Aterectomía rotacional transluminal percutánea para la enfermedad coronaria
Referencias
Referencias de los estudios incluidos en esta revisión
Referencias de los estudios excluidos de esta revisión
Referencias de los estudios en espera de evaluación
Referencias adicionales
Characteristics of studies
Characteristics of included studies [ordered by study ID]
| Study characteristics | ||
| Methods | RCT | |
| Participants | Group 1 PTCRA: N = 152 Group 2 PTCA: N = 146 Inclusions: angina or objective evidence of target vessel‐related ischaemia, or both; documented ISR > 70% by visual assessment within a stent ± 5 mm of the stent edges, stent diameter ≥ 2.5 mm (balloon during implantation), ISR as the only lesion for treatment, length of ISR of 10 to 50 mm by visual assessment, and lesion accessible for rotablation Exclusions: acute MI within the previous month, left ventricular ejection fraction < 30%, evidence of intraluminal thrombus or dissection, unprotected ostial stenoses, missing visualisation of the distal lumen after crossing with a guidewire, stents obviously not fully expanded, stents at or directly distal to a bend > 45°, stents implanted within the previous 3 months, and stents with a classic coil design that might impair QCA | |
| Interventions | Group 1: the final burr‐to‐artery (stent) ratio was ≥ 0.7. Adjunctive PTCA was performed with a balloon 0.25 to 0.5 mm larger than during stent implantation with a pressure of ≤ 6 atm. If the investigator was not satisfied with the angiographic result, higher pressures in 2‐atm steps were allowed. The use of ≥ 160,000 rpm was initially proposed, during the study, this was changed to ≥ 140,000 rpm. Operators were urged to avoid drops ≥ 5000 rpm Group 2: balloon angioplasty was performed with locally customised balloon catheters. The balloon‐to‐artery ratio should be ≥ 1.0; the inflation pressure used was at the discretion of the investigator to achieve a final diameter stenosis of < 30% Pre‐medication: patients received a bolus of heparin 10,000 to 15,000 IU before the intervention. Supplementary heparin was used under activated clotting time monitoring (≥ 250 s). All patients were continuously treated with of acetylsalicylic acid (aspirin) 100 mg for 6 months and ticlopidine 250 mg twice daily, or clopidogrel 75 mg once daily for ≥ 2 weeks after the procedure | |
| Outcomes | Primary study end point: minimum lumen diameter assessed from quantitative angiography at 6 months after treatment Secondary end point: safety and efficacy (short‐term success), event‐free survival and re‐stenosis (> 50% diameter reduction) of the target lesion after 6 months | |
| Notes | ‐ | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | "Balance between treatment arms within the centers was achieved by randomizing in blocks." Insufficient information |
| Allocation concealment (selection bias) | Unclear risk | Insufficient information |
| Blinding of participants and personnel (performance bias) | Low risk | Not blinded |
| Blinding of outcome assessment (detection bias) | Low risk | Not blinded |
| Incomplete outcome data (attrition bias) | Unclear risk | Incomplete outcome data for both primary and secondary end points |
| Selective reporting (reporting bias) | Unclear risk | The study protocol is available and all of the study's pre‐specified (primary and secondary) outcomes that are of interest in the review have been reported in the pre‐specified way |
| Study characteristics | ||
| Methods | RCT | |
| Participants | Group 1 PTCRA: N = 252 Group 2 PTCA: N = 250 Inclusions: patients aged 20 to 80 years with angiographically documented coronary artery disease and clinical symptoms of angina. Angiographic inclusion criteria: stenosis was considered haemodynamically significant and eligible for the study, if there was a reduction in luminal area of 70% to 99% and diameters were < 1 mm for a length of at least 5 mm. In addition at least one secondary criterion had to be fulfilled, such as heavily calcified, ostial, bifurcational location, eccentric, diffuse, within an angulated (> 45°) segment Exclusions: patients with unstable angina, MI within the previous 4 weeks, previous coronary angioplasty of the target vessel within the last 2 months, poor left ventricular function (ejection fraction ≤ 30%) or any other condition that will limit long‐term prognosis were excluded from the study | |
| Interventions | Group 1: PTCRA was performed with burr sizes from 1.25 to 2.5 mm, recommended burr speed was 160,000 to 190,000 rpm with each sequence being < 30 s; intracoronary nitroglycerin 100 to 200 µg was administered after each sequence. It was advised to use incremental burr sizes to achieve a burr‐to‐artery ratio of at least 0.7. The decision about performing an adjunctive PTCA at low pressure (< 4 atm) was left to the operator Group 2: PTCA was performed with balloon lengths of 20 to 40 mm. The technique to achieve an optimal angiographic result was left to the operator. The use of stents for bail out (flow‐limiting dissections, severe recoil, vessel closure) or unsatisfactory results (residual diameter stenosis > 50%) was allowed, but was explicitly not encouraged Pre‐medication: included acetylsalicylic acid (aspirin). In both treatment arms IV vasodilating pre‐treatment consisted of nitroglycerin 2 to 4 mg/hour and nifedipine 0.5 to 1.5 mg/hour at least 2 hours before the intervention, accompanied by a 500‐mL saline infusion. In the catheterisation laboratory heparin was administered as a bolus of 15,000 to 20,000 units to maintain the activated clotting time above 350 s during the procedure. Intracoronary nitroglycerin was allowed according to operator judgement | |
| Outcomes | Primary study end points: 1. procedural success, defined as angiographically confirmed residual stenoses < 50% and stenosis reduction of at least 20% in the absence of new MI, emergency CABG and death 2. 6 months' re‐stenosis in the treated segment defined as (a) > 50% diameter stenosis or (b) > 50% diameter stenosis and > 50% late loss of the acute luminal gain 3. major cardiac events during the follow‐up period Secondary end point: clinical outcome as assessed by the angina grading of the Canadian Cardiovascular Society Classification and the exercise tolerance scale of the modified Bruce protocol | |
