mean time between the baseline and follow‐up procedure | |
| Notes | Abstract only. No contact information could be obtained. | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Not described |
| Allocation concealment (selection bias) | Unclear risk | Not described |
| Blinding of participants and personnel (performance bias) | Unclear risk | Not described |
| Blinding of outcome assessment (detection bias) | Unclear risk | Not described |
| Incomplete outcome data (attrition bias) | Unclear risk | The number of dropouts was unclear. |
| Selective reporting (reporting bias) | Unclear risk | There was no pre‐published protocol, and the trial did not report on our primary outcomes. |
| Other bias | Unclear risk | It was unclear how the trial was funded. |
| Study characteristics | ||
| Methods | Parallel‐design randomised clinical trial in the UK | |
| Participants | 167 participants presented with STEMI Male:female = not reported Mean age = 57.5 years Exclusion criteria: not reported. | |
| Interventions | Experimental group: paclitaxel‐eluting stents. Control group: bare‐metal stent. Co‐intervention: abciximab was used unless contraindicated. | |
| Outcomes | TLR, stent thrombosis, mortality | |
| Notes | Abstract only. Trial is ongoing. We were unable to locate data from the completed trial. Estimated recruitment was 250 participants. We were unable to locate contact information for the authors. | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Not described |
| Allocation concealment (selection bias) | Unclear risk | Not described |
| Blinding of participants and personnel (performance bias) | Unclear risk | Not described |
| Blinding of outcome assessment (detection bias) | Unclear risk | Not described |
| Incomplete outcome data (attrition bias) | Unclear risk | The number of dropouts was unclear. |
| Selective reporting (reporting bias) | Unclear risk | There was no pre‐published protocol, and the trial did not report on our primary outcomes. |
| Other bias | Unclear risk | It was unclear how the trial was funded. |
| Study characteristics | ||
| Methods | Parallel‐design randomised clinical trial in Spain | |
| Participants | 120 participants with STEMI over the age of 18 years who were candidates for primary angioplasty and who met the following criteria were included: (1) chest pain lasting for > 30 minutes with elevation of the ST‐segment by 1 mm or more on 2 or more contiguous electrocardiographic leads or recent‐onset left branch blocking, and (2) admitted to the hospital centre within the first 12 hours after the onset of symptoms. Male:female = 95:19 Mean age = 64.5 years Exclusion criteria: patients in a state of cardiogenic shock and/or Killip IV before randomisation; the partial or total administration of prior fibrinolytic treatment or administration of any glycoprotein IIb/IIIa inhibitors during the previous 30 days; chronic kidney failure requiring dialysis; pregnant women; history of haemorrhagic diathesis or allergy to aspirin, clopidogrel, and/or abciximab; major surgery in the last 15 days; active bleeding or previous stroke in the last 6 months; and a life expectancy of less than 6 months. Patients with a reference diameter < 2.25 mm and > 4.0 mm by visual estimation in the infarction‐related artery were excluded from the study. | |
| Interventions | Experimental group: drug‐eluting stent and clopidogrel for at least 9 months. Control group: bare‐metal stent and clopidogrel for at least 1 month. Co‐intervention: before the procedure, all participants received aspirin (300 to 500 mg by mouth as the loading dose and then 100 mg a day indefinitely) plus clopidogrel (300 or 600 mg as the loading dose). Abciximab was administered to all participants as a bolus at a dose of 0.25 Ag/kg, followed by an infusion at a dose of 0.125 Ag/kg per minute for 12 hours. Heparin was administered as a bolus in relation to the participant’s body weight at a dose of 70 U/kg (maximum 7000 U), with additional doses to maintain an activated clotting time of between 200 and 250 seconds. | |
| Outcomes | Clinical follow‐up was performed at 1, 3, 6, 9, and 12 months through visits to the clinic by the participant; the participant was also was contacted afterward by phone. The primary endpoint is a composite of death, nonfatal MI, and recurrent myocardial ischaemia within a follow‐up of 360 days after initial procedure. Participants with > 1 event will be assigned the highest‐ranked event. Secondary endpoints include freedom, at day 30 and month 12, from death, recurrent MI, and clinically driven TVR, defined as any coronary artery bypass graft surgery or a second PCI of the original target vessel performed for recurrent myocardial ischaemia. | |
| Notes | Under the protocol, those participants randomised to sirolimus‐eluting stent plus abciximab could only receive BMS in the infarct‐related artery if there had previously been a failure in the implanting of a sirolimus‐eluting stent that prevented its repeated use due to the impossibility of reaching the implant area and if the use of BMS resolved this situation. Contacted about allocation concealment, blinding, pre‐published protocol, funding, complete number of stent thrombosis, cardiovascular death at 1 year, serious adverse events at 1 months and 1 year, data for participants not receiving PCI/stent by email: [email protected] on 13 March 2017. | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | "Randomization was performed with the aid of a basic computer program." |
| Allocation concealment (selection bias) | Unclear risk | Not described |
| Blinding of participants and personnel (performance bias) | Unclear risk | The trial was described as "double‐blind", but it was unclear who was blinded and how blinding was maintained. |
| Blinding of outcome assessment (detection bias) | Unclear risk | The trial was described as "double‐blind", but it was unclear who was blinded and how blinding was maintained. |
| Incomplete outcome data (attrition bias) | Unclear risk | There was incomplete outcome data for above 5% of participants in the BMS group (6/60), and there was a difference in dropout rate (6/60 vs 0/60, BMS and DES respectively). |
| Selective reporting (reporting bias) | Unclear risk | There was no pre‐published protocol, and the trial did not report on serious adverse events. |
| Other bias | Unclear risk | It was unclear how the trial was funded. |
| Study characteristics | ||
| Methods | Parallel‐design randomised clinical trial in the Netherlands | |
| Participants | 474 participants with NSTEMI hospitalised with ischaemic chest pain or dyspnoea at rest, with the last episode occurring 24 hours or less before randomisation, and had at least 2 of 3 of the following high‐risk characteristics: (1) evidence of extensive myocardial ischaemia on ECG (shown by new cumulative ST depression > 5 mm or temporary ST‐segment elevation in 2 contiguous leads < 30 min), (2) elevated biomarkers (troponin T > 0.10 μg/L or myoglobin > 150 μg/L) or elevated CK‐MB fraction (> 6% of total CK), (3) age above 65 years from the ELISA‐3 trial (178 participants). Additionally, NSTEMI participants who did not meet the inclusion criteria for high‐risk NSTEMI from the ELISA‐3 registry were included (296 participants). Male:female = 351:123 Mean age = 65.2 years Exclusion criteria: persistent ST‐segment elevation, symptoms of ongoing myocardial ischaemia despite optimal medical therapy, contraindication for diagnostic angiography, active bleeding, cardiogenic shock, acute posterior infarction, and life expectancy < 1 year. | |
| Interventions | Experimental group: everolimus‐eluting stent. Control group: bare‐metal stent. Co‐intervention: dual antiplatelet therapy (acetylsalicylic acid and clopidogrel) for the duration of 1 year. | |
| Outcomes | Angiographic for the participants randomised from the ELISA‐3 study, MACE and stent thrombosis for all participants | |
| Notes | ISRCTN Register (ISRCTN39230163) retrospectively registered. Study participants were taken from both the ELISA‐3 study and the ELISA‐3 registry of participants not included due to being high‐risk NSTEMI patients. We contacted the authors at [email protected] on the 23 March 2017 regarding random sequence generation and specific data on death, cardiac death, or myocardial infarction. | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Not described |
| Allocation concealment (selection bias) | Low risk | Closed‐envelope system |
| Blinding of participants and personnel (performance bias) | Low risk | Participants and operators were blinded. |
| Blinding of outcome assessment (detection bias) | Low risk | Clinical endpoints were adjudicated by investigators blinded to participants’ treatment allocation. |
| Incomplete outcome data (attrition bias) | Low risk | Less than 5% dropped out. |
| Selective reporting (reporting bias) | High risk | The protocol was retrospectively published. |
| Other bias | High risk | The trial was funded by Abbott. |
| Study characteristics | ||
| Methods | Parallel‐design randomised clinical trial in Spain, Italy, and the Netherlands | |
| Participants | 1504 participants presented with STEMI with the following electrocardiogram criteria: at least 1 mm in 2 or more standard leads or at least 2 mm in 2 or more contiguous precordial leads or left bundle branch block that was not known to be old, within the first 48 h after the symptoms onset requiring emergent PCI with a vessel size ranging between 2.25 mm and 4.0 mm without other anatomical restrictions could be included. Male:female = 1244:260 Mean age = 61.2 years Exclusion criteria: age younger than 18 years; pregnancy; patients with known intolerance to aspirin, clopidogrel, heparin, stainless steel, everolimus or contrast material; patients on chronic treatment with anti‐vitamin K agents, and STEMI secondary to stent thrombosis. | |
| Interventions | Experimental group: Xience V Multi‐Link Vision everolimus‐eluting stent. Control group 1: cobalt chromium Multi‐Link Vision BMS. Co‐intervention: at the index procedure, participants received appropriate anticoagulation and other therapy according to standard hospital practice. Either unfractionated heparin or bivalirudin might be used for procedural anticoagulation. The use of glycoprotein IIb/IIIa inhibitors was left to the discretion of the investigator. Aspirin (loading dose 250 to 500 mg) and clopidogrel (loading dose of at least 300 mg) had to be given before percutaneous coronary intervention for those participants not on chronic antiplatelet treatment. Neither prasugrel nor ticagrelor was approved during the recruitment period. Clopidogrel was prescribed for at least 1 year (75 mg per day) and aspirin (100 mg) indefinitely. Compliance to dual antiplatelet therapy refers to the concomitant use of both drugs during the prescription time of 1 year. Manual thrombectomy followed by direct stenting was the recommended technique in this setting, although other devices could also be used if considered necessary. Operators were instructed to use only the assigned stent type at the index procedure. | |
| Outcomes | Death, MI, TVR, TLR, stent thrombosis, procedural success, bleeding | |
| Notes | NCT00828087 prospectively published. | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Computer‐generated random numbers |
| Allocation concealment (selection bias) | Low risk | Centralised by telephone |
| Blinding of participants and personnel (performance bias) | Unclear risk | The participants were blinded to the allocation, however the personnel were not. |
| Blinding of outcome assessment (detection bias) | High risk | There was no description of blinding of outcome assessors. |
| Incomplete outcome data (attrition bias) | Low risk | Less than 5% dropped out. |
| Selective reporting (reporting bias) | Low risk | The protocol was pre‐published, and all outcomes were reported. |
| Other bias | High risk | The trial was funded by Abbott Vascular to the Spanish Heart Foundation. |
| Study characteristics | ||
| Methods | Parallel‐design randomised clinical trial in China | |
| Participants | 156 participants with (1) onset of chest discomfort within the prior 12 hours and ST‐segment elevation (at least 1 mm in 2 standard leads or at least 2 mm in 2 contiguous precordial leads) or new or presumably new left bundle branch block; (2) no upper limitation for age; (3) willing to comply with the follow‐up schedule and procedures; (4) candidate for primary PCI; (5) no contraindications of anticoagulants and antiplatelets; (6) suitable angiographic anatomy for primary PCI. Male:female = 126:30 Mean age = 58.7 years Exclusion criteria: (1) fever and cough during the past 48 hours; (2) severely calcified lesion unsuitable for balloon pre‐dilation; (3) low left ventricular ejection fraction (≤ 40%); (4) renal dysfunction (serum creatinine > 103 μmol/L); (5) life expectancy < 1 year; (6) intolerant or hypersensitive to sirolimus, aspirin, clopidogrel, heparin, stainless steel, or iodine‐containing contrast medium; (7) participated in another research protocol; and (8) unsuitable for stent implantation. | |
| Interventions | Experimental group: Firebird stent (Firebird stent group). Control group 1: Driver stent (cobalt‐chromium alloy stent, Medtronic Ltd., USA) (BMS group). Co‐intervention: all procedures were performed via a femoral or radial access using standard techniques. Oral loading dose of aspirin (300 mg) and clopidogrel (300 mg) were given immediately after establishment of STEMI diagnosis. Weight‐adjusted heparin (8000 to 10,000 IU) was administered at the same time. Postprocedural antiplatelet regimen included 300 mg aspirin per day for 4 weeks and lifelong 100 mg per day, 75 mg clopidogrel per day for 9 to 12 months, and use of low molecular weight heparin for 1 week. Successful stent implantation was defined as < 20% residual stenosis in the stented segment with TIMI flow 3. | |
| Outcomes | In‐stent and in‐segment late luminal loss, binary angiographic restenosis, MACE, stent thrombosis | |
| Notes | It was unclear how many participants were actually randomised since all participants received Firebird stent the last 4 months, therefore no data could be used in our meta‐analyses. We contacted the authors on 21 March 2017 at [email protected] for data on the participants randomised, sequence generation, allocation concealment, blinding, incomplete outcome data, wether they pre‐published a protocol, and funding information. | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Not described |
| Allocation concealment (selection bias) | Unclear risk | Not described |
| Blinding of participants and personnel (performance bias) | Unclear risk | Not described |
| Blinding of outcome assessment (detection bias) | Unclear risk | Not described |
| Incomplete outcome data (attrition bias) | Unclear risk | The number of dropouts was unclear. |
| Selective reporting (reporting bias) | Unclear risk | There was no pre‐published protocol, and the trial did not report on our primary outcomes. |
| Other bias | Unclear risk | It was unclear how the trial was funded. |
| Study characteristics | ||
| Methods | Parallel‐design randomised clinical trial in Spain | |
| Participants | 436 participants age 18 years or older; symptom onset within 12 hours before random assignment; chest pain lasting more than 30 minutes; ST‐segment elevation of at least 0.1 mV in at least 2 limb leads, ST‐segment elevation of at least 0.2 mV in 2 or more contiguous precordial leads, or left bundle branch block or paced rhythm; and no severe heart failure (Killip class 3). Male:female = 358:78 Mean age = 61 years Exclusion criteria: cardiogenic shock, defined as a systolic blood pressure 90 mmHg with no response to fluid administration or 100 mmHg in patients with supportive treatment and no bradycardia; suspected mechanical complications of acute myocardial infarction; previous coronary artery bypass graft; non‐cardiac disease that is likely to jeopardise the planned termination of the study; women of childbearing potential unless they had a negative pregnancy test result; active bleeding and recent surgery (within 2 weeks) contraindicating the use of heparin, tirofiban, or platelet aggregation inhibitors; contraindications for thrombolysis (previous haemorrhagic stroke at any time, history of non‐haemorrhagic cerebrovascular accident within the previous 12 months, intracerebral neoplasm, active internal bleeding, suspected aortic dissection, uncontrolled hypertension 180/110 in several measurements, any other known intracerebral condition not covered in contraindications, current use of anticoagulants or heparin use within 8 hours, known bleeding diathesis, recent trauma (4 weeks) including head trauma or traumatic or prolonged (10 minutes) cardiopulmonary resuscitation or recent major surgery or biopsy (8 weeks), non‐compressible vascular punctures, recent (4 weeks) internal bleeding, pregnancy, and active peptic ulcer); history of hypersensitivity to aspirin, ticlopidine, clopidogrel, heparin, tirofiban, or stainless steel; known renal failure, creatinine 2.5 mg/dL; known impaired hepatic function that contraindicates the use of clopidogrel; known thrombocytopenia (100,000); participation in other trials; known multivessel disease identified as not suitable for revascularisation; and known peripheral vascular disease that makes cardiac catheterisation difficult. | |
| Interventions | Experimental group: paclitaxel‐eluting stents (Taxus stents; Boston Scientific, Natick, MA). Control group: bare‐metal stents (Express stents; Boston Scientific). Co‐intervention: participants underwent catheterisation within 3 to 12 hours of random assignment. The infarct‐related artery was dilated if there was total occlusion, the stenosis was greater than 50%, or the TIMI flow grade was less than 3. Stenting of culprit lesions was performed when they were morphologically suitable for stenting and when the procedure was expected to achieve an adequate result. To avoid thrombus compression and embolisation, direct stenting was attempted when possible. Immediately after stenting, participants received a loading dose of 300 mg of clopidogrel and 75 mg daily for 1 year. Maintenance aspirin therapy was administered indefinitely at 80 to 325 mg once daily (coated or uncoated), unless contraindicated. The trial was divided in 4 groups; 2 groups received tirofiban as co‐intervention. Participants randomly assigned to tirofiban received 150 to 325 mg of non‐enteric‐coated aspirin orally (chewed) or 500 mg IV as soon as STEMI was identified. Immediate thrombolysis with tenecteplase was administered according to the instructions in the Summary of Product Characteristics for the treatment of STEMI (30 mg if body weight was less than 60 kg, 35 mg if it was 60 to 69 kg, 40 mg if it was 70 to 79 kg, 45 mg if it was 80 to 89 kg, and 50 mg if it was 90 kg or more). No enoxaparin bolus was given to these participants; enoxaparin was administered as a subcutaneous injection at 0.75 mg/kg. This subcutaneous dose was the only dose administered if the coronary intervention was successfully performed within 8 hours of randomisation. Tirofiban was started 2 hours after tenecteplase with a fixed 25 g/kg IV bolus followed by 0.15 g/kg/min in IV infusion for 24 hours. The infusion was reduced by 50% if severe renal failure (creatinine clearance 30 mL/h or creatinine 2 mg/dL) was observed. The rationale for withholding tirofiban for 2 hours after fibrinolytic treatment was based on the pharmacokinetics and pharmacodynamics of tenecteplase. In a previous study with 103 participants, 14 participants receiving tenecteplase exhibited biphasic elimination from the plasma with a mean initial half‐life of 22 minutes and a mean terminal half‐life of 115 minutes. This mean terminal half‐life of 115 minutes motivated the rationale for withholding tirofiban for 2 hours in order to avoid bleeding complications. Participants randomly assigned to no tirofiban received 150 to 325 mg of non–enteric‐coated aspirin orally (chewed) or 500 mg IV as soon as STEMI was identified. Immediate thrombolysis with tenecteplase was administered, with the doses and mode of administration described above. An enoxaparin bolus of 30 mg followed by a subcutaneous dose of 1 mg/kg was administered in participants 75 years old. Participants over 75 years did not receive the enoxaparin bolus, and the subcutaneous injection was reduced to 0.75 mg/kg. This subcutaneous dose was also the only dose administered if coronary intervention was successfully performed within 8 hours of random assignment. | |
| Outcomes | Rate of binary stenosis, epicardial and myocardial flow, stent thrombosis, complicated myocardial infarction, major bleeding | |
| Notes | Cross‐overs, NCT00306228 retrospectively. We contacted the authors on 21.03.17 at [email protected] regarding random sequence generation, blinding, and additional data. | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Not described |
| Allocation concealment (selection bias) | Low risk | Central telephone system |
| Blinding of participants and personnel (performance bias) | Unclear risk | Not described |
| Blinding of outcome assessment (detection bias) | Low risk | Clinical outcome was adjudicated by an independent clinical events committee blinded to study group assignment. |
| Incomplete outcome data (attrition bias) | Unclear risk | More than 5% dropped out for angiographic follow‐up, but not for clinical follow‐up. |
| Selective reporting (reporting bias) | Unclear risk | The protocol was produced after enrolment. |
| Other bias | Low risk | The trial was funded by Red Temática de Enfermedades Cardiovasculares (RECAVA) of the Instituto de Salud Carlos III (Spanish Ministry of Science and Innovation), from the Fondo de Investigación Sanitaria of the Instituto de Salud Carlos III (Spanish Ministry of Science and Innovation), and from the Junta de Castilla y León. |
| Study characteristics | ||
| Methods | Randomised clinical trial with a factorial (2x2) design in Finland | |
| Participants | 164 participants with STEMI. Male:female = not available Mean age = 63 years (from meta‐analysis from 2010) Exclusion criteria: none stated. | |
| Interventions | Experimental group: paclitaxel‐eluting Taxus Express stent. Control group: BMS (Liberte). Co‐intervention: in addition to abciximab or a thrombolytic agent, all participants received aspirin, enoxaparin, and clopidogrel in the acute phase. Those treated with prehospital thrombolysis also received a glycoprotein IIb/IIIa blocker during and after PCI. Clopidogrel was prescribed for 12 months if tolerated. | |
| Outcomes | Target vessel revascularisation, stent thrombosis, quantative angiographic analysis, mortality (not reported in a manner that could be used) | |
