SUPPLEMENTARY MATERIAL. Online Appendix 1. PubMed search strategy for trials comparing carotid artery stenting to carotid endarterectomy *

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1 SUPPLEMENTARY MATERIAL Online Appendix 1. PubMed search strategy for trials comparing carotid artery stenting to carotid endarterectomy * Search Number Description Number of Publications 1 (((carotid stenosis[mesh Terms]) OR ((carotid*[title/abstract]) AND stenos*[title/abstract])) 19,340 2 (stents[mesh Terms]) OR ((carotid*[title/abstract]) AND stent*[title/abstract]) 55,467 3 ((carotid endarterectomy[mesh Terms]) OR ((carotid*[title/abstract]) AND endarterectom*[title/abstract])) 11, and 2 and 3 1, and (((randomized controlled trial[pt]) OR (controlled clinical trial[pt]) OR (randomized[tiab] OR randomised[tiab]) OR (placebo[tiab]) OR (drug therapy[sh]) OR (randomly[tiab]) OR (trial[tiab]) OR (groups[tiab])) NOT (animals[mh] NOT humans[mh])) limited to English or French 655 * Date of search: October 22, 2014 HIRU etiology search filter (hedge) for best balance of sensitivity and specificity 1

2 Online Appendix 2. Ovid MEDLINE search strategy for trials comparing carotid artery stenting to carotid endarterectomy * Search Number Description Number of Publications 1 (carotid*.mp. and stenos*.mp.) or (exp Carotid Stenosis/) 19,480 2 ((exp Stents/ or stent*.mp.) and (exp Carotid Arteries/ or exp Carotid Artery Diseases/)) or (carotid*.mp. and stent*.mp.) 6,038 3 (carotid*.mp. and endarterectom*.mp.) or (exp Endarterectomy, Carotid/) 12, and 2 and 3 1, and ((randomized controlled trial or controlled clinical trial).pt. or randomized.ab. or randomised.ab. or placebo.ab. or drug therapy.fs. or randomly.ab. or trial.ab. or groups.ab.) not (exp animals/ not humans.sh.) limited to English and French 658 * Date of search: October 22, 2014 HIRU etiology search filter (hedge) for best balance of sensitivity and specificity 1

3 Online Appendix 3. Ovid EMBASE search strategy for trials comparing carotid artery stenting to carotid endarterectomy* Search Number Description Number of Publications 1 (exp carotid artery/ and exp stenosis/) or (carotid*.mp. and stenosis.mp.) 22,187 2 ((exp carotid artery obstruction/ or exp carotid artery disease/ or carotid*.mp.) and (stent*.mp. or exp stent/)) or (exp carotid artery stenting/) 3 ((exp carotid artery obstruction/ or exp carotid artery disease/ or carotid*.mp.) and (endartarectom*.mp. or exp endartarectomy/)) or (exp carotid endarterectomy/) 11,306 17, and 2 and 3 2, and (crossover-procedure/ or double-blind procedure/ or randomized controlled trial/ or single-blind procedure/ or (random* or factorial* or crossover* or cross over* or placebo* or (doubl* adj blind*) or (singl* adj blind*) or assign* or allocat* or volunteer*).tw.) limited to English and French 555 * Date of search: October 22, 2014 HIRU etiology search filter (hedge) for best balance of sensitivity and specificity 1

4 Online Appendix 4. Cochrane Library of Register Controlled Trials search strategy for trials comparing carotid artery stenting to carotid endarterectomy * Search Number Description Number of Publications 1 (MeSH descriptor: [Carotid Stenosis] explode all trees) OR (carotid*:ti,ab,kn (Word variations have been searched)) and (stenos*:ti,ab,kn (Word variations have been searched)) 2 ((MeSH descriptor: [Carotid Artery Diseases] explode all trees) AND (MeSH descriptor: [Stents] explode all trees)) OR ((carotid*:ti,ab,kn (Word variations have been searched)) AND (stent*:ti,ab,kn (Word variations have been searched))) 3 ((MeSH descriptor: [Carotid Artery Diseases] explode all trees) AND (MeSH descriptor: [Endarterectomy] explode all trees)) OR ((carotid*:ti,ab,kn (Word variations have been searched)) AND (endarterectom*:ti,ab,kn (Word variations have been searched))) OR (MeSH descriptor: [Endarterectomy, Carotid] explode all trees) 1, , and 2 and limited to trials 138 * Date of search: October 22, 2014

