Long-term outcomes after stenting versus endarterectomy for treatment of symptomatic carotid stenosis: the International Carotid Stenting Study (ICSS) randomised trial

Leo H Bonati, Joanna Dobson, Roland L Featherstone, Jörg Ederle, H Bart van der Worp, Gert J de Borst, Willem P Th M Mali, Jonathan D Beard, Trevor Cleveland, Stefan T Engelter, Philippe A Lyrer, Gary A Ford, Paul J Dorman, Martin M Brown, International Carotid Stenting Study investigators, J Bamford, J Beard, M Bland, A W Bradbury, M M Brown, W Hacke, A Halliday, I Malik, J L Mas, A J McGuire, P Sidhu, G Venables, M M Brown, A Clifton, P Gaines, R Collins, A Molyneux, R Naylor, C Warlow, J M Ferro, D Thomas, L Coward, J Dobson, D Doig, J Ederle, R F Featherstone, F Kennedy, H Tindall, E Turner, D J H McCabe, A Wallis, M Brooks, B Chambers, A Chan, H Dewey, G Donnan, G Fell, M Hoare, M Molan, A Roberts, N Roberts, B Beiles, C Bladin, C Clifford, M Grigg, G New, R Bell, S Bower, W Chong, M Holt, P G Than, S Gett, J Quinn, M Ray, A Wong, P Woodruff, R Foreman, D Schultz, R Scroop, N Atkinson, W Cambell, S Davis, P Field, P Milne, P Mitchell, B Tress, B Yan, A Beasley, D Dunbabin, D Stary, S Walker, P Cras, J M H Hendriks, P Van, A Z St, M Bosiers, K Deloose, A Z Sint Jan Brugge-Oostende, V Devos, J Ghekiere, G Vanhooren, P Astarci, F Hammer, V Lacroix, A Peeters, R Verhelst, Imelda Ziekenhuis, L DeJaegher, N Daneault, S Lanthier, L-H Lebrun, V Oliva, J Raymond, D Roy, G Soulez, M Hill, W Hu, M Hudion, J Wong, A Albäck, S Curtze, H Harno, P Ijäs, K Lappalainen, M Lepäntalo, A Meretoja, S Mustanoja, T Paananen, M Railo, T Sairanen, L Soinne, A Vehmas, P Vikatmaa, M Goertler, Z Halloul, P Brennan, C Kelly, A Leahy, J Moroney, J Thornton, M J W Koelemay, P J Nederkoorn, J A A Reekers, B W E M Roos, P M T Pattynama, L C van Dijk, H M van Sambeek, H van Urk, H J M Verhagen, S F de Bruijn, R Keunen, B Knippenberg, A Mosch, F Treurniet, L van Dijk, H van Overhagen, J Wever, A A M van Hasselt, D J Zeilstra, J Boiten, G J Lycklama, J D Blankensteijn, F E De Leeuw, L J Schultze, G J de Borst, G A P de Kort, L J Kapelle, T H Lo, W P Th M Mali, F Moll, P A Barber, R Bourchier, A Hill, A Holden, S J Bakke, K Krohg, M Skjelland, B Tennøe, P Bialek, Z Biejat, W Czepiel, A Czlonkowska, A Dowzenko, J Buczek, A Kobayashi, M Lelek, J Polanski, J Kirbis, Z Milosevic, B Zvan, J Blasco, A Chamorro, J Macho, L San, J Branera, D Canovas, J Perendreu, K Björses, A Gottsäter, T Mätzsch, B Sonesson, B Berg, M Delle, J Formgren, N Nyman, R Takolander, T Andersson, J Malmstedt, M Soderman, C Wahlgren, N Wahlgren, S Binaghi, L Hirt, P Michel, P Ruchat, L H Bonati, S T Engelter, A L Jacob, E Kirsch, P A Lyrer, C Bonvin, A Kalangos, K Lovblad, R Sztajzel, N Higgins, P J Kirkpatrick, P Martin, K Varty, D Adam, J Bell, A W Bradbury, P Crowe, M Gannon, M J Henderson, D Sandler, R A Shinton, J M Scriven, T Wilmink, A Egun, R Guta, S Punekar, D M Seriki, G Thomson, J A Brennan, T P Enevoldson, G Gilling-Smith, D A Gould, P L Harris, R G McWilliams, R White, K G Prakash, F Serracino-Inglott, G