Karotidna endarterektomija za liječenje simptomatske karotidne stenoze
Appendices
Appendix 1. Cochrane Central Register of Controlled Trials (CENTRAL) search strategy
Cochrane Central Register of Controlled Trials (CENTRAL; 2016, Issue 7) in the Cochrane Library (searched July 2016)
ID Search Hits
#1 [mh ^"cerebrovascular disorders"] or [mh ^"basal ganglia cerebrovascular disease"] or [mh ^"brain ischemia"] or [mh "brain infarction"] or [mh ^"hypoxia‐ischemia, brain"] or [mh ^"ischemic attack, transient"] or [mh ^"carotid artery diseases"] or [mh ^"carotid artery thrombosis"] or [mh ^"carotid artery, internal, dissection"] or [mh ^"carotid stenosis"] or [mh "carotid artery injuries"] or [mh ^"intracranial arterial diseases"] or [mh ^"cerebral arterial diseases"] or [mh ^"infarction, anterior cerebral artery"] or [mh ^"infarction, middle cerebral artery"] or [mh ^"infarction, posterior cerebral artery"] or [mh "intracranial embolism and thrombosis"] or [mh stroke] or [mh ^"vertebral artery dissection"] 9527
#2 (isch*emi* near/6 (stroke* or apoplex* or cerebral next vasc* or cerebrovasc* or cva or attack*)):ti,ab 6375
#3 ((brain or cerebr* or cerebell* or vertebrobasil* or hemispher* or intracran* or intracerebral or infratentorial or supratentorial or middle next cerebr* or mca* or anterior next circulation) near/5 (isch*emi* or infarct* or thrombo* or emboli*)):ti,ab 4928
#4 (transient next isch* or TIA or TIAs):ti,ab 1587
#5 (carotid near/5 (stenosis or thrombo* or disease* or arter* or atherosclero* or atheroma* or narrow* or plaque* or occlus* or occlud* or constrict* or emboli* or block*)):ti,ab 3150
#6 #1 or #2 or #3 or #4 or #5 18660
#7 [mh ^"carotid artery diseases"/SU] or [mh ^"carotid artery thrombosis"/SU] or [mh ^"carotid artery, internal, dissection"/SU] or [mh ^"carotid stenosis"/SU] or [mh "carotid artery injuries"/SU] or [mh "Carotid Arteries"/SU] 492
#8 [mh ^"Endarterectomy, Carotid"] 538
#9 (carotid near/5 (endarterectomy or thromboendarterectomy or surgery or revasculari* or eversion)):ti,ab 1349
#10 CEA:ti,ab 709
#11 [mh ^"carotid artery diseases"] or [mh ^"carotid artery thrombosis"] or [mh ^"carotid artery, internal, dissection"] or [mh ^"carotid stenosis"] or [mh "carotid artery injuries"] or [mh "Carotid Arteries"] 1782
#12 carotid:ti,ab 4715
#13 #11 or #12 4854
#14 [mh ^Endarterectomy] 122
#15 #13 and #14 71
#16 #7 or #8 or #9 or #10 or #15 1946
#17 #6 and #16 1056
Appendix 2. MEDLINE Ovid search strategy
MEDLINE Ovid Revised July 2016 (1966 to July 2016)
1. cerebrovascular disorders/ or basal ganglia cerebrovascular disease/ or brain ischemia/ or exp brain infarction/ or hypoxia‐ischemia, brain/ or ischemic attack, transient/ or carotid artery diseases/ or carotid artery thrombosis/ or carotid artery, internal, dissection/ or carotid stenosis/ or exp carotid artery injuries/ or intracranial arterial diseases/ or cerebral arterial diseases/ or infarction, anterior cerebral artery/ or infarction, middle cerebral artery/ or infarction, posterior cerebral artery/ or exp "intracranial embolism and thrombosis"/ or exp stroke/ or vertebral artery dissection/
2. (isch?emi$ adj6 (stroke$ or apoplex$ or cerebral vasc$ or cerebrovasc$ or cva or attack$)).tw.