| Notes | ‐ | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | "Randomization was carried out with computer generated permutated blocks for each participating centre" |
| Allocation concealment (selection bias) | Unclear risk | Insufficient information |
| Blinding of participants and personnel (performance bias) | Low risk | Insufficient information, but the review authors judge that the outcome is not likely to be influenced by lack of blinding |
| Blinding of outcome assessment (detection bias) | Low risk | Insufficient information, but the review authors judge that the outcome is not likely to be influenced by lack of blinding |
| Incomplete outcome data (attrition bias) | High risk | "Complete follow‐up over 6 months was available from 423/497 patients". 15% loss to follow‐up |
| Selective reporting (reporting bias) | Low risk | The study protocol is available and all of the study's pre‐specified outcomes that are of interest in the review have been reported in the pre‐specified way |
| Study characteristics | ||
| Methods | RCT | |
| Participants | Group 1 PTCRA: N = 227 Group 2 PTCA: N = 219 Inclusions: target lesion on angiography of ≥ 70% diameter stenosis by careful visual estimate and evidence of myocardial ischaemia caused by the target lesion, defined as either symptoms of angina or positive results of a functional study. The lesion had to be no more than 20 mm in length within a native coronary artery with a reference diameter of 2.0 to 3.0 mm, without other haemodynamically significant stenoses in that vessel that warranted re‐vascularisation Exclusions: lesions with severe calcification, past history of 3 prior procedures involving the target lesion, contraindication to emergent CABG surgery, MI within 7 days before the procedure, rest angina unrelieved by medical therapy within the preceding 48 hours The angiographic criteria for patient exclusion were: total occlusion presence of thrombus, aorto‐ostial lesions, vessel angulation > 60°, bifurcation lesions requiring intervention on both involved vessels, prior stent re‐vascularisation proximal to the target lesion | |
| Interventions | Group 1: a stepped burr approach was used to achieve a final burr‐to‐artery ratio of 0.70 to 0.85. A platform speed of approximately 180,000 rpm was used for burrs ≤ 2.0 mm in diameter, and 160,000 was used for burrs > 2.0 mm. It was recommended that there be no burr decelerations of > 5000 rpm. After rotational arthrectomy, in cases where a suboptimal result had been achieved, low‐pressure adjunctive balloon angioplasty with inflation pressures not exceeding 1 atm was permitted Group 2: the final balloon size was selected to provide a balloon‐to‐artery ratio of between 0.9 and 1.1. The final pressure and duration of balloon inflation were left to the discretion of the operator Pre‐medication: all patients received acetylsalicylic acid (aspirin) 325 mg orally, a calcium channel blocker and IV heparin before the start of the procedure. Intracoronary nitroglycerin was administered before baseline and after intervention angiography | |
| Outcomes | Primary study end point: target vessel failure as defined as the composite end point of death, Q‐wave MI, and clinically driven repeat re‐vascularisation of the target vessel Secondary study end points: acute procedural success that was a composite of attainment of a < 50% diameter stenosis in the absence of in hospital major adverse cardiac events; acute device success, defined as the achievement < 50% stenosis of the target lesion without cross‐over treatment or unplanned coronary stenting; binary angiographic re‐stenosis, defined as per cent diameter stenosis > 50% at the 8‐month follow‐up; target lesion re‐vascularisation, defined as clinically driven re‐vascularisation of the target lesion; target vessel re‐vascularisation, defined as clinically driven re‐vascularisation of any lesion of the target vessel; and MI, defined as: 1) Q‐wave, the development of new, pathological Q‐waves in ≥ 2 contiguous leads with post‐procedure CK‐MB levels higher than normal, or 2) non‐Q‐wave, elevation of post‐procedure CK levels to > 2 times normal with CK‐MB levels higher than normal in the absence of new, pathological Q waves | |
| Notes | ‐ | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | "Patients were randomised" |
| Allocation concealment (selection bias) | Unclear risk | Insufficient information |
| Blinding of participants and personnel (performance bias) | Low risk | Incomplete description of blinding, but outcomes are not likely to be influenced by lack of blinding |
| Blinding of outcome assessment (detection bias) | Low risk | "An independent clinical events committee that was unaware of each patient's treatment assignment adjudicated all major adverse cardiac events" |
| Incomplete outcome data (attrition bias) | Unclear risk | Patient loss to follow‐up similar in both groups. Large number lost |
| Selective reporting (reporting bias) | Low risk | The study protocol is available and all of the study's pre‐specified (primary and secondary) outcomes that are of interest in the review have been reported in the pre‐specified way |
| Study characteristics | ||
| Methods | RCT | |
| Participants | No specific entry criteria reported | |
| Interventions | Pre‐medication not stated Group 1: PTCRA with adjunctive PTCA and stent placement Group 2: PTCA with stent placement | |
| Outcomes | ‐ | |
| Notes | Insufficient information reported, unable to obtain full text for review | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Insufficient information |
| Allocation concealment (selection bias) | Unclear risk | Insufficient information |
| Blinding of participants and personnel (performance bias) | Unclear risk | Insufficient information |
| Blinding of outcome assessment (detection bias) | Unclear risk | Insufficient information |
| Incomplete outcome data (attrition bias) | Unclear risk | Insufficient information |
| Selective reporting (reporting bias) | Unclear risk | Insufficient information |
| Study characteristics | ||
| Methods | RCT | |