5 Online Appendix 5. Procedural characteristics for carotid artery stenting and carotid endarterectomy in trials comparing carotid artery stenting to carotid endarterectomy Trial CAS Medication as Co-Intervention Type of Stents and EPD Medication as Co-Intervention CEA Endarterectomy Type CREST 2, 3 48hrs * before: ASA, 325mg BID + clopidogrel, 75mg BID. After: ASA, mg daily for 30 days + clopidogrel, 75mg daily, or ticlopidine, 250mg BID, for 4 weeks RX Acculink stent and RX Acculink EPD 48hrs before: ASA, 325mg daily. After: same for 1 year NR ICSS 4, 5 Combination of ASA and clopidogrel At discretion of the interventionist, approved by CE mark Antiplatelet or anticoagulation therapy if indicated Standard or eversion. SPACE 6, 7 72hrs before: ASA, 100mg + clopidogrel, 75mg daily. After: same for 30 days At discretion of the interventionist, approved by CE mark ASA 100mg before, during, and after CEA At discretion of the operator EVA-3S hrs before: ASA, mg + clopidogrel, 75mg or ticlopidine, 500mg daily. After: same for 30 days Only stents approved by accreditation committee NR NR 11, 12 CAVATAS 24hrs before: ASA, 150mg daily After: continue antiplatelet during follow-up Wallstent, Streker, or Palmaz Before: NR. After: continue antiplatelet during follow-up NR 72hrs before: ASA, mg daily + SAPPHIRE 13, 14 clopidogrel, 75mg 24hrs before. After: clopidogrel 2-4 weeks + ASA indefinitely Smart or Precise, with EPD Angioguard or Angioguard XP 72hrs before: ASA, mg daily. After: same indefinitely At discretion of the operator Brooks et al Before: ASA, 325mg + clopidogrel, 75mg Wallstent Before: ASA, 325mg + clopidogrel, 75mg NR Steinbauer et al. 18 ASA, 100mg + clopidogrel, 75mg for 1 month. After 30 days: ASA, 300mg daily Wallstent ASA, 100mg + clopidogrel, 75mg for 1month. After 30 days: ASA, 300mg daily Abbreviations: CAS = carotid artery stenting; CEA = carotid endarterectomy; EPD = embolic-protection device; CE = Communauté Européenne; ASA = aspirin; BID = twice a day; mg = milligram; hrs = hours. * When CAS within 48 hours of randomization, give ASA 650mg and clopidogrel 450mg 4hrs before CAS. Other regimens include ticlopidine, 250mg BID, clopidogrel, 75mg daily, ASA 81mg daily, or ASA and extended-release dipyridamole BID. Eversion

6 Online Appendix 6. Baseline characteristics of patients in trials comparing carotid artery stenting to carotid endarterectomy *, Trial Age Mean (SD) Women Vascular Risk Factors History of Vascular Diseases Carotid Stenosis HTN DM Smoking Hyperlipidemia Stroke TIA CAD Ipsilateral 70% Severe Contralateral CREST 2, (12.5) NR NR NR ICSS 4, (12.7) , SPACE 6, (0.1) NR EVA-3S (14.9) , CAVATAS 11, ** 38.1 **, SAPPHIRE 13, (12.2) NR 24.3 Brooks et al NR NR NR 66.1 NR NR Steinbauer et al (7.9) NR Abbreviations: HTN = hypertension; DM = diabetes mellitus; TIA = transient ischemic attack; CAD = cardiovascular disease; CS = carotid stenosis; SD = standard deviation. * Table is presented in decreasing order of the total number of randomized patients. Data are presented in percentage of total number of patients. Median. On treatment for the vascular risk factor. Include past and present smoker. Qualifying event. ** Within 6 months prior to randomization. Include occlusion of the contralateral carotid artery. Include >70% contralateral carotid stenosis. Only the patients in Brooks et al are symptomatic and report a total of 17 strokes (NIH<4) and 65 TIA as presenting symptom. Brooks et al is a long-term follow-up of the combined populations presented separately in Brooks et al and Brooks et al The total number of patients intended to treat is 189 (85 asymptomatic patients from 2001 and 104 symptomatic patients from 2004).