3. ((brain or cerebr$ or cerebell$ or vertebrobasil$ or hemispher$ or intracran$ or intracerebral or infratentorial or supratentorial or middle cerebr$ or mca$ or anterior circulation) adj5 (isch?emi$ or infarct$ or thrombo$ or emboli$)).tw.
4. (transient isch$ or TIA or TIAs).tw.
5. (carotid adj5 (stenosis or thrombo$ or disease$ or arter$ or atherosclero$ or atheroma$ or narrow$ or plaque$ or occlus$ or occlud$ or constrict$ or emboli* or block$)).tw.
6. 1 or 2 or 3 or 4 or 5
7. carotid artery diseases/su or carotid artery thrombosis/su or carotid artery, internal, dissection/su or carotid stenosis/su or exp carotid artery injuries/su or exp Carotid Arteries/su
8. Endarterectomy, Carotid/
9. (carotid adj5 (endarterectomy or thromboendarterectomy or surgery or revasculari$ or eversion)).tw.
10. CEA.tw.
11. carotid artery diseases/ or carotid artery thrombosis/ or carotid artery, internal, dissection/ or carotid stenosis/ or exp carotid artery injuries/ or exp Carotid Arteries/
12. carotid.tw.
13. 11 or 12
14. Endarterectomy/
15. 13 and 14
16. 7 or 8 or 9 or 10 or 15
17. Randomized Controlled Trials as Topic/
18. random allocation/
19. Controlled Clinical Trials as Topic/
20. control groups/
21. clinical trials as topic/
22. randomized controlled trial.pt.
23. controlled clinical trial.pt.
24. clinical trial.pt.
25. (random$ or RCT or RCTs).tw.
26. (controlled adj5 (trial$ or stud$)).tw.
27. (clinical$ adj5 trial$).tw.
28. ((control or treatment or experiment$ or intervention) adj5 (group$ or subject$ or patient$)).tw.
29. (quasi‐random$ or quasi random$ or pseudo‐random$ or pseudo random$).tw.
30. ((control or experiment$ or conservative) adj5 (treatment or therapy or procedure or manage$)).tw.
31. trial.ti.
32. (assign$ or allocat$).tw.
33. controls.tw.
34. or/17‐33
35. 6 and 16 and 34
36. exp animals/ not humans.sh.
37. 35 not 36
38. limit 37 to ed=20100301‐20160731
Appendix 3. Embase Ovid search strategy
Embase Ovid Revised July 2016 (1990 to July 2016)
1. cerebrovascular disease/ or brain infarction/ or brain stem infarction/ or cerebellum infarction/ or exp brain ischemia/ or carotid artery disease/ or exp carotid artery obstruction/ or carotid artery injury/ or carotid atherosclerosis/ or cerebral artery disease/ or exp cerebrovascular accident/ or exp occlusive cerebrovascular disease/ or stroke patient/
2. (isch?emi$ adj6 (stroke$ or apoplex$ or cerebral vasc$ or cerebrovasc$ or cva or attack$)).tw.
3. ((brain or cerebr$ or cerebell$ or vertebrobasil$ or hemispher$ or intracran$ or intracerebral or infratentorial or supratentorial or middle cerebr$ or mca$ or anterior circulation) adj5 (isch?emi$ or infarct$ or thrombo$ or emboli$)).tw.
4. (transient isch$ or TIA or TIAs).tw.
5. (carotid adj5 (stenosis or thrombo$ or disease$ or arter$ or atherosclero$ or atheroma$ or narrow$ or plaque$ or occlus$ or occlud$ or constrict$ or emboli* or block$)).tw.
6. 1 or 2 or 3 or 4 or 5
7. carotid artery disease/su or exp carotid artery obstruction/su or carotid artery injury/su or carotid atherosclerosis/su or exp carotid artery/su
8. carotid endarterectomy/ or carotid artery surgery/
9. (carotid adj5 (endarterectomy or thromboendarterectomy or surgery or revasculari$ or eversion)).tw.