| Participants | Group 1 PTCRA: N = 24 Group 2 PTCA: N = 26 Inclusions: patients with stable or unstable angina with at least 1 lesion (> 50% stenosis) in a native vessel suitable for angioplasty. Additional inclusion criteria for angioscopy were coronary artery lumen diameter between 2.5 and 3.5 mm; target lesion in a straight segment of artery; lesion at least 20 mm away from the coronary ostium; absence of left main coronary artery disease Exclusions: acute MI within 24 hours before the procedure, a re‐stenotic lesion, a total occlusion, or a vein graft lesion | |
| Interventions | Group 1: PTCRA using 8F‐9F sheath. 1 burr used per lesion with size chosen to obtain a burr‐to‐artery ratio of 0.7. Adjunctive PTCA performed after PTCRA with inflation pressure < 6 atm Group 2: PTCA using "standard techniques". 8F sheath and balloon size chosen to obtain a balloon‐to‐artery ratio of approximately 1.0 Pre‐medication: acetylsalicylic acid (aspirin); IV heparin 10,000 IU bolus and intracoronary nitroglycerin 150 mg | |
| Outcomes | Angioscopic findings defined as: 1. Flaps, graded 1 to 3 2. Thrombi, graded 1 to 3 3. Subintimal haemorrhage 4. Longitudinal dissection Angiographic success defined as residual stenosis ≤ 50% in the absence of severe coronary artery dissection (grade D1 or higher) Clinical success defined as angiographic success in the absence of major complications, such as death, MI and bypass surgery | |
| Notes | ‐ | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | "After initial angiography each patient was randomized". Insufficient information |
| Allocation concealment (selection bias) | Unclear risk | Insufficient information |
| Blinding of participants and personnel (performance bias) | Low risk | Insufficient information, but the review authors judge that the outcome is not likely to be influenced by lack of blinding |
| Blinding of outcome assessment (detection bias) | Low risk | Angioscopic and angiographic assessors were blinded, unclear if clinical assessors were blinded, but the review authors judge that the outcome is not likely to be influenced by lack of blinding |
| Incomplete outcome data (attrition bias) | Low risk | No missing outcome data |
| Selective reporting (reporting bias) | Low risk | The study protocol is available and all of the study's pre‐specified outcomes that are of interest in the review have been reported in the pre‐specified way |
| Study characteristics | ||
| Methods | RCT | |
| Participants | Group 1 PTCRA: N = 231 Group 2 ELCA: N = 232 Group 3 PTCA: N = 222 Inclusions: target lesions and vessels suitable for all techniques. Patients with multi‐vessel coronary disease were also eligible, but the culprit lesion was specified as the target before coronary intervention began Exclusions: lesion characteristics (stenosis angulation > 60°, bend stenosis with an outwardly eccentric lumen, and bifurcational lesions requiring double guidewires) and vessel (extreme proximal vessel tortuosity, saphenous bypass graft or presence of intraluminal thrombus (filling defect), and total occlusion deemed not transferable with guidewires), acute MI or PTCA of any other vessel within the last 4 months | |
| Interventions | Group 1: PTCRA used burr sizes from 1.25 to 2.25 mm rotating at 160,000 to 180,000 rpm with each sequence lasting from 10 to 15 seconds with extended pauses to allow for washout of debris. Teflon sheath over the drive shaft flushed with solution containing a cocktail of heparin 10,000 IU, nitroglycerin 2 mg and verapamil 5 mg in 500 mL saline. Target burr‐to‐artery ratio was 0.67. Adjunctive PTCA used to obtain < 50% residual stenosis. Inflation pressures used were at most 4 atm Group 2: ELCA used 2 different 308‐nm xenon chloride excimer lasers. The first system used a pulse duration of 210 ns, a pulse repetition rate of 20 to 30 Hz, and energy to 45 to 70 mJ/mm3. The second used a pulse duration of 135 ns, a pulse repetition rate of 25 Hz and energy of 45 to 60 mJ/mm3. No saline infusion protocol used. Adjunctive PTCA used to obtain < 50% residual stenosis. Inflation pressures were at most 4 atm Group 3: PTCA used any approved rapid exchange balloon dilation system of length 20, 30, 35 and 40 mm. Specific protocols used to achieve optimal angiographic results left to the operator. Recommendations include a balloon‐to‐artery ratio of 1 and incremental increase of pressure by 1 atm per 10 to 15 seconds until full expansion Pre‐medication: 1 day prior to procedure, acetylsalicylic acid (aspirin) > 160 mg and oral nitrates. Heparin 25,000 IU bolus restricted to patients with long, spiral dissections | |
| Outcomes | ‐ | |
| Notes | ‐ | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | "Treatment assignments were cross‐checked against a computer‐generated randomization sequence" |
| Allocation concealment (selection bias) | Low risk | "Randomization to one of the three treatment arms was carried out by means of sealed envelopes on the day of admission" |
| Blinding of participants and personnel (performance bias) | High risk | "This is an unblinded study" |
| Blinding of outcome assessment (detection bias) | High risk | "This is an unblinded study" |
| Incomplete outcome data (attrition bias) | Low risk | "Primary analysis of procedural angiographic and clinical outcomes was based on the intention‐to‐treat principle and involved all randomized patients" |
| Selective reporting (reporting bias) | Low risk | Authors addressed sources of bias |
| Study characteristics | ||
| Methods | RCT | |
| Participants | Group 1 PTCRA: N = 32 Group 2 PTCA: N = 32 Inclusion: patients with a significant stenosis (defined as > 60% reduction of the lumen diameter as assessed by quantitative computed angiography) in 1 or more major coronary vessels, a clinical indication for re‐vascularisation, and a left ventricular ejection fraction > 40% Exclusions: Ms within the last month, re‐stenosis, bypass graft lesions, presence of intraluminal defect, ostial lesions and total occlusions | |
| Interventions | Group 1: several burr passes of < 15 seconds. Burr‐to‐artery ratio 50% to 70% "Medium sized bur" passed for 15 seconds followed by adjunctive balloon angioplasty. Intracoronary injection of isosorbide dinitrate 2 mg Group 2: balloon‐artery ratio of 1:1. Use of a 7F or 8F catheter Pre‐medication: acetylsalicylic acid (aspirin) 250 mg/day for 3 days prior to intervention. 10,000 units of heparin given IV before procedure | |