| Notes | The trial was part of a larger trial randomising participants to abciximab‐facilitated percutaneous coronary intervention (afPcI, n= 90) with prehospital thrombolysis (PHt, n= 74). 0 cross‐overs. 12 participants died, but from which groups was not described in the publication. It should be noted that it seems more participants are missing from the DES group at angiographic follow‐up (13) than the BMS group (7). The publication states that 12 of these participants died, 5 declined to have follow‐up, 1 was lost to follow‐up, and 1 had renal failure. 1 participant was unaccounted for. Data for mortality were taken from previous meta‐analysis. We contacted the authors at [email protected] on 23 April 2017, but received no reply. | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Not described |
| Allocation concealment (selection bias) | Unclear risk | Not described |
| Blinding of participants and personnel (performance bias) | Unclear risk | Not described |
| Blinding of outcome assessment (detection bias) | Unclear risk | Not described |
| Incomplete outcome data (attrition bias) | Low risk | Just 1 participant was lost to follow‐up. |
| Selective reporting (reporting bias) | Unclear risk | There was no pre‐published protocol, and the trial did not report on mortality, serious adverse events, or MACE. |
| Other bias | Unclear risk | It was unclear how the trial was funded. |
| Study characteristics | ||
| Methods | Randomised clinical trial with parallel/factorial design in USA, Netherlands, Italy, Spain, Germany, UK, Israel, Argentina, Poland, Austria, Norway, Sweden, and Denmark | |
| Participants | 3006 participants 18 years of age or older presenting within 12 hours after the onset of symptoms and who had ST‐segment elevation of 1 mm or more in 2 or more contiguous leads, new left bundle branch block, or true posterior myocardial infarction were considered for enrolment. Patients were considered eligible for random assignment to paclitaxel‐eluting stents or bare‐metal stents if an acute infarct–related artery was present in which all lesions requiring PCI had a visually estimated reference‐vessel diameter between 2.25 mm and 4.0 mm, without excessive tortuosity or severe calcification. Male:female = 2307:699 Mean age = 59.6 years Exclusion criteria: hypersensitivity or contraindication to heparin, both abciximab and eptifibatide, aspirin, both clopidogrel and ticlopidine, bivalirudin, paclitaxel of Taxol, the polymer components of the Taxus stent, stainless steel, or contrast media (refractory to medications or history of anaphylaxis). Prior administration of thrombolytic therapy, bivalirudin, glycoprotein IIb/IIIa inhibitors, low molecular weight heparin, or fondaparinux for this admission. Current use of warfarin. Systemic (IV) paclitaxel or Taxol use within 12 months. Female of childbearing potential, unless a recent pregnancy test is negative, who possibly plans to become pregnant any time after enrolment into this study. History of bleeding diathesis or known coagulopathy (including heparin‐induced thrombocytopenia) or refusal of blood transfusions. History of intracerebral mass, aneurysm, arteriovenous malformation, or haemorrhagic stroke. Stroke or transient ischaemic attack within the past 6 months or any permanent residual neurologic defect. Gastrointestinal or genitourinary bleeding within the last 2 months or major surgery within 6 wk. Recent history or known current platelet count < 100,000 cells/mm3 or haemoglobin < 10 g/dL. Extensive peripheral vascular disease, such that emergent angiography and intervention in the opinion of the investigator is likely to be difficult or complicated. An elective surgical procedure is planned that would necessitate interruption of thienopyridines during the first 6 months' postenrolment. Non‐cardiac comorbid conditions are present with life expectancy < 1 year or that could result in protocol non‐compliance. Patients who are actively participating in another drug or device investigational study, who have not completed the primary endpoint follow‐up period. Previous enrolment in this trial. Patients who underwent coronary stent implantation within the past 30 days. 1 or more haemodynamically significant lesion(s) present in the infarct vessel (or side branches) that can only undergo balloon angioplasty or cannot be stented with a study stent (i.e. do not meet the angiographic inclusion criteria for a study stent). The presence of a bifurcation lesion in the infarct vessel that will definitely require the implantation of 2 stents for treatment. Anticipated need for greater than 100 mm of study stent length. The infarct‐related artery is an unprotected left main segment. Patients with significant multivessel disease or anatomical features otherwise unfavourable for angioplasty such that the patient will have a high likelihood of requiring bypass surgery before 30 days. The culprit vessel or lesion cannot be identified. Patient presenting with possible/probable stent thrombosis. Any patient in whom angiography demonstrates the infarct lesion to be at the site of a previously implanted stent (bare metal or drug eluting). | |
| Interventions | Experimental group: paclitaxel‐eluting stents (Taxus Express, Boston Scientific). Control group: identical bare‐metal stents (Express, Boston Scientific). Co‐intervention: aspirin (324 mg administered in chewable form or 500 mg administered intravenously) was given in the emergency room, after which 300 to 325 mg was given orally every day during the hospitalisation and 75 to 81 mg every day thereafter indefinitely. A loading dose of clopidogrel (either 300 mg or 600 mg, at the discretion of the investigator) was administered before catheterisation, followed by 75 mg orally every day for at least 6 months (with a recommendation of 1 year or longer). | |
| Outcomes | Major adverse cardiovascular events consisting of death, reinfarction, stroke, and stent thrombosis, TLR, TVR | |
| Notes | Before randomisation for stents, participants were randomised either to heparin + glycoprotein IIa/IIIa inhibitors or bivalirudin alone without breaking the protocol for randomisation for stents. We contacted the authors on 23 April 2017 at [email protected] regarding blinding and unpublished data, but have received no reply. | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Computerised interactive voice response system |
| Allocation concealment (selection bias) | Low risk | Computerised interactive voice response system |
| Blinding of participants and personnel (performance bias) | Unclear risk | Not described |
| Blinding of outcome assessment (detection bias) | Low risk | Independent clinical events committee, unaware of treatment assignment |
| Incomplete outcome data (attrition bias) | Unclear risk | More than 5% dropped out at 3 years' follow‐up, but not at 1 year. |
| Selective reporting (reporting bias) | Unclear risk | Enrolment begun before the protocol were published. |
| Other bias | High risk | The trial was funded by Merck, Nycomed, OrbusNeich, Pfizer, Possis Medical, Promed, Sanofi‐Aventis, Siemens, Solvay, Terumo, and Tyco. |
| Study characteristics | ||
| Methods | Parallel‐design randomised clinical trial in Germany | |
| Participants | 135 participants referred from the emergency department for stent implantation due to ACS, diagnosed by ST‐elevation myocardial infarction or cardiac enzyme elevation. Male:female = 83:37 (analysed only) Mean age = 62.5 years Exclusion criteria: not described. | |
| Interventions | Experimental group: dexamethasone‐eluting stent (Dexamet, Abbott Vascular Devices). Control group 1: BMS (BiodivYsio, Biocompatibles Cardiovascular Ltd.) consisting of the same stent design without the drug. Co‐intervention: the target lesion was a de novo lesion in a native coronary artery. The balloon size was required to reach a balloon‐to‐artery ratio of 1.0 to 1.1. Predilation was performed before stent implantation. All participants received aspirin (100 mg/d, indefinitely) and clopidogrel as a 300 mg loading dose before stent implantation, followed by a dose of 75 mg/d for 12 months. Stents of various dimensions were used (nominal diameter, 2.50 to 4.00 mm; length, 8.00 to 18.00 mm). Postinterventional medical therapy was similar in both groups. | |
| Outcomes | Quantitative coronary angiographic analysis, intracoronary ultrasound analysis and quantitative measurements | |
| Notes | We were unable to find a protocol. MACE was not defined. We contacted the authors at [email protected]‐muenchen.de on 23 April 2017, but received no reply. | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Not described |
| Allocation concealment (selection bias) | Unclear risk | Not described |
| Blinding of participants and personnel (performance bias) | Unclear risk | Not described |
| Blinding of outcome assessment (detection bias) | Unclear risk | Only the quantitative coronary angiographic analysis was described as blinded. |
| Incomplete outcome data (attrition bias) | Unclear risk | The number of dropouts was unclear. |
| Selective reporting (reporting bias) | Unclear risk | There was no pre‐published protocol, and the trial did not report on serious adverse events. |
| Other bias | Unclear risk | It was unclear how the trial was funded. |
| Study characteristics | ||
| Methods | Parallel‐design randomised clinical trial in 1 centre in the Netherlands | |
| Participants | 310 participants with STEMI symptoms started 9 h before the procedure and the ECG demonstrated STEMI (ST‐segment elevation 0.2 mV in 2 contiguous leads in V 1 through V 3 or 0.1 mV in other leads, or (presumed) new left bundle branch block). The target lesion length should be equal to or less than 24 mm. Male:female = 241:69 Mean age = 59.15 years Exclusion criteria: 1) age 18 years or 80 years; 2) left main stenosis of 50%; 3) triple‐vessel | |
| Interventions | Experimental group: sirolimus‐eluting stent (Cypher, Cordis Corp., Miami Lakes, FL). Control group: BMS (Vision, Guidant Corp., Indianapolis, IN). Co‐intervention: during the study period, all participants were treated according to the institutional STEMI protocol, which included standardised outpatient follow‐up. Before the procedure all participants received 300 mg of aspirin, 300 to 600 mg of clopidogrel, and Aspirin (80 to 100 mg/day) was prescribed indefinitely and clopidogrel (75 mg/day) for 12 months. Participants were treated with beta‐blocking agents, statins, and angiotensin‐converting enzyme inhibitors or angiotensin II blockers. | |
| Outcomes | The primary endpoint of the study was in‐segment late luminal loss at 9‐month follow‐up angiography. Secondary endpoints were angiographic restenosis and late stent malapposition at 9 months. Additional secondary endpoints were death, MI, TVR, TLR, target vessel failure, stent thrombosis, procedural success, and clinical success. | |
| Notes | 1 participant crossed over from the DES group to the BMS group. ISRCTN62825862 (registered retrospectively). We contacted the authors at [email protected] on 23 April 2017, but have received no reply. | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Not described |
| Allocation concealment (selection bias) | Unclear risk | Not described |
| Blinding of participants and personnel (performance bias) | High risk | Single‐blind |
| Blinding of outcome assessment (detection bias) | Low risk | "Patients and operators performing the follow‐up angiography were blinded to the treatment assignment." |
| Incomplete outcome data (attrition bias) | Low risk | 6 participants were lost from the BMS group and none from the DES group, but due to the low number of participants with missing data, we have assessed the trial as low risk. |
| Selective reporting (reporting bias) | Unclear risk | There was no pre‐published protocol, and the trial did not report on serious adverse events. |
| Other bias | High risk | This study was supported by the Netherlands Heart Foundation and by an unrestricted research grant from Guidant Inc., Nieuwegein, the Netherlands. Dr Jukema is an established clinical investigator of the Netherlands Heart Foundation (grant 2001D032). |
| Study characteristics | ||
| Methods | Parallel‐design randomised clinical trial in Italy, Argentina, and Spain | |
| Participants | 745 participants with (1) chest pain for longer than 30 minutes with an electrocardiographic ST‐segment elevation of 1 mm or greater in 2 or more contiguous electrocardiogram leads, or with a new left bundle branch block, and (2) admission either within 12 hours of symptom onset or between 12 and 24 hours after onset with evidence of continuing ischaemia. Male:female = 565:180 Mean age = 63.8 years Exclusion criteria: administration of fibrinolytics in the previous 30 days, major surgery within 15 days, and active bleeding or previous stroke in the last 6 months. | |
| Interventions | Experimental group: sirolimus‐eluting stent. Control group 1: uncoated stent type approved by the regulatory agency. Co‐intervention: the participants were additionally randomised to either abciximab or tirofiban. Heparin was given at 40 to 70 U/kg, targeting an activated clotting time of at least 200 seconds. Participants received aspirin (160 to 325 mg orally or 250 mg intravenously, followed by 80 to 125 mg/d orally indefinitely) and clopidogrel (300 mg orally and then 75 mg/d for at least 3 months). | |
| Outcomes | Death, reinfarction, TVR, stent thrombosis, bleeding, thrombocytopenia | |
| Notes | 12 cross‐overs from DES to BMS, NCT00229515 (retrospectively). We contacted the authors on 23 April 2017 at [email protected] regarding which stents were used and additional data, but have received no reply. | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Computer‐generated sequence |
| Allocation concealment (selection bias) | Low risk | Sealed envelopes |
| Blinding of participants and personnel (performance bias) | High risk | Open‐label study |
| Blinding of outcome assessment (detection bias) | Low risk | Clinical outcomes were assessed by an independent adjudication committee whose members were blinded to treatment assignments. |
| Incomplete outcome data (attrition bias) | Low risk | Less than 5% dropped out. |
| Selective reporting (reporting bias) | High risk | The protocol was published after enrolment of participants. |
| Other bias | High risk | The trial was funded by University of Ferrara and a grant from Merck. |
| Study characteristics | ||
| Methods | Parallel‐design, single‐centre, randomised clinical trial in Italy | |
| Participants | 44 participants with STEMI 12 hours after symptom onset (prolonged chest pain for more than 20 min, unresponsive to nitroglycerin, and ST‐segment elevation of at least 1 mm in 2 or more contiguous leads, or true posterior myocardial infarction), an infarct artery in a native coronary vessel with 70% diameter stenosis, a reference vessel diameter of 2.5 to 3.75 mm, and underwent primary PCI with stent implantation. Male:female = 34:10 Mean age = 61.1 years Exclusion criteria: patients with left main disease, infarct lesions in bypass grafts, cardiogenic shock, renal failure, recent major bleeding, allergy to aspirin or clopidogrel, on anticoagulant therapy, or with no suitable anatomy for optical coherence tomography (ostial lesions, extreme tortuosity, and large vessels 3.75 mm in diameter) were excluded. | |
| Interventions | Experimental group: Endeavor zotarolimus‐eluting stent. Control group: Driver bare‐metal stent. Co‐intervention: percutaneous coronary intervention was performed according to standard techniques. Direct stenting, thrombus aspiration, and use of glycoprotein IIb/IIIa inhibitors were allowed and left to the operator’s discretion. All participants were pre‐treated with aspirin 250 mg intravenously and clopidogrel 300 mg orally before PCI, followed by daily administration of clopidogrel 75 mg for at least 6 months after discharge and aspirin indefinitely. Participants received unfractionated heparin during PCI to maintain an activated clotting time of 300 s or more. | |
| Outcomes | Uncovered struts, maximum length of uncovered segments, percentage of malapposed struts and maximum length of malapposed segments, neointimal response, death, MI, and stent thromboses | |
| Notes | No cross‐overs, ClinicalTrials.gov number NCT00704561. We contacted the authors at [email protected] on 23 April 2017, but have received no reply. | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Not described |
| Allocation concealment (selection bias) | Unclear risk | Not described |
| Blinding of participants and personnel (performance bias) | High risk | "Open label" |
| Blinding of outcome assessment (detection bias) | Unclear risk | Core laboratory personnel were blinded to the treatment assignment. |
| Incomplete outcome data (attrition bias) | Low risk | "Clinical follow‐up was complete in all patients at 1 year." |
| Selective reporting (reporting bias) | Low risk | The outcomes were stated on ClinicalTrials.gov 2 months after trial start. |
| Other bias | High risk | "Supported by Ospedali Riuniti di Bergamo (Bergamo, Italy) with grant support from Medtronic CardioVascular, Santa Rosa, California. Dr. Guagliumi has received grant/research support from Boston Scientific Corporation, Medtronic Vascular, LightLab Imaging, and Labcoat and is a consultant for Boston Scientific Corporation and Volcano Corporation. Dr. Costa is on the Speakers’ Bureau and is a consultant for Boston Scientific Corporation, Sanofi‐Aventis, and Eli Lilly and is on the Speakers’ Bureau and is a member of the Scientific Advisory Board for Abbott, Cordis, LightLab Imaging, and Scitec. Dr. Sirbu has received grant/research support from LightLab Imaging." |
| Study characteristics | ||
| Methods | Parallel‐design randomised clinical trial with 2 experimental groups in Italy | |
| Participants | 270 participants with STEMI who fulfilled all of the following criteria: 1) chest pain for more than 30 min; 2) ST‐segment elevation of 1 mm or more in 2 or more contiguous electrocardiograph leads or with presumably new left bundle branch block; 3) hospital admission within 12 h from symptoms onset. Male:female = 190:80 Mean age = 62 years Exclusion criteria: "Exclusion criteria included: 1) active internal bleeding or a history of bleeding diathesis within the previous 30 days; 2) history of intracranial hemorrhage, intracranial neoplasm, arteriovenous malformation or aneurysm; 3) known allergy to sirolimus, paclitaxel, heparin, aspirin, or clopidogrel; 4) history of stroke within 30 days or any history of hemorrhagic stroke; 5) major surgical procedure or severe physical trauma within the previous month; 6) history, symptoms, or findings suggestive of aortic | |
| Interventions | Experimental group: Taxus paclitaxel‐eluting stent. Control group: bare‐metal stent. Co‐intervention: in the coronary care unit, all participants received 70 U/kg IV bolus of unfractionated heparin plus 1000 U/h infusion (to maintain an activated clotting time of at least 200 s), aspirin intravenously (500 mg), and clopidogrel (300 mg loading dose). All participants received up‐stream glycoprotein IIb/IIIa inhibitors as a routine adjunctive therapy before primary PCI. Postinterventional antiplatelet therapy for all participants included in the 3 study groups consisted of aspirin (100 mg) indefinitely and clopidogrel (75 mg for 6 months). | |
| Outcomes | The primary endpoint was TLR at 1‐year follow‐up. | |
| Notes | We halved the control group to account for the 2 experimental arms and to avoid double‐counting. Clinical trial number NCT00759850, registered retrospectively. We contacted the authors at [email protected] on 23 April 2017, but have received no reply. | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Computer generated |
| Allocation concealment (selection bias) | Low risk | Sealed envelopes |
| Blinding of participants and personnel (performance bias) | High risk | "Open Label" |
| Blinding of outcome assessment (detection bias) | Low risk | "All events were reviewed by 2 cardiologists blinded to treatment assignment." "Offline quantitative coronary angiography (Integris Allura, Philips, Best, the Netherlands) were performed by 2 experienced technicians who were unaware of treatment assignment with the averaging scores if they were not in agreement." |
| Incomplete outcome data (attrition bias) | Low risk | "No patient was lost to follow‐up." |
| Selective reporting (reporting bias) | Unclear risk | There was no pre‐published protocol (registered retrospectively at ClinicalTrials.gov), and the trial did not report on serious adverse events. |
| Other bias | Low risk | San Giuseppe Moscati Hospital funded the study (from ClinicalTrials.gov). |
| Study characteristics | ||
| Methods | Parallel‐design, single‐centre, randomised clinical trial with 2 experimental groups in Italy | |
| Participants | 270 participants with STEMI who fulfilled all the following criteria: 1) chest pain for more than 30 min; 2) ST‐segment elevation of 1 mm or more in 2 or more contiguous electrocardiograph leads or with presumably new left bundle branch block; 3) hospital admission within 12 h from symptoms onset. Male:female = 190:80 Mean age = 62 years Exclusion criteria: "Exclusion criteria included: 1) active internal bleeding or a history of bleeding diathesis within the previous 30 days; 2) history of intracranial hemorrhage, intracranial neoplasm, arteriovenous malformation or aneurysm; 3) known allergy to sirolimus, paclitaxel, heparin, aspirin, or clopidogrel; 4) history of stroke within 30 days or any history of hemorrhagic stroke; 5) major surgical procedure or severe physical trauma within the previous month; 6) history, symptoms, or findings suggestive of aortic dissection; 7) thrombolytic/fibrinolytic therapy within 24 h; 8) history of thrombocytopenia; 9) hemorrhagic retinopathy; 10) patients on warfarin or acenocoumarol with international normalized ratio 2; and 11) pregnancy. A vessel size 2.25 mm was the only angiographic exclusion criteria." | |
| Interventions | Experimental group: Cypher sirolimus‐eluting stent. Control group: bare‐metal stent. Co‐intervention: in the coronary care unit, all participants received 70 U/kg IV bolus of unfractionated heparin plus 1000 U/h infusion (to maintain an activated clotting time of at least 200 s), aspirin intravenously (500 mg), and clopidogrel (300 mg loading dose). All participants received up‐stream glycoprotein IIb/IIIa inhibitors as a routine adjunctive therapy before primary PCI. Postinterventional antiplatelet therapy for all participants included in the 3 study groups consisted of aspirin (100 mg) indefinitely and clopidogrel (75 mg for 6 months). | |
| Outcomes | The primary endpoint was TLR at 1‐year follow‐up. | |
| Notes | We halved the control group to account for the 2 experimental arms and to avoid double‐counting. Clinical trial number NCT00759850, registered retrospectively. | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Computer generated |
| Allocation concealment (selection bias) | Low risk | Sealed envelopes |
| Blinding of participants and personnel (performance bias) | High risk | "Open Label" |
| Blinding of outcome assessment (detection bias) | Low risk | "All events were reviewed by 2 cardiologists blinded to treatment assignment." "Offline quantitative coronary angiography (Integris Allura, Philips, Best, the Netherlands) were performed by 2 experienced technicians who were unaware of treatment assignment with the averaging scores if they were not in agreement." |