7 Online Appendix 7. Revised Cochrane Collaboration s tool for quality assessment in trials comparing carotid artery stenting to carotid endarterectomy * Trials Sequence generation Allocation concealment Blinding of outcome assessors Incomplete outcome data Selective outcome reporting Other Funding CREST 2, 3 Low Low Low Low Low Low Low ICSS 4, 5 Low Low Low Low Low Low Low SPACE 6, 7 Low Low Low Low Low Low Low EVA-3S 8-10 Low Unclear Low Low Low Unclear Low CAVATAS 11, 12 Low Low Low Low Low Low Low SAPPHIRE 13, 14 Low Low Low Low High Unclear High Brooks et al Unclear Unclear Low Low Low Low Unclear Steinbauer et al. 18 Unclear Unclear Low Low Low Unclear Low * Each criterion has been evaluated as being High, Low, or Unclear regarding the risk of bias following the guidelines of the Cochrane Collaboration s tool for assessing risk of bias in randomised trials. 19 The domains were evaluated as Unclear when the methods used for the randomization or treatment allocation were not clearly reported. The domain of other was evaluated as Unclear when the trials stopped early. SAPPHIRE was assigned a high risk of bias for incomplete outcome reporting due to important difference in lost of follow-up between the 2 arms. Given the nature of the interventions under investigation, blinding of treatment status was not possible, but trials received a low risk of bias if outcome assessment was done in a blinded manner.

8 Online Appendix 8. Cumulative incidence of periprocedural stroke in trials comparing carotid artery stenting to carotid endarterectomy Favors CAS Favors CEA

9 Online Appendix 9. Cumulative incidence of periprocedural stroke or death in trials comparing carotid artery stenting to carotid endarterectomy Favors CAS Favors CEA

10 Online Appendix 10. Cumulative incidence of severe periprocedural hematoma in trials comparing carotid artery stenting to carotid endarterectomy Favors CAS Favors CEA

11 Online Appendix 11. Cumulative incidence of periprocedural cranial nerve palsy in trials comparing carotid artery stenting to carotid endarterectomy Favors CAS Favors CEA

12 Online Appendix 12. Other periprocedural outcomes reported in trials comparing carotid artery stenting to carotid endarterectomy* Trial CAS (n) CEA (n) Severe Hematoma (%) Cranial Nerve Palsy (%) Bradycardia (%) Hypotension (%) Restenosis (%) CAS CEA CAS CEA CAS CEA CAS CEA CAS CEA CREST 2, 3 1,262 1, ICSS 4, NR NR NR NR SPACE 6, NR NR NR NR NR NR NR NR EVA-3S NR 0.0 NR 0.0 NR NR CAVATAS 11, NR NR NR NR SAPPHIRE 13, NR NR NR NR NR NR NR NR Brooks et al NR Steinbauer et al ** 13.6 ** 0.0 ** 2.3 ** NR NR NR NR 4.7,** 0.0,** Abbreviations: CAS = carotid artery stenting; CEA = carotid endarterectomy. * Table is presented in decreasing order of the total number of randomized patients. A total of 58 of 1086 patients at 2 years. A total of 62 of 1105 patients at 2 years. Severe stenosis (70-99%) or occlusion amongst the patients followed-up by ultrasound at one year (173 patients in the CAS group and 174 patients in the CEA group). Significant restenosis 70%. Composite of 11 (4.2%) events of bradycardia or hypotension in CAS reported. ** At one year. Data reported in the table for these endpoints are for symptomatic patients only. Bradycardia and hypotension were not reported as individual events for asymptomatic patients. However a composite of the two endpoints was reported in the CAS group (5/43 [11.6%]) and in the CEA group (0/42 [0.0%]). Cumulative 5-year risk of severe restenosis ( 70%) or occlusion.