10. CEA.tw.
11. carotid artery disease/ or exp carotid artery obstruction/ or carotid artery injury/ or carotid atherosclerosis/ or exp carotid artery/
12. carotid.tw.
13. 11 or 12
14. Endarterectomy/
15. 13 and 14
16. 7 or 8 or 9 or 10 or 15
17. Randomized Controlled Trial/ or "randomized controlled trial (topic)"/
18. Randomization/
19. Controlled clinical trial/ or "controlled clinical trial (topic)"/
20. control group/ or controlled study/
21. clinical trial/
22. (random$ or RCT or RCTs).tw.
23. (controlled adj5 (trial$ or stud$)).tw.
24. (clinical$ adj5 trial$).tw.
25. ((control or treatment or experiment$ or intervention) adj5 (group$ or subject$ or patient$)).tw.
26. (quasi‐random$ or quasi random$ or pseudo‐random$ or pseudo random$).tw.
27. ((control or experiment$ or conservative) adj5 (treatment or therapy or procedure or manage$)).tw.
28. trial.ti.
29. (assign$ or allocat$).tw.
30. controls.tw.
31. or/17‐30
32. 6 and 16 and 31
33. (exp animals/ or exp invertebrate/ or animal experiment/ or animal model/ or animal tissue/ or animal cell/ or nonhuman/) not (human/ or normal human/ or human cell/)
34. 32 not 33
35. limit 34 to dd=20100301‐20160731
Appendix 4. Search strategies for other databases
Database: Web of Science Core Collection ‐ Thomson Reuters (2001 to 18 January 2017)
1. Topic=(Carotid stenosis) AND Topic=(Carotid endarterectomy); Timespan=All Years (2593)
Searches of trial registers for ongoing and registered trials
Database: ClinicalTrials.gov
1. carotid stenosis (228)
2. symptomatic carotid stenosis (40)
3. carotid endarterectomy (145)
4. symptomatic carotid stenosis AND carotid endarterectomy (20)
5. symptomatic AND carotid stenosis AND carotid endarterectomy (20)
Database: WHO International Clinical Trials Registry Platform (ICTRP; 15 January 2017)
1. carotid stenosis (235)
2. symptomatic carotid stenosis (5)
3. carotid endarterectomy (5510)
4. symptomatic carotid stenosis AND carotid endarterectomy (5)
5. symptomatic AND carotid stenosis AND carotid endarterectomy (14)
Appendix 5. Criteria for judging risk of bias
1. Was the allocation sequence randomly generated?
Low risk of bias
The investigators describe a random component in the sequence generation process such as: referring to a random number table; using a computer random number generator; coin tossing; shuffling cards or envelopes; throwing dice; drawing of lots.
High risk of bias
The investigators describe a non‐random component in the sequence generation process. Usually, the description would involve some systematic, non‐random approach, for example: sequence generated by odd or even date of birth; sequence generated by some rule based on date (or day) of admission; sequence generated by some rule based on hospital or clinic record number.
Unclear
Insufficient information about the sequence generation process to permit judgement of low or high risk of bias.
2. Was the treatment allocation adequately concealed?
Low risk of bias
Participants and investigators enrolling participants could not foresee assignment because one of the following, or an equivalent method, was used to conceal allocation: central allocation (including telephone, web‐based and pharmacy‐controlled randomisation); sequentially‐numbered drug containers of identical appearance; sequentially‐numbered, opaque, sealed envelopes.
High risk of bias
Participants or investigators enrolling participants could possibly foresee assignments and thus introduce selection bias, such as allocation based on: use of an open random allocation schedule (e.g. a list of random numbers); assignment envelopes without appropriate safeguards (e.g. envelopes were unsealed, non‐opaque or not sequentially numbered); alternation or rotation; date of birth; case record number; any other explicitly unconcealed procedure.