| Incomplete outcome data (attrition bias) | Low risk | "No patient was lost to follow‐up." |
| Selective reporting (reporting bias) | Unclear risk | There was no pre‐published protocol (registered retrospectively at ClinicalTrials.gov), and the trial did not report on serious adverse events. |
| Other bias | Low risk | San Giuseppe Moscati Hospital funded the study (from ClinicalTrials.gov). |
| Study characteristics | ||
| Methods | Parallel‐design randomised clinical trial in the Netherlands | |
| Participants | 619 participants with an acute myocardial infarction with ST‐segment elevation (> 20 minutes of chest pain and at least 1 mm of ST‐segment elevation in at least 2 contiguous leads or a new left bundle branch block), reperfusion was expected to be achieved within 6 hours after the onset of symptoms, and the native coronary artery was considered to be suitable for primary PCI with stent implantation. Male:female = 470:149 Mean age = 61 years Exclusion criteria: patients were excluded if they had received thrombolytic therapy; the infarction was caused by in‐stent thrombosis or restenosis; there was a contraindication to aspirin, clopidogrel, or both; patients were participating in another clinical trial; cardiogenic shock was evident before randomisation; the neurologic outcome after resuscitation was uncertain; they had undergone intubation, ventilation, or both; there was known intracranial disease; or the estimated life expectancy was less than 6 months. | |
| Interventions | Experimental group: paclitaxel‐eluting stent (Taxus Express2, Boston Scientific). Control group: uncoated stent (Express2 or Liberté, Boston Scientific). Co‐intervention: aspirin (at a dose of 100 to 500 mg) and clopidogrel (300 mg) were administered upon arrival at the hospital. A glycoprotein IIb/IIIa receptor blocker was administered at the discretion of the operator. A bolus of 10,000 IU of unfractionated heparin was administered before the procedure. Coronary angiography was performed through | |
| Outcomes | The primary endpoint was the first occurrence of a serious adverse cardiac event at 12 months, including death from cardiac causes, recurrent myocardial infarction requiring hospitalisation, and ischaemia‐driven revascularisation of a target lesion. The secondary endpoints of the study were revascularisation of a target lesion and a composite of death from cardiac causes or recurrent myocardial infarction. | |
| Notes | ISRCTN65027270 (registered retrospectively). We contacted the authors at [email protected] on 7 March 2017, but received no reply. | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Not described |
| Allocation concealment (selection bias) | Low risk | "Assignment to study groups was performed with the use of sealed envelopes" |
| Blinding of participants and personnel (performance bias) | Unclear risk | "Patients, referring physicians, investigators responsible for obtaining follow‐up information, and interventionalists performing repeated procedures were all unaware of treatment assignments" "Drs. Laarman and Suttorp adjudicated all end points of the study in a blinded fashion."; however the trial was described as single‐blinded. |
| Blinding of outcome assessment (detection bias) | Low risk | "Patients, referring physicians, investigators responsible for obtaining follow‐up information, and interventionalists performing repeated procedures were all unaware of treatment assignments" "Drs. Laarman and Suttorp adjudicated all end points of the study in a blinded fashion." |
| Incomplete outcome data (attrition bias) | Low risk | Less than 5% with incomplete outcome data in both groups. |
| Selective reporting (reporting bias) | Unclear risk | There was no pre‐published protocol, and the trial did not report on quality of life. |
| Other bias | Low risk | "The trial was entirely funded by the Department of Interventional Cardiology at Onze Lieve Vrouwe Gasthuis" |
| Study characteristics | ||
| Methods | Parallel‐design, single‐centre, randomised clinical trial in Italy | |
| Participants | 80 participants younger than 75 years with chest pain persisting ≥ 30 minutes that was associated with ST‐segment elevation ≥ 0.1 mV in ≥ 2 continuous electrocardiographic leads. Male:female = 66:14 Mean age = 60.7 years Exclusion criteria: clinical exclusion criteria were cardiogenic shock, thrombolytic therapy, oral anticoagulant therapy, prolonged cardiopulmonary resuscitation, previous coronary artery bypass graft, PCI, or ischaemic stroke within 6 months, and haemorrhagic diathesis. Angiographic exclusion criteria were represented by previous stenting of the infarct‐related artery and a reference vessel diameter of the culprit lesion of < 2.25 mm by visual estimate. | |
| Interventions | Experimental group: Taxus paclitaxel‐eluting stent. Control group: Express bare‐metal stents. Co‐intervention: primary PCI was performed according to standard care. After stent implantation, intravascular ultrasound was performed on the stented segment and further postdilation was left to operator discretion. All participants received abciximab (ReoPro, Centocor, Malvern, PA) as a bolus of 0.25 mg/kg of body weight followed by a 12‐hour infusion at a rate of 0.125 µg/kg/min. Unfractioned heparin was given as an initial bolus of 70 IU/kg, and additional boluses were administered during the procedure to achieve an activated clotting time of 250 to 300 seconds. Participants were routinely treated with aspirin (250 to 500 mg IV bolus followed by 100 mg/day orally indefinitely) and clopidogrel (300 mg loading dose and 75 mg/day for 9 months). | |
| Outcomes | The primary endpoint was a percentage of the stent volume obstructed by neointimal hyperplasia measured by intravascular ultrasound at 7 ± 1 months. Secondary endpoints were 7 ± 1 months angiographic binary restenosis rate and MACE, i.e. any death, non‐fatal myocardial infarction, and TLR at discharge, at 1 and 7 ± 1 months’ follow‐up. | |
| Notes | We contacted the authors at [email protected] regarding random sequence generation, allocation concealment, blinding of outcome assessors, pre‐published protocol, and trial funding, but have received no reply. | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Not described |
| Allocation concealment (selection bias) | Unclear risk | Not described |
| Blinding of participants and personnel (performance bias) | High risk | Operators not blinded. |
| Blinding of outcome assessment (detection bias) | Unclear risk | Not described |
| Incomplete outcome data (attrition bias) | Low risk | No dropouts |
| Selective reporting (reporting bias) | Unclear risk | There was no pre‐published protocol, and the trial did not report on serious adverse events. |
| Other bias | Unclear risk | It was unclear how the trial was funded. |
| Study characteristics | ||
| Methods | Parallel‐design randomised clinical trial in Italy | |
| Participants | 320 participants who were 18 years of age, had symptoms of acute MI for 30 min but 12 h, and had 1 mm ST‐segment elevation in at least 2 contiguous leads or left bundle branch block. Male:female = 256:64 Mean age = 62.5 years Exclusion criteria: cardiogenic shock (systolic blood pressure 80 mmHg for 30 min or need for intravenous pressors or intra‐aortic balloon counterpulsation); a history of bleeding diathesis, leukopenia, thrombocytopenia, or severe hepatic or renal dysfunction; non‐cardiac illness associated with a life expectancy of 1 year; left main coronary artery or graft disease; participation in another study; or inability to give informed consent owing to prolonged cardiopulmonary resuscitation. | |
| Interventions | Experimental group: Cypher sirolimus‐eluting stent. Control group: BX stent (bare‐metal stent). Co‐intervention: the study protocol recommended that aspirin (500 mg intravenously) and beta‐blockers (in the absence of contraindications) be administered in the emergency room. Clopidogrel, an inhibitor of adenosine diphosphate–induced platelet aggregation, was given as a bolus of 4 tablets immediately after the procedure and was continued for 1 year in both groups. The glycoprotein IIb/IIIa receptor inhibitor abciximab (ReoPro, Eli Lilly, Indianapolis, IN; Centocor, Horsham, PA) was administered as a 0.25 mg/kg bolus followed by a 12‐hour infusion (0.125 g/kg/min; maximum 10 g/min). If it was not started in the emergency room, abciximab therapy was initiated in the catheterisation laboratory before coronary angiography. The heparin dose was calculated to achieve an activated clotting time of 200 to 250 s. | |
| Outcomes | The primary endpoint for the trial was binary restenosis at the 1‐year angiographic follow‐up. The secondary endpoints were TLR, TVR, MACE, and target vessel failure at 1 year. | |
| Notes | No mention of cross‐overs. Clinical trial number NCT00288210 (registered retrospectively). We contacted the authors at [email protected] on 12 April 2017 regarding a pre‐published protocol, whether they had recorded serious adverse events comprehensively, and whether they had data for cardiovascular mortality. | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | The allocation schedule was based on computer‐generated random numbers. |
| Allocation concealment (selection bias) | Low risk | Sealed, sequentially numbered, opaque allocation envelopes |
| Blinding of participants and personnel (performance bias) | Unclear risk | Not described |
| Blinding of outcome assessment (detection bias) | Low risk | All serious clinical events, including stent thrombosis, were reviewed by 2 authors (AG and DA), who were unaware of stent assignment. |
| Incomplete outcome data (attrition bias) | Low risk | Less than 5% with incomplete outcome data for clinical outcomes in both groups. More than 5% missing angiographic control at 1 year (50% in both groups). |
| Selective reporting (reporting bias) | Unclear risk | There was no pre‐published protocol, and the trial did not report on serious adverse events or cardiovascular mortality. |
| Other bias | Low risk | San Camillo Hospital, Rome, funded the study (taken from ClinicalTrials.gov). |
| Study characteristics | ||
| Methods | Parallel‐design randomised clinical trial in Austria | |
| Participants | 16 participants with a first ST‐elevation anterior myocardial infarction who were eligible for primary percutaneous coronary intervention. Male:female = 12:4 Mean age = 55.5 years Exclusion criteria: not described. | |
| Interventions | Experimental group: sirolimus‐eluting stent (Cypher, Cordis Corp., Miami, FL). Control group: bare‐metal stent (Driver, Medtronic, Minneapolis, MN). Co‐intervention: postinterventional therapy consisted of aspirin (100 mg/d), clopidogrel (75 mg/d for 3 months), beta‐blockers, angiotensin‐converting enzyme or ‐receptor blockers, and a statin, if indicated. The second day after stent implantation, granulocyte‐colony stimulating factor mobilised autologous stem cells therapy at a daily dose of 10 μg/kg body weight divided into 2 subcutaneous injections was initiated. | |
| Outcomes | Quantitative coronary angiography, death | |
| Notes | We contacted the authors at [email protected] on 23 March 2017 regarding randomisation, blinding, funding, protocol, and additional clinical outcomes, but have received no reply. | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Not described |
| Allocation concealment (selection bias) | Unclear risk | Not described |
| Blinding of participants and personnel (performance bias) | Unclear risk | Not described |
| Blinding of outcome assessment (detection bias) | Unclear risk | Not described |
| Incomplete outcome data (attrition bias) | Low risk | No participants were lost to follow‐up. |
| Selective reporting (reporting bias) | Unclear risk | No protocol could be obtained. |
| Other bias | Unclear risk | It was unclear how the trial was funded. |
| Study characteristics | ||
| Methods | Parallel‐design randomised clinical trial in Croatia | |
| Participants | 79 participants who underwent stent implantation in acute coronary syndrome from January 2003 to May 2004. A diagnosis of ACS included acute myocardial infarction with ST elevation, prolonged angina for more than 20 minutes, or recurrent episodes at rest with indicators of cardiac ischaemia or injury (cardiac enzyme elevation and ST‐segment denivelation). Male:female = 62:17 Mean age = 57.8 years Exclusion criteria: patients with previous PCI or coronary artery bypass graft surgery, multivessel, diffuse disease, tortuous vessel, arteries less than 3 mm in diameter, distal stenosis location, and left main and bifurcation lesions. | |
| Interventions | Experimental group: sirolimus‐eluting stent. Control group 1: bare‐metal stent. Co‐intervention: all procedures were performed using standard transfemoral approach (6) with 7 French guiding catheters (6). All participants received aspirin (300 mg), heparin (10,000 IU or more in longer procedures), and eptifibatide. Standard PCI was performed with balloon predilation, stent placement, and postdilation if needed. Postprocedural medications included aspirin 100 mg/d and ticlopidine 500 mg/d (clopidogrel was not available). Ticlopidine was stopped 6 weeks after the procedure. | |
| Outcomes | Quantitative coronary arteriography analysis, death, MI, coronary artery bypass grafting, TLR, MACE | |
| Notes | The trial had a third arm randomising participants to stent grafts. NCT00452517 (retrospectively registered). We contacted the authors at [email protected]‐com.hr on 12 April 2017 regarding random sequence generation, blinding of outcome assessment, pre‐published protocol, the number of participants with complete data, trial funding, and serious adverse events. The email appeared to be no longer functioning, and we were unable to find additional contact information. | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Computer‐generated randomisation codes |
| Allocation concealment (selection bias) | Unclear risk | Not described |
| Blinding of participants and personnel (performance bias) | Unclear risk | Not described |
| Blinding of outcome assessment (detection bias) | Unclear risk | Not described |
| Incomplete outcome data (attrition bias) | Unclear risk | The number of dropouts was unclear. |
| Selective reporting (reporting bias) | High risk | Protocol was published retrospectively. |
| Other bias | Unclear risk | Not described |
| Study characteristics | ||
| Methods | Parallel‐design randomised clinical trial conducted in 48 centres in France and Germany | |
| Participants | 715 participants with symptoms that began less than 12 hours before catheterisation and if the electrocardiogram showed ST‐segment elevation (at least 1 mm in 2 or more standard leads or at least 2 mm in 2 or more contiguous precordial leads). Male:female = 558:154 Mean age = 59.25 years Exclusion criteria: clinical criteria for exclusion included the administration of fibrinolytic agents for the index infarction, overt acute heart failure, a previously documented left ventricular ejection fraction of less than 30%, previous myocardial infarction, and an estimated life expectancy of less than 12 months. | |
| Interventions | Experimental group: sirolimus‐eluting stent (Cypher or Cypher Select, Cordis, Johnson & Johnson). Control group: any commercially available uncoated stent. Co‐intervention: participants were premedicated with aspirin (at least 100 mg) and unfractionated heparin (5000 to 10,000 IU). A loading dose of 300 mg of clopidogrel was administered either before or immediately after PCI. Heparin was administered throughout the procedure in order to maintain an activated clotting time of 250 seconds or longer. Administration of platelet glycoprotein IIb/IIIa inhibitors was left to the investigator’s discretion. Combined antiplatelet therapy included daily administration of aspirin (100 mg) and either clopidogrel (75 mg) or ticlopidine (250 mg). Dual antiplatelet therapy was recommended for at least 6 months, and aspirin therapy was recommended indefinitely. | |
| Outcomes | The primary endpoint was target vessel failure, defined as the composite of TVR, recurrent infarction, or target vessel–related death at 1 year. The secondary endpoints included the rate of successful treatment of the lesion, defined by residual stenosis of less than 50% of the reference luminal diameter on quantitative coronary analysis and a TIMI flow grade of 3, and in‐stent late luminal loss on quantitative coronary analysis at 8 months. | |
| Notes | No cross‐overs noted. ClinicalTrials.gov: NCT00232830 (registered retrospectively). We contacted the authors at [email protected] on 12 April 2017 regarding random sequence generation, blinding of outcome assessment, pre‐published protocol, and serious adverse events, but it seemed that our emails were rejected by the author's email service. | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Not described |
| Allocation concealment (selection bias) | Low risk | Sealed envelopes |
| Blinding of participants and personnel (performance bias) | High risk | "Patients, but not investigators, were unaware of the treatment assignment" |
| Blinding of outcome assessment (detection bias) | Unclear risk | Not described |
| Incomplete outcome data (attrition bias) | Low risk | Only 3 participants had missing data at 1‐year follow‐up. At 4 years' follow‐up 81% had follow‐up data. The trial used multiple imputation to deal with missing data. |
| Selective reporting (reporting bias) | Unclear risk | There was no pre‐published protocol, and the trial did not report on serious adverse events. |
| Other bias | High risk | "The TYPHOON trial was an investigator‐initiated trial sponsored by Cordis Corporation, a Johnson & Johnson company. Dr. Spaulding was a member of a Cordis scientific advisory board; has received honorarium from Cordis for speaker's fees; and has been a full‐time employee of the Cordis Corporation since June 1, 2010. Dr. Varenne is a speaker for Cordis, Boston Scientific, and Abbott. Drs. Cebrian, Wang, and Stoll are full‐time employees of the Cordis Corporation and have Johnson & Johnson stock options. Dr. Fajadet is a consultant for Cordis and Abbott. Dr. Erglis is on the advisory board for Cordis. Dr. Hosten is employed by the Cordis Corporation as a consultant. Dr. Henry is part of the Cordis Exchange program." |
ACS: acute coronary syndrome
BMS: bare‐metal stent
CK‐MB: myocardial band isoenzyme of creatine kinase
DES: drug‐eluting stent
ECG: electrocardiogram
IV: intravenous
MACE: major adverse cardiac events
MI: myocardial infarction
NSTEMI: non‐ST‐segment elevation myocardial infarction
PCI: percutaneous coronary intervention
STEMI: ST‐segment elevation myocardial infarction
TLR: target lesion revascularisation
TVR: target vessel revascularisation
Characteristics of excluded studies [ordered by study ID]
| Study | Reason for exclusion |
| Wrong intervention: the participants were not randomised to drug‐eluting stents versus bare‐metal stents but to bivalirudin versus no bivalirudin | |
| Wrong intervention: not drug‐eluting stent | |
| Not a randomised clinical trial | |
| Not a randomised clinical trial | |
| Not a randomised clinical trial | |
| Wrong control: not bare‐metal stent | |
| Not a randomised clinical trial | |
| Not a randomised clinical trial | |
| Not a randomised clinical trial | |
| Not a randomised clinical trial | |
| Wrong intervention: the intervention group did not receive a drug‐eluting stent, but a bio‐engineered stent with struts covered by murine monoclonal antibodies against human CD34 antigen (Genous) | |
| Not a randomised clinical trial | |
| Wrong intervention: bare‐metal stent versus bare‐metal stent | |
| Not a randomised clinical trial | |
| Wrong control: the control group received either drug‐eluting or bare‐metal stent | |
| Not a randomised clinical trial | |
| Not a randomised clinical trial | |
| Excludes myocardial infarction participants | |
| Not a randomised clinical trial | |
| Multi‐intervention: the experimental group received tirofiban in addition to a drug‐eluting stent, whereas the control group received abciximab in addition to a bare‐metal stent | |
| Not a randomised clinical trial | |
| Wrong intervention: not drug‐eluting stent | |
| Wrong intervention: not drug‐eluting stent | |
| Wrong control: not bare‐metal stent | |
| Wrong intervention: not drug‐eluting stent | |
| Wrong control: not bare‐metal stent |
Characteristics of studies awaiting classification [ordered by study ID]
| Methods | Parallel design, single‐centre, randomised clinical trial with 2 different experimental arms in Switzerland |
| Participants | 826 participants treated with PCI and stenting at the University Hospital of Basel, Switzerland between 5 May 2003 and 31 May 2004 were included in BASKET, irrespective of indication for PCI. Male:female = 320:84 Mean age = 64 years Exclusion criteria: a target vessel diameter of 4 mm or greater, as the largest available DES size was 3.5 mm (n = 23); presence of restenotic lesions, given the different causes and outcome of restenotic lesions (n = 49); and no consent, primarily due to patients’ or referring physicians’ preference for DES before angiography and inability of patients to give informed consent (n = 90). |
| Interventions | Experimental group 1: sirolimus‐coated Cypher stent. Control group: cobalt chromium‐based Vision/Pixel stent. Co‐intervention: in participants with ST‐elevation myocardial infarction, primary PCI was the treatment of choice. Participants with non‐ST‐elevation myocardial infarction or unstable angina were treated urgently within 24 h of chest pain if possible, mostly with glycoprotein IIb/IIIa blocker therapy. All participants were treated with clopidogrel for 6 months (300 mg periprocedurally, maintenance dose 75 mg per day) irrespective of stents used. Otherwise, participants received usual standard of care, i.e. aspirin 100 mg daily and a statin; other drugs, including glycoprotein IIb/IIIa blockers, were used as clinically indicated. |
| Outcomes | The primary endpoint was cost‐effectiveness after 6 months, with effectiveness defined as reduction of major adverse cardiac events, i.e. cardiac death, non‐fatal myocardial infarction, and target vessel revascularisation. Mortality from other causes was also analysed, but these events were not included as primary endpoints. Non‐fatal myocardial infarction apart from the index intervention was diagnosed on the basis of a typical rise (and fall) of cardiac enzyme concentration, typical chest pain, and new pathological Q‐waves or ischaemic ST‐T wave changes, or both, in the electrocardiogram, according to current guidelines. Quality of life was assessed with the EQ‐5D. |
| Notes | No cross‐overs reported. No ClinicalTrials.gov number or other pre‐published protocol found. We contacted the author regarding random sequence generation, pre‐published protocol, blinding of participants and personnel, composite outcome of cardiac death and myocardial infarction, data after 6 months, and data for STEMI, NSTEMI, unstable and stable angina separately by email: [email protected] on 19 March 2017. |