13 Online Appendix 13. Risk difference in terms of periprocedural myocardial infarction in trials comparing carotid artery stenting to carotid endarterectomy Favors CAS Favors CEA

14 Online Appendix 14. Risk difference in terms of any periprocedural stroke in trials comparing carotid artery stenting to carotid endarterectomy Favors CAS Favors CEA

15 Online Appendix 15. Stratification by age of cumulative incidence of long-term stroke in trial comparing carotid artery stenting to carotid endarterectomy Favors CAS Favors CEA

16 Online Appendix 16. Sex-specific subgroups analyses of long-term adverse events in trials comparing carotid artery stenting to carotid endarterectomy * Trial Women CAS CEA HR 95% CI CAS CEA HR 95% CI Men p value of interaction CREST 2, 3, 37 (8.9) 26 (6.7) (6.2) 50 (6.8) , ICSS 4, 5, 30 (11.9) 25 (10.0) , (10.8) 32 (5.3) , SPACE 6, 7, 14 (8.3) 11 (6.7) , (9.9) 39 (9.6) , EVA-3S 8-10, NR NR NR NR NR NR NR NR 0.03 CAVATAS 11, 12, 21 (27.3) 12 (16.0) , (22.4) 39 (21.9) , SAPPHIRE 13, 14 NR NR NR NR NR NR NR NR NR Brooks et al NR NR NR NR NR NR NR NR NR Steinbauer et al. 18 NR NR NR NR NR NR NR NR NR Abbreviations: CAS = carotid artery stenting; CEA = carotid endarterectomy; HR = hazard ratio; CI = confidence interval. * Table is presented in decreasing order of the total number of randomized patients and includes data for the primary endpoint of each included trial. Events include any periprocedural stroke, myocardial infarction, or death, and any postprocedural ipsilateral stroke for the 4-year period. Events include first stroke, death, or procedural myocardial infarction within 120 days of randomization. Events include ipsilateral ischemic stroke within 2 years plus periprocedural (30 day) stroke and death. Events include ipsilateral stroke within 4 years including periprocedural stroke or death. Although no quantitative number of events or HR were published, Figure 4 in the 2008 publication of EVA-3S showed that CEA had superior outcome amongst men, but CAS had superior outcomes amongst women. Events include stroke in any territory that lasted more than 7 days or periprocedural death.

17 Online Appendix 17. Stratification by sex of cumulative incidence of long-term stroke in trial comparing carotid artery stenting to carotid endarterectomy Favors CAS Favors CEA

18 Online Appendix 18. Stratification by symptomatic status of cumulative incidence of long-term stroke in trial comparing carotid artery stenting to carotid endarterectomy Favors CAS Favors CEA

19 Online Appendix 19. Stratification by symptomatic status of cumulative incidence of long-term ipsilateral stroke or periprocedural stroke or death in trial comparing carotid artery stenting to carotid endarterectomy Favors CAS Favors CEA