| Outcomes | Primary end point: primary success rate defined as lesion stenosis reduction > 20% with residual stenosis < 50% in the absence of death, emergency CABG, or Q‐wave MI Secondary end point: re‐stenosis rate | |
| Notes | ‐ | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | A centralised randomisation was done with blocking in groups of 4 assigned patients to 2 treatment groups |
| Allocation concealment (selection bias) | Unclear risk | Insufficient information |
| Blinding of participants and personnel (performance bias) | Unclear risk | Insufficient information |
| Blinding of outcome assessment (detection bias) | Low risk | "A technician and a cardiologist unaware of the protocol" |
| Incomplete outcome data (attrition bias) | High risk | 10 patients have no follow‐up data. Loss to follow‐up not explained |
| Selective reporting (reporting bias) | Low risk | All outcomes reported from available sample patients |
| Study characteristics | ||
| Methods | RCT | |
| Participants | Group 1 PTCRA: N = 21 Group 2 PTCA: N = 20 Inclusion: patients with long, 'denovo lesions'. Lesion length > 20 mm, stenosis diameter > 50% in a native left anterior descending artery between 2 and 2.9 mm in size. Exclusions: contraindication to antiplatelet therapy, total occlusion, infarct‐related artery, left ventricular dysfunction (ejection fraction < 40%), or an inability to follow the protocol | |
| Interventions | Group 1: single burr. Burr‐to‐artery ratio 0.6. Either 1.5 to 2.0 mm burr at 160,000 rpm or > 2.0 burr at 140,000 rpm Group 2: non‐compliant balloon. Balloon‐artery ratio of 1.1:1. Pressures < 4 atm Tubular stents used in both patients Pre‐medication: ticlopidine twice daily for 3 days prior and acetylsalicylic acid (aspirin) 200 mg for both groups | |
| Outcomes | Primary end point: incidence of angiographic re‐stenosis at follow‐up Secondary end point: adverse clinical events such as MI, stroke or target vessel re‐vascularisation | |
| Notes | ‐ | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | "Computer generated randomization lists" Comment: adequate sequence generation |
| Allocation concealment (selection bias) | Unclear risk | Insufficient information |
| Blinding of participants and personnel (performance bias) | Unclear risk | Insufficient information |
| Blinding of outcome assessment (detection bias) | Low risk | "Two experienced angiographers unaware of the study purpose performed the angiographic measurements" |
| Incomplete outcome data (attrition bias) | Low risk | All patients have clinical follow‐up for at least 12 months |
| Selective reporting (reporting bias) | Low risk | All outcomes reported from sample patients |
| Study characteristics | ||
| Methods | RCT | |
| Participants | Group 1 PTCRA: N = 58 Group 2 CBA: N = 55 Inclusion criteria: diffuse ISR (lesion length N10 mm, diameter stenosis N50%) in a native coronary artery with angina, demonstrable MI Exclusion criteria: acute MI < 72 hours before treatment, poor renal function (serum creatinine N3.0 mg/dL), pregnancy, contraindication to antiplatelet therapy and concomitant serious disease with expected survival of < 2 years | |
| Interventions | Group 1: single burr approach. Burr‐to‐artery ratio 0.7 Group 2: single of multi‐balloon approach dependent on size of the lesion. Pressures up to 14 atm used Brachytherapy was then used to deliver a 18‐Gy dose of B radiation 1.0 mm deep into vessel wall. Fractionation was allowed in patients with severe angina or significant haemodynamic instability Pre‐medication: all participants were given with acetylsalicylic acid (aspirin) 200 mg/day, clopidogrel 75 mg/day and cilostazol 200 mg/day for 2 days prior to intervention | |
| Outcomes | Primary end point: angiographic re‐stenosis at 6 months Secondary end point: major adverse cardiac event, MI, death, target lesion re‐vascularisation) at 9 months | |
| Notes | ||
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | "Patients were randomly assigned" |
| Allocation concealment (selection bias) | Unclear risk | Insufficient information |
| Blinding of participants and personnel (performance bias) | Unclear risk | Insufficient information |
| Blinding of outcome assessment (detection bias) | Unclear risk | "Experienced angiographers used an online quantitative… system" Comment: no discussion as to whether assessors were separate from study or aware of groups |
| Incomplete outcome data (attrition bias) | Unclear risk | "We obtained angiographic follow‐up in 90 patients (80%), 47 in group 1 and 43 in group 2" Comment: 20% of patients lost to angiographic follow‐up with no discussion regarding reasons why the patients were not reviewed. 9‐month clinical data were available for all patients, but not at 6 months. No discussion by the authors |
| Selective reporting (reporting bias) | Low risk | All obtained data is reported |
| Study characteristics | ||
| Methods | Retrospective analysis of clinical trial | |
| Participants | Group 1 RA + PTCA: N = 130 Group 2 ELCA + PTCA: N = 119 Inclusions: diffuse (> 10 mm in length) ISR in tubular slotted or multi‐cellular stents Exclusions: limited to patients participating in brachytherapy protocols, focal ISR, and saphenous vein graft ISR | |
| Interventions | Group 1: mean value of the largest laser fibre catheter used was 1.81 ± 0.18 mm in diameter; the maximum catheter size was 1.4 mm in 19 (12%), 1.7 mm in 59 (37%), and 2.0 mm in 80 (51%) cases. The laser catheter–to–artery ratio was 0.72 ± 0.21. A single‐pass technique was used in 52%. Energy densities were 35 to 55 mJ/mm2 (mean 45.7 ± 5.5 mJ/mm2). A 'saline flush' technique was used in all cases. Adjunct PTCA was performed with nominal balloon size 3.6 ± 0.6 mm, balloon‐to‐artery ratio 1.3 ± 0.3, and maximum inflation pressure 17 ± 3 atm. Additional stents were placed in 41 (25.6%) lesions Group 2: the mean value of the largest laser fibre catheter used was 1.81 ± 0.18 mm in diameter; the maximum catheter size was 1.4 mm in 19 (12%), 1.7 mm in 59 (37%), and 2.0 mm in 80 (51%) cases. The laser catheter–to–artery ratio was 0.72 ± 0.21. A single‐pass technique was used in 52%. Energy densities were 35 to 55 mJ/mm2 (mean 45.7 ± 5.5 mJ/mm2). A 'saline flush' technique was used in all cases. Adjunct PTCA was performed with nominal balloon size 3.6 ± 0.6 mm, balloon‐to‐artery ratio 1.3 ± 0.3, and maximum inflation pressure 17 ± 3 atm. Additional stents were placed in 41 (25.6%) lesions Pre‐medication: not stated | |