| Methods | Parallel design, single‐centre, randomised clinical trial with 2 different experimental arms in Switzerland |
| Participants | 826 participants treated with PCI and stenting at the University Hospital of Basel, Switzerland between 5 May 2003 and 31 May 2004 were included in BASKET, irrespective of indication for PCI. Male:female = 320:84 Mean age = 64 years Exclusion criteria: a target vessel diameter of 4 mm or greater, as the largest available DES size was 3.5 mm (n = 23); presence of restenotic lesions, given the different causes and outcome of restenotic lesions (n = 49); and no consent, primarily due to patients’ or referring physicians’ preference for DES before angiography and inability of patients to give informed consent (n = 90). |
| Interventions | Experimental group 2: paclitaxel‐coated Taxus stent. Control group: cobalt chromium‐based Vision/Pixel stent. Co‐intervention: in participants with ST‐elevation myocardial infarction, primary PCI was the treatment of choice. Participants with non‐ST‐elevation myocardial infarction or unstable angina were treated urgently within 24 h of chest pain if possible, mostly with glycoprotein IIb/IIIa blocker therapy. All participants were treated with clopidogrel for 6 months (300 mg periprocedurally, maintenance dose 75 mg per day) irrespective of stents used. Otherwise, participants received usual standard of care, i.e. aspirin 100 mg daily and a statin; other drugs, including glycoprotein IIb/IIIa blockers, were used as clinically indicated. |
| Outcomes | The primary endpoint was cost‐effectiveness after 6 months, with effectiveness defined as reduction of major adverse cardiac events, i.e. cardiac death, non‐fatal myocardial infarction, and target vessel revascularisation. Mortality from other causes was also analysed, but these events were not included as primary endpoints. Non‐fatal myocardial infarction apart from the index intervention was diagnosed on the basis of a typical rise (and fall) of cardiac enzyme concentration, typical chest pain, and new pathological Q‐waves or ischaemic ST‐T wave changes, or both, in the electrocardiogram, according to current guidelines. Quality of life was assessed with the EQ‐5D. |
| Notes | No cross‐overs reported. No ClinicalTrials.gov number or other pre‐published protocol found. We contacted the author regarding random sequence generation, pre‐published protocol, blinding of participants and personnel, composite outcome of cardiac death and myocardial infarction, data after 6 months, and data for STEMI, NSTEMI, unstable and stable angina separately by email: [email protected] on 19 March 2017. |
| Methods | Parallel‐design randomised clinical trial in Switzerland, Denmark, Austria, and Italy |
| Participants | 2314 participants who presented with chronic or acute coronary disease, who underwent angioplasty with stenting, and who required only stents that were 3.0 mm or more in diameter. No restrictions were placed on the number of treated lesions or vessels, the length of treated lesions, or the number of stents placed. Male:female = 1749:565 Mean age = 66.3 years Exclusion criteria: cardiogenic shock; in‐stent restenosis or thrombosis of stents placed before the study; unprotected left main coronary artery (i.e. with no functioning bypass graft) or substantial stenosis in a bypass graft; plans for any surgery within 12 months; a need for oral anticoagulation, an increased risk of bleeding, or known intolerance to or suspected noncompliance with long‐term antiplatelet therapy; or circumstances that would have made follow‐up impossible. In addition, patients requiring stents larger than 4.0 mm in diameter were excluded because no sirolimus‐eluting stents of this size were available. |
| Interventions | Experimental group 1: first‐generation sirolimus‐eluting stent (Cypher Select, Cordis). Experimental group 2: second‐generation everolimus‐eluting stent (Xience V, Abbott Control group: bare‐metal (cobalt–chromium) stent (Vision, Abbott Vascular). Co‐intervention: all participants were prescribed aspirin at a daily dose of 75 to 100 mg indefinitely and clopidogrel at a daily dose of 75 mg for 1 year, after a loading dose of 300 mg or 600 mg, regardless of stent type. Therapeutic agents for secondary prevention, such as statins, were prescribed according to current guidelines. |
| Outcomes | Primary outcomes: death from cardiac causes or non‐fatal myocardial infarction at 2 years. Secondary outcomes: efficacy endpoint of target vessel revascularisation and the safety endpoint of late death from cardiac causes or non‐fatal myocardial infarction. |
| Notes | Current Controlled Trials number ISRCTN72444640. We contacted the authors at [email protected] on 13 April 2017, but have received no reply. |
| Methods | Randomised clinical trial with a parallel/factorial design in Switzerland, Denmark, Germany, and Austria |
| Participants | 2299 participants with chronic or acute coronary artery disease requiring angioplasty and stenting with stents ≥ 3.0 mm in diameter by visual assessment. No restrictions applied to the number of treated lesions or vessels, length of treated lesions, or number of stents implanted. Male:female = 1780:519 Mean age = 62.3 years Exclusion criteria: cardiogenic shock; in‐stent restenosis or thrombosis; unprotected left main coronary artery or bypass graft disease; planned surgery within 12 months; need for oral anticoagulation, increased bleeding risk, known intolerance to or suspected noncompliance with long‐term antiplatelet drug therapy; history of transient ischaemic attack or stroke; or circumstances that would have made follow‐up impossible. |
| Interventions | Experimental group 1: second‐generation Biolimus A9–eluting biodegradable‐polymer stainless‐steel DES (Nobori, Terumo). Experimental group 2: second‐generation everolimus‐eluting durable‐polymer cobalt‐chromium DES (Xience Prime, Abbott Vascular). Control group: generation thin‐strut BMS coated with a biocompatible silicone‐carbide layer (PRO‐Kinetic, Biotronik). Co‐intervention: all participants received a loading dose of 60 mg prasugrel with a maintenance dose of 10 mg daily, risk‐adjusted to 5 mg in participants aged > 75 years or body weight < 60 kg. Prasugrel was prescribed for 12 months after stenting with DES and for participants with acute coronary syndrome and for 4 weeks after elective stenting with BMS. To ensure adherence to antiplatelet therapy, participants were given the drug in monthly packages at regular intervals from the study centres. No further prasugrel was provided after 12 months. All other concomitant treatments were prescribed according to current guidelines. |
| Outcomes | Primary outcomes: major adverse cardiac events (i.e. a combination of cardiac death, non‐fatal myocardial infarction, or clinically driven non‐myocardial infarction–related target vessel revascularisation). Secondary outcomes: TVR, stent thrombosis, myocardial infarction, cardiac death. |
| Notes | ClinicalTrials.gov NCT01166685. We contacted the authors at [email protected] on 13 April 2017, but have received no reply. |
| Methods | Parallel‐design randomised clinical trial in Germany |
| Participants | 129 participants with a single, de‐novo, coronary stenosis (diameter 2.5 to 4.0 mm, length of stenosis ≤ 25 mm). Male:female = 65:64 (50% male) Mean age = not stated Exclusion criteria: none stated. |
| Interventions | Experimental group: Axxion (paclitaxel) polymer‐free stent. Control group: bare‐metal stent. Co‐intervention: none stated. |
| Outcomes | Primary: MACE after 30 days. |
| Notes | No contact information could be obtained. |
| Methods | Parallel‐design randomised clinical trial in Latvia and Australia |
| Participants | 103 participants with clinically symptomatic left main coronary artery disease with angiographic evidence of 50% diameter stenosis of left main coronary artery suitable for stent implantation. The left main coronary artery was considered unprotected if there was no CABG to left anterior descending artery branches or left circumflex branches. All patients were good candidates for CABG. Male:female = 86:17 Mean age = 61.7 years Exclusion criteria: none stated. |
| Interventions | Experimental group: Taxus Express paclitaxel‐eluting stent. Control group: Express or Liberte BMS. Co‐intervention: all participants received cutting balloon intervention before stenting. A maximum of 24 hours before the PCI procedure, all participants received 100 mg aspirin and a loading dose (300 mg) of clopidogrel. Participants were required to take clopidogrel 75 mg daily for at least 6 months after the PCI procedure. During the procedure, all participants were administered 10,000 IU of heparin or low‐molecular‐weight heparin, depending on the particpant’s weight. Glycoprotein IIb/IIIa inhibitors were given at the operator’s discretion. |
| Outcomes | Intravascular ultrasound characteristics, death, cardiac death, MI, stent thrombosis, TLR, MACE |
| Notes | We contacted the authors at [email protected] regarding separate data on ACS participants. |
| Methods | Parallel‐design randomised clinical trial in Germany |
| Participants | 42 participants with de novo coronary lesions with a reference diameter between 2.75 and 4.0 mm with lesion length 18 mm. Male:female = 36:6 Mean age = 65 years Exclusion criteria: none stated. |
| Interventions | Experimental group: S‐Stent (Biosensors International) everolimus eluting with a bioresorbable polymer. Control group: bare‐metal stent. Co‐intervention: all participants received aspirin (325 mg/d) and clopidogrel (300 mg loading dose immediately and 75 mg/d for 6 months). |
| Outcomes | Primary outcomes: the primary endpoint was MACE, including death, CABG to the target vessel, Q‐wave and non–Q‐wave myocardial infarction, and TLR at 30 days. Secondary outcomes: the secondary endpoint was to compare quantitative angiographic and intravascular ultrasound observation within the vessel as well as the clinical performance of the everolimus‐eluting stent with regard to device success, MACE, and restenosis rate at 6‐month follow‐up. |
| Notes | No registration with ClinicalTrials.gov. We contacted the authors at [email protected] on 15 April 2017, but have received no reply. |
| Methods | Parallel‐design randomised clinical trial at 3 sites in Germany |
| Participants | 64 participants with de novo coronary lesions with a reference diameter between 2.75 and 4.0 mm with lesion length 18 mm. Male:female = not stated Mean age = not stated Exclusion criteria: none stated. |
| Interventions | Experimental group: S‐Stent (Biosensors International) everolimus eluting with a bioresorbable polymer. Control group: bare‐metal stent. Co‐intervention: aspirin and clopidogrel for 6 months. |
| Outcomes | MACE, including death, CABG to the target vessel, Q‐wave and non–Q‐wave myocardial infarction, and TLR at 1 and 6 months. Stent thrombosis and restenosis. |
| Notes | No registration with ClinicalTrials.gov. We contacted the authors at [email protected] on 15 April 2017, but have received no reply. |
| Methods | Parallel‐design randomised clinical trial in China |
| Participants | 200 participants with coronary heart disease (36.5% acute myocardial infarction). Male:female = 144:56 Mean age = not stated Exclusion criteria: none stated. |
| Interventions | Experimental group: Janus tacrolimus‐eluting stent. Control group: Tecnic Carbostent (bare‐metal stent). Co‐intervention: clopidogrel for 4 months and aspirin lifelong. |
| Outcomes | MACE, cardiovascular mortality, myocardial infarction, TLR |
| Notes | Abstract only. No contact information could be obtained. |
| Methods | Parallel‐design randomised clinical trial in China |
| Participants | 152 participants with coronary small vessel lesions (inside diameter 3.0 mm on quantitative coronary angiography). Male:female = not stated Mean age = not stated Exclusion criteria: none stated. |
| Interventions | Experimental group: sirolimus‐eluting Cypher stents. Control group: uncoated stents. Co‐intervention: standard antiplatelet and anticoagulation agents and individual modifications as needed. |
| Outcomes | Mortality, stent thrombosis, restenosis |
| Notes | Abstract only. No contact information could be found. |
| Methods | Parallel‐design randomised clinical trial at 8 sites in Norway |
| Participants | 9013 men and women who were at least 18 years of age and who presented with stable angina or an acute coronary syndrome, had lesions in native coronary arteries or coronary artery grafts (all of which were amenable for implantation of either drug‐eluting stents or bare‐metal stents), had a Norwegian national identification number and were able to communicate in Norwegian, and provided informed consent. Male:female = 6657:2356 Mean age = 62.6 years Exclusion criteria: "Patients were excluded if they had previously been treated with a coronary stent, had a bifurcation lesion requiring treatment with a two‐stent technique, had a serious medical condition other than coronary artery disease with a life expectancy of less than 5 years, were participating in another randomized trial, had intolerable side effects to any drug in use during PCI or contraindications to long‐term dual‐antiplatelet therapy or had been prescribed warfarin, or were not able to follow the trial protocol, as judged by the investigator." |
| Interventions | Experimental group: any commercially available stent in Norway (Promus, Xience, Endeavor, Endeavor Resolute, Cypher, Taxus). Control group 1: any commercially available stent in Norway (Driver, Integrity, Liberte, Multi‐Link Vision, Multi‐Link 8, Chrono Carbostent, Multi‐Link Flexmaster, Graftmaster, Coroflex Blue, Multi‐Link Zeta). Co‐intervention: "All the patients in the two groups were prescribed aspirin at a daily dose of 75 mg indefinitely and clopidogrel at a daily dose of 75 mg for 9 months after the procedure regardless of the randomized assignment or the indication for PCI." |
| Outcomes | The primary outcome was a composite of death from any cause and non‐fatal spontaneous myocardial infarction at a median follow‐up of 5 years, as specified in an amendment to the protocol made by the steering committee in May 2012. Secondary outcomes were subcategories of death; fatal and non‐fatal spontaneous and periprocedural myocardial infarction and stroke; hospitalisation for unstable angina pectoris; revascularisation of a target lesion, target vessel, or non‐target vessel with PCI or CABG; definite stent thrombosis; major bleeding episodes; and health‐related quality of life. |
| Notes | ClinicalTrials.gov NCT00811772 (prospectively). We contacted the authors at [email protected] on 12 April 2017. We received an initial reply and were informed we would receive data for ACS and stable angina participants separately. We have not yet received these data. |
| Methods | Randomised clinical trial with a parallel design in Italy |
| Participants | 2013 participants ≥ 18 years old with chronic stable coronary artery disease or acute coronary syndrome, including non–ST‐elevation and ST‐elevation MI. Patients were eligible if they had ≥ 1 lesion with a diameter stenosis of ≥ 50% that was suitable for coronary stent implantation in a vessel with a reference vessel diameter of ≥ 2.25 mm and were undergoing elective, urgent, or emergent coronary angioplasty with intended stent implantation. Male:female = 1538:475 Mean age = 68.3 years Exclusion criteria: known allergy to acetylsalicylic acid or clopidogrel, planned surgery within 24 months of PCI unless the dual antiplatelet therapy could be maintained throughout the perisurgical period, history of bleeding diathesis, major surgery within 15 days, active bleeding or previous stroke in the last 6 months, concomitant or foreseeable need for oral anticoagulation therapy, pregnancy, life expectancy less than 24 months, participation in another trial, and inability to provide informed consent. |
| Interventions | Experimental group 1: Endeavor Sprint zotarolimus‐eluting stent (Medtronic, Santa Rosa, CA). Experimental group 2: Taxus paclitaxel‐eluting stent (Boston Scientific, Natick, MA). Experimental group 3: Xience V everolimus‐eluting stent (Abbott Vascular, Santa Clara, CA). Control group: third‐generation thin‐strut BMS. Co‐intervention: all participants received aspirin (160 to 325 mg orally or 500 mg intravenously as a loading dose and then 80 to 160 mg orally indefinitely) and clopidogrel as follows: 300 or 600 mg orally as a loading dose to be given preferably before PCI but not later than at the time the participant leaves the catheterisation laboratory and then 75 mg/d for the treatment duration provided by the randomisation scheme. At 30 days, participants in each stent group were randomised in a balanced fashion to 6 months of dual antiplatelet treatment (SHORT arm) versus prolonging aspirin and clopidogrel for 24 months (LONG arm). |
| Outcomes | Myocardial infarction, death, stroke, cardiac death, stent thrombosis, TVR |
| Notes | We contacted the authors at [email protected] regarding separate data. All participants were re‐randomised after 30 days to 6 or 24 months clopidogrel. ClinicalTrials.gov NCT00611286. |
| Methods | Randomised clinical trial with a parallel/factorial design in Italy |
| Participants | 257 participants aged 18 years or older, with a documented diagnosis of acute coronary syndrome (without persistent ST‐segment elevation), stable angina pectoris, or silent myocardial ischaemia as shown by exercise stress test. Additional eligibility criteria were the presence of a single, previously untreated 50% to 99% target lesion in a native coronary artery 2.75 mm in diameter or less, which could be completely covered by a single stent (maximum length 33 mm). The patients could have had single‐vessel or multivessel disease, but in the latter case had to have the non‐randomised lesion located in other coronary vessels. Male:female = 184:73 Mean age = 63.6 years Exclusion criteria: recent ST‐segment elevation acute coronary syndrome (within the previous 15 days), severe calcifications or thrombus‐containing lesions, a left ventricular ejection fraction less than 30%, and known allergies to aspirin, clopidogrel, ticlopidine, heparin, stainless steel, contrast agents, or sirolimus. |
| Interventions | Experimental group: sirolimus‐eluting stent (Cypher balloon‐expandable stent; Cordis, Miami Lakes, FL). Control group 1: uncoated stent of identical architecture and radiographic appearance (BX Sonic balloon‐expandable stent; Cordis) Co‐intervention: all participants received oral aspirin once daily and clopidogrel (a loading dose of 300 mg at least 2 hours before the procedure). Participants who had been pre‐treated with ticlopidine (250 mg twice a day) or clopidogrel (75 mg once daily) for at least 72 hours did not receive a clopidogrel loading dose. During the procedure, heparin was given as a bolus at 70 U/kg, with additional boluses to maintain an activated clotting time of more than 250 seconds. The use of glycoprotein IIb/IIIa inhibitors was encouraged but left to the discretion of the attending physician. Heparin administration was discontinued immediately after the procedure. |
| Outcomes | Primary outcome: 8‐month angiographic binary insegment restenosis rate. Secondary outcomes: procedural success, 8‐month in‐segment minimal luminal diameter, late luminal loss, late loss index, and major adverse cardiac and cerebrovascular events. |
| Notes | We contacted the authors at [email protected] regarding separate data for NSTEMI participants and stable participants, but have received no reply. |
| Methods | Randomised clinical trial with a parallel/factorial design in the UK and Spain |
| Participants | 800 participants > 80 years of age. Coronary disease warranting use of DES (15 mm long or < 3 mm wide) was a requirement. Patients with non–ST‐segment elevation myocardial infarction, unstable angina, and stable angina were eligible to participate. Male:female = 481:319 Mean age = 83.5 Exclusion criteria: acute ST‐segment elevation myocardial infarction, cardiogenic shock, thrombocytopenia (< 50 X 109/mm3), poor life expectancy, gastrointestinal haemorrhage < 3 months, or previous intracerebral bleeding. |
| Interventions | Experimental group: second‐generation everolimus‐eluting stents (Xience, Abbott Vascular, Santa Clara, CA). Control group: bare‐metal Vision stents (Abbott Vascular). Co‐intervention: before PCI, loading doses of aspirin 300 mg and clopidogrel 600 mg were given unless the participants were established on these drugs. Long‐term treatment with warfarin was not a contraindication, but caution was emphasised. The use of glycoprotein IIb/IIIa inhibitors was at the discretion of the operator, but caution was urged. |
| Outcomes | Death, haemorrhage, MI, TVR |
| Notes | ISRCTN92243650. We contacted the authors at [email protected] regarding separate data on participants with acute coronary syndrome and participants with stable angina pectoris as well as regarding blinding. |
| Methods | Randomised clinical trial with a parallel/factorial design in Italy, Switzerland, Portugal, and Hungary |
| Participants | 1606 participants with high bleeding risk and/or the presence of relative or absolute contraindications to long‐term dual antiplatelet treatment and/or high thrombosis risk due to systemic disorders or planned non‐cardiac surgery and/or low restenosis risk based on angiographic findings. Male:female = 1133:473 Mean age = 73.7 years Exclusion criteria: pregnancy; women of childbearing potential must have had a negative pregnancy test (urine or serum human chorionic gonadotropin), preferably < 24 hours, but at a minimum within 7 days prior to randomisation. Patients who were unable to give informed consent or who were unwilling to undergo planned follow‐up through 12 months, or both. |
| Interventions | Experimental group: Zotarolimus‐Eluting Endeavor Sprint stent (E‐ZES) (Santa Rosa, CA). Control group: all types of third‐generation thin‐strut BMS. Co‐intervention: all eligible participants received aspirin (160 to 325 mg orally or 500 mg intravenously as a loading dose and then 80 to 160 mg orally per day) and clopidogrel (300 or 600 mg orally as a loading dose followed by 75 mg/day) or prasugrel (60 mg loading dose followed by 10 or 5 mg/day) or ticagrelor (180 mg loading dose followed by 90 mg twice daily). Participants who were not eligible for dual antiplatelet treatment were treated with either aspirin or clopidogrel (or prasugrel or ticagrelor) monotherapy. |
| Outcomes | All‐cause death, non‐fatal MI, or any target vessel revascularisation, stent thrombosis, bleeding |
| Notes | ClinicalTrials.gov NCT01385319 (prospectively). We contacted the authors at [email protected]; [email protected] on 13 April 2017, but have received no reply. |
ACS: acute coronary syndrome
BMS: bare‐metal stent
CABG: coronary artery bypass grafting