20 Online Appendix 20. Meta-regression models of characteristics in trials comparing carotid artery stenting to carotid endarterectomy Characteristics Coefficient estimate* 95% CI p value Sex (proportion of females) , Use of EPD , Median length of follow-up , Median recruitment period , Minimal operator requirements , Symptomatic status , Age (proportion of older * ) , Abbreviations: CI = confidence interval; EPD = embolic-protection device. * The coefficient represents the change on the ln(relative risk) scale associated each of the study or patient characteristic. With the point estimate for the composite endpoint of long-term ipsilateral stroke, periprocedural stroke, or periprocedural death being greater than 1, coefficients greater than 0 suggest that the characteristic moves the treatment effect further away from the null value (i.e., ln(relative risk) = 0 or RR = 1) and thus increases the relative risk of the composite endpoint with stenting relative to endarterectomy. Coefficients less than 0 suggest that the characteristic brings the treatment effect closer to the null value (i.e., ln(relative risk) = 0 or RR = 1) and thus decreases the relative risk of the composite endpoint with stenting relative to endarterectomy. However, all point estimates are accompanied by wide 95% CIs that include unity, indicating that none of the above characteristics impact the association of this composite endpoint and carotid artery stenting versus carotid endarterectomy. Older is defined as patient 68 years old in SPACE and CAVATAS, and 70 years old in ICSS.

21 Online Appendix 21. Perioperative stroke outcomes by use of embolic protection devices and patient risk profile Some Use of EPD * No Use of EPD Outcome Number of RCTs RR (95% CI) I 2 Number of RCTs RR (95% CI) I 2 Low Risk Patients: Any Stroke or Death (1.23, 2.24) (1.12, 2.02) 0 Any Stroke (1.24, 2.25) (0.47, 1.58) 0 High Risk Patients: Any Stroke or Death Any Stroke (0.37, 3.86) All Patients: Any Stroke or Death (1.23, 2.24) (1.12, 2.02) 0 Any Stroke (1.26, 2.13) (0.47, 1.58) 0 Abbreviations: CI = confidence interval; EPD = embolic-protection device; RCT = randomized controlled trial. * Defined as all trials were the use of EPD was >0%. Results of random-effects meta-analysis.

22 Online Appendix 22. Random- and fixed-effects models comparing carotid artery stenting to carotid endarterectomy Outcome Number of included trials Random-effects Model RR (95% CI) Fixed-effects Model I 2 Periprocedural: Any stroke (1.11, 2.01) 1.50 (1.21, 1.86) 42.2% Stroke or death (1.12, 2.02) 1.51 (1.23, 1.85) 43.3% MI (0.29, 0.78) 0.47 (0.29, 0.78) 0.0% Hematoma (0.21, 0.57) 0.35 (0.22, 0.55) 6.5% Cranial nerve palsy (0.04, 0.14) 0.08 (0.04, 0.14) 0.0% Long-term: Any stroke (1.16, 1.61) 1.37 (1.19, 1.58) 21.0% Ipsilateral stroke * (1.20, 1.75) 1.45 (1.20, 1.74) 1.9% Abbreviations: RR = relative risk; MI = myocardial infarction; CI = confidence interval. * Ipsilateral stroke includes periprocedural composite of stroke or death.

23 Online Appendix 23. Influence analysis of trials comparing the effect of carotid artery stenting to that of carotid endarterectomy on longterm any stroke outcome Study Risk Ratio RR 95% CI Omitting CREST (2, 3) Omitting ICSS (4, 5) Omitting SPACE (6, 7) Omitting EVA 3S (8 10) Omitting CAVATAS (11, 12) Omitting SAPPHIRE (13, 14) Omitting Brooks et al. (15 17) [1.09; 1.67] [1.09; 1.52] [1.22; 1.69] [1.13; 1.67] [1.10; 1.65] [1.17; 1.65] [1.18; 1.57] Random effects model 1.36 [1.16; 1.61] Favors CAS Favors CEA