| Outcomes | Primary end point: minimal lumen diameter, reference diameter, and per cent diameter stenosis were measured by: coronary angiography, quantative planar IVUS and volumetric IVUS Secondary end point: major late clinical events were source documented and adjudicated (death, Q‐wave MI, and ischaemia‐driven target lesion site re‐vascularisation) | |
| Notes | ‐ | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | High risk | "Lesions were not randomized to the 2 treatment strategies" |
| Allocation concealment (selection bias) | High risk | "Operators were not blinded to any of the IVUS imaging runs" |
| Blinding of participants and personnel (performance bias) | Unclear risk | Insufficient information |
| Blinding of outcome assessment (detection bias) | Unclear risk | Insufficient information |
| Incomplete outcome data (attrition bias) | Low risk | No missing outcome measures |
| Selective reporting (reporting bias) | Low risk | "No significant between‐group differences in preintervention or final postintervention quantitative coronary angiographic or planar IVUS measurements of luminal dimensions" |
| Study characteristics | ||
| Methods | RCT | |
| Participants | Group 1 PTCRA: N = 100 Group 2 PTCA: N = 100 Inclusions: diffuse ISR who were lesion length of ≥ 10 mm in a high‐pressure deployed stent (3.0 to 3.5 mm in size) at least 8 weeks before current PCI Exclusion criteria: patients with acute MI, underdeployed stents (stents cross‐sectional area < 60% of average of proximal and distal vessel area), inability to cross the lesion with the guidewire, possible or definite thrombus within the stent, unprotected left main coronary artery disease of > 50% obviating the use of 8F guiding catheter or failure to obtain informed consent | |
| Interventions | Group 1: RA using an 8F to 10F guide catheter and a step‐burr approach to achieve a > 0.70 burr‐to‐artery ratio. Rotablator burr was activated at 160,000 to 180,000 rpm and a pecking motion used to avoid decelerations of > 5000 rpm. Post‐dilation with a semi‐compliant long (20 mm) balloon with a balloon‐to‐artery ratio of 1.1 to 1.2:1 was performed at 3 to 6 atm PTCA group: a semi‐compliant or non‐compliant long balloon with balloon‐to‐artery ratio of 1.1 to 1.2:1 was used for high‐pressure inflation (12 to 16 atm). Decision to use a coronary stent was left to the discretion of the operator and its use was advised only in those cases with > 30% residual diameter stenosis or significant intimal dissections Pre‐medication: all patients received acetylsalicylic acid (aspirin) 325 mg orally and heparin 70 units/kg IV bolus. Subsequently, IV heparin boluses were given periodically to maintain the activated clotting time between 250 and 300 s throughout the procedure with a trend towards lower values (225 to 250 s) if glycoprotein IIb/IIIa inhibitor was used. The IIb/IIIa inhibitors were administered only if clinically necessary due to procedural events and were rarely started before procedure | |
| Outcomes | Primary end point: incidence of repeat target lesion re‐vascularisation at 9 months Secondary end points: MACE defined as death, MI or repeat target lesion intervention (PCI or bypass surgery) | |
| Notes | ‐ | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | "A total of 200 patients were randomized, 100 to PRCA and 100 to PTCA". Method unclear |
| Allocation concealment (selection bias) | Unclear risk | Insufficient information |
| Blinding of participants and personnel (performance bias) | Unclear risk | Insufficient information |
| Blinding of outcome assessment (detection bias) | Unclear risk | Insufficient information |
| Incomplete outcome data (attrition bias) | Unclear risk | Missing data not reporting in text |
| Selective reporting (reporting bias) | Low risk | All relevant outcomes reported |
| Study characteristics | ||
| Methods | RCT | |
| Participants | Group 1 PCTRA: N = 328 Group 2 PTCA: N = 342 No specific entry criteria mentioned | |
| Interventions | Intervention: rotational ablation prior to stenting Comparison: balloon dilation prior to stenting | |
| Outcomes | Post‐treatment minimal luminal diameter, angiographic success, clinical success, MACE (in hospital), non‐Q MI, re‐intervention | |
| Notes | ‐ | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Insufficient information |
| Allocation concealment (selection bias) | Unclear risk | Insufficient information |
| Blinding of participants and personnel (performance bias) | Unclear risk | Insufficient information |
| Blinding of outcome assessment (detection bias) | Unclear risk | Insufficient information |
| Incomplete outcome data (attrition bias) | High risk | Data only available for 194/370 PTCA and 170/328 PTCRA participants |
| Selective reporting (reporting bias) | Unclear risk | Insufficient information |
atm: atmosphere; CABG: coronary artery bypass graft; CBA: cutting balloon angioplasty; CK‐MB: creatine kinase MB; ELCA: excimer laser coronary angioplasty; ISR: in‐stent re‐stenosis; IU: international units; IV: intravenous; IVUS: intravascular ultrasound; MI: myocardial infarction; PCI: percutaneous coronary intervention; PTCA: percutaneous transluminal coronary angioplasty; PTCRA: percutaneous transluminal coronary rotational atherectomy; QCA: quantitative coronary angiography; RA: rotational atherectomy; RCT: randomised controlled trial; rpm: revolutions per minute.
Characteristics of excluded studies [ordered by study ID]
| Study | Reason for exclusion |
| Not an RCT | |
| Cross‐over study | |
| Case‐series study | |
| Both groups received PTCRA | |
| Case series, not an RCT | |
| Non‐randomised retrospective trial | |
| Retrospective study | |
| Case series, not an RCT | |
| All patients received PTCRA | |
| Case series, not an RCT | |
| Earlier paper on Parikh 2011 ‐ all patients received orbital artherectomy | |
| All patients received orbital artherectomy | |
| All patients received PTCRA | |
| Case series, not an RCT | |
| All patients received PTCRA | |
| Not an RCT | |
| Both groups received PTCRA | |
| Observational study | |
| Both groups received PTCRA | |
| Narrative review, not an RCT |
PTCRA: percutaneous transluminal coronary rotational atherectomy; RCT: randomised controlled trial.