DES: drug‐eluting stent
MACE: major adverse cardiac events
MI: myocardial infarction
NSTEMI: non‐ST‐segment elevation myocardial infarction
PCI: percutaneous coronary intervention
STEMI: ST‐segment elevation myocardial infarction
TLR: target lesion revascularisation
TVR: target vessel revascularisation
Data and analyses
| Outcome or subgroup title | No. of studies | No. of participants | Statistical method | Effect size |
| 1.1 All‐cause mortality Show forest plot | 22 | 11250 | Risk Ratio (M‐H, Random, 95% CI) | 0.90 [0.78, 1.03] |
| Analysis 1.1  Comparison 1: Drug‐eluting stents versus bare‐metal stents for acute coronary syndrome at maximum follow‐up, Outcome 1: All‐cause mortality | ||||
| 1.2 All‐cause mortality best‐worst Show forest plot | 22 | 11775 | Risk Ratio (M‐H, Random, 95% CI) | 0.60 [0.44, 0.80] |
| Analysis 1.2  Comparison 1: Drug‐eluting stents versus bare‐metal stents for acute coronary syndrome at maximum follow‐up, Outcome 2: All‐cause mortality best‐worst | ||||
| 1.3 All‐cause mortality worst‐best Show forest plot | 22 | 11775 | Risk Ratio (M‐H, Random, 95% CI) | 1.27 [0.99, 1.64] |
| Analysis 1.3  Comparison 1: Drug‐eluting stents versus bare‐metal stents for acute coronary syndrome at maximum follow‐up, Outcome 3: All‐cause mortality worst‐best | ||||
| 1.4 All‐cause mortality according to type of drug‐eluting stent Show forest plot | 22 | 11250 | Risk Ratio (M‐H, Random, 95% CI) | 0.90 [0.78, 1.03] |
| Analysis 1.4  Comparison 1: Drug‐eluting stents versus bare‐metal stents for acute coronary syndrome at maximum follow‐up, Outcome 4: All‐cause mortality according to type of drug‐eluting stent | ||||
| 1.4.1 Biodegradable (Biolimus) | 1 | 1157 | Risk Ratio (M‐H, Random, 95% CI) | 0.89 [0.54, 1.45] |
| 1.4.2 Everolimus | 1 | 1458 | Risk Ratio (M‐H, Random, 95% CI) | 0.73 [0.54, 1.00] |
| 1.4.3 Paclitaxel | 8 | 4468 | Risk Ratio (M‐H, Random, 95% CI) | 0.89 [0.71, 1.12] |
| 1.4.4 Sirolimus | 9 | 3113 | Risk Ratio (M‐H, Random, 95% CI) | 0.89 [0.68, 1.16] |
| 1.4.5 Zotarolimus | 1 | 44 | Risk Ratio (M‐H, Random, 95% CI) | Not estimable |
| 1.4.6 Mixed | 1 | 626 | Risk Ratio (M‐H, Random, 95% CI) | 1.34 [0.91, 1.98] |
| 1.4.7 Unclear | 1 | 384 | Risk Ratio (M‐H, Random, 95% CI) | 0.43 [0.02, 7.39] |
| 1.5 All‐cause mortality according to type of ACS Show forest plot | 22 | 11250 | Risk Ratio (M‐H, Random, 95% CI) | 0.90 [0.78, 1.03] |
| Analysis 1.5  Comparison 1: Drug‐eluting stents versus bare‐metal stents for acute coronary syndrome at maximum follow‐up, Outcome 5: All‐cause mortality according to type of ACS | ||||
| 1.5.1 STEMI | 21 | 11171 | Risk Ratio (M‐H, Random, 95% CI) | 0.90 [0.78, 1.03] |
| 1.5.2 Acute coronary syndrome | 1 | 79 | Risk Ratio (M‐H, Random, 95% CI) | Not estimable |
| 1.6 All‐cause mortality according to length of maximum follow‐up Show forest plot | 22 | 11250 | Risk Ratio (M‐H, Random, 95% CI) | 0.90 [0.78, 1.03] |
| Analysis 1.6  Comparison 1: Drug‐eluting stents versus bare‐metal stents for acute coronary syndrome at maximum follow‐up, Outcome 6: All‐cause mortality according to length of maximum follow‐up | ||||
| 1.6.1 Less or equal to 6 months | 4 | 726 | Risk Ratio (M‐H, Random, 95% CI) | 0.85 [0.29, 2.53] |
| 1.6.2 Between 6 and 12 months | 6 | 1315 | Risk Ratio (M‐H, Random, 95% CI) | 0.81 [0.54, 1.21] |
| 1.6.3 Between 1 and 3 years | 3 | 703 | Risk Ratio (M‐H, Random, 95% CI) | 0.99 [0.55, 1.76] |
| 1.6.4 More or equal to 3 years | 8 | 8490 | Risk Ratio (M‐H, Random, 95% CI) | 0.90 [0.77, 1.05] |
| 1.6.5 Unclear | 1 | 16 | Risk Ratio (M‐H, Random, 95% CI) | Not estimable |
| 1.7 All‐cause mortality according to registration status Show forest plot | 22 | 11250 | Risk Ratio (M‐H, Random, 95% CI) | 0.90 [0.78, 1.03] |
| Analysis 1.7  Comparison 1: Drug‐eluting stents versus bare‐metal stents for acute coronary syndrome at maximum follow‐up, Outcome 7: All‐cause mortality according to registration status | ||||
| 1.7.1 Pre‐registration | 3 | 1301 | Risk Ratio (M‐H, Random, 95% CI) | 0.85 [0.52, 1.39] |
| 1.7.2 Post‐registration | 13 | 9028 | Risk Ratio (M‐H, Random, 95% CI) | 0.89 [0.77, 1.03] |
| 1.7.3 No registration | 6 | 921 | Risk Ratio (M‐H, Random, 95% CI) | 1.09 [0.54, 2.20] |
| 1.8 Serious adverse events Show forest plot | 23 | 11724 | Risk Ratio (M‐H, Fixed, 95% CI) | 0.80 [0.74, 0.86] |
| Analysis 1.8  Comparison 1: Drug‐eluting stents versus bare‐metal stents for acute coronary syndrome at maximum follow‐up, Outcome 8: Serious adverse events | ||||
| 1.9 Serious adverse events best‐worst Show forest plot | 23 | 12249 | Risk Ratio (M‐H, Fixed, 95% CI) | 0.67 [0.62, 0.71] |
| Analysis 1.9  Comparison 1: Drug‐eluting stents versus bare‐metal stents for acute coronary syndrome at maximum follow‐up, Outcome 9: Serious adverse events best‐worst | ||||
| 1.10 Serious adverse events worst‐best Show forest plot | 23 | 12249 | Risk Ratio (M‐H, Fixed, 95% CI) | 0.98 [0.91, 1.05] |
| Analysis 1.10  Comparison 1: Drug‐eluting stents versus bare‐metal stents for acute coronary syndrome at maximum follow‐up, Outcome 10: Serious adverse events worst‐best | ||||
| 1.11 Serious adverse events according to type of drug‐eluting stent Show forest plot | 23 | 11724 | Risk Ratio (M‐H, Fixed, 95% CI) | 0.80 [0.74, 0.86] |
| Analysis 1.11  Comparison 1: Drug‐eluting stents versus bare‐metal stents for acute coronary syndrome at maximum follow‐up, Outcome 11: Serious adverse events according to type of drug‐eluting stent | ||||
| 1.11.1 Biodegradable (Biolimus) | 1 | 1157 | Risk Ratio (M‐H, Fixed, 95% CI) | 0.75 [0.58, 0.98] |
| 1.11.2 Everolimus | 2 | 1932 | Risk Ratio (M‐H, Fixed, 95% CI) | 0.82 [0.69, 0.97] |
| 1.11.3 Paclitaxel | 8 | 4468 | Risk Ratio (M‐H, Fixed, 95% CI) | 0.86 [0.76, 0.96] |
| 1.11.4 Sirolimus | 9 | 3113 | Risk Ratio (M‐H, Fixed, 95% CI) | 0.74 [0.64, 0.84] |
| 1.11.5 Zotarolimus | 1 | 44 | Risk Ratio (M‐H, Fixed, 95% CI) | 1.33 [0.17, 10.70] |
| 1.11.6 Mixed | 1 | 626 | Risk Ratio (M‐H, Fixed, 95% CI) | 0.74 [0.54, 1.01] |
| 1.11.7 Unclear | 1 | 384 | Risk Ratio (M‐H, Fixed, 95% CI) | 0.93 [0.52, 1.69] |
| 1.12 Serious adverse events according to type of ACS Show forest plot | 23 | 11724 | Risk Ratio (M‐H, Fixed, 95% CI) | 0.80 [0.74, 0.86] |
| Analysis 1.12  Comparison 1: Drug‐eluting stents versus bare‐metal stents for acute coronary syndrome at maximum follow‐up, Outcome 12: Serious adverse events according to type of ACS | ||||
| 1.12.1 STEMI | 21 | 11171 | Risk Ratio (M‐H, Fixed, 95% CI) | 0.80 [0.75, 0.86] |
| 1.12.2 Acute coronary syndrome | 1 | 79 | Risk Ratio (M‐H, Fixed, 95% CI) | 0.58 [0.29, 1.15] |
| 1.12.3 NSTEMI | 1 | 474 | Risk Ratio (M‐H, Fixed, 95% CI) | 0.78 [0.50, 1.23] |
| 1.13 Serious adverse events according to length of maximum follow‐up Show forest plot | 23 | 11724 | Risk Ratio (M‐H, Fixed, 95% CI) | 0.80 [0.74, 0.86] |
| Analysis 1.13  Comparison 1: Drug‐eluting stents versus bare‐metal stents for acute coronary syndrome at maximum follow‐up, Outcome 13: Serious adverse events according to length of maximum follow‐up | ||||
| 1.13.1 Less or equal to 6 months | 4 | 726 | Risk Ratio (M‐H, Fixed, 95% CI) | 0.67 [0.45, 0.99] |
| 1.13.2 Between 6 and 12 months | 7 | 1748 | Risk Ratio (M‐H, Fixed, 95% CI) | 0.85 [0.69, 1.05] |
| 1.13.3 Between 1 and 3 years | 3 | 744 | Risk Ratio (M‐H, Fixed, 95% CI) | 0.64 [0.47, 0.88] |
| 1.13.4 More or equal to 3 years | 8 | 8490 | Risk Ratio (M‐H, Fixed, 95% CI) | 0.81 [0.75, 0.88] |
| 1.13.5 Unclear | 1 | 16 | Risk Ratio (M‐H, Fixed, 95% CI) | Not estimable |
| 1.14 Serious adverse events according to registration status Show forest plot | 23 | 11724 | Risk Ratio (M‐H, Fixed, 95% CI) | 0.80 [0.74, 0.86] |
| Analysis 1.14  Comparison 1: Drug‐eluting stents versus bare‐metal stents for acute coronary syndrome at maximum follow‐up, Outcome 14: Serious adverse events according to registration status | ||||
| 1.14.1 Pre‐registration | 3 | 1301 | Risk Ratio (M‐H, Fixed, 95% CI) | 0.71 [0.55, 0.91] |
| 1.14.2 Post‐registration | 14 | 9502 | Risk Ratio (M‐H, Fixed, 95% CI) | 0.81 [0.75, 0.87] |
| 1.14.3 No registration | 6 | 921 | Risk Ratio (M‐H, Fixed, 95% CI) | 0.83 [0.57, 1.20] |
| 1.15 Major cardiovascular events Show forest plot | 20 | 10939 | Risk Ratio (M‐H, Random, 95% CI) | 0.96 [0.83, 1.11] |
| Analysis 1.15  Comparison 1: Drug‐eluting stents versus bare‐metal stents for acute coronary syndrome at maximum follow‐up, Outcome 15: Major cardiovascular events | ||||
| 1.16 Major cardiovascular events best‐worst Show forest plot | 20 | 11596 | Risk Ratio (M‐H, Random, 95% CI) | 0.53 [0.39, 0.72] |
| Analysis 1.16  Comparison 1: Drug‐eluting stents versus bare‐metal stents for acute coronary syndrome at maximum follow‐up, Outcome 16: Major cardiovascular events best‐worst | ||||
| 1.17 Major cardiovascular events worst‐best Show forest plot | 20 | 11596 | Risk Ratio (M‐H, Random, 95% CI) | 1.40 [0.97, 2.00] |
| Analysis 1.17  Comparison 1: Drug‐eluting stents versus bare‐metal stents for acute coronary syndrome at maximum follow‐up, Outcome 17: Major cardiovascular events worst‐best | ||||
| 1.18 Major cardiovascular events according to type of drug‐eluting stent Show forest plot | 20 | 10939 | Risk Ratio (M‐H, Random, 95% CI) | 0.96 [0.83, 1.11] |
| Analysis 1.18  Comparison 1: Drug‐eluting stents versus bare‐metal stents for acute coronary syndrome at maximum follow‐up, Outcome 18: Major cardiovascular events according to type of drug‐eluting stent | ||||
| 1.18.1 Biodegradable (Biolimus) | 1 | 1104 | Risk Ratio (M‐H, Random, 95% CI) | 0.90 [0.54, 1.49] |
| 1.18.2 Everolimus | 1 | 1458 | Risk Ratio (M‐H, Random, 95% CI) | 0.85 [0.58, 1.24] |
| 1.18.3 Paclitaxel | 7 | 4305 | Risk Ratio (M‐H, Random, 95% CI) | 1.01 [0.81, 1.26] |
| 1.18.4 Sirolimus | 8 | 3018 | Risk Ratio (M‐H, Random, 95% CI) | 0.89 [0.64, 1.24] |
| 1.18.5 Zotarolimus | 1 | 44 | Risk Ratio (M‐H, Random, 95% CI) | Not estimable |
| 1.18.6 Mixed | 1 | 626 | Risk Ratio (M‐H, Random, 95% CI) | 1.04 [0.60, 1.81] |
| 1.18.7 Unclear | 1 | 384 | Risk Ratio (M‐H, Random, 95% CI) | 1.36 [0.54, 3.40] |
| 1.19 Major cardiovascular events according to type of ACS Show forest plot | 20 | 10939 | Risk Ratio (M‐H, Random, 95% CI) | 0.96 [0.83, 1.11] |
| Analysis 1.19  Comparison 1: Drug‐eluting stents versus bare‐metal stents for acute coronary syndrome at maximum follow‐up, Outcome 19: Major cardiovascular events according to type of ACS | ||||
| 1.19.1 STEMI | 19 | 10860 | Risk Ratio (M‐H, Random, 95% CI) | 0.96 [0.83, 1.12] |
| 1.19.2 Acute coronary syndrome | 1 | 79 | Risk Ratio (M‐H, Random, 95% CI) | 0.68 [0.12, 3.87] |
| 1.20 Major cardiovascular events according to length of maximum follow‐up Show forest plot | 20 | 10939 | Risk Ratio (M‐H, Random, 95% CI) | 0.96 [0.83, 1.11] |
| Analysis 1.20  Comparison 1: Drug‐eluting stents versus bare‐metal stents for acute coronary syndrome at maximum follow‐up, Outcome 20: Major cardiovascular events according to length of maximum follow‐up | ||||
| 1.20.1 Less or equal to 6 months | 3 | 563 | Risk Ratio (M‐H, Random, 95% CI) | 1.04 [0.48, 2.28] |
| 1.20.2 Between 1 and 3 years | 9 | 2018 | Risk Ratio (M‐H, Random, 95% CI) | 0.89 [0.69, 1.16] |
| 1.20.3 More or equal to 3 years | 8 | 8358 | Risk Ratio (M‐H, Random, 95% CI) | 0.99 [0.82, 1.19] |
| 1.21 Major cardiovascular events according to registration status Show forest plot | 20 | 10939 | Risk Ratio (M‐H, Random, 95% CI) | 0.96 [0.83, 1.11] |
| Analysis 1.21  Comparison 1: Drug‐eluting stents versus bare‐metal stents for acute coronary syndrome at maximum follow‐up, Outcome 21: Major cardiovascular events according to registration status | ||||
| 1.21.1 Pre‐registration | 3 | 1248 | Risk Ratio (M‐H, Random, 95% CI) | 0.86 [0.52, 1.42] |
| 1.21.2 Post‐registration | 13 | 8949 | Risk Ratio (M‐H, Random, 95% CI) | 0.97 [0.83, 1.14] |
| 1.21.3 No registration | 4 | 742 | Risk Ratio (M‐H, Random, 95% CI) | 0.95 [0.47, 1.93] |
| 1.22 Cardiovascular mortality Show forest plot | 15 | 9248 | Risk Ratio (M‐H, Random, 95% CI) | 0.91 [0.76, 1.09] |
| Analysis 1.22  Comparison 1: Drug‐eluting stents versus bare‐metal stents for acute coronary syndrome at maximum follow‐up, Outcome 22: Cardiovascular mortality | ||||
| 1.23 Cardiovascular mortality best‐worst Show forest plot | 15 | 9742 | Risk Ratio (M‐H, Random, 95% CI) | 0.50 [0.32, 0.77] |
| Analysis 1.23  Comparison 1: Drug‐eluting stents versus bare‐metal stents for acute coronary syndrome at maximum follow‐up, Outcome 23: Cardiovascular mortality best‐worst | ||||
| 1.24 Cardiovascular mortality worst‐best Show forest plot | 15 | 9742 | Risk Ratio (M‐H, Random, 95% CI) | 1.49 [1.06, 2.11] |
| Analysis 1.24  Comparison 1: Drug‐eluting stents versus bare‐metal stents for acute coronary syndrome at maximum follow‐up, Outcome 24: Cardiovascular mortality worst‐best | ||||
| 1.25 Cardiovascular mortality according to type of drug‐eluting stent Show forest plot | 15 | 9248 | Risk Ratio (M‐H, Random, 95% CI) | 0.91 [0.76, 1.09] |
| Analysis 1.25  Comparison 1: Drug‐eluting stents versus bare‐metal stents for acute coronary syndrome at maximum follow‐up, Outcome 25: Cardiovascular mortality according to type of drug‐eluting stent | ||||
| 1.25.1 Biodegradable (Biolimus) | 1 | 1104 | Risk Ratio (M‐H, Random, 95% CI) | 0.90 [0.54, 1.49] |
| 1.25.2 Everolimus | 1 | 1458 | Risk Ratio (M‐H, Random, 95% CI) | 0.85 [0.58, 1.24] |
| 1.25.3 Paclitaxel | 6 | 4141 | Risk Ratio (M‐H, Random, 95% CI) | 0.86 [0.65, 1.13] |
| 1.25.4 Sirolimus | 5 | 1875 | Risk Ratio (M‐H, Random, 95% CI) | 0.81 [0.52, 1.25] |
| 1.25.5 Zotarolimus | 1 | 44 | Risk Ratio (M‐H, Random, 95% CI) | Not estimable |
| 1.25.6 Mixed | 1 | 626 | Risk Ratio (M‐H, Random, 95% CI) | 2.40 [1.17, 4.93] |
| 1.26 Cardiovascular mortality according to type of ACS Show forest plot | 15 | 9248 | Risk Ratio (M‐H, Random, 95% CI) | 0.91 [0.76, 1.09] |
| Analysis 1.26  Comparison 1: Drug‐eluting stents versus bare‐metal stents for acute coronary syndrome at maximum follow‐up, Outcome 26: Cardiovascular mortality according to type of ACS | ||||
| 1.26.1 STEMI | 15 | 9248 | Risk Ratio (M‐H, Random, 95% CI) | 0.91 [0.76, 1.09] |
| 1.26.2 Acute coronary syndrome | 0 | 0 | Risk Ratio (M‐H, Random, 95% CI) | Not estimable |
| 1.27 Cardiovascular mortality according to length of maximum follow‐up Show forest plot | 15 | 9248 | Risk Ratio (M‐H, Random, 95% CI) | 0.91 [0.76, 1.09] |
| Analysis 1.27  Comparison 1: Drug‐eluting stents versus bare‐metal stents for acute coronary syndrome at maximum follow‐up, Outcome 27: Cardiovascular mortality according to length of maximum follow‐up | ||||
| 1.27.1 Less or equal to 6 months | 1 | 100 | Risk Ratio (M‐H, Random, 95% CI) | 0.21 [0.01, 4.23] |
| 1.27.2 Between 6 and 12 months | 6 | 1584 | Risk Ratio (M‐H, Random, 95% CI) | 0.94 [0.65, 1.35] |
| 1.27.3 Between 1 and 3 years | 2 | 270 | Risk Ratio (M‐H, Random, 95% CI) | 0.56 [0.23, 1.32] |
| 1.27.4 More or equal to 3 years | 6 | 7294 | Risk Ratio (M‐H, Random, 95% CI) | 0.95 [0.72, 1.27] |
| 1.28 Cardiovascular mortality according to registration status Show forest plot | 15 | 9248 | Risk Ratio (M‐H, Random, 95% CI) | 0.91 [0.76, 1.09] |
| Analysis 1.28  Comparison 1: Drug‐eluting stents versus bare‐metal stents for acute coronary syndrome at maximum follow‐up, Outcome 28: Cardiovascular mortality according to registration status | ||||
| 1.28.1 Pre‐registration | 3 | 1248 | Risk Ratio (M‐H, Random, 95% CI) | 0.86 [0.52, 1.42] |
| 1.28.2 Post‐registration | 10 | 7806 | Risk Ratio (M‐H, Random, 95% CI) | 0.93 [0.73, 1.18] |
| 1.28.3 No registration | 2 | 194 | Risk Ratio (M‐H, Random, 95% CI) | 0.71 [0.16, 3.16] |
| 1.29 Myocardial infarction Show forest plot | 19 | 10217 | Risk Ratio (M‐H, Random, 95% CI) | 0.98 [0.82, 1.18] |
| Analysis 1.29  Comparison 1: Drug‐eluting stents versus bare‐metal stents for acute coronary syndrome at maximum follow‐up, Outcome 29: Myocardial infarction | ||||
| 1.30 Myocardial infarction best‐worst Show forest plot | 19 | 10851 | Risk Ratio (M‐H, Random, 95% CI) | 0.46 [0.33, 0.66] |
| Analysis 1.30  Comparison 1: Drug‐eluting stents versus bare‐metal stents for acute coronary syndrome at maximum follow‐up, Outcome 30: Myocardial infarction best‐worst | ||||
| 1.31 Myocardial infarction worst‐best Show forest plot | 19 | 10851 | Risk Ratio (M‐H, Random, 95% CI) | 1.56 [1.00, 2.45] |
| Analysis 1.31  Comparison 1: Drug‐eluting stents versus bare‐metal stents for acute coronary syndrome at maximum follow‐up, Outcome 31: Myocardial infarction worst‐best | ||||
| 1.32 Myocardial infarction according to type of drug‐eluting stent Show forest plot | 19 | 10217 | Risk Ratio (M‐H, Random, 95% CI) | 0.98 [0.82, 1.18] |
| Analysis 1.32  Comparison 1: Drug‐eluting stents versus bare‐metal stents for acute coronary syndrome at maximum follow‐up, Outcome 32: Myocardial infarction according to type of drug‐eluting stent | ||||
| 1.32.1 Biodegradable (Biolimus) | 1 | 1118 | Risk Ratio (M‐H, Random, 95% CI) | 0.64 [0.36, 1.15] |
| 1.32.2 Everolimus | 1 | 1458 | Risk Ratio (M‐H, Random, 95% CI) | 1.29 [0.79, 2.11] |
| 1.32.3 Paclitaxel | 7 | 4305 | Risk Ratio (M‐H, Random, 95% CI) | 1.05 [0.75, 1.46] |
| 1.32.4 Sirolimus | 7 | 2282 | Risk Ratio (M‐H, Random, 95% CI) | 0.90 [0.58, 1.39] |
| 1.32.5 Zotarolimus | 1 | 44 | Risk Ratio (M‐H, Random, 95% CI) | Not estimable |
| 1.32.6 Mixed | 1 | 626 | Risk Ratio (M‐H, Random, 95% CI) | 0.74 [0.40, 1.36] |
| 1.32.7 Unclear | 1 | 384 | Risk Ratio (M‐H, Random, 95% CI) | 1.36 [0.54, 3.40] |
| 1.33 Myocardial infarction according to type of ACS Show forest plot | 19 | 10217 | Risk Ratio (M‐H, Random, 95% CI) | 0.98 [0.82, 1.18] |
| Analysis 1.33  Comparison 1: Drug‐eluting stents versus bare‐metal stents for acute coronary syndrome at maximum follow‐up, Outcome 33: Myocardial infarction according to type of ACS | ||||
| 1.33.1 STEMI | 18 | 10138 | Risk Ratio (M‐H, Random, 95% CI) | 0.98 [0.82, 1.18] |
| 1.33.2 Acute coronary syndrome | 1 | 79 | Risk Ratio (M‐H, Random, 95% CI) | 0.68 [0.12, 3.87] |
| 1.34 Myocardial infarction according to length of maximum follow‐up Show forest plot | 19 | 10217 | Risk Ratio (M‐H, Random, 95% CI) | 0.98 [0.82, 1.18] |
| Analysis 1.34  Comparison 1: Drug‐eluting stents versus bare‐metal stents for acute coronary syndrome at maximum follow‐up, Outcome 34: Myocardial infarction according to length of maximum follow‐up | ||||
| 1.34.1 Less or equal to 6 months | 3 | 563 | Risk Ratio (M‐H, Random, 95% CI) | 1.17 [0.52, 2.63] |
| 1.34.2 Between 6 and 12 months | 7 | 1748 | Risk Ratio (M‐H, Random, 95% CI) | 0.98 [0.58, 1.66] |
| 1.34.3 Between 1 and 3 years | 2 | 270 | Risk Ratio (M‐H, Random, 95% CI) | 0.55 [0.24, 1.25] |
| 1.34.4 More or equal to 3 years | 7 | 7636 | Risk Ratio (M‐H, Random, 95% CI) | 1.00 [0.80, 1.25] |
| 1.35 Myocardial infarction according to registration status Show forest plot | 19 | 10217 | Risk Ratio (M‐H, Random, 95% CI) | 0.98 [0.82, 1.18] |
| Analysis 1.35  Comparison 1: Drug‐eluting stents versus bare‐metal stents for acute coronary syndrome at maximum follow‐up, Outcome 35: Myocardial infarction according to registration status | ||||
| 1.35.1 Pre‐registration | 3 | 1262 | Risk Ratio (M‐H, Random, 95% CI) | 0.64 [0.36, 1.15] |
| 1.35.2 Post‐registration | 12 | 8213 | Risk Ratio (M‐H, Random, 95% CI) | 1.03 [0.85, 1.26] |
| 1.35.3 No registration | 4 | 742 | Risk Ratio (M‐H, Random, 95% CI) | 0.97 [0.44, 2.12] |
| 1.36 Stent thrombosis Show forest plot | 21 | 11350 | Risk Ratio (M‐H, Random, 95% CI) | 0.96 [0.80, 1.16] |
| Analysis 1.36  Comparison 1: Drug‐eluting stents versus bare‐metal stents for acute coronary syndrome at maximum follow‐up, Outcome 36: Stent thrombosis | ||||
| 1.37 Stent thrombosis best‐worst Show forest plot | 21 | 12007 | Risk Ratio (M‐H, Random, 95% CI) | 0.47 [0.32, 0.67] |
| Analysis 1.37  Comparison 1: Drug‐eluting stents versus bare‐metal stents for acute coronary syndrome at maximum follow‐up, Outcome 37: Stent thrombosis best‐worst | ||||
| 1.38 Stent thrombosis worst‐best Show forest plot | 21 | 12007 | Risk Ratio (M‐H, Random, 95% CI) | 1.55 [1.12, 2.15] |
| Analysis 1.38  Comparison 1: Drug‐eluting stents versus bare‐metal stents for acute coronary syndrome at maximum follow‐up, Outcome 38: Stent thrombosis worst‐best | ||||
| 1.39 Stent thrombosis according to type of drug‐eluting stent Show forest plot | 21 | 11350 | Risk Ratio (M‐H, Random, 95% CI) | 0.96 [0.80, 1.16] |
| Analysis 1.39  Comparison 1: Drug‐eluting stents versus bare‐metal stents for acute coronary syndrome at maximum follow‐up, Outcome 39: Stent thrombosis according to type of drug‐eluting stent | ||||
| 1.39.1 Biodegradable (Biolimus) | 1 | 1104 | Risk Ratio (M‐H, Random, 95% CI) | 0.72 [0.40, 1.30] |
| 1.39.2 Everolimus | 2 | 1932 | Risk Ratio (M‐H, Random, 95% CI) | 0.60 [0.34, 1.08] |
| 1.39.3 Paclitaxel | 7 | 4305 | Risk Ratio (M‐H, Random, 95% CI) | 1.01 [0.73, 1.39] |
| 1.39.4 Sirolimus | 8 | 2957 | Risk Ratio (M‐H, Random, 95% CI) | 1.04 [0.76, 1.41] |
| 1.39.5 Zotarolimus | 1 | 44 | Risk Ratio (M‐H, Random, 95% CI) | Not estimable |
| 1.39.6 Mixed | 1 | 626 | Risk Ratio (M‐H, Random, 95% CI) | 1.00 [0.52, 1.92] |
| 1.39.7 Unclear | 1 | 382 | Risk Ratio (M‐H, Random, 95% CI) | 2.16 [0.82, 5.70] |
| 1.40 Stent thrombosis according to type of ACS Show forest plot | 21 | 11350 | Risk Ratio (M‐H, Random, 95% CI) | 0.96 [0.80, 1.16] |
| Analysis 1.40  Comparison 1: Drug‐eluting stents versus bare‐metal stents for acute coronary syndrome at maximum follow‐up, Outcome 40: Stent thrombosis according to type of ACS | ||||
| 1.40.1 STEMI | 20 | 10876 | Risk Ratio (M‐H, Random, 95% CI) | 0.98 [0.81, 1.18] |
| 1.40.2 NSTEMI | 1 | 474 | Risk Ratio (M‐H, Random, 95% CI) | 0.44 [0.12, 1.68] |
| 1.41 Stent thrombosis according to length of maximum follow‐up Show forest plot | 21 | 11350 | Risk Ratio (M‐H, Random, 95% CI) | 0.96 [0.80, 1.16] |
| Analysis 1.41  Comparison 1: Drug‐eluting stents versus bare‐metal stents for acute coronary syndrome at maximum follow‐up, Outcome 41: Stent thrombosis according to length of maximum follow‐up | ||||
| 1.41.1 Less or equal to 6 months | 2 | 482 | Risk Ratio (M‐H, Random, 95% CI) | 2.16 [0.82, 5.70] |
| 1.41.2 Between 6 and 12 months | 7 | 1748 | Risk Ratio (M‐H, Random, 95% CI) | 0.83 [0.46, 1.49] |
| 1.41.3 Between 1 and 3 years | 3 | 744 | Risk Ratio (M‐H, Random, 95% CI) | 0.57 [0.25, 1.29] |
| 1.41.4 More or equal to 3 years | 8 | 8360 | Risk Ratio (M‐H, Random, 95% CI) | 0.98 [0.78, 1.22] |
| 1.41.5 Unclear | 1 | 16 | Risk Ratio (M‐H, Random, 95% CI) | 0.20 [0.01, 3.61] |
| 1.42 Stent thrombosis according to registration status Show forest plot | 21 | 11350 | Risk Ratio (M‐H, Random, 95% CI) | 0.96 [0.80, 1.16] |
| Analysis 1.42  Comparison 1: Drug‐eluting stents versus bare‐metal stents for acute coronary syndrome at maximum follow‐up, Outcome 42: Stent thrombosis according to registration status | ||||
| 1.42.1 Pre‐registration | 3 | 1248 | Risk Ratio (M‐H, Random, 95% CI) | 0.72 [0.40, 1.30] |
| 1.42.2 Post‐registration | 13 | 9346 | Risk Ratio (M‐H, Random, 95% CI) | 0.99 [0.81, 1.21] |
| 1.42.3 No registration | 5 | 756 | Risk Ratio (M‐H, Random, 95% CI) | 0.70 [0.22, 2.20] |