24 SUPPLEMENTAL REFERENCES 1. McMaster University. Search Filters for MEDLINE in Ovid Syntax and the PubMed translation - Health Information Research Unit: Evidence-Based Health Informatics [Internet]. Cited 2014, Oct 6. Available from: 2. Brott TG, Hobson RW, Howard G, Roubin GS, Clark WM, Brooks W, Mackey A, Hill MD, Leimgruber PP, Sheffet AJ, Howard VJ, Moore WS, Voeks JH, Hopkins LN, Cutlip DE, Cohen DJ, Popma JJ, Ferguson RD, Cohen SN, Blackshear JL, Silver FL, Mohr JP, Lal BK and Meschia JF. Stenting versus endarterectomy for treatment of carotid-artery stenosis. The N Engl J Med. 2010;363: Howard VJ, Lutsep HL, Mackey A, Demaerschalk BM, Sam AD, Gonzales NR, Sheffet AJ, Voeks JH, Meschia JF and Brott TG. Influence of sex on outcomes of stenting versus endarterectomy: A subgroup analysis of the Carotid Revascularization Endarterectomy versus Stenting Trial (CREST). Lancet Neurol. 2011;10: Ederle J, Dobson J, Featherstone RL, Bonati LH, van der Worp HB, de Borst GJ, Lo TH, Gaines P, Dorman PJ, Macdonald S, Lyrer PA, Hendriks JM, McCollum C, Nederkoorn PJ and Brown MM. Carotid artery stenting compared with endarterectomy in patients with symptomatic carotid stenosis (International Carotid Stenting Study): an interim analysis of a randomised controlled trial. Lancet. 2010;375: Bonati LH, Dobson J, Featherstone RL, Ederle J, van der Worp HB, de Borst GJ, Mali WP, Beard JD, Cleveland T, Engelter ST, Lyrer PA, Ford GA, Dorman PJ and Brown MM. Long-term outcomes after stenting versus endarterectomy for treatment of symptomatic carotid stenosis: the International Carotid Stenting Study (ICSS) randomised trial. Lancet. 2014;385:

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26 Carotid And Vertebral Artery Transluminal Angioplasty Study (CAVATAS): long-term follow-up of a randomised trial. Lancet Neurol. 2009;8: Brown MM. Endovascular versus surgical treatment in patients with carotid stenosis in the Carotid and Vertebral Artery Transluminal Angioplasty Study (CAVATAS): A randomised trial. Lancet. 2001;357: Yadav JS, Wholey MH, Kuntz RE, Fayad P, Katzen BT, Mishkel GJ, Bajwa TK, Whitlow P, Strickman NE, Jaff MR, Popma JJ, Snead DB, Cutlip DE, Firth BG and Ouriel K. Protected carotid-artery stenting versus endarterectomy in high-risk patients. N Engl J Med. 2004;351: Gurm HS, Yadav JS, Fayad P, Katzen BT, Mishkel GJ, Bajwa TK, Ansel G, Strickman NE, Wang H, Cohen SA, Massaro JM and Cutlip DE. Long-term results of carotid stenting versus endarterectomy in high-risk patients. N Engl J Med. 2008;358: Brooks WH, McClure RR, Jones MR, Coleman TC and Breathitt L. Carotid angioplasty and stenting versus carotid endarterectomy: randomized trial in a community hospital. J Am Coll Cardiol. 2001;38: Brooks WH, McClure RR, Jones MR, Coleman TL and Breathitt L. Carotid angioplasty and stenting versus carotid endarterectomy for treatment of asymptomatic carotid stenosis: a randomized trial in a community hospital. Neurosurg. 2004;54:318-24; discussion Brooks WH, Jones MR, Gisler P, McClure RR, Coleman TC, Breathitt L and Spear C. Carotid angioplasty with stenting versus endarterectomy: 10-Year randomized trial in a community hospital. J Am Coll Cardiol: Cardiovasc Interv. 2014;7: Steinbauer MGM, Pfister K, Greindl M, Schlachetzki F, Borisch I, Schuirer G, Feuerbach S and Kasprzak PM. Alert for increased long-term follow-up after carotid artery stenting: Results of a prospective, randomized, single-center trial of carotid artery stenting vs carotid endarterectomy. J Vasc Surg. 2008;48:93-98.

27 19. Higgins JP, Altman DG, Gotzsche PC, Juni P, Moher D, Oxman AD, Savovic J, Schulz KF, Weeks L and Sterne JA. The Cochrane Collaboration's tool for assessing risk of bias in randomised trials. BMJ (Clinical research ed). 2011;343:d5928.