Characteristics of studies awaiting classification [ordered by study ID]
| Methods | |
| Participants | |
| Interventions | |
| Outcomes | |
| Notes | Awaiting translation |
| Methods | Randomised control trial |
| Participants | |
| Interventions | |
| Outcomes | |
| Notes | Have contacted authors |
Data and analyses
| Outcome or subgroup title | No. of studies | No. of participants | Statistical method | Effect size |
| 1.1 Procedural success Show forest plot | 1 | Risk Ratio (M‐H, Random, 95% CI) | Subtotals only | |
| Analysis 1.1  Comparison 1: 'Non‐complex' coronary lesions, Outcome 1: Procedural success | ||||
| Outcome or subgroup title | No. of studies | No. of participants | Statistical method | Effect size |
| 2.1 Re‐stenosis rates Show forest plot | 5 | Risk Ratio (M‐H, Random, 95% CI) | Subtotals only | |
| Analysis 2.1  Comparison 2: Complex coronary lesions, Outcome 1: Re‐stenosis rates | ||||
| 2.1.1 Six months | 5 | 855 | Risk Ratio (M‐H, Random, 95% CI) | 1.05 [0.83, 1.33] |
| 2.1.2 One year | 1 | 254 | Risk Ratio (M‐H, Random, 95% CI) | 1.21 [0.95, 1.55] |
| Outcome or subgroup title | No. of studies | No. of participants | Statistical method | Effect size |
| 3.1 Re‐stenosis rates Show forest plot | 3 | Risk Ratio (M‐H, Random, 95% CI) | Totals not selected | |
| Analysis 3.1  Comparison 3: In‐stent re‐stenosis, Outcome 1: Re‐stenosis rates | ||||
| 3.1.1 Six months | 1 | Risk Ratio (M‐H, Random, 95% CI) | Totals not selected | |
| 3.1.2 One year | 2 | Risk Ratio (M‐H, Random, 95% CI) | Totals not selected | |
| 3.2 Minimum luminal diameter Show forest plot | 4 | Mean Difference (IV, Random, 95% CI) | Totals not selected | |
| Analysis 3.2  Comparison 3: In‐stent re‐stenosis, Outcome 2: Minimum luminal diameter | ||||
| 3.2.1 Six months | 2 | Mean Difference (IV, Random, 95% CI) | Totals not selected | |
| 3.2.2 One year | 2 | Mean Difference (IV, Random, 95% CI) | Totals not selected | |
| Outcome or subgroup title | No. of studies | No. of participants | Statistical method | Effect size |
| 4.1 MACE as a composite event Show forest plot | 4 | Risk Ratio (M‐H, Random, 95% CI) | Subtotals only | |
| Analysis 4.1  Comparison 4: Major adverse cardiac events, Outcome 1: MACE as a composite event | ||||
| 4.1.1 In‐hospital period | 4 | 1315 | Risk Ratio (M‐H, Random, 95% CI) | 1.27 [0.86, 1.90] |
| 4.1.2 Six months' follow‐up | 1 | 396 | Risk Ratio (M‐H, Random, 95% CI) | 1.25 [0.99, 1.59] |
| 4.2 Myocardial infarction Show forest plot | 9 | Risk Ratio (M‐H, Random, 95% CI) | Subtotals only | |
| Analysis 4.2  Comparison 4: Major adverse cardiac events, Outcome 2: Myocardial infarction | ||||
| 4.2.1 In‐hospital period | 9 | 2218 | Risk Ratio (M‐H, Random, 95% CI) | 1.42 [0.75, 2.70] |
| 4.2.2 Six months' follow‐up | 3 | 932 | Risk Ratio (M‐H, Random, 95% CI) | 1.08 [0.35, 3.40] |
| 4.3 Emergency CABG Show forest plot | 9 | Risk Ratio (M‐H, Random, 95% CI) | Subtotals only | |
| Analysis 4.3  Comparison 4: Major adverse cardiac events, Outcome 3: Emergency CABG | ||||
| 4.3.1 In‐hospital period | 9 | 2218 | Risk Ratio (M‐H, Random, 95% CI) | 1.21 [0.43, 3.40] |
| 4.3.2 Six months' follow‐up | 2 | 819 | Risk Ratio (M‐H, Random, 95% CI) | 0.93 [0.54, 1.61] |
| 4.4 Death Show forest plot | 9 | Risk Ratio (M‐H, Random, 95% CI) | Subtotals only | |
| Analysis 4.4  Comparison 4: Major adverse cardiac events, Outcome 4: Death | ||||
| 4.4.1 In‐hospital period | 9 | 2218 | Risk Ratio (M‐H, Random, 95% CI) | 0.67 [0.22, 2.05] |
| 4.4.2 Six months' follow‐up | 3 | 932 | Risk Ratio (M‐H, Random, 95% CI) | 0.67 [0.21, 2.06] |
| Outcome or subgroup title | No. of studies | No. of participants | Statistical method | Effect size |
| 5.1 Perforation Show forest plot | 5 | 1948 | Risk Ratio (M‐H, Random, 95% CI) | 4.28 [0.92, 19.83] |
| Analysis 5.1  Comparison 5: Adverse events, Outcome 1: Perforation | ||||
| 5.2 Angiographic dissection Show forest plot | 3 | 949 | Risk Ratio (M‐H, Random, 95% CI) | 0.48 [0.34, 0.68] |
| Analysis 5.2  Comparison 5: Adverse events, Outcome 2: Angiographic dissection | ||||
| 5.3 Bailout stenting Show forest plot | 2 | 955 | Risk Ratio (M‐H, Random, 95% CI) | 0.29 [0.09, 0.87] |
| Analysis 5.3  Comparison 5: Adverse events, Outcome 3: Bailout stenting | ||||
| 5.4 Spasm Show forest plot | 3 | 1019 | Risk Ratio (M‐H, Random, 95% CI) | 9.23 [4.61, 18.47] |
| Analysis 5.4  Comparison 5: Adverse events, Outcome 4: Spasm | ||||
| 5.5 Transient vessel occlusion Show forest plot | 5 | 1700 | Risk Ratio (M‐H, Random, 95% CI) | 2.49 [1.25, 4.99] |
| Analysis 5.5  Comparison 5: Adverse events, Outcome 5: Transient vessel occlusion | ||||
| 5.6 'Slow flow' Show forest plot | 4 | 1442 | Risk Ratio (M‐H, Random, 95% CI) | 2.68 [1.28, 5.59] |
| Analysis 5.6  Comparison 5: Adverse events, Outcome 6: 'Slow flow' | ||||
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.