| 1.43 Target vessel revascularisation Show forest plot | 23 | 11770 | Risk Ratio (M‐H, Fixed, 95% CI) | 0.58 [0.52, 0.65] |
| Analysis 1.43  Comparison 1: Drug‐eluting stents versus bare‐metal stents for acute coronary syndrome at maximum follow‐up, Outcome 43: Target vessel revascularisation | ||||
| 1.44 Target vessel revascularisation best‐worst Show forest plot | 23 | 12368 | Risk Ratio (M‐H, Fixed, 95% CI) | 0.41 [0.37, 0.45] |
| Analysis 1.44  Comparison 1: Drug‐eluting stents versus bare‐metal stents for acute coronary syndrome at maximum follow‐up, Outcome 44: Target vessel revascularisation best‐worst | ||||
| 1.45 Target vessel revascularisation worst‐best Show forest plot | 23 | 12368 | Risk Ratio (M‐H, Fixed, 95% CI) | 0.98 [0.89, 1.07] |
| Analysis 1.45  Comparison 1: Drug‐eluting stents versus bare‐metal stents for acute coronary syndrome at maximum follow‐up, Outcome 45: Target vessel revascularisation worst‐best | ||||
| 1.46 Target vessel revascularisation according to type of drug‐eluting stent Show forest plot | 23 | 11770 | Risk Ratio (M‐H, Fixed, 95% CI) | 0.58 [0.52, 0.65] |
| Analysis 1.46  Comparison 1: Drug‐eluting stents versus bare‐metal stents for acute coronary syndrome at maximum follow‐up, Outcome 46: Target vessel revascularisation according to type of drug‐eluting stent | ||||
| 1.46.1 Biodegradable (Biolimus) | 1 | 1118 | Risk Ratio (M‐H, Fixed, 95% CI) | 0.45 [0.29, 0.70] |
| 1.46.2 Everolimus | 2 | 1932 | Risk Ratio (M‐H, Fixed, 95% CI) | 0.57 [0.42, 0.78] |
| 1.46.3 Sirolimus | 9 | 3062 | Risk Ratio (M‐H, Fixed, 95% CI) | 0.54 [0.44, 0.66] |
| 1.46.4 Paclitaxel | 8 | 4530 | Risk Ratio (M‐H, Fixed, 95% CI) | 0.63 [0.53, 0.75] |
| 1.46.5 Mixed | 1 | 626 | Risk Ratio (M‐H, Fixed, 95% CI) | 0.52 [0.35, 0.76] |
| 1.46.6 Unclear | 1 | 382 | Risk Ratio (M‐H, Fixed, 95% CI) | 2.16 [0.82, 5.70] |
| 1.46.7 Dexamethasone | 1 | 120 | Risk Ratio (M‐H, Fixed, 95% CI) | 0.60 [0.32, 1.12] |
| 1.47 Target vessel revascularisation according to type of ACS Show forest plot | 23 | 11770 | Risk Ratio (M‐H, Fixed, 95% CI) | 0.58 [0.52, 0.65] |
| Analysis 1.47  Comparison 1: Drug‐eluting stents versus bare‐metal stents for acute coronary syndrome at maximum follow‐up, Outcome 47: Target vessel revascularisation according to type of ACS | ||||
| 1.47.1 STEMI | 20 | 11097 | Risk Ratio (M‐H, Fixed, 95% CI) | 0.59 [0.53, 0.66] |
| 1.47.2 Acute coronary syndrome | 2 | 199 | Risk Ratio (M‐H, Fixed, 95% CI) | 0.49 [0.27, 0.86] |
| 1.47.3 NSTEMI | 1 | 474 | Risk Ratio (M‐H, Fixed, 95% CI) | 0.37 [0.18, 0.77] |
| 1.48 Target vessel revascularisation according to length of maximum follow‐up Show forest plot | 23 | 11770 | Risk Ratio (M‐H, Fixed, 95% CI) | 0.58 [0.52, 0.65] |
| Analysis 1.48  Comparison 1: Drug‐eluting stents versus bare‐metal stents for acute coronary syndrome at maximum follow‐up, Outcome 48: Target vessel revascularisation according to length of maximum follow‐up | ||||
| 1.48.1 Less or equal to 6 months | 4 | 724 | Risk Ratio (M‐H, Fixed, 95% CI) | 0.46 [0.25, 0.84] |
| 1.48.2 Between 6 and 12 months | 8 | 1930 | Risk Ratio (M‐H, Fixed, 95% CI) | 0.58 [0.43, 0.78] |
| 1.48.3 Between 1 and 3 years | 3 | 744 | Risk Ratio (M‐H, Fixed, 95% CI) | 0.33 [0.19, 0.56] |
| 1.48.4 More or equal to 3 years | 8 | 8372 | Risk Ratio (M‐H, Fixed, 95% CI) | 0.61 [0.54, 0.69] |
| 1.48.5 Unclear | 0 | 0 | Risk Ratio (M‐H, Fixed, 95% CI) | Not estimable |
| 1.49 Target vessel revascularisation according to registration status Show forest plot | 23 | 11770 | Risk Ratio (M‐H, Fixed, 95% CI) | 0.58 [0.52, 0.65] |
| Analysis 1.49  Comparison 1: Drug‐eluting stents versus bare‐metal stents for acute coronary syndrome at maximum follow‐up, Outcome 49: Target vessel revascularisation according to registration status | ||||
| 1.49.1 Pre‐registration | 3 | 1262 | Risk Ratio (M‐H, Fixed, 95% CI) | 0.42 [0.28, 0.65] |
| 1.49.2 Post‐registration | 14 | 9425 | Risk Ratio (M‐H, Fixed, 95% CI) | 0.60 [0.53, 0.67] |
| 1.49.3 No registration | 6 | 1083 | Risk Ratio (M‐H, Fixed, 95% CI) | 0.56 [0.38, 0.82] |
| Outcome or subgroup title | No. of studies | No. of participants | Statistical method | Effect size |
| 2.1 All‐cause mortality Show forest plot | 6 | 3213 | Risk Ratio (M‐H, Fixed, 95% CI) | 0.78 [0.49, 1.22] |
| Analysis 2.1  Comparison 2: Drug‐eluting stents versus bare‐metal stents for acute coronary syndrome at one month, Outcome 1: All‐cause mortality | ||||
| 2.2 All‐cause mortality best‐worst Show forest plot | 6 | 3231 | Risk Ratio (M‐H, Random, 95% CI) | 0.61 [0.40, 0.95] |
| Analysis 2.2  Comparison 2: Drug‐eluting stents versus bare‐metal stents for acute coronary syndrome at one month, Outcome 2: All‐cause mortality best‐worst | ||||
| 2.3 All‐cause mortality worst‐best Show forest plot | 6 | 3231 | Risk Ratio (M‐H, Random, 95% CI) | 0.92 [0.60, 1.43] |
| Analysis 2.3  Comparison 2: Drug‐eluting stents versus bare‐metal stents for acute coronary syndrome at one month, Outcome 3: All‐cause mortality worst‐best | ||||
| 2.4 All‐cause mortality according to type of drug‐eluting stent Show forest plot | 6 | 3213 | Risk Ratio (M‐H, Fixed, 95% CI) | 0.78 [0.49, 1.22] |
| Analysis 2.4  Comparison 2: Drug‐eluting stents versus bare‐metal stents for acute coronary syndrome at one month, Outcome 4: All‐cause mortality according to type of drug‐eluting stent | ||||
| 2.4.1 Everolimus | 1 | 1498 | Risk Ratio (M‐H, Fixed, 95% CI) | 0.78 [0.36, 1.71] |
| 2.4.2 Paclitaxel | 3 | 857 | Risk Ratio (M‐H, Fixed, 95% CI) | 0.83 [0.42, 1.64] |
| 2.4.3 Sirolimus | 2 | 858 | Risk Ratio (M‐H, Fixed, 95% CI) | 0.68 [0.26, 1.78] |
| 2.5 All‐cause mortality according to type of ACS Show forest plot | 6 | 3213 | Risk Ratio (M‐H, Fixed, 95% CI) | 0.78 [0.49, 1.22] |
| Analysis 2.5  Comparison 2: Drug‐eluting stents versus bare‐metal stents for acute coronary syndrome at one month, Outcome 5: All‐cause mortality according to type of ACS | ||||
| 2.5.1 STEMI | 6 | 3213 | Risk Ratio (M‐H, Fixed, 95% CI) | 0.78 [0.49, 1.22] |
| 2.6 All‐cause mortality according to registration status Show forest plot | 6 | 3213 | Risk Ratio (M‐H, Fixed, 95% CI) | 0.78 [0.49, 1.22] |
| Analysis 2.6  Comparison 2: Drug‐eluting stents versus bare‐metal stents for acute coronary syndrome at one month, Outcome 6: All‐cause mortality according to registration status | ||||
| 2.6.1 Post‐registration | 3 | 2856 | Risk Ratio (M‐H, Fixed, 95% CI) | 0.68 [0.41, 1.14] |
| 2.6.2 No registration | 3 | 357 | Risk Ratio (M‐H, Fixed, 95% CI) | 1.28 [0.47, 3.47] |
| 2.7 Serious adverse events Show forest plot | 7 | 3313 | Risk Ratio (M‐H, Random, 95% CI) | 0.65 [0.45, 0.93] |
| Analysis 2.7  Comparison 2: Drug‐eluting stents versus bare‐metal stents for acute coronary syndrome at one month, Outcome 7: Serious adverse events | ||||
| 2.8 Serious adverse events best‐worst Show forest plot | 7 | 3331 | Risk Ratio (M‐H, Random, 95% CI) | 0.56 [0.40, 0.80] |
| Analysis 2.8  Comparison 2: Drug‐eluting stents versus bare‐metal stents for acute coronary syndrome at one month, Outcome 8: Serious adverse events best‐worst | ||||
| 2.9 Serious adverse events worst‐best Show forest plot | 7 | 3331 | Risk Ratio (M‐H, Random, 95% CI) | 0.73 [0.52, 1.03] |
| Analysis 2.9  Comparison 2: Drug‐eluting stents versus bare‐metal stents for acute coronary syndrome at one month, Outcome 9: Serious adverse events worst‐best | ||||
| 2.10 Serious adverse events according to type of drug‐eluting stent Show forest plot | 7 | 3313 | Risk Ratio (M‐H, Random, 95% CI) | 0.65 [0.45, 0.93] |
| Analysis 2.10  Comparison 2: Drug‐eluting stents versus bare‐metal stents for acute coronary syndrome at one month, Outcome 10: Serious adverse events according to type of drug‐eluting stent | ||||
| 2.10.1 Everolimus | 1 | 1498 | Risk Ratio (M‐H, Random, 95% CI) | 0.55 [0.30, 0.98] |
| 2.10.2 Paclitaxel | 4 | 957 | Risk Ratio (M‐H, Random, 95% CI) | 0.77 [0.41, 1.46] |
| 2.10.3 Sirolimus | 2 | 858 | Risk Ratio (M‐H, Random, 95% CI) | 0.67 [0.35, 1.28] |
| 2.11 Serious adverse events according to type of ACS Show forest plot | 7 | 3313 | Risk Ratio (M‐H, Random, 95% CI) | 0.65 [0.45, 0.93] |
| Analysis 2.11  Comparison 2: Drug‐eluting stents versus bare‐metal stents for acute coronary syndrome at one month, Outcome 11: Serious adverse events according to type of ACS | ||||
| 2.11.1 STEMI | 7 | 3313 | Risk Ratio (M‐H, Random, 95% CI) | 0.65 [0.45, 0.93] |
| 2.12 Serious adverse events according to registration status Show forest plot | 7 | 3313 | Risk Ratio (M‐H, Random, 95% CI) | 0.65 [0.45, 0.93] |
| Analysis 2.12  Comparison 2: Drug‐eluting stents versus bare‐metal stents for acute coronary syndrome at one month, Outcome 12: Serious adverse events according to registration status | ||||
| 2.12.1 Pre‐registration | 1 | 100 | Risk Ratio (M‐H, Random, 95% CI) | 0.35 [0.01, 8.31] |
| 2.12.2 Post‐registration | 3 | 2856 | Risk Ratio (M‐H, Random, 95% CI) | 0.60 [0.41, 0.88] |
| 2.12.3 No registration | 3 | 357 | Risk Ratio (M‐H, Random, 95% CI) | 1.09 [0.43, 2.76] |
| 2.13 Major cardiovascular events Show forest plot | 6 | 3150 | Risk Ratio (M‐H, Random, 95% CI) | 0.68 [0.43, 1.08] |
| Analysis 2.13  Comparison 2: Drug‐eluting stents versus bare‐metal stents for acute coronary syndrome at one month, Outcome 13: Major cardiovascular events | ||||
| 2.14 Major cardiovascular events best‐worst Show forest plot | 6 | 3168 | Risk Ratio (M‐H, Random, 95% CI) | 0.54 [0.35, 0.84] |
| Analysis 2.14  Comparison 2: Drug‐eluting stents versus bare‐metal stents for acute coronary syndrome at one month, Outcome 14: Major cardiovascular events best‐worst | ||||
| 2.15 Major cardiovascular events worst‐best Show forest plot | 6 | 3168 | Risk Ratio (M‐H, Random, 95% CI) | 0.82 [0.53, 1.27] |
| Analysis 2.15  Comparison 2: Drug‐eluting stents versus bare‐metal stents for acute coronary syndrome at one month, Outcome 15: Major cardiovascular events worst‐best | ||||
| 2.16 Major cardiovascular events according to type of drug‐eluting stent Show forest plot | 6 | 3150 | Risk Ratio (M‐H, Random, 95% CI) | 0.68 [0.43, 1.08] |
| Analysis 2.16  Comparison 2: Drug‐eluting stents versus bare‐metal stents for acute coronary syndrome at one month, Outcome 16: Major cardiovascular events according to type of drug‐eluting stent | ||||
| 2.16.1 Everolimus | 1 | 1498 | Risk Ratio (M‐H, Random, 95% CI) | 0.78 [0.36, 1.71] |
| 2.16.2 Paclitaxel | 3 | 794 | Risk Ratio (M‐H, Random, 95% CI) | 0.66 [0.32, 1.37] |
| 2.16.3 Sirolimus | 2 | 858 | Risk Ratio (M‐H, Random, 95% CI) | 0.60 [0.25, 1.45] |
| 2.17 Major cardiovascular events according to type of ACS Show forest plot | 6 | 3150 | Risk Ratio (M‐H, Random, 95% CI) | 0.68 [0.43, 1.08] |
| Analysis 2.17  Comparison 2: Drug‐eluting stents versus bare‐metal stents for acute coronary syndrome at one month, Outcome 17: Major cardiovascular events according to type of ACS | ||||
| 2.17.1 STEMI | 6 | 3150 | Risk Ratio (M‐H, Random, 95% CI) | 0.68 [0.43, 1.08] |
| 2.18 Major cardiovascular events according to registration status Show forest plot | 6 | 3150 | Risk Ratio (M‐H, Random, 95% CI) | 0.68 [0.43, 1.08] |
| Analysis 2.18  Comparison 2: Drug‐eluting stents versus bare‐metal stents for acute coronary syndrome at one month, Outcome 18: Major cardiovascular events according to registration status | ||||
| 2.18.1 Pre‐registration | 1 | 100 | Risk Ratio (M‐H, Random, 95% CI) | 0.35 [0.01, 8.31] |
| 2.18.2 Post‐registration | 3 | 2856 | Risk Ratio (M‐H, Random, 95% CI) | 0.67 [0.41, 1.09] |
| 2.18.3 No registration | 2 | 194 | Risk Ratio (M‐H, Random, 95% CI) | 0.92 [0.24, 3.58] |
| 2.19 Cardiovascular mortality Show forest plot | 5 | 2406 | Risk Ratio (M‐H, Fixed, 95% CI) | 0.73 [0.43, 1.25] |
| Analysis 2.19  Comparison 2: Drug‐eluting stents versus bare‐metal stents for acute coronary syndrome at one month, Outcome 19: Cardiovascular mortality | ||||
| 2.20 Cardiovascular mortality best‐worst Show forest plot | 5 | 2423 | Risk Ratio (M‐H, Fixed, 95% CI) | 0.53 [0.32, 0.88] |
| Analysis 2.20  Comparison 2: Drug‐eluting stents versus bare‐metal stents for acute coronary syndrome at one month, Outcome 20: Cardiovascular mortality best‐worst | ||||
| 2.21 Cardiovascular mortality worst‐best Show forest plot | 5 | 2423 | Risk Ratio (M‐H, Random, 95% CI) | 0.90 [0.54, 1.50] |
| Analysis 2.21  Comparison 2: Drug‐eluting stents versus bare‐metal stents for acute coronary syndrome at one month, Outcome 21: Cardiovascular mortality worst‐best | ||||
| 2.22 Cardiovascular mortality according to type of drug‐eluting stent Show forest plot | 5 | 2406 | Risk Ratio (M‐H, Fixed, 95% CI) | 0.73 [0.43, 1.25] |
| Analysis 2.22  Comparison 2: Drug‐eluting stents versus bare‐metal stents for acute coronary syndrome at one month, Outcome 22: Cardiovascular mortality according to type of drug‐eluting stent | ||||
| 2.22.1 Everolimus | 1 | 1498 | Risk Ratio (M‐H, Fixed, 95% CI) | 0.78 [0.36, 1.71] |
| 2.22.2 Paclitaxel | 3 | 794 | Risk Ratio (M‐H, Fixed, 95% CI) | 0.67 [0.30, 1.46] |
| 2.22.3 Sirolimus | 1 | 114 | Risk Ratio (M‐H, Fixed, 95% CI) | 0.90 [0.13, 6.17] |
| 2.23 Cardiovascular mortality according to type of ACS Show forest plot | 5 | 2406 | Risk Ratio (M‐H, Fixed, 95% CI) | 0.73 [0.43, 1.25] |
| Analysis 2.23  Comparison 2: Drug‐eluting stents versus bare‐metal stents for acute coronary syndrome at one month, Outcome 23: Cardiovascular mortality according to type of ACS | ||||
| 2.23.1 STEMI | 5 | 2406 | Risk Ratio (M‐H, Fixed, 95% CI) | 0.73 [0.43, 1.25] |
| 2.24 Cardiovascular mortality according to registration status Show forest plot | 5 | 2406 | Risk Ratio (M‐H, Fixed, 95% CI) | 0.73 [0.43, 1.25] |
| Analysis 2.24  Comparison 2: Drug‐eluting stents versus bare‐metal stents for acute coronary syndrome at one month, Outcome 24: Cardiovascular mortality according to registration status | ||||
| 2.24.1 Pre‐registration | 1 | 100 | Risk Ratio (M‐H, Fixed, 95% CI) | 0.35 [0.01, 8.31] |
| 2.24.2 Post‐registration | 2 | 2112 | Risk Ratio (M‐H, Fixed, 95% CI) | 0.70 [0.39, 1.25] |
| 2.24.3 No registration | 2 | 194 | Risk Ratio (M‐H, Fixed, 95% CI) | 1.30 [0.27, 6.38] |
| 2.25 Myocardial infarction Show forest plot | 6 | 3150 | Risk Ratio (M‐H, Random, 95% CI) | 0.51 [0.26, 0.98] |
| Analysis 2.25  Comparison 2: Drug‐eluting stents versus bare‐metal stents for acute coronary syndrome at one month, Outcome 25: Myocardial infarction | ||||
| 2.26 Myocardial infarction best‐worst Show forest plot | 6 | 3168 | Risk Ratio (M‐H, Random, 95% CI) | 0.37 [0.20, 0.68] |
| Analysis 2.26  Comparison 2: Drug‐eluting stents versus bare‐metal stents for acute coronary syndrome at one month, Outcome 26: Myocardial infarction best‐worst | ||||
| 2.27 Myocardial infarction worst‐best Show forest plot | 6 | 3168 | Risk Ratio (M‐H, Random, 95% CI) | 0.74 [0.41, 1.32] |
| Analysis 2.27  Comparison 2: Drug‐eluting stents versus bare‐metal stents for acute coronary syndrome at one month, Outcome 27: Myocardial infarction worst‐best | ||||
| 2.28 Myocardial infarction according to type of drug‐eluting stent Show forest plot | 6 | 3150 | Risk Ratio (M‐H, Random, 95% CI) | 0.51 [0.26, 0.98] |
| Analysis 2.28  Comparison 2: Drug‐eluting stents versus bare‐metal stents for acute coronary syndrome at one month, Outcome 28: Myocardial infarction according to type of drug‐eluting stent | ||||
| 2.28.1 Everolimus | 1 | 1498 | Risk Ratio (M‐H, Random, 95% CI) | 0.55 [0.19, 1.64] |
| 2.28.2 Paclitaxel | 3 | 794 | Risk Ratio (M‐H, Random, 95% CI) | 0.38 [0.09, 1.63] |
| 2.28.3 Sirolimus | 2 | 858 | Risk Ratio (M‐H, Random, 95% CI) | 0.54 [0.20, 1.46] |
| 2.29 Myocardial infarction according to type of ACS Show forest plot | 6 | 3150 | Risk Ratio (M‐H, Random, 95% CI) | 0.51 [0.26, 0.98] |
| Analysis 2.29  Comparison 2: Drug‐eluting stents versus bare‐metal stents for acute coronary syndrome at one month, Outcome 29: Myocardial infarction according to type of ACS | ||||
| 2.29.1 STEMI | 6 | 3150 | Risk Ratio (M‐H, Random, 95% CI) | 0.51 [0.26, 0.98] |
| 2.30 Myocardial infarction according to registration status Show forest plot | 6 | 3150 | Risk Ratio (M‐H, Random, 95% CI) | 0.51 [0.26, 0.98] |
| Analysis 2.30  Comparison 2: Drug‐eluting stents versus bare‐metal stents for acute coronary syndrome at one month, Outcome 30: Myocardial infarction according to registration status | ||||
| 2.30.1 Pre‐registration | 1 | 100 | Risk Ratio (M‐H, Random, 95% CI) | Not estimable |
| 2.30.2 Post‐registration | 3 | 2856 | Risk Ratio (M‐H, Random, 95% CI) | 0.50 [0.25, 1.00] |
| 2.30.3 No registration | 2 | 194 | Risk Ratio (M‐H, Random, 95% CI) | 0.59 [0.07, 4.69] |
| 2.31 Stent thrombosis Show forest plot | 5 | 3070 | Risk Ratio (M‐H, Random, 95% CI) | 0.48 [0.26, 0.90] |
| Analysis 2.31  Comparison 2: Drug‐eluting stents versus bare‐metal stents for acute coronary syndrome at one month, Outcome 31: Stent thrombosis | ||||
| 2.32 Stent thrombosis best‐worst Show forest plot | 5 | 3088 | Risk Ratio (M‐H, Random, 95% CI) | 0.36 [0.20, 0.65] |
| Analysis 2.32  Comparison 2: Drug‐eluting stents versus bare‐metal stents for acute coronary syndrome at one month, Outcome 32: Stent thrombosis best‐worst | ||||
| 2.33 Stent thrombosis worst‐best Show forest plot | 5 | 3088 | Risk Ratio (M‐H, Random, 95% CI) | 0.68 [0.39, 1.18] |
| Analysis 2.33  Comparison 2: Drug‐eluting stents versus bare‐metal stents for acute coronary syndrome at one month, Outcome 33: Stent thrombosis worst‐best | ||||
| 2.34 Stent thrombosis according to type of drug‐eluting stent Show forest plot | 5 | 3070 | Risk Ratio (M‐H, Random, 95% CI) | 0.48 [0.26, 0.90] |
| Analysis 2.34  Comparison 2: Drug‐eluting stents versus bare‐metal stents for acute coronary syndrome at one month, Outcome 34: Stent thrombosis according to type of drug‐eluting stent | ||||
| 2.34.1 Everolimus | 1 | 1498 | Risk Ratio (M‐H, Random, 95% CI) | 0.37 [0.15, 0.95] |
| 2.34.2 Paclitaxel | 2 | 714 | Risk Ratio (M‐H, Random, 95% CI) | 0.66 [0.11, 3.94] |
| 2.34.3 Sirolimus | 2 | 858 | Risk Ratio (M‐H, Random, 95% CI) | 0.58 [0.23, 1.46] |
| 2.35 Stent thrombosis according to type of ACS Show forest plot | 5 | 3070 | Risk Ratio (M‐H, Random, 95% CI) | 0.48 [0.26, 0.90] |
| Analysis 2.35  Comparison 2: Drug‐eluting stents versus bare‐metal stents for acute coronary syndrome at one month, Outcome 35: Stent thrombosis according to type of ACS | ||||
| 2.35.1 STEMI | 5 | 3070 | Risk Ratio (M‐H, Random, 95% CI) | 0.48 [0.26, 0.90] |
| 2.36 Stent thrombosis according to registration status Show forest plot | 5 | 3070 | Risk Ratio (M‐H, Random, 95% CI) | 0.48 [0.26, 0.90] |
| Analysis 2.36  Comparison 2: Drug‐eluting stents versus bare‐metal stents for acute coronary syndrome at one month, Outcome 36: Stent thrombosis according to registration status | ||||
| 2.36.1 Pre‐registration | 1 | 100 | Risk Ratio (M‐H, Random, 95% CI) | Not estimable |
| 2.36.2 Post‐registration | 3 | 2856 | Risk Ratio (M‐H, Random, 95% CI) | 0.47 [0.25, 0.88] |
| 2.36.3 No registration | 1 | 114 | Risk Ratio (M‐H, Random, 95% CI) | 0.90 [0.06, 14.04] |
| 2.37 Target vessel revascularisation Show forest plot | 6 | 3233 | Risk Ratio (M‐H, Random, 95% CI) | 0.50 [0.31, 0.82] |
| Analysis 2.37  Comparison 2: Drug‐eluting stents versus bare‐metal stents for acute coronary syndrome at one month, Outcome 37: Target vessel revascularisation | ||||
| 2.38 Target vessel revascularisation best‐worst Show forest plot | 6 | 3251 | Risk Ratio (M‐H, Random, 95% CI) | 0.41 [0.26, 0.66] |
| Analysis 2.38  Comparison 2: Drug‐eluting stents versus bare‐metal stents for acute coronary syndrome at one month, Outcome 38: Target vessel revascularisation best‐worst | ||||
| 2.39 Target vessel revascularisation worst‐best Show forest plot | 6 | 3251 | Risk Ratio (M‐H, Random, 95% CI) | 0.62 [0.40, 0.98] |
| Analysis 2.39  Comparison 2: Drug‐eluting stents versus bare‐metal stents for acute coronary syndrome at one month, Outcome 39: Target vessel revascularisation worst‐best | ||||
| 2.40 Target vessel revascularisation according to type of drug‐eluting stent Show forest plot | 6 | 3233 | Risk Ratio (M‐H, Random, 95% CI) | 0.50 [0.31, 0.82] |
| Analysis 2.40  Comparison 2: Drug‐eluting stents versus bare‐metal stents for acute coronary syndrome at one month, Outcome 40: Target vessel revascularisation according to type of drug‐eluting stent | ||||
| 2.40.1 Everolimus | 1 | 1498 | Risk Ratio (M‐H, Random, 95% CI) | 0.36 [0.17, 0.76] |
| 2.40.2 Paclitaxel | 3 | 877 | Risk Ratio (M‐H, Random, 95% CI) | 0.52 [0.18, 1.49] |
| 2.40.3 Sirolimus | 2 | 858 | Risk Ratio (M‐H, Random, 95% CI) | 0.77 [0.29, 2.04] |
| 2.41 Target vessel revascularisation according to type of ACS Show forest plot | 6 | 3233 | Risk Ratio (M‐H, Random, 95% CI) | 0.50 [0.31, 0.82] |
| Analysis 2.41  Comparison 2: Drug‐eluting stents versus bare‐metal stents for acute coronary syndrome at one month, Outcome 41: Target vessel revascularisation according to type of ACS | ||||
| 2.41.1 STEMI | 6 | 3233 | Risk Ratio (M‐H, Random, 95% CI) | 0.50 [0.31, 0.82] |
| 2.42 Target vessel revascularisation according to registration status Show forest plot | 6 | 3233 | Risk Ratio (M‐H, Random, 95% CI) | 0.50 [0.31, 0.82] |
| Analysis 2.42  Comparison 2: Drug‐eluting stents versus bare‐metal stents for acute coronary syndrome at one month, Outcome 42: Target vessel revascularisation according to registration status | ||||
| 2.42.1 Pre‐registration | 1 | 100 | Risk Ratio (M‐H, Random, 95% CI) | Not estimable |
| 2.42.2 Post‐registration | 3 | 2856 | Risk Ratio (M‐H, Random, 95% CI) | 0.53 [0.32, 0.90] |
| 2.42.3 No registration | 2 | 277 | Risk Ratio (M‐H, Random, 95% CI) | 0.34 [0.09, 1.29] |
study flow diagram.
Risk of bias graph: review authors' judgements about each risk of bias item presented as percentages across all included studies.
Risk of bias summary: review authors' judgements about each risk of bias item for each included study.
Trial Sequential Analysis of drug‐eluting stents versus bare‐metal stents on all‐cause mortality at maximum follow‐up in 21 trials. The diversity‐adjusted required information size (RIS) was calculated based on mortality in the control group of 7.76%; risk ratio reduction (RRR) of 10% in the experimental group; type I error of 2.0%; and type II error of 20% (80% power). No diversity was noted. The diversity‐adjusted required information size was 45,046 participants. The cumulative Z‐curve (blue line) did not cross the trial sequential monitoring boundaries for benefit or harm (red inward‐sloping lines). The cumulative Z‐curve did not cross the inner‐wedge futility line (the inner‐wedge futility could not be calculated due to too little information). Additionally, the cumulative Z‐score did not cross the RIS. The green dotted line shows conventional boundaries (2.0%).
Trial Sequential Analysis of drug‐eluting stents versus bare‐metal stents on serious adverse events at maximum follow‐up in 22 trials. The diversity‐adjusted required information size (RIS) was calculated based on a rate of serious adverse events in the control group of 22.95%; risk ratio reduction (RRR) of 10% in the experimental group; type I error of 2.0%; and type II error of 20% (80% power). No diversity was noted. The diversity‐adjusted required information size was 24,853 participants. The cumulative Z‐curve (blue line) crossed the trial sequential monitoring boundaries for benefit. The green dotted line shows conventional boundaries (2.0%).