Unclear
Insufficient information to permit judgement of low or high risk of bias. This is usually the case if the method of concealment is not described or not described in sufficient detail to allow a definite judgement, for example if the use of assignment envelopes is described, but it remains unclear whether envelopes were sequentially numbered, opaque, and sealed.
3. Blinding ‐ was knowledge of the allocated interventions adequately prevented during the study?
Low risk of bias
Any one of the following:
• No blinding, but the review authors judge that the outcome and the outcome measurement are not likely to be influenced by lack of blinding.
• Blinding of participants and key study personnel ensured, and unlikely that the blinding could have been broken.
• Either participants or some key study personnel were not blinded, but outcome assessment was blinded and the non‐blinding of others unlikely to introduce bias.
High risk of bias
Any one of the following:
• No blinding or incomplete blinding, and the outcome or outcome measurement is likely to be influenced by lack of blinding.
• Blinding of key study participants and personnel attempted, but likely that the blinding could have been broken.
• Either participants or some key study personnel were not blinded, and the non‐blinding of others likely to introduce bias.
Unclear
Either of the following:
• Insufficient information to permit judgement of low or high risk of bias.
• The study did not address this outcome.
4. Were incomplete outcome data adequately addressed?
Low risk of bias
Any one of the following:
• No missing outcome data.
• Reasons for missing outcome data unlikely to be related to true outcome (for survival data, censoring unlikely to be introducing bias).
• Missing outcome data balanced in numbers across intervention groups, with similar reasons for missing data across groups.
• For dichotomous outcome data, the proportion of missing outcomes compared with observed event risk not enough to have a clinically relevant impact on the intervention effect estimate.
• For continuous outcome data, plausible effect size (difference in means or standardised difference in means) among missing outcomes not enough to have a clinically relevant impact on observed effect size.
• Missing data have been imputed using appropriate methods.
High risk of bias
Any one of the following:
• Reason for missing outcome data likely to be related to true outcome, with either imbalance in numbers or reasons for missing data across intervention groups.
• For dichotomous outcome data, the proportion of missing outcomes compared with observed event risk enough to induce clinically relevant bias in intervention effect estimate.
• For continuous outcome data, plausible effect size (difference in means or standardised difference in means) among missing outcomes enough to induce clinically relevant bias in observed effect size.
• ’As‐treated’ analysis done with substantial departure of the intervention received from that assigned at randomisation.
• Potentially inappropriate application of simple imputation.
Unclear
Either of the following:
• Insufficient reporting of attrition or exclusions to permit judgement of low or high risk of bias (e.g. number randomised not stated, no reasons for missing data provided).
• The study did not address this outcome.
5. Are reports of the study free of suggestion of selective outcome reporting?
Low risk of bias
Either of the following:
• 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.
• The study protocol is not available but it is clear that the published reports include all expected outcomes, including those that were pre‐specified (convincing text of this nature may be uncommon).
High risk of bias
Any one of the following:
• Not all of the study’s pre‐specified primary outcomes have been reported.
• One or more primary outcomes are reported using measurements, analysis methods or subsets of the data (e.g. subscales) that were not pre‐specified.
• One or more reported primary outcomes were not pre‐specified (unless clear justification for their reporting is provided, such as an unexpected adverse effect).
• One or more outcomes of interest in the review are reported incompletely, so that they cannot be entered in a meta‐analysis.
• The study report fails to include results for a key outcome that would be expected to have been reported for such a study.
Unclear
Insufficient information to permit judgement of low or high risk of bias. It is likely that the majority of studies will fall into this category.
6. Other sources of potential bias
Low risk of bias
The study appears to be free of other sources of bias.
High risk of bias
There is at least one important risk of bias. For example, the study:
• had a potential source of bias related to the specific study design used; or
• has been claimed to have been fraudulent; or
• had some other problem.
Unclear
There may be a risk of bias, but there is either:
• insufficient information to assess whether an important risk of bias exists; or
• insufficient rationale or evidence that an identified problem will introduce bias.
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.
Comparison 1 Surgery versus no surgery, Outcome 1 Any stroke or operative death.