Comparison 1: 'Non‐complex' coronary lesions, Outcome 1: Procedural success
Comparison 2: Complex coronary lesions, Outcome 1: Re‐stenosis rates
Comparison 3: In‐stent re‐stenosis, Outcome 1: Re‐stenosis rates
Comparison 3: In‐stent re‐stenosis, Outcome 2: Minimum luminal diameter
Comparison 4: Major adverse cardiac events, Outcome 1: MACE as a composite event
Comparison 4: Major adverse cardiac events, Outcome 2: Myocardial infarction
Comparison 4: Major adverse cardiac events, Outcome 3: Emergency CABG
Comparison 4: Major adverse cardiac events, Outcome 4: Death
Comparison 5: Adverse events, Outcome 1: Perforation
Comparison 5: Adverse events, Outcome 2: Angiographic dissection
Comparison 5: Adverse events, Outcome 3: Bailout stenting
Comparison 5: Adverse events, Outcome 4: Spasm
Comparison 5: Adverse events, Outcome 5: Transient vessel occlusion
Comparison 5: Adverse events, Outcome 6: 'Slow flow'
| Lesion type | Characteristics | Note |
|---|---|---|
| Type A | Discrete (< 10 mm), concentric, readily accessible, non‐angulated segment (< 45°), smooth contour, little or no calcification, less than totally occlusive, not ostial in location, no major branch involvement, absence of thrombus | |
| Type B | Tubular (10 to 20 mm), eccentric, moderate tortuosity of proximal segment, moderately angulated segment (between 45° and 90°), irregular contour, moderate to heavy calcification, total occlusion < 3 months old, ostial in location, bifurcation lesions requiring double guidewires, some thrombus present | Type B lesions with only 1 adverse characteristic were classified further as Type B1 lesions, while those with more than 1 adverse characteristic were classified as Type B2 lesions (Ellis 1990) |
| Type C | Diffuse (> 20 mm), excessive tortuosity of proximal segment, extremely angulated segments (> 90°), total occlusion > 3 months old, Inability to protect major side branches, degenerated vein grafts with friable lesions | |
| ACC: American College of Cardiology; AHA: American Heart Association. | ||
| Study ID | Location | Dates of enrolment | Sample size | Age (years) mean (SD)† | Males (%) † | Follow‐up |
|---|---|---|---|---|---|---|
| ARTIST | Europe; multicentre | Unknown | 298 | 61 (11) | 97.9 | 6 months |
| COBRA | Germany; multicentre | May 1992 to May 1996 | 502 | PTCRA = 62 (9); PTCA = 61 (9) | PTCRA = 74; PTCA = 73 | 6 months |
| DART | USA; multicentre | Jun 1995 to Jun 1996 | 447 | PTCRA = 61 (10); PTCA = 61 (11) | PTCRA = 60; PTCA = 70.0 | 6 months to 1 year |
| EDRES | Saudi Arabia; single centre | To Feb 1997 | 150 | Unknown | PTCRA = 86.7; PTCA = 88.0 | 6 months |
| Eltchaninoff | France; single centre | Unknown | 50 | PTCRA = 61 (11); PTCA = 56 (11) | PTCRA = 81.8; PTCA = 91.7 | In‐hospital |
| ERBAC | Germany; single centre | Oct 1991 to Aug 1991; Jan 1993 to Dec 1993 | 685 | PTCRA = 61.6 (10); PTCA = 62.5 (9.5); ELCA = 61.7 (8.8) | PTCRA = 79.6; PTCA = 72.0; ELCA = 77.6 | 6 months to 1 year |
| Guerin | France; single centre | Apr 1992 to Sep 1993 | 64 | PTCRA = 64.6 (10.8); PTCA = 63.3 (10.4) | PTCRA = 78.1; PTCA = 71.9 | 6 months |
| Kwon | Korea; single centre | Apr 1999 to Jan 2001 | 41 | PTCRA = 62.5 (8.6); PTCA = 61.6 (10.4) | PTCRA = 61.6; PTCA = 70.0 | In‐hospital 1 month 3 months 6 months |
| Lee | Korea; single centre | Jun 2001 to Jan 2003 | 113 | PTCRA = 58 (9); PTCA = 59 (10) | PTCRA = 36.0; PTCA = 37.0 | In‐hospital 6 months |
| Mehran | Unknown | Unknown | 249 | PTCRA = 62 (13); ELCA = 63 (11) | PTCRA = 68.1; ELCA = 67.7 | ‐ |
| ROSTER | USA; single centre | Unknown | 200 | Unknown | Unknown | In‐hospital |
| SPORT | USA | ‐ | 675 | PTCRA = 63.6; PTCA = 64.4 | PTCRA = 68.0; PTCA = 69.9 | In‐hospital |
| ELCA: excimer laser coronary angioplasty; PTCA: percutaneous transluminal coronary angioplasty; SD: standard deviation; PTCRA: percutaneous transluminal coronary rotational atherectomy. | ||||||
| Study | Patient criteria |
|---|---|
| ARTIST | Symptomatic, diffuse in‐stent re‐stenosis (10 to 50 mm in length) at least 3 months after stent implantation |
| COBRA | Patients aged 20 to 80 years with angiographically documented coronary artery disease and clinical symptoms of angina or anginal equivalents. The target coronary stenosis was considered haemodynamically significant and eligible for the study if there was a reduction in luminal area of 70% to 99% and absolute stenosis diameters were < 1 mm for a length of at least 5 mm as visually estimated by the operator. In addition, 1 secondary criterion had to be fulfilled, such as a heavily calcified, ostial or bifurcation location, or 1 that was eccentric, diffuse or within an angulated (> 45°) segment. Exclusions: unstable angina, MI within the previous 4 weeks, previous coronary angioplasty of the target vessel within the last 2 months, poor left ventricular function (ejection fraction ≤ 30%), or any other condition that will limit long‐term prognosis |
| DART | No specific entry criteria reported. Tested effectiveness of rotational atherectomy versus PTCA in vessels < 3 mm |
| EDRES | No specific entry criteria reported |
| Eltchaninoff | Patients were eligible for the study if they had stable or unstable angina with at least 1 lesion (> 50% stenosis) in a native vessel suitable for angioplasty. Additional inclusion criteria for angioscopy were coronary artery lumen diameter between 2.5 and 3.5 mm; location of the target lesion in a straight segment of the artery; location of the lesion at least 20 mm away from the coronary ostium; absence of left main coronary artery disease. Exclusions: acute MI within 24 hours before the procedure, a re‐stenotic lesion, a total occlusion or a vein graft lesion |
| ERBAC | Patients were included if they had target lesions and vessels suitable for all 3 techniques. Patients with multi‐vessel coronary disease were also eligible, but the culprit lesion was specified as the target before coronary intervention began. Exclusions: lesion characteristics (stenosis angulation > 60°, bend stenosis with an outwardly eccentric lumen, and bifurcational lesions requiring double guidewires) and vessel (extreme proximal vessel tortuosity, saphenous bypass graft or presence of intraluminal thrombus (filling defect), and total occlusion deemed not transferable with guidewires). Patients with acute MI and those who had undergone PTCA of any other vessel within the last 4 months were also excluded |
| Guerin | Patients presenting with a significant stenosis (defined as > 60% reduction of the lumen diameter as assessed by quantitative computed angiography) in ≥ 1 major coronary vessels, a clinical indication for re‐vascularisation, and a left ventricular ejection fraction > 40%. Exclusions: MI within the last month, re‐stenosis, bypass graft lesions, presence of intraluminal defect, ostial lesions and total occlusions |
| Kwon | Patients with long, 'denovo lesions'. Lesion length > 20 mm, stenosis diameter > 50% in a native left anterior descending artery between 2 and 2.9 mm in size. Exclusions: contraindication to antiplatelet therapy, total occlusion, infarct‐related artery, left ventricular dysfunction (ejection fraction < 40%) or an inability to follow the protocol |
| Lee | Diffuse in‐stent re‐stenosis (lesion length > 10 mm, diameter stenosis N50%) in a native coronary artery with angina, demonstrable myocardial ischaemia |
| ROSTER | No specific entry criteria reported. Tested effectiveness of PTCRA versus PTCA in diffuse in‐stent re‐stenosis |
| SPORT | No specific entry criteria reported |
| MI: myocardial infarction; PTCA: percutaneous transluminal coronary angioplasty; PTCRA: percutaneous transluminal coronary rotational atherectomy. | |
| Study | Definition of MI |
|---|---|
| ARTIST | New Q waves or creatine kinase and creatine kinase MB greater than twice normal, or both |
| COBRA | Rise in creatine kinase of more than 3 times the normal limit in the presence of Q waves |
| Eltchaninoff | Not stated. Standard 12‐lead electrocardiogram and serial measurement of total and MB fraction of creatine kinase was performed while in hospital |
| ERBAC | New Q waves in ≥ 2 contiguous leads and a creatine kinase elevation of 2 or more times the upper limit of normal and/or elevated creatine kinase‐MB fraction to at least twice the upper limit of normal |
| Guerin | Not stated. Electrocardiographic descriptors used |
| Outcome or subgroup title | No. of studies | No. of participants | Statistical method | Effect size |
| 1.1 Procedural success Show forest plot | 1 | Risk Ratio (M‐H, Random, 95% CI) | Subtotals only | |
| Outcome or subgroup title | No. of studies | No. of participants | Statistical method | Effect size |
| 2.1 Re‐stenosis rates Show forest plot | 5 | Risk Ratio (M‐H, Random, 95% CI) | Subtotals only | |
| 2.1.1 Six months | 5 | 855 | Risk Ratio (M‐H, Random, 95% CI) | 1.05 [0.83, 1.33] |
| 2.1.2 One year | 1 | 254 | Risk Ratio (M‐H, Random, 95% CI) | 1.21 [0.95, 1.55] |
| Outcome or subgroup title | No. of studies | No. of participants | Statistical method | Effect size |
| 3.1 Re‐stenosis rates Show forest plot | 3 | Risk Ratio (M‐H, Random, 95% CI) | Totals not selected | |
| 3.1.1 Six months | 1 | Risk Ratio (M‐H, Random, 95% CI) | Totals not selected | |
| 3.1.2 One year | 2 | Risk Ratio (M‐H, Random, 95% CI) | Totals not selected | |
| 3.2 Minimum luminal diameter Show forest plot | 4 | Mean Difference (IV, Random, 95% CI) | Totals not selected | |
| 3.2.1 Six months | 2 | Mean Difference (IV, Random, 95% CI) | Totals not selected | |
| 3.2.2 One year | 2 | Mean Difference (IV, Random, 95% CI) | Totals not selected | |
| Outcome or subgroup title | No. of studies | No. of participants | Statistical method | Effect size |
| 4.1 MACE as a composite event Show forest plot | 4 | Risk Ratio (M‐H, Random, 95% CI) | Subtotals only | |
| 4.1.1 In‐hospital period | 4 | 1315 | Risk Ratio (M‐H, Random, 95% CI) | 1.27 [0.86, 1.90] |
| 4.1.2 Six months' follow‐up | 1 | 396 | Risk Ratio (M‐H, Random, 95% CI) | 1.25 [0.99, 1.59] |
| 4.2 Myocardial infarction Show forest plot | 9 | Risk Ratio (M‐H, Random, 95% CI) | Subtotals only | |
| 4.2.1 In‐hospital period | 9 | 2218 | Risk Ratio (M‐H, Random, 95% CI) | 1.42 [0.75, 2.70] |
| 4.2.2 Six months' follow‐up | 3 | 932 | Risk Ratio (M‐H, Random, 95% CI) | 1.08 [0.35, 3.40] |
| 4.3 Emergency CABG Show forest plot | 9 | Risk Ratio (M‐H, Random, 95% CI) | Subtotals only | |
| 4.3.1 In‐hospital period | 9 | 2218 | Risk Ratio (M‐H, Random, 95% CI) | 1.21 [0.43, 3.40] |
| 4.3.2 Six months' follow‐up | 2 | 819 | Risk Ratio (M‐H, Random, 95% CI) | 0.93 [0.54, 1.61] |
| 4.4 Death Show forest plot | 9 | Risk Ratio (M‐H, Random, 95% CI) | Subtotals only | |
| 4.4.1 In‐hospital period | 9 | 2218 | Risk Ratio (M‐H, Random, 95% CI) | 0.67 [0.22, 2.05] |
| 4.4.2 Six months' follow‐up | 3 | 932 | Risk Ratio (M‐H, Random, 95% CI) | 0.67 [0.21, 2.06] |
| Outcome or subgroup title | No. of studies | No. of participants | Statistical method | Effect size |
| 5.1 Perforation Show forest plot | 5 | 1948 | Risk Ratio (M‐H, Random, 95% CI) | 4.28 [0.92, 19.83] |
| 5.2 Angiographic dissection Show forest plot | 3 | 949 | Risk Ratio (M‐H, Random, 95% CI) | 0.48 [0.34, 0.68] |
| 5.3 Bailout stenting Show forest plot | 2 | 955 | Risk Ratio (M‐H, Random, 95% CI) | 0.29 [0.09, 0.87] |
| 5.4 Spasm Show forest plot | 3 | 1019 | Risk Ratio (M‐H, Random, 95% CI) | 9.23 [4.61, 18.47] |
| 5.5 Transient vessel occlusion Show forest plot | 5 | 1700 | Risk Ratio (M‐H, Random, 95% CI) | 2.49 [1.25, 4.99] |
| 5.6 'Slow flow' Show forest plot | 4 | 1442 | Risk Ratio (M‐H, Random, 95% CI) | 2.68 [1.28, 5.59] |