Trial Sequential Analysis of drug‐eluting stents versus bare‐metal stents on target vessel revascularisation at maximum follow‐up in 22 trials. The diversity‐adjusted required information size (RIS) was calculated based on a rate of target vessel revascularisations in the control group of 13.28%; risk ratio reduction (RRR) of 30% in the experimental group; type I error of 3.33%; and type II error of 20% (80% power). No diversity was noted. The diversity‐adjusted required information size was 5361 participants. The cumulative Z‐curve (blue line) crossed the trial sequential monitoring boundaries for benefit. The green dotted line shows conventional boundaries (3.33%).
Comparison 1: Drug‐eluting stents versus bare‐metal stents for acute coronary syndrome at maximum follow‐up, Outcome 1: All‐cause mortality
Comparison 1: Drug‐eluting stents versus bare‐metal stents for acute coronary syndrome at maximum follow‐up, Outcome 2: All‐cause mortality best‐worst
Comparison 1: Drug‐eluting stents versus bare‐metal stents for acute coronary syndrome at maximum follow‐up, Outcome 3: All‐cause mortality worst‐best
Comparison 1: Drug‐eluting stents versus bare‐metal stents for acute coronary syndrome at maximum follow‐up, Outcome 4: All‐cause mortality according to type of drug‐eluting stent
Comparison 1: Drug‐eluting stents versus bare‐metal stents for acute coronary syndrome at maximum follow‐up, Outcome 5: All‐cause mortality according to type of ACS
Comparison 1: Drug‐eluting stents versus bare‐metal stents for acute coronary syndrome at maximum follow‐up, Outcome 6: All‐cause mortality according to length of maximum follow‐up
Comparison 1: Drug‐eluting stents versus bare‐metal stents for acute coronary syndrome at maximum follow‐up, Outcome 7: All‐cause mortality according to registration status
Comparison 1: Drug‐eluting stents versus bare‐metal stents for acute coronary syndrome at maximum follow‐up, Outcome 8: Serious adverse events
Comparison 1: Drug‐eluting stents versus bare‐metal stents for acute coronary syndrome at maximum follow‐up, Outcome 9: Serious adverse events best‐worst
Comparison 1: Drug‐eluting stents versus bare‐metal stents for acute coronary syndrome at maximum follow‐up, Outcome 10: Serious adverse events worst‐best
Comparison 1: Drug‐eluting stents versus bare‐metal stents for acute coronary syndrome at maximum follow‐up, Outcome 11: Serious adverse events according to type of drug‐eluting stent
Comparison 1: Drug‐eluting stents versus bare‐metal stents for acute coronary syndrome at maximum follow‐up, Outcome 12: Serious adverse events according to type of ACS
Comparison 1: Drug‐eluting stents versus bare‐metal stents for acute coronary syndrome at maximum follow‐up, Outcome 13: Serious adverse events according to length of maximum follow‐up
Comparison 1: Drug‐eluting stents versus bare‐metal stents for acute coronary syndrome at maximum follow‐up, Outcome 14: Serious adverse events according to registration status
Comparison 1: Drug‐eluting stents versus bare‐metal stents for acute coronary syndrome at maximum follow‐up, Outcome 15: Major cardiovascular events
Comparison 1: Drug‐eluting stents versus bare‐metal stents for acute coronary syndrome at maximum follow‐up, Outcome 16: Major cardiovascular events best‐worst
Comparison 1: Drug‐eluting stents versus bare‐metal stents for acute coronary syndrome at maximum follow‐up, Outcome 17: Major cardiovascular events worst‐best
Comparison 1: Drug‐eluting stents versus bare‐metal stents for acute coronary syndrome at maximum follow‐up, Outcome 18: Major cardiovascular events according to type of drug‐eluting stent
Comparison 1: Drug‐eluting stents versus bare‐metal stents for acute coronary syndrome at maximum follow‐up, Outcome 19: Major cardiovascular events according to type of ACS
Comparison 1: Drug‐eluting stents versus bare‐metal stents for acute coronary syndrome at maximum follow‐up, Outcome 20: Major cardiovascular events according to length of maximum follow‐up
Comparison 1: Drug‐eluting stents versus bare‐metal stents for acute coronary syndrome at maximum follow‐up, Outcome 21: Major cardiovascular events according to registration status
Comparison 1: Drug‐eluting stents versus bare‐metal stents for acute coronary syndrome at maximum follow‐up, Outcome 22: Cardiovascular mortality
Comparison 1: Drug‐eluting stents versus bare‐metal stents for acute coronary syndrome at maximum follow‐up, Outcome 23: Cardiovascular mortality best‐worst
Comparison 1: Drug‐eluting stents versus bare‐metal stents for acute coronary syndrome at maximum follow‐up, Outcome 24: Cardiovascular mortality worst‐best
Comparison 1: Drug‐eluting stents versus bare‐metal stents for acute coronary syndrome at maximum follow‐up, Outcome 25: Cardiovascular mortality according to type of drug‐eluting stent
Comparison 1: Drug‐eluting stents versus bare‐metal stents for acute coronary syndrome at maximum follow‐up, Outcome 26: Cardiovascular mortality according to type of ACS
Comparison 1: Drug‐eluting stents versus bare‐metal stents for acute coronary syndrome at maximum follow‐up, Outcome 27: Cardiovascular mortality according to length of maximum follow‐up
Comparison 1: Drug‐eluting stents versus bare‐metal stents for acute coronary syndrome at maximum follow‐up, Outcome 28: Cardiovascular mortality according to registration status
Comparison 1: Drug‐eluting stents versus bare‐metal stents for acute coronary syndrome at maximum follow‐up, Outcome 29: Myocardial infarction
Comparison 1: Drug‐eluting stents versus bare‐metal stents for acute coronary syndrome at maximum follow‐up, Outcome 30: Myocardial infarction best‐worst
Comparison 1: Drug‐eluting stents versus bare‐metal stents for acute coronary syndrome at maximum follow‐up, Outcome 31: Myocardial infarction worst‐best
Comparison 1: Drug‐eluting stents versus bare‐metal stents for acute coronary syndrome at maximum follow‐up, Outcome 32: Myocardial infarction according to type of drug‐eluting stent
Comparison 1: Drug‐eluting stents versus bare‐metal stents for acute coronary syndrome at maximum follow‐up, Outcome 33: Myocardial infarction according to type of ACS
Comparison 1: Drug‐eluting stents versus bare‐metal stents for acute coronary syndrome at maximum follow‐up, Outcome 34: Myocardial infarction according to length of maximum follow‐up
Comparison 1: Drug‐eluting stents versus bare‐metal stents for acute coronary syndrome at maximum follow‐up, Outcome 35: Myocardial infarction according to registration status
Comparison 1: Drug‐eluting stents versus bare‐metal stents for acute coronary syndrome at maximum follow‐up, Outcome 36: Stent thrombosis
Comparison 1: Drug‐eluting stents versus bare‐metal stents for acute coronary syndrome at maximum follow‐up, Outcome 37: Stent thrombosis best‐worst
Comparison 1: Drug‐eluting stents versus bare‐metal stents for acute coronary syndrome at maximum follow‐up, Outcome 38: Stent thrombosis worst‐best
Comparison 1: Drug‐eluting stents versus bare‐metal stents for acute coronary syndrome at maximum follow‐up, Outcome 39: Stent thrombosis according to type of drug‐eluting stent
Comparison 1: Drug‐eluting stents versus bare‐metal stents for acute coronary syndrome at maximum follow‐up, Outcome 40: Stent thrombosis according to type of ACS
Comparison 1: Drug‐eluting stents versus bare‐metal stents for acute coronary syndrome at maximum follow‐up, Outcome 41: Stent thrombosis according to length of maximum follow‐up
Comparison 1: Drug‐eluting stents versus bare‐metal stents for acute coronary syndrome at maximum follow‐up, Outcome 42: Stent thrombosis according to registration status
Comparison 1: Drug‐eluting stents versus bare‐metal stents for acute coronary syndrome at maximum follow‐up, Outcome 43: Target vessel revascularisation
Comparison 1: Drug‐eluting stents versus bare‐metal stents for acute coronary syndrome at maximum follow‐up, Outcome 44: Target vessel revascularisation best‐worst
Comparison 1: Drug‐eluting stents versus bare‐metal stents for acute coronary syndrome at maximum follow‐up, Outcome 45: Target vessel revascularisation worst‐best
Comparison 1: Drug‐eluting stents versus bare‐metal stents for acute coronary syndrome at maximum follow‐up, Outcome 46: Target vessel revascularisation according to type of drug‐eluting stent
Comparison 1: Drug‐eluting stents versus bare‐metal stents for acute coronary syndrome at maximum follow‐up, Outcome 47: Target vessel revascularisation according to type of ACS
Comparison 1: Drug‐eluting stents versus bare‐metal stents for acute coronary syndrome at maximum follow‐up, Outcome 48: Target vessel revascularisation according to length of maximum follow‐up
Comparison 1: Drug‐eluting stents versus bare‐metal stents for acute coronary syndrome at maximum follow‐up, Outcome 49: Target vessel revascularisation according to registration status
Comparison 2: Drug‐eluting stents versus bare‐metal stents for acute coronary syndrome at one month, Outcome 1: All‐cause mortality
Comparison 2: Drug‐eluting stents versus bare‐metal stents for acute coronary syndrome at one month, Outcome 2: All‐cause mortality best‐worst
Comparison 2: Drug‐eluting stents versus bare‐metal stents for acute coronary syndrome at one month, Outcome 3: All‐cause mortality worst‐best
Comparison 2: Drug‐eluting stents versus bare‐metal stents for acute coronary syndrome at one month, Outcome 4: All‐cause mortality according to type of drug‐eluting stent
Comparison 2: Drug‐eluting stents versus bare‐metal stents for acute coronary syndrome at one month, Outcome 5: All‐cause mortality according to type of ACS
Comparison 2: Drug‐eluting stents versus bare‐metal stents for acute coronary syndrome at one month, Outcome 6: All‐cause mortality according to registration status
Comparison 2: Drug‐eluting stents versus bare‐metal stents for acute coronary syndrome at one month, Outcome 7: Serious adverse events
Comparison 2: Drug‐eluting stents versus bare‐metal stents for acute coronary syndrome at one month, Outcome 8: Serious adverse events best‐worst
Comparison 2: Drug‐eluting stents versus bare‐metal stents for acute coronary syndrome at one month, Outcome 9: Serious adverse events worst‐best
Comparison 2: Drug‐eluting stents versus bare‐metal stents for acute coronary syndrome at one month, Outcome 10: Serious adverse events according to type of drug‐eluting stent
Comparison 2: Drug‐eluting stents versus bare‐metal stents for acute coronary syndrome at one month, Outcome 11: Serious adverse events according to type of ACS
Comparison 2: Drug‐eluting stents versus bare‐metal stents for acute coronary syndrome at one month, Outcome 12: Serious adverse events according to registration status
Comparison 2: Drug‐eluting stents versus bare‐metal stents for acute coronary syndrome at one month, Outcome 13: Major cardiovascular events
Comparison 2: Drug‐eluting stents versus bare‐metal stents for acute coronary syndrome at one month, Outcome 14: Major cardiovascular events best‐worst
Comparison 2: Drug‐eluting stents versus bare‐metal stents for acute coronary syndrome at one month, Outcome 15: Major cardiovascular events worst‐best
Comparison 2: Drug‐eluting stents versus bare‐metal stents for acute coronary syndrome at one month, Outcome 16: Major cardiovascular events according to type of drug‐eluting stent
Comparison 2: Drug‐eluting stents versus bare‐metal stents for acute coronary syndrome at one month, Outcome 17: Major cardiovascular events according to type of ACS
Comparison 2: Drug‐eluting stents versus bare‐metal stents for acute coronary syndrome at one month, Outcome 18: Major cardiovascular events according to registration status
Comparison 2: Drug‐eluting stents versus bare‐metal stents for acute coronary syndrome at one month, Outcome 19: Cardiovascular mortality
Comparison 2: Drug‐eluting stents versus bare‐metal stents for acute coronary syndrome at one month, Outcome 20: Cardiovascular mortality best‐worst
Comparison 2: Drug‐eluting stents versus bare‐metal stents for acute coronary syndrome at one month, Outcome 21: Cardiovascular mortality worst‐best
Comparison 2: Drug‐eluting stents versus bare‐metal stents for acute coronary syndrome at one month, Outcome 22: Cardiovascular mortality according to type of drug‐eluting stent
Comparison 2: Drug‐eluting stents versus bare‐metal stents for acute coronary syndrome at one month, Outcome 23: Cardiovascular mortality according to type of ACS
Comparison 2: Drug‐eluting stents versus bare‐metal stents for acute coronary syndrome at one month, Outcome 24: Cardiovascular mortality according to registration status
Comparison 2: Drug‐eluting stents versus bare‐metal stents for acute coronary syndrome at one month, Outcome 25: Myocardial infarction
Comparison 2: Drug‐eluting stents versus bare‐metal stents for acute coronary syndrome at one month, Outcome 26: Myocardial infarction best‐worst
Comparison 2: Drug‐eluting stents versus bare‐metal stents for acute coronary syndrome at one month, Outcome 27: Myocardial infarction worst‐best
Comparison 2: Drug‐eluting stents versus bare‐metal stents for acute coronary syndrome at one month, Outcome 28: Myocardial infarction according to type of drug‐eluting stent
Comparison 2: Drug‐eluting stents versus bare‐metal stents for acute coronary syndrome at one month, Outcome 29: Myocardial infarction according to type of ACS
Comparison 2: Drug‐eluting stents versus bare‐metal stents for acute coronary syndrome at one month, Outcome 30: Myocardial infarction according to registration status
Comparison 2: Drug‐eluting stents versus bare‐metal stents for acute coronary syndrome at one month, Outcome 31: Stent thrombosis
Comparison 2: Drug‐eluting stents versus bare‐metal stents for acute coronary syndrome at one month, Outcome 32: Stent thrombosis best‐worst
Comparison 2: Drug‐eluting stents versus bare‐metal stents for acute coronary syndrome at one month, Outcome 33: Stent thrombosis worst‐best
Comparison 2: Drug‐eluting stents versus bare‐metal stents for acute coronary syndrome at one month, Outcome 34: Stent thrombosis according to type of drug‐eluting stent
Comparison 2: Drug‐eluting stents versus bare‐metal stents for acute coronary syndrome at one month, Outcome 35: Stent thrombosis according to type of ACS
Comparison 2: Drug‐eluting stents versus bare‐metal stents for acute coronary syndrome at one month, Outcome 36: Stent thrombosis according to registration status
Comparison 2: Drug‐eluting stents versus bare‐metal stents for acute coronary syndrome at one month, Outcome 37: Target vessel revascularisation
Comparison 2: Drug‐eluting stents versus bare‐metal stents for acute coronary syndrome at one month, Outcome 38: Target vessel revascularisation best‐worst
Comparison 2: Drug‐eluting stents versus bare‐metal stents for acute coronary syndrome at one month, Outcome 39: Target vessel revascularisation worst‐best
Comparison 2: Drug‐eluting stents versus bare‐metal stents for acute coronary syndrome at one month, Outcome 40: Target vessel revascularisation according to type of drug‐eluting stent
Comparison 2: Drug‐eluting stents versus bare‐metal stents for acute coronary syndrome at one month, Outcome 41: Target vessel revascularisation according to type of ACS
Comparison 2: Drug‐eluting stents versus bare‐metal stents for acute coronary syndrome at one month, Outcome 42: Target vessel revascularisation according to registration status
| Drug‐eluting stents compared to bare‐metal stents for acute coronary syndrome | ||||||
| Patient or population: People with acute coronary syndrome | ||||||
| Outcomes | Anticipated absolute effects* (95% CI) | Relative effect | № of participants | Quality of the evidence | Comments | |
|---|---|---|---|---|---|---|
| Risk with bare‐metal stents | Risk with drug‐eluting stents | |||||
| All‐cause mortality at maximum follow‐up | Study population | RR 0.90 | 11,250 | ⊕⊕⊝⊝ | Trial Sequential Analysis for a RRR of 10% showed that neither the boundary for futility, benefit or harm was breached, hence the risk of imprecision of the outcome result is high. Multiple eligible treatments were used in 1 trial, generating a further comparison (21 trials reporting on 22 experimental groups). | |
| 78 per 1000 | 70 per 1000 | |||||
| Serious adverse events at maximum follow‐up | Study population | RR 0.80 | 11,724 | ⊕⊕⊝⊝ | Trial Sequential Analysis for a RRR of 10% showed that the boundary for benefit was breached, hence the risk of imprecision of the outcome result is low. Multiple eligible treatments were used in 1 trial, generating a further comparison (22 trials reporting on 23 experimental groups). | |
| 230 per 1000 | 184 per 1000 | |||||
| Major cardiovascular events at maximum Follow‐up: median 12 months | Study population | RR 0.96 | 10,939 | ⊕⊝⊝⊝ | Trial Sequential Analysis for a RRR of 10% showed that neither the boundary for futility, benefit or harm was breached, hence the risk of imprecision of the outcome result is high. Multiple eligible treatments were used in 1 trial, generating a further comparison (19 trials reporting on 20 experimental groups). | |
| 66 per 1000 | 63 per 1000 | |||||
| Quality of life at maximum follow‐up ‐ not reported | ‐ | ‐ | ‐ | ‐ | ‐ | |
| Cardiovascular mortality at maximum follow‐up | Study population | RR 0.91 | 9248 | ⊕⊝⊝⊝ | Trial Sequential Analysis for a RRR of 10% showed that neither the boundary for futility, benefit or harm was breached, hence the risk of imprecision of the outcome result is high. Multiple eligible treatments were used in 1 trial, generating a further comparison (14 trials reporting on 15 experimental groups). | |
| 58 per 1000 | 53 per 1000 | |||||
| Myocardial infarction at maximum follow‐up | Study population | RR 0.98 | 10,217 | ⊕⊝⊝⊝ | Trial Sequential Analysis for a RRR of 10% showed that neither the boundary for futility, benefit or harm was breached, hence the risk of imprecision of the outcome result is high. Multiple eligible treatments were used in 1 trial, generating a further comparison (18 trials reporting on 19 experimental groups). | |
| 48 per 1000 | 47 per 1000 | |||||
| Angina at maximum follow‐up ‐ not reported | ‐ | ‐ | ‐ | ‐ | ‐ | |
| *The risk in the intervention group (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI). | ||||||
| GRADE Working Group grades of evidence | ||||||
| 1Downgraded one level for serious risk of imprecision due to our required information size not being met. | ||||||
| Outcome or subgroup title | No. of studies | No. of participants | Statistical method | Effect size |
| 1.1 All‐cause mortality Show forest plot | 22 | 11250 | Risk Ratio (M‐H, Random, 95% CI) | 0.90 [0.78, 1.03] |
| 1.2 All‐cause mortality best‐worst Show forest plot | 22 | 11775 | Risk Ratio (M‐H, Random, 95% CI) | 0.60 [0.44, 0.80] |
| 1.3 All‐cause mortality worst‐best Show forest plot | 22 | 11775 | Risk Ratio (M‐H, Random, 95% CI) | 1.27 [0.99, 1.64] |
| 1.4 All‐cause mortality according to type of drug‐eluting stent Show forest plot | 22 | 11250 | Risk Ratio (M‐H, Random, 95% CI) | 0.90 [0.78, 1.03] |
| 1.4.1 Biodegradable (Biolimus) | 1 | 1157 | Risk Ratio (M‐H, Random, 95% CI) | 0.89 [0.54, 1.45] |
| 1.4.2 Everolimus | 1 | 1458 | Risk Ratio (M‐H, Random, 95% CI) | 0.73 [0.54, 1.00] |
| 1.4.3 Paclitaxel | 8 | 4468 | Risk Ratio (M‐H, Random, 95% CI) | 0.89 [0.71, 1.12] |
| 1.4.4 Sirolimus | 9 | 3113 | Risk Ratio (M‐H, Random, 95% CI) | 0.89 [0.68, 1.16] |
| 1.4.5 Zotarolimus | 1 | 44 | Risk Ratio (M‐H, Random, 95% CI) | Not estimable |
| 1.4.6 Mixed | 1 | 626 | Risk Ratio (M‐H, Random, 95% CI) | 1.34 [0.91, 1.98] |
| 1.4.7 Unclear | 1 | 384 | Risk Ratio (M‐H, Random, 95% CI) | 0.43 [0.02, 7.39] |
| 1.5 All‐cause mortality according to type of ACS Show forest plot | 22 | 11250 | Risk Ratio (M‐H, Random, 95% CI) | 0.90 [0.78, 1.03] |
| 1.5.1 STEMI | 21 | 11171 | Risk Ratio (M‐H, Random, 95% CI) | 0.90 [0.78, 1.03] |
| 1.5.2 Acute coronary syndrome | 1 | 79 | Risk Ratio (M‐H, Random, 95% CI) | Not estimable |
| 1.6 All‐cause mortality according to length of maximum follow‐up Show forest plot | 22 | 11250 | Risk Ratio (M‐H, Random, 95% CI) | 0.90 [0.78, 1.03] |
| 1.6.1 Less or equal to 6 months | 4 | 726 | Risk Ratio (M‐H, Random, 95% CI) | 0.85 [0.29, 2.53] |
| 1.6.2 Between 6 and 12 months | 6 | 1315 | Risk Ratio (M‐H, Random, 95% CI) | 0.81 [0.54, 1.21] |
| 1.6.3 Between 1 and 3 years | 3 | 703 | Risk Ratio (M‐H, Random, 95% CI) | 0.99 [0.55, 1.76] |
| 1.6.4 More or equal to 3 years | 8 | 8490 | Risk Ratio (M‐H, Random, 95% CI) | 0.90 [0.77, 1.05] |
| 1.6.5 Unclear | 1 | 16 | Risk Ratio (M‐H, Random, 95% CI) | Not estimable |
| 1.7 All‐cause mortality according to registration status Show forest plot | 22 | 11250 | Risk Ratio (M‐H, Random, 95% CI) | 0.90 [0.78, 1.03] |
| 1.7.1 Pre‐registration | 3 | 1301 | Risk Ratio (M‐H, Random, 95% CI) | 0.85 [0.52, 1.39] |
| 1.7.2 Post‐registration | 13 | 9028 | Risk Ratio (M‐H, Random, 95% CI) | 0.89 [0.77, 1.03] |
| 1.7.3 No registration | 6 | 921 | Risk Ratio (M‐H, Random, 95% CI) | 1.09 [0.54, 2.20] |
| 1.8 Serious adverse events Show forest plot | 23 | 11724 | Risk Ratio (M‐H, Fixed, 95% CI) | 0.80 [0.74, 0.86] |
| 1.9 Serious adverse events best‐worst Show forest plot | 23 | 12249 | Risk Ratio (M‐H, Fixed, 95% CI) | 0.67 [0.62, 0.71] |
| 1.10 Serious adverse events worst‐best Show forest plot | 23 | 12249 | Risk Ratio (M‐H, Fixed, 95% CI) | 0.98 [0.91, 1.05] |
| 1.11 Serious adverse events according to type of drug‐eluting stent Show forest plot | 23 | 11724 | Risk Ratio (M‐H, Fixed, 95% CI) | 0.80 [0.74, 0.86] |
| 1.11.1 Biodegradable (Biolimus) | 1 | 1157 | Risk Ratio (M‐H, Fixed, 95% CI) | 0.75 [0.58, 0.98] |
| 1.11.2 Everolimus | 2 | 1932 | Risk Ratio (M‐H, Fixed, 95% CI) | 0.82 [0.69, 0.97] |
| 1.11.3 Paclitaxel | 8 | 4468 | Risk Ratio (M‐H, Fixed, 95% CI) | 0.86 [0.76, 0.96] |
| 1.11.4 Sirolimus | 9 | 3113 | Risk Ratio (M‐H, Fixed, 95% CI) | 0.74 [0.64, 0.84] |
| 1.11.5 Zotarolimus | 1 | 44 | Risk Ratio (M‐H, Fixed, 95% CI) | 1.33 [0.17, 10.70] |
| 1.11.6 Mixed | 1 | 626 | Risk Ratio (M‐H, Fixed, 95% CI) | 0.74 [0.54, 1.01] |
| 1.11.7 Unclear | 1 | 384 | Risk Ratio (M‐H, Fixed, 95% CI) | 0.93 [0.52, 1.69] |
| 1.12 Serious adverse events according to type of ACS Show forest plot | 23 | 11724 | Risk Ratio (M‐H, Fixed, 95% CI) | 0.80 [0.74, 0.86] |
| 1.12.1 STEMI | 21 | 11171 | Risk Ratio (M‐H, Fixed, 95% CI) | 0.80 [0.75, 0.86] |
| 1.12.2 Acute coronary syndrome | 1 | 79 | Risk Ratio (M‐H, Fixed, 95% CI) | 0.58 [0.29, 1.15] |
| 1.12.3 NSTEMI | 1 | 474 | Risk Ratio (M‐H, Fixed, 95% CI) | 0.78 [0.50, 1.23] |
| 1.13 Serious adverse events according to length of maximum follow‐up Show forest plot | 23 | 11724 | Risk Ratio (M‐H, Fixed, 95% CI) | 0.80 [0.74, 0.86] |
| 1.13.1 Less or equal to 6 months | 4 | 726 | Risk Ratio (M‐H, Fixed, 95% CI) | 0.67 [0.45, 0.99] |