Comparison 1 Surgery versus no surgery, Outcome 2 Ipsilateral ischaemic stroke and any operative stroke or death.
Comparison 1 Surgery versus no surgery, Outcome 3 Disabling or fatal ipsilateral ischaemic or operative stroke and death.
Comparison 2 Subgroup analyses (5‐year cumulative risk of ipsilateral carotid ischaemic stroke, and any stroke or death within 30 days after surgery, according to 3 variables in patients with > 50% carotid stenosis in ECST and NASCET), Outcome 1 Sex.
Comparison 2 Subgroup analyses (5‐year cumulative risk of ipsilateral carotid ischaemic stroke, and any stroke or death within 30 days after surgery, according to 3 variables in patients with > 50% carotid stenosis in ECST and NASCET), Outcome 2 Age (years).
Comparison 2 Subgroup analyses (5‐year cumulative risk of ipsilateral carotid ischaemic stroke, and any stroke or death within 30 days after surgery, according to 3 variables in patients with > 50% carotid stenosis in ECST and NASCET), Outcome 3 Time since last event (weeks).
| Carotid endarterectomy for symptomatic carotid stenosis | ||||||
| Patients or population: people with carotid stenosis and recent transient ischaemic attacks (TIA) or minor ischaemic strokes in the territory of that artery Settings: in hospitals with carotid centres1 Intervention: best medical therapy with carotid surgery2,3 Comparison: best medical therapy without carotid surgery2 | ||||||
| Outcomes | Illustrative comparative risks* (95% CI) | Relative effect (95% CI) | Number of (studies) | Quality of the evidence (GRADE) | Comments | |
| Assumed risk | Corresponding risk | |||||
| Best medical treatment alone | Best medical treatment with carotid surgery | |||||
| Any stroke or operative death | Near occlusion | RR 0.95 (0.59 to 1.53) | 271 (2 studies) | ++++ High4 | None of these RCTs could be blinded for surgeons or patients due to the nature of the intervention. | |
| 22 per 100 | 20 per 100 | |||||
| 70% to 99% carotid stenosis | RR 0.53 (0.42 to 0.67) | 1095 (3 studies) | +++Ο Moderate5 | |||
| 29 per 100 | 15 per 100 | |||||
| 50% to 69% carotid stenosis | RR 0.77 (0.63 to 0.94) | 1549 (3 studies) | +++Ο Moderate5 | |||
| 23 per 100 | 18 per 100 | |||||
| 30% to 49% carotid stenosis | RR 0.97 (0.79 to 1.19) | 1429 (2 studies) | ++++ High4 | |||
| 21 per 100 | 20 per 100 | |||||
| < 30% carotid stenosis | RR 1.25 (0.99 ‐ 1.56) | 1746 (2 studies) | ++++ High4 | |||
| 14 per 100 | 17 per 100 | |||||
| Ipsilateral ischaemic stroke, and any operative stroke or death | Near occlusion | RR 1.03 (0.57 to 1.84) | 271 (2 studies) | ++++ High4 | None of these RCTs could be blinded for surgeons or patients due to the nature of the intervention. | |
| 15 per 100 | 15 per 100 | |||||
| 70% to 99% carotid stenosis | RR 0.47 (0.25 to 0.88) | 1095 (3 studies) | +++Ο Moderate5 | |||