Subramanian, M G Walker, M Clarke, M Davis, S A Dixit, P Dorman, A Dyker, G Ford, A Golkar, D Lambert, T Lees, S Louw, S Macdonald, A D Mendelow, H Rodgers, G Stansby, M Wyatt, T Baker, L Jones, D Mitchell, E Munro, M Thornton, D Baker, N Davis, G Hamilton, D McCabe, A Platts, J Tibballs, J Beard, T Cleveland, D Dodd, R Nair, A Nassef, S Nawaz, G Venables, A Belli, A Clifton, A Halliday, H Markus, R McFarland, R Morgan, A Pereira, J Chataway, N Cheshire, R Gibbs, M Hammady, M Jenkins, I Malik, J Wolfe, M Adiseshiah, C Bishop, S Brew, R Jäger, N Kitchen, R Ashleigh, S Butterfield, G E Gamble, C McCollum, A Nasim, P O'Neill, J Wong, R D Edwards, K R Lees, A J MacKay, J Moss, P Rogers, Leo H Bonati, Joanna Dobson, Roland L Featherstone, Jörg Ederle, H Bart van der Worp, Gert J de Borst, Willem P Th M Mali, Jonathan D Beard, Trevor Cleveland, Stefan T Engelter, Philippe A Lyrer, Gary A Ford, Paul J Dorman, Martin M Brown, International Carotid Stenting Study investigators, J Bamford, J Beard, M Bland, A W Bradbury, M M Brown, W Hacke, A Halliday, I Malik, J L Mas, A J McGuire, P Sidhu, G Venables, M M Brown, A Clifton, P Gaines, R Collins, A Molyneux, R Naylor, C Warlow, J M Ferro, D Thomas, L Coward, J Dobson, D Doig, J Ederle, R F Featherstone, F Kennedy, H Tindall, E Turner, D J H McCabe, A Wallis, M Brooks, B Chambers, A Chan, H Dewey, G Donnan, G Fell, M Hoare, M Molan, A Roberts, N Roberts, B Beiles, C Bladin, C Clifford, M Grigg, G New, R Bell, S Bower, W Chong, M Holt, P G Than, S Gett, J Quinn, M Ray, A Wong, P Woodruff, R Foreman, D Schultz, R Scroop, N Atkinson, W Cambell, S Davis, P Field, P Milne, P Mitchell, B Tress, B Yan, A Beasley, D Dunbabin, D Stary, S Walker, P Cras, J M H Hendriks, P Van, A Z St, M Bosiers, K Deloose, A Z Sint Jan Brugge-Oostende, V Devos, J Ghekiere, G Vanhooren, P Astarci, F Hammer, V Lacroix, A Peeters, R Verhelst, Imelda Ziekenhuis, L DeJaegher, N Daneault, S Lanthier, L-H Lebrun, V Oliva, J Raymond, D Roy, G Soulez, M Hill, W Hu, M Hudion, J Wong, A Albäck, S Curtze, H Harno, P Ijäs, K Lappalainen, M Lepäntalo, A Meretoja, S Mustanoja, T Paananen, M Railo, T Sairanen, L Soinne, A Vehmas, P Vikatmaa, M Goertler, Z Halloul, P Brennan, C Kelly, A Leahy, J Moroney, J Thornton, M J W Koelemay, P J Nederkoorn, J A A Reekers, B W E M Roos, P M T Pattynama, L C van Dijk, H M van Sambeek, H van Urk, H J M Verhagen, S F de Bruijn, R Keunen, B Knippenberg, A Mosch, F Treurniet, L van Dijk, H van Overhagen, J Wever, A A M van Hasselt, D J Zeilstra, J Boiten, G J Lycklama, J D Blankensteijn, F E De Leeuw, L J Schultze, G J de Borst, G A P de Kort, L J Kapelle, T H Lo, W P Th M Mali, F Moll, P A Barber, R Bourchier, A Hill, A Holden, S J Bakke, K Krohg, M Skjelland, B Tennøe, P Bialek, Z Biejat, W Czepiel, A Czlonkowska, A Dowzenko, J Buczek, A Kobayashi, M Lelek, J Polanski, J Kirbis, Z Milosevic, B Zvan, J Blasco, A Chamorro, J Macho, L San, J Branera, D Canovas, J Perendreu, K Björses, A Gottsäter, T Mätzsch, B Sonesson, B Berg, M Delle, J Formgren, N Nyman, R Takolander, T Andersson, J Malmstedt, M