| 1.13.2 Between 6 and 12 months | 7 | 1748 | Risk Ratio (M‐H, Fixed, 95% CI) | 0.85 [0.69, 1.05] |
| 1.13.3 Between 1 and 3 years | 3 | 744 | Risk Ratio (M‐H, Fixed, 95% CI) | 0.64 [0.47, 0.88] |
| 1.13.4 More or equal to 3 years | 8 | 8490 | Risk Ratio (M‐H, Fixed, 95% CI) | 0.81 [0.75, 0.88] |
| 1.13.5 Unclear | 1 | 16 | Risk Ratio (M‐H, Fixed, 95% CI) | Not estimable |
| 1.14 Serious adverse events according to registration status Show forest plot | 23 | 11724 | Risk Ratio (M‐H, Fixed, 95% CI) | 0.80 [0.74, 0.86] |
| 1.14.1 Pre‐registration | 3 | 1301 | Risk Ratio (M‐H, Fixed, 95% CI) | 0.71 [0.55, 0.91] |
| 1.14.2 Post‐registration | 14 | 9502 | Risk Ratio (M‐H, Fixed, 95% CI) | 0.81 [0.75, 0.87] |
| 1.14.3 No registration | 6 | 921 | Risk Ratio (M‐H, Fixed, 95% CI) | 0.83 [0.57, 1.20] |
| 1.15 Major cardiovascular events Show forest plot | 20 | 10939 | Risk Ratio (M‐H, Random, 95% CI) | 0.96 [0.83, 1.11] |
| 1.16 Major cardiovascular events best‐worst Show forest plot | 20 | 11596 | Risk Ratio (M‐H, Random, 95% CI) | 0.53 [0.39, 0.72] |
| 1.17 Major cardiovascular events worst‐best Show forest plot | 20 | 11596 | Risk Ratio (M‐H, Random, 95% CI) | 1.40 [0.97, 2.00] |
| 1.18 Major cardiovascular events according to type of drug‐eluting stent Show forest plot | 20 | 10939 | Risk Ratio (M‐H, Random, 95% CI) | 0.96 [0.83, 1.11] |
| 1.18.1 Biodegradable (Biolimus) | 1 | 1104 | Risk Ratio (M‐H, Random, 95% CI) | 0.90 [0.54, 1.49] |
| 1.18.2 Everolimus | 1 | 1458 | Risk Ratio (M‐H, Random, 95% CI) | 0.85 [0.58, 1.24] |
| 1.18.3 Paclitaxel | 7 | 4305 | Risk Ratio (M‐H, Random, 95% CI) | 1.01 [0.81, 1.26] |
| 1.18.4 Sirolimus | 8 | 3018 | Risk Ratio (M‐H, Random, 95% CI) | 0.89 [0.64, 1.24] |
| 1.18.5 Zotarolimus | 1 | 44 | Risk Ratio (M‐H, Random, 95% CI) | Not estimable |
| 1.18.6 Mixed | 1 | 626 | Risk Ratio (M‐H, Random, 95% CI) | 1.04 [0.60, 1.81] |
| 1.18.7 Unclear | 1 | 384 | Risk Ratio (M‐H, Random, 95% CI) | 1.36 [0.54, 3.40] |
| 1.19 Major cardiovascular events according to type of ACS Show forest plot | 20 | 10939 | Risk Ratio (M‐H, Random, 95% CI) | 0.96 [0.83, 1.11] |
| 1.19.1 STEMI | 19 | 10860 | Risk Ratio (M‐H, Random, 95% CI) | 0.96 [0.83, 1.12] |
| 1.19.2 Acute coronary syndrome | 1 | 79 | Risk Ratio (M‐H, Random, 95% CI) | 0.68 [0.12, 3.87] |
| 1.20 Major cardiovascular events according to length of maximum follow‐up Show forest plot | 20 | 10939 | Risk Ratio (M‐H, Random, 95% CI) | 0.96 [0.83, 1.11] |
| 1.20.1 Less or equal to 6 months | 3 | 563 | Risk Ratio (M‐H, Random, 95% CI) | 1.04 [0.48, 2.28] |
| 1.20.2 Between 1 and 3 years | 9 | 2018 | Risk Ratio (M‐H, Random, 95% CI) | 0.89 [0.69, 1.16] |
| 1.20.3 More or equal to 3 years | 8 | 8358 | Risk Ratio (M‐H, Random, 95% CI) | 0.99 [0.82, 1.19] |
| 1.21 Major cardiovascular events according to registration status Show forest plot | 20 | 10939 | Risk Ratio (M‐H, Random, 95% CI) | 0.96 [0.83, 1.11] |
| 1.21.1 Pre‐registration | 3 | 1248 | Risk Ratio (M‐H, Random, 95% CI) | 0.86 [0.52, 1.42] |
| 1.21.2 Post‐registration | 13 | 8949 | Risk Ratio (M‐H, Random, 95% CI) | 0.97 [0.83, 1.14] |
| 1.21.3 No registration | 4 | 742 | Risk Ratio (M‐H, Random, 95% CI) | 0.95 [0.47, 1.93] |
| 1.22 Cardiovascular mortality Show forest plot | 15 | 9248 | Risk Ratio (M‐H, Random, 95% CI) | 0.91 [0.76, 1.09] |
| 1.23 Cardiovascular mortality best‐worst Show forest plot | 15 | 9742 | Risk Ratio (M‐H, Random, 95% CI) | 0.50 [0.32, 0.77] |
| 1.24 Cardiovascular mortality worst‐best Show forest plot | 15 | 9742 | Risk Ratio (M‐H, Random, 95% CI) | 1.49 [1.06, 2.11] |
| 1.25 Cardiovascular mortality according to type of drug‐eluting stent Show forest plot | 15 | 9248 | Risk Ratio (M‐H, Random, 95% CI) | 0.91 [0.76, 1.09] |
| 1.25.1 Biodegradable (Biolimus) | 1 | 1104 | Risk Ratio (M‐H, Random, 95% CI) | 0.90 [0.54, 1.49] |
| 1.25.2 Everolimus | 1 | 1458 | Risk Ratio (M‐H, Random, 95% CI) | 0.85 [0.58, 1.24] |
| 1.25.3 Paclitaxel | 6 | 4141 | Risk Ratio (M‐H, Random, 95% CI) | 0.86 [0.65, 1.13] |
| 1.25.4 Sirolimus | 5 | 1875 | Risk Ratio (M‐H, Random, 95% CI) | 0.81 [0.52, 1.25] |
| 1.25.5 Zotarolimus | 1 | 44 | Risk Ratio (M‐H, Random, 95% CI) | Not estimable |
| 1.25.6 Mixed | 1 | 626 | Risk Ratio (M‐H, Random, 95% CI) | 2.40 [1.17, 4.93] |
| 1.26 Cardiovascular mortality according to type of ACS Show forest plot | 15 | 9248 | Risk Ratio (M‐H, Random, 95% CI) | 0.91 [0.76, 1.09] |
| 1.26.1 STEMI | 15 | 9248 | Risk Ratio (M‐H, Random, 95% CI) | 0.91 [0.76, 1.09] |
| 1.26.2 Acute coronary syndrome | 0 | 0 | Risk Ratio (M‐H, Random, 95% CI) | Not estimable |
| 1.27 Cardiovascular mortality according to length of maximum follow‐up Show forest plot | 15 | 9248 | Risk Ratio (M‐H, Random, 95% CI) | 0.91 [0.76, 1.09] |
| 1.27.1 Less or equal to 6 months | 1 | 100 | Risk Ratio (M‐H, Random, 95% CI) | 0.21 [0.01, 4.23] |
| 1.27.2 Between 6 and 12 months | 6 | 1584 | Risk Ratio (M‐H, Random, 95% CI) | 0.94 [0.65, 1.35] |
| 1.27.3 Between 1 and 3 years | 2 | 270 | Risk Ratio (M‐H, Random, 95% CI) | 0.56 [0.23, 1.32] |
| 1.27.4 More or equal to 3 years | 6 | 7294 | Risk Ratio (M‐H, Random, 95% CI) | 0.95 [0.72, 1.27] |
| 1.28 Cardiovascular mortality according to registration status Show forest plot | 15 | 9248 | Risk Ratio (M‐H, Random, 95% CI) | 0.91 [0.76, 1.09] |
| 1.28.1 Pre‐registration | 3 | 1248 | Risk Ratio (M‐H, Random, 95% CI) | 0.86 [0.52, 1.42] |
| 1.28.2 Post‐registration | 10 | 7806 | Risk Ratio (M‐H, Random, 95% CI) | 0.93 [0.73, 1.18] |
| 1.28.3 No registration | 2 | 194 | Risk Ratio (M‐H, Random, 95% CI) | 0.71 [0.16, 3.16] |
| 1.29 Myocardial infarction Show forest plot | 19 | 10217 | Risk Ratio (M‐H, Random, 95% CI) | 0.98 [0.82, 1.18] |
| 1.30 Myocardial infarction best‐worst Show forest plot | 19 | 10851 | Risk Ratio (M‐H, Random, 95% CI) | 0.46 [0.33, 0.66] |
| 1.31 Myocardial infarction worst‐best Show forest plot | 19 | 10851 | Risk Ratio (M‐H, Random, 95% CI) | 1.56 [1.00, 2.45] |
| 1.32 Myocardial infarction according to type of drug‐eluting stent Show forest plot | 19 | 10217 | Risk Ratio (M‐H, Random, 95% CI) | 0.98 [0.82, 1.18] |
| 1.32.1 Biodegradable (Biolimus) | 1 | 1118 | Risk Ratio (M‐H, Random, 95% CI) | 0.64 [0.36, 1.15] |
| 1.32.2 Everolimus | 1 | 1458 | Risk Ratio (M‐H, Random, 95% CI) | 1.29 [0.79, 2.11] |
| 1.32.3 Paclitaxel | 7 | 4305 | Risk Ratio (M‐H, Random, 95% CI) | 1.05 [0.75, 1.46] |
| 1.32.4 Sirolimus | 7 | 2282 | Risk Ratio (M‐H, Random, 95% CI) | 0.90 [0.58, 1.39] |
| 1.32.5 Zotarolimus | 1 | 44 | Risk Ratio (M‐H, Random, 95% CI) | Not estimable |
| 1.32.6 Mixed | 1 | 626 | Risk Ratio (M‐H, Random, 95% CI) | 0.74 [0.40, 1.36] |
| 1.32.7 Unclear | 1 | 384 | Risk Ratio (M‐H, Random, 95% CI) | 1.36 [0.54, 3.40] |
| 1.33 Myocardial infarction according to type of ACS Show forest plot | 19 | 10217 | Risk Ratio (M‐H, Random, 95% CI) | 0.98 [0.82, 1.18] |
| 1.33.1 STEMI | 18 | 10138 | Risk Ratio (M‐H, Random, 95% CI) | 0.98 [0.82, 1.18] |
| 1.33.2 Acute coronary syndrome | 1 | 79 | Risk Ratio (M‐H, Random, 95% CI) | 0.68 [0.12, 3.87] |
| 1.34 Myocardial infarction according to length of maximum follow‐up Show forest plot | 19 | 10217 | Risk Ratio (M‐H, Random, 95% CI) | 0.98 [0.82, 1.18] |
| 1.34.1 Less or equal to 6 months | 3 | 563 | Risk Ratio (M‐H, Random, 95% CI) | 1.17 [0.52, 2.63] |
| 1.34.2 Between 6 and 12 months | 7 | 1748 | Risk Ratio (M‐H, Random, 95% CI) | 0.98 [0.58, 1.66] |
| 1.34.3 Between 1 and 3 years | 2 | 270 | Risk Ratio (M‐H, Random, 95% CI) | 0.55 [0.24, 1.25] |
| 1.34.4 More or equal to 3 years | 7 | 7636 | Risk Ratio (M‐H, Random, 95% CI) | 1.00 [0.80, 1.25] |
| 1.35 Myocardial infarction according to registration status Show forest plot | 19 | 10217 | Risk Ratio (M‐H, Random, 95% CI) | 0.98 [0.82, 1.18] |
| 1.35.1 Pre‐registration | 3 | 1262 | Risk Ratio (M‐H, Random, 95% CI) | 0.64 [0.36, 1.15] |
| 1.35.2 Post‐registration | 12 | 8213 | Risk Ratio (M‐H, Random, 95% CI) | 1.03 [0.85, 1.26] |
| 1.35.3 No registration | 4 | 742 | Risk Ratio (M‐H, Random, 95% CI) | 0.97 [0.44, 2.12] |
| 1.36 Stent thrombosis Show forest plot | 21 | 11350 | Risk Ratio (M‐H, Random, 95% CI) | 0.96 [0.80, 1.16] |
| 1.37 Stent thrombosis best‐worst Show forest plot | 21 | 12007 | Risk Ratio (M‐H, Random, 95% CI) | 0.47 [0.32, 0.67] |
| 1.38 Stent thrombosis worst‐best Show forest plot | 21 | 12007 | Risk Ratio (M‐H, Random, 95% CI) | 1.55 [1.12, 2.15] |
| 1.39 Stent thrombosis according to type of drug‐eluting stent Show forest plot | 21 | 11350 | Risk Ratio (M‐H, Random, 95% CI) | 0.96 [0.80, 1.16] |
| 1.39.1 Biodegradable (Biolimus) | 1 | 1104 | Risk Ratio (M‐H, Random, 95% CI) | 0.72 [0.40, 1.30] |
| 1.39.2 Everolimus | 2 | 1932 | Risk Ratio (M‐H, Random, 95% CI) | 0.60 [0.34, 1.08] |
| 1.39.3 Paclitaxel | 7 | 4305 | Risk Ratio (M‐H, Random, 95% CI) | 1.01 [0.73, 1.39] |
| 1.39.4 Sirolimus | 8 | 2957 | Risk Ratio (M‐H, Random, 95% CI) | 1.04 [0.76, 1.41] |
| 1.39.5 Zotarolimus | 1 | 44 | Risk Ratio (M‐H, Random, 95% CI) | Not estimable |
| 1.39.6 Mixed | 1 | 626 | Risk Ratio (M‐H, Random, 95% CI) | 1.00 [0.52, 1.92] |
| 1.39.7 Unclear | 1 | 382 | Risk Ratio (M‐H, Random, 95% CI) | 2.16 [0.82, 5.70] |
| 1.40 Stent thrombosis according to type of ACS Show forest plot | 21 | 11350 | Risk Ratio (M‐H, Random, 95% CI) | 0.96 [0.80, 1.16] |
| 1.40.1 STEMI | 20 | 10876 | Risk Ratio (M‐H, Random, 95% CI) | 0.98 [0.81, 1.18] |
| 1.40.2 NSTEMI | 1 | 474 | Risk Ratio (M‐H, Random, 95% CI) | 0.44 [0.12, 1.68] |
| 1.41 Stent thrombosis according to length of maximum follow‐up Show forest plot | 21 | 11350 | Risk Ratio (M‐H, Random, 95% CI) | 0.96 [0.80, 1.16] |
| 1.41.1 Less or equal to 6 months | 2 | 482 | Risk Ratio (M‐H, Random, 95% CI) | 2.16 [0.82, 5.70] |
| 1.41.2 Between 6 and 12 months | 7 | 1748 | Risk Ratio (M‐H, Random, 95% CI) | 0.83 [0.46, 1.49] |
| 1.41.3 Between 1 and 3 years | 3 | 744 | Risk Ratio (M‐H, Random, 95% CI) | 0.57 [0.25, 1.29] |
| 1.41.4 More or equal to 3 years | 8 | 8360 | Risk Ratio (M‐H, Random, 95% CI) | 0.98 [0.78, 1.22] |
| 1.41.5 Unclear | 1 | 16 | Risk Ratio (M‐H, Random, 95% CI) | 0.20 [0.01, 3.61] |
| 1.42 Stent thrombosis according to registration status Show forest plot | 21 | 11350 | Risk Ratio (M‐H, Random, 95% CI) | 0.96 [0.80, 1.16] |
| 1.42.1 Pre‐registration | 3 | 1248 | Risk Ratio (M‐H, Random, 95% CI) | 0.72 [0.40, 1.30] |
| 1.42.2 Post‐registration | 13 | 9346 | Risk Ratio (M‐H, Random, 95% CI) | 0.99 [0.81, 1.21] |
| 1.42.3 No registration | 5 | 756 | Risk Ratio (M‐H, Random, 95% CI) | 0.70 [0.22, 2.20] |
| 1.43 Target vessel revascularisation Show forest plot | 23 | 11770 | Risk Ratio (M‐H, Fixed, 95% CI) | 0.58 [0.52, 0.65] |
| 1.44 Target vessel revascularisation best‐worst Show forest plot | 23 | 12368 | Risk Ratio (M‐H, Fixed, 95% CI) | 0.41 [0.37, 0.45] |
| 1.45 Target vessel revascularisation worst‐best Show forest plot | 23 | 12368 | Risk Ratio (M‐H, Fixed, 95% CI) | 0.98 [0.89, 1.07] |
| 1.46 Target vessel revascularisation according to type of drug‐eluting stent Show forest plot | 23 | 11770 | Risk Ratio (M‐H, Fixed, 95% CI) | 0.58 [0.52, 0.65] |
| 1.46.1 Biodegradable (Biolimus) | 1 | 1118 | Risk Ratio (M‐H, Fixed, 95% CI) | 0.45 [0.29, 0.70] |
| 1.46.2 Everolimus | 2 | 1932 | Risk Ratio (M‐H, Fixed, 95% CI) | 0.57 [0.42, 0.78] |
| 1.46.3 Sirolimus | 9 | 3062 | Risk Ratio (M‐H, Fixed, 95% CI) | 0.54 [0.44, 0.66] |
| 1.46.4 Paclitaxel | 8 | 4530 | Risk Ratio (M‐H, Fixed, 95% CI) | 0.63 [0.53, 0.75] |
| 1.46.5 Mixed | 1 | 626 | Risk Ratio (M‐H, Fixed, 95% CI) | 0.52 [0.35, 0.76] |
| 1.46.6 Unclear | 1 | 382 | Risk Ratio (M‐H, Fixed, 95% CI) | 2.16 [0.82, 5.70] |
| 1.46.7 Dexamethasone | 1 | 120 | Risk Ratio (M‐H, Fixed, 95% CI) | 0.60 [0.32, 1.12] |
| 1.47 Target vessel revascularisation according to type of ACS Show forest plot | 23 | 11770 | Risk Ratio (M‐H, Fixed, 95% CI) | 0.58 [0.52, 0.65] |
| 1.47.1 STEMI | 20 | 11097 | Risk Ratio (M‐H, Fixed, 95% CI) | 0.59 [0.53, 0.66] |
| 1.47.2 Acute coronary syndrome | 2 | 199 | Risk Ratio (M‐H, Fixed, 95% CI) | 0.49 [0.27, 0.86] |
| 1.47.3 NSTEMI | 1 | 474 | Risk Ratio (M‐H, Fixed, 95% CI) | 0.37 [0.18, 0.77] |
| 1.48 Target vessel revascularisation according to length of maximum follow‐up Show forest plot | 23 | 11770 | Risk Ratio (M‐H, Fixed, 95% CI) | 0.58 [0.52, 0.65] |
| 1.48.1 Less or equal to 6 months | 4 | 724 | Risk Ratio (M‐H, Fixed, 95% CI) | 0.46 [0.25, 0.84] |
| 1.48.2 Between 6 and 12 months | 8 | 1930 | Risk Ratio (M‐H, Fixed, 95% CI) | 0.58 [0.43, 0.78] |
| 1.48.3 Between 1 and 3 years | 3 | 744 | Risk Ratio (M‐H, Fixed, 95% CI) | 0.33 [0.19, 0.56] |
| 1.48.4 More or equal to 3 years | 8 | 8372 | Risk Ratio (M‐H, Fixed, 95% CI) | 0.61 [0.54, 0.69] |
| 1.48.5 Unclear | 0 | 0 | Risk Ratio (M‐H, Fixed, 95% CI) | Not estimable |
| 1.49 Target vessel revascularisation according to registration status Show forest plot | 23 | 11770 | Risk Ratio (M‐H, Fixed, 95% CI) | 0.58 [0.52, 0.65] |
| 1.49.1 Pre‐registration | 3 | 1262 | Risk Ratio (M‐H, Fixed, 95% CI) | 0.42 [0.28, 0.65] |
| 1.49.2 Post‐registration | 14 | 9425 | Risk Ratio (M‐H, Fixed, 95% CI) | 0.60 [0.53, 0.67] |
| 1.49.3 No registration | 6 | 1083 | Risk Ratio (M‐H, Fixed, 95% CI) | 0.56 [0.38, 0.82] |
| Outcome or subgroup title | No. of studies | No. of participants | Statistical method | Effect size |
| 2.1 All‐cause mortality Show forest plot | 6 | 3213 | Risk Ratio (M‐H, Fixed, 95% CI) | 0.78 [0.49, 1.22] |
| 2.2 All‐cause mortality best‐worst Show forest plot | 6 | 3231 | Risk Ratio (M‐H, Random, 95% CI) | 0.61 [0.40, 0.95] |
| 2.3 All‐cause mortality worst‐best Show forest plot | 6 | 3231 | Risk Ratio (M‐H, Random, 95% CI) | 0.92 [0.60, 1.43] |
| 2.4 All‐cause mortality according to type of drug‐eluting stent Show forest plot | 6 | 3213 | Risk Ratio (M‐H, Fixed, 95% CI) | 0.78 [0.49, 1.22] |
| 2.4.1 Everolimus | 1 | 1498 | Risk Ratio (M‐H, Fixed, 95% CI) | 0.78 [0.36, 1.71] |
| 2.4.2 Paclitaxel | 3 | 857 | Risk Ratio (M‐H, Fixed, 95% CI) | 0.83 [0.42, 1.64] |
| 2.4.3 Sirolimus | 2 | 858 | Risk Ratio (M‐H, Fixed, 95% CI) | 0.68 [0.26, 1.78] |
| 2.5 All‐cause mortality according to type of ACS Show forest plot | 6 | 3213 | Risk Ratio (M‐H, Fixed, 95% CI) | 0.78 [0.49, 1.22] |
| 2.5.1 STEMI | 6 | 3213 | Risk Ratio (M‐H, Fixed, 95% CI) | 0.78 [0.49, 1.22] |
| 2.6 All‐cause mortality according to registration status Show forest plot | 6 | 3213 | Risk Ratio (M‐H, Fixed, 95% CI) | 0.78 [0.49, 1.22] |
| 2.6.1 Post‐registration | 3 | 2856 | Risk Ratio (M‐H, Fixed, 95% CI) | 0.68 [0.41, 1.14] |
| 2.6.2 No registration | 3 | 357 | Risk Ratio (M‐H, Fixed, 95% CI) | 1.28 [0.47, 3.47] |
| 2.7 Serious adverse events Show forest plot | 7 | 3313 | Risk Ratio (M‐H, Random, 95% CI) | 0.65 [0.45, 0.93] |
| 2.8 Serious adverse events best‐worst Show forest plot | 7 | 3331 | Risk Ratio (M‐H, Random, 95% CI) | 0.56 [0.40, 0.80] |
| 2.9 Serious adverse events worst‐best Show forest plot | 7 | 3331 | Risk Ratio (M‐H, Random, 95% CI) | 0.73 [0.52, 1.03] |
| 2.10 Serious adverse events according to type of drug‐eluting stent Show forest plot | 7 | 3313 | Risk Ratio (M‐H, Random, 95% CI) | 0.65 [0.45, 0.93] |
| 2.10.1 Everolimus | 1 | 1498 | Risk Ratio (M‐H, Random, 95% CI) | 0.55 [0.30, 0.98] |
| 2.10.2 Paclitaxel | 4 | 957 | Risk Ratio (M‐H, Random, 95% CI) | 0.77 [0.41, 1.46] |
| 2.10.3 Sirolimus | 2 | 858 | Risk Ratio (M‐H, Random, 95% CI) | 0.67 [0.35, 1.28] |
| 2.11 Serious adverse events according to type of ACS Show forest plot | 7 | 3313 | Risk Ratio (M‐H, Random, 95% CI) | 0.65 [0.45, 0.93] |
| 2.11.1 STEMI | 7 | 3313 | Risk Ratio (M‐H, Random, 95% CI) | 0.65 [0.45, 0.93] |
| 2.12 Serious adverse events according to registration status Show forest plot | 7 | 3313 | Risk Ratio (M‐H, Random, 95% CI) | 0.65 [0.45, 0.93] |
| 2.12.1 Pre‐registration | 1 | 100 | Risk Ratio (M‐H, Random, 95% CI) | 0.35 [0.01, 8.31] |
| 2.12.2 Post‐registration | 3 | 2856 | Risk Ratio (M‐H, Random, 95% CI) | 0.60 [0.41, 0.88] |
| 2.12.3 No registration | 3 | 357 | Risk Ratio (M‐H, Random, 95% CI) | 1.09 [0.43, 2.76] |
| 2.13 Major cardiovascular events Show forest plot | 6 | 3150 | Risk Ratio (M‐H, Random, 95% CI) | 0.68 [0.43, 1.08] |
| 2.14 Major cardiovascular events best‐worst Show forest plot | 6 | 3168 | Risk Ratio (M‐H, Random, 95% CI) | 0.54 [0.35, 0.84] |
| 2.15 Major cardiovascular events worst‐best Show forest plot | 6 | 3168 | Risk Ratio (M‐H, Random, 95% CI) | 0.82 [0.53, 1.27] |
| 2.16 Major cardiovascular events according to type of drug‐eluting stent Show forest plot | 6 | 3150 | Risk Ratio (M‐H, Random, 95% CI) | 0.68 [0.43, 1.08] |
| 2.16.1 Everolimus | 1 | 1498 | Risk Ratio (M‐H, Random, 95% CI) | 0.78 [0.36, 1.71] |
| 2.16.2 Paclitaxel | 3 | 794 | Risk Ratio (M‐H, Random, 95% CI) | 0.66 [0.32, 1.37] |
| 2.16.3 Sirolimus | 2 | 858 | Risk Ratio (M‐H, Random, 95% CI) | 0.60 [0.25, 1.45] |
| 2.17 Major cardiovascular events according to type of ACS Show forest plot | 6 | 3150 | Risk Ratio (M‐H, Random, 95% CI) | 0.68 [0.43, 1.08] |
| 2.17.1 STEMI | 6 | 3150 | Risk Ratio (M‐H, Random, 95% CI) | 0.68 [0.43, 1.08] |
| 2.18 Major cardiovascular events according to registration status Show forest plot | 6 | 3150 | Risk Ratio (M‐H, Random, 95% CI) | 0.68 [0.43, 1.08] |
| 2.18.1 Pre‐registration | 1 | 100 | Risk Ratio (M‐H, Random, 95% CI) | 0.35 [0.01, 8.31] |
| 2.18.2 Post‐registration | 3 | 2856 | Risk Ratio (M‐H, Random, 95% CI) | 0.67 [0.41, 1.09] |
| 2.18.3 No registration | 2 | 194 | Risk Ratio (M‐H, Random, 95% CI) | 0.92 [0.24, 3.58] |
| 2.19 Cardiovascular mortality Show forest plot | 5 | 2406 | Risk Ratio (M‐H, Fixed, 95% CI) | 0.73 [0.43, 1.25] |
| 2.20 Cardiovascular mortality best‐worst Show forest plot | 5 | 2423 | Risk Ratio (M‐H, Fixed, 95% CI) | 0.53 [0.32, 0.88] |
| 2.21 Cardiovascular mortality worst‐best Show forest plot | 5 | 2423 | Risk Ratio (M‐H, Random, 95% CI) | 0.90 [0.54, 1.50] |
| 2.22 Cardiovascular mortality according to type of drug‐eluting stent Show forest plot | 5 | 2406 | Risk Ratio (M‐H, Fixed, 95% CI) | 0.73 [0.43, 1.25] |
| 2.22.1 Everolimus | 1 | 1498 | Risk Ratio (M‐H, Fixed, 95% CI) | 0.78 [0.36, 1.71] |
| 2.22.2 Paclitaxel | 3 | 794 | Risk Ratio (M‐H, Fixed, 95% CI) | 0.67 [0.30, 1.46] |
| 2.22.3 Sirolimus | 1 | 114 | Risk Ratio (M‐H, Fixed, 95% CI) | 0.90 [0.13, 6.17] |
| 2.23 Cardiovascular mortality according to type of ACS Show forest plot | 5 | 2406 | Risk Ratio (M‐H, Fixed, 95% CI) | 0.73 [0.43, 1.25] |
| 2.23.1 STEMI | 5 | 2406 | Risk Ratio (M‐H, Fixed, 95% CI) | 0.73 [0.43, 1.25] |
| 2.24 Cardiovascular mortality according to registration status Show forest plot | 5 | 2406 | Risk Ratio (M‐H, Fixed, 95% CI) | 0.73 [0.43, 1.25] |
| 2.24.1 Pre‐registration | 1 | 100 | Risk Ratio (M‐H, Fixed, 95% CI) | 0.35 [0.01, 8.31] |
| 2.24.2 Post‐registration | 2 | 2112 | Risk Ratio (M‐H, Fixed, 95% CI) | 0.70 [0.39, 1.25] |
| 2.24.3 No registration | 2 | 194 | Risk Ratio (M‐H, Fixed, 95% CI) | 1.30 [0.27, 6.38] |
| 2.25 Myocardial infarction Show forest plot | 6 | 3150 | Risk Ratio (M‐H, Random, 95% CI) | 0.51 [0.26, 0.98] |
| 2.26 Myocardial infarction best‐worst Show forest plot | 6 | 3168 | Risk Ratio (M‐H, Random, 95% CI) | 0.37 [0.20, 0.68] |
| 2.27 Myocardial infarction worst‐best Show forest plot | 6 | 3168 | Risk Ratio (M‐H, Random, 95% CI) | 0.74 [0.41, 1.32] |
| 2.28 Myocardial infarction according to type of drug‐eluting stent Show forest plot | 6 | 3150 | Risk Ratio (M‐H, Random, 95% CI) | 0.51 [0.26, 0.98] |
| 2.28.1 Everolimus | 1 | 1498 | Risk Ratio (M‐H, Random, 95% CI) | 0.55 [0.19, 1.64] |
| 2.28.2 Paclitaxel | 3 | 794 | Risk Ratio (M‐H, Random, 95% CI) | 0.38 [0.09, 1.63] |
| 2.28.3 Sirolimus | 2 | 858 | Risk Ratio (M‐H, Random, 95% CI) | 0.54 [0.20, 1.46] |
| 2.29 Myocardial infarction according to type of ACS Show forest plot | 6 | 3150 | Risk Ratio (M‐H, Random, 95% CI) | 0.51 [0.26, 0.98] |
| 2.29.1 STEMI | 6 | 3150 | Risk Ratio (M‐H, Random, 95% CI) | 0.51 [0.26, 0.98] |
| 2.30 Myocardial infarction according to registration status Show forest plot | 6 | 3150 | Risk Ratio (M‐H, Random, 95% CI) | 0.51 [0.26, 0.98] |
| 2.30.1 Pre‐registration | 1 | 100 | Risk Ratio (M‐H, Random, 95% CI) | Not estimable |
| 2.30.2 Post‐registration | 3 | 2856 | Risk Ratio (M‐H, Random, 95% CI) | 0.50 [0.25, 1.00] |
| 2.30.3 No registration | 2 | 194 | Risk Ratio (M‐H, Random, 95% CI) | 0.59 [0.07, 4.69] |
| 2.31 Stent thrombosis Show forest plot | 5 | 3070 | Risk Ratio (M‐H, Random, 95% CI) | 0.48 [0.26, 0.90] |
| 2.32 Stent thrombosis best‐worst Show forest plot | 5 | 3088 | Risk Ratio (M‐H, Random, 95% CI) | 0.36 [0.20, 0.65] |
| 2.33 Stent thrombosis worst‐best Show forest plot | 5 | 3088 | Risk Ratio (M‐H, Random, 95% CI) | 0.68 [0.39, 1.18] |
| 2.34 Stent thrombosis according to type of drug‐eluting stent Show forest plot | 5 | 3070 | Risk Ratio (M‐H, Random, 95% CI) | 0.48 [0.26, 0.90] |
| 2.34.1 Everolimus | 1 | 1498 | Risk Ratio (M‐H, Random, 95% CI) | 0.37 [0.15, 0.95] |
| 2.34.2 Paclitaxel | 2 | 714 | Risk Ratio (M‐H, Random, 95% CI) | 0.66 [0.11, 3.94] |
| 2.34.3 Sirolimus | 2 | 858 | Risk Ratio (M‐H, Random, 95% CI) | 0.58 [0.23, 1.46] |
| 2.35 Stent thrombosis according to type of ACS Show forest plot | 5 | 3070 | Risk Ratio (M‐H, Random, 95% CI) | 0.48 [0.26, 0.90] |
| 2.35.1 STEMI | 5 | 3070 | Risk Ratio (M‐H, Random, 95% CI) | 0.48 [0.26, 0.90] |
| 2.36 Stent thrombosis according to registration status Show forest plot | 5 | 3070 | Risk Ratio (M‐H, Random, 95% CI) | 0.48 [0.26, 0.90] |
| 2.36.1 Pre‐registration | 1 | 100 | Risk Ratio (M‐H, Random, 95% CI) | Not estimable |
| 2.36.2 Post‐registration | 3 | 2856 | Risk Ratio (M‐H, Random, 95% CI) | 0.47 [0.25, 0.88] |
| 2.36.3 No registration | 1 | 114 | Risk Ratio (M‐H, Random, 95% CI) | 0.90 [0.06, 14.04] |
| 2.37 Target vessel revascularisation Show forest plot | 6 | 3233 | Risk Ratio (M‐H, Random, 95% CI) | 0.50 [0.31, 0.82] |
| 2.38 Target vessel revascularisation best‐worst Show forest plot | 6 | 3251 | Risk Ratio (M‐H, Random, 95% CI) | 0.41 [0.26, 0.66] |
| 2.39 Target vessel revascularisation worst‐best Show forest plot | 6 | 3251 | Risk Ratio (M‐H, Random, 95% CI) | 0.62 [0.40, 0.98] |
| 2.40 Target vessel revascularisation according to type of drug‐eluting stent Show forest plot | 6 | 3233 | Risk Ratio (M‐H, Random, 95% CI) | 0.50 [0.31, 0.82] |
| 2.40.1 Everolimus | 1 | 1498 | Risk Ratio (M‐H, Random, 95% CI) | 0.36 [0.17, 0.76] |
| 2.40.2 Paclitaxel | 3 | 877 | Risk Ratio (M‐H, Random, 95% CI) | 0.52 [0.18, 1.49] |
| 2.40.3 Sirolimus | 2 | 858 | Risk Ratio (M‐H, Random, 95% CI) | 0.77 [0.29, 2.04] |
| 2.41 Target vessel revascularisation according to type of ACS Show forest plot | 6 | 3233 | Risk Ratio (M‐H, Random, 95% CI) | 0.50 [0.31, 0.82] |
| 2.41.1 STEMI | 6 | 3233 | Risk Ratio (M‐H, Random, 95% CI) | 0.50 [0.31, 0.82] |
| 2.42 Target vessel revascularisation according to registration status Show forest plot | 6 | 3233 | Risk Ratio (M‐H, Random, 95% CI) | 0.50 [0.31, 0.82] |
| 2.42.1 Pre‐registration | 1 | 100 | Risk Ratio (M‐H, Random, 95% CI) | Not estimable |
| 2.42.2 Post‐registration | 3 | 2856 | Risk Ratio (M‐H, Random, 95% CI) | 0.53 [0.32, 0.90] |
| 2.42.3 No registration | 2 | 277 | Risk Ratio (M‐H, Random, 95% CI) | 0.34 [0.09, 1.29] |