| 23 per 100 | 10 per 100 | |||||
| 50% to 69% carotid stenosis | RR 0.84 (0.60 to 1.18) | 1549 (3 studies) | +++Ο Moderate5 | |||
| 15 per 100 | 12 per 100 | |||||
| 30% to 49% carotid stenosis | RR 0.93 (0.62 to 1.38) | 1429 (2 studies) | ++++ High4 | |||
| 15 per 100 | 13 per 100 | |||||
| < 30% carotid stenosis | RR 1.27 (0.80 to 2.01) | 1746 (2 studies) | ++++ High4 | |||
| 9 per 100 | 11 per 100 | |||||
| *The basis for the assumed risk is provided in footnotes. The corresponding risk (and its 95% confidence interval) is based on the assumed risk in the intervention group and the relative effect of the intervention (and its 95% CI). CI: Confidence interval; RR: Risk ratio GRADE: GRADE Working Group grades of evidence (see explanations) | ||||||
| 1 ECST recruited from 100 centres in 14 European countries, NASCET from 106 centres mainly in the USA and Canada, but including some centres in Europe, Israel, South Africa and Australia, and the VACSP trial from 16 Veterans Affairs medical centres in the USA 2 The recommended dose of aspirin for best medical treatment was 1300 mg in NASCET, 325 mg in the VACSP trial, and unspecified in ECST 3 The median time from randomisation to trial surgery was two days in the VACSP trial, three days in NASCET and 14 days in ECST. 4 All 2 studies (ECST, NASCET) are unconfounded truly randomised controlled trials and conducted on an intention to treat principle with adequate concealment, Few patients were lost to follow up in any of these studies (follow up 99.8‐100%) 5 All 3 studies (ECST, NASCET, VACSP) are unconfounded truly randomised controlled trials and conducted on an intention‐to‐treat principle. However, the allocation concealment was not described in one trial (VACSP). In addition, ECST and NASCET were both stopped after appropriately pre‐specified interim analyses showed that the trial stopping rules had been met. VACSP was also stopped with 193 participants after the results of ECST and NASCET were announced. | ||||||
| Subgroups | Ipsilaterial ischaemic stroke in medical group | |||
| HR | 95% CI (‐) | P | ||
| Predefined patient subgroups | ||||
| Sex (females versus males) | 0.79 | (0.64 to 0.97) | 0.03 | |
| Age | < 65 years | 1.00 | 0.001 | |
| 65 to 74 years | 1.23 | (1.00 to 1.51) | ||
| 75+ years | 1.70 | (1.28 to 2.56) | ||
| Time since last event | < 2 weeks | 1.00 | 0.003 | |
| 2 to 4 weeks | 0.80 | (0.61 to 1.06) | ||
| 4 to 12 weeks | 0.69 | (0.55 to 0.88) | ||
| > 12 weeks | 0.61 | (0.46 to 0.82) | ||
| Primary symptomatic event | Ocular only | 1.00 | < 0.001 | |
| Cerebral TIA | 1.88 | (1.38 to 2.55) | ||
| Stroke | 2.33 | (1.74 to 3.13) | ||
| Diabetes | 1.31 | (1.05 to 1.65) | 0.02 | |
| Irregular/ulcerated plaque | 1.35 | (1.11 to 1.64) | 0.003 | |
| Contralateral ICA occlusion | 1.30 | (0.09 to 1.88) | 0.16 | |
| Post‐hoc patient subgroups | ||||
| Duration of cerebral TIA | 1 hour or less | 1.00 | ||
| > 1 hour | 1.45 | (1.03 to 2.04) | 0.03 | |
| Previous TIA or stroke | 1.20 | (0.99 to 1.46) | 0.07 | |
| Myocardial infarction | 1.40 | (1.11 to 1.77) | 0.004 | |
| Angina | 1.26 | (1.02 to 1.56) | 0.03 | |
| Treated hypertension | 1.39 | (1.15 to 1.68) | 0.001 | |
| Treated hyperlipidaemia | 0.78 | (0.62 to 0.98) | 0.03 | |
| Smoking | 0.96 | (0.80 to 1.16) | 0.70 | |
| ICA: internal carotid artery | ||||
| Subgroups | Perioperative stroke or death in surgery group | |||
| HR | 95% CI (‐) | P | ||
| Predefined patient subgroups | ||||
| Sex (females versus males) | 1.50 | (1.14 to 1.97) | 0.004 | |
| Age | < 65 years | 1.00 | 0.78 | |
| 65 to 74 years | 0.99 | (0.76 to 1.32) | ||
| 75+ years | 0.83 | (0.49 to 1.41) | ||
| Time since last event | < 2 weeks | 1.00 | 0.69 | |
| 2 to 4 weeks | 1.22 | (0.78 to 1.90) | ||
| 4 to 12 weeks | 1.14 | (0.77 to 1.68) | ||
| > 12 weeks | 1.28 | (0.84 to 1.95) | ||
| Primary symptomatic event | Ocular only | 1.00 | < 0.001 | |
| Cerebral TIA | 2.62 | (1.68 to 4.09) | ||
| Stroke | 1.91 | (1.22 to 3.01) | ||
| Diabetes | 1.45 | (1.05 to 2.02) | 0.03 | |
| Irregular/ulcerated plaque | 1.37 | (1.03 to 1.82) | 0.03 | |
| Contralateral ICA occlusion | 2.21 | (1.33 to 3.67) | 0.002 | |
| Post‐hoc patient subgroups | ||||
| Duration of cerebral TIA | 1 hour or less | 1.00 | ||
| > 1 hour | 1.24 | (0.81 to 1.92) | 0.33 | |
| Previous TIA or stroke | 1.59 | (1.21 to 2.09) | 0.001 | |
| Myocardial infarction | 0.87 | (0.59 to 1.27) | 0.46 | |
| Angina | 0.67 | (0.47 to 0.97) | 0.03 | |
| Treated hypertension | 1.33 | (1.02 to 1.74) | 0.04 | |
| Treated hyperlipidaemia | 1.06 | (0.74 to 1.51) | 0.75 | |
| Smoking | 0.97 | (0.74 to 1.27) | 0.81 | |
| ICA: internal carotid artery | ||||
| Effect of surgery on the risk of the primary outcome (P value) | |||
| Relative risk reduction | Absolute reduction in 5‐year actuarial risk | ||
| Cox model | 5‐year actuarial risk | ||
| Predefined patient subgroups | |||
| Sex | 0.007 | 0.008 | 0.003 |
| Age groups | 0.09 | 0.04 | 0.03 |
| Time since last event groups | 0.04 | 0.05 | 0.009 |
| Primary symptomatic event | 0.21 | 0.30 | 0.16 |
| Diabetes | 0.51 | 0.85 | 0.63 |
| Irregular/ulcerated plaque | 0.58 | 0.23 | 0.10 |
| Contralateral ICA occlusion | 0.30 | 0.34 | 0.25 |
| Post‐hoc subgroups | |||
| Duration of cerebral TIA | 0.44 | 0.47 | 0.42 |
| Previous TIA or stroke | 0.08 | 0.23 | 0.50 |
| Myocardial infarction | 0.06 | 0.02 | 0.01 |
| Angina | 0.08 | 0.11 | 0.06 |
| Treated hypertension | 0.19 | 0.29 | 0.09 |
| Treated hyperlipidaemia | 0.63 | 0.85 | 0.85 |
| Smoking | 0.40 | 0.40 | 0.38 |
| ICA: internal carotid artery | |||
| Outcome or subgroup title | No. of studies | No. of participants | Statistical method | Effect size |
| 1 Any stroke or operative death Show forest plot | 3 | Risk Ratio (M‐H, Fixed, 95% CI) | Subtotals only | |
| 1.1 Near occlusion | 2 | 271 | Risk Ratio (M‐H, Fixed, 95% CI) | 0.95 [0.59, 1.53] |
| 1.2 70% to 99% | 3 | 1095 | Risk Ratio (M‐H, Fixed, 95% CI) | 0.53 [0.42, 0.67] |
| 1.3 50% to 69% | 3 | 1549 | Risk Ratio (M‐H, Fixed, 95% CI) | 0.77 [0.63, 0.94] |
| 1.4 30% to 49% | 2 | 1429 | Risk Ratio (M‐H, Fixed, 95% CI) | 0.97 [0.79, 1.19] |
| 1.5 < 30% | 2 | 1746 | Risk Ratio (M‐H, Fixed, 95% CI) | 1.25 [0.99, 1.56] |
| 2 Ipsilateral ischaemic stroke and any operative stroke or death Show forest plot | 3 | Risk Ratio (M‐H, Random, 95% CI) | Subtotals only | |
| 2.1 Near occlusion | 2 | 271 | Risk Ratio (M‐H, Random, 95% CI) | 1.03 [0.57, 1.84] |
| 2.2 70% to 99% | 3 | 1095 | Risk Ratio (M‐H, Random, 95% CI) | 0.47 [0.25, 0.88] |
| 2.3 50% to 69% | 3 | 1549 | Risk Ratio (M‐H, Random, 95% CI) | 0.84 [0.60, 1.18] |
| 2.4 30% to 49% | 2 | 1429 | Risk Ratio (M‐H, Random, 95% CI) | 0.93 [0.62, 1.38] |
| 2.5 < 30% | 2 | 1746 | Risk Ratio (M‐H, Random, 95% CI) | 1.27 [0.80, 2.01] |
| 3 Disabling or fatal ipsilateral ischaemic or operative stroke and death Show forest plot | 3 | Risk Ratio (M‐H, Fixed, 95% CI) | Subtotals only | |
| 3.1 Near occlusion | 2 | 271 | Risk Ratio (M‐H, Fixed, 95% CI) | 1.29 [0.51, 3.27] |
| 3.2 70% to 99% | 3 | 1095 | Risk Ratio (M‐H, Fixed, 95% CI) | 0.40 [0.26, 0.64] |
| 3.3 50% to 69% | 2 | 1502 | Risk Ratio (M‐H, Fixed, 95% CI) | 0.73 [0.46, 1.15] |
| 3.4 30% to 49% | 2 | 1429 | Risk Ratio (M‐H, Fixed, 95% CI) | 0.96 [0.60, 1.54] |
| 3.5 < 30% | 2 | 1746 | Risk Ratio (M‐H, Fixed, 95% CI) | 1.72 [0.99, 2.96] |
| Outcome or subgroup title | No. of studies | No. of participants | Statistical method | Effect size |
| 1 Sex Show forest plot | 2 | Risk Difference (M‐H, Fixed, 95% CI) | Subtotals only | |
| 1.1 Men | 2 | 1886 | Risk Difference (M‐H, Fixed, 95% CI) | ‐0.10 [‐0.13, ‐0.06] |
| 1.2 Women | 2 | 832 | Risk Difference (M‐H, Fixed, 95% CI) | ‐0.03 [‐0.07, 0.02] |
| 2 Age (years) Show forest plot | 2 | Risk Difference (M‐H, Fixed, 95% CI) | Subtotals only | |
| 2.1 < 65 | 2 | 1281 | Risk Difference (M‐H, Fixed, 95% CI) | ‐0.05 [‐0.09, ‐0.01] |
| 2.2 65 to 74 | 2 | 1143 | Risk Difference (M‐H, Fixed, 95% CI) | ‐0.07 [‐0.12, ‐0.03] |
| 2.3 > 75 | 2 | 294 | Risk Difference (M‐H, Fixed, 95% CI) | ‐0.17 [‐0.26, ‐0.09] |
| 3 Time since last event (weeks) Show forest plot | 2 | Risk Difference (M‐H, Fixed, 95% CI) | Subtotals only | |
| 3.1 < 2 | 2 | 624 | Risk Difference (M‐H, Fixed, 95% CI) | ‐0.17 [‐0.24, ‐0.11] |
| 3.2 2 to 4 | 2 | 483 | Risk Difference (M‐H, Fixed, 95% CI) | ‐0.09 [‐0.15, ‐0.02] |
| 3.3 4 to 12 | 2 | 1058 | Risk Difference (M‐H, Fixed, 95% CI) | ‐0.05 [‐0.09, ‐0.01] |
| 3.4 > 12 | 2 | 553 | Risk Difference (M‐H, Fixed, 95% CI) | 0.00 [‐0.06, 0.06] |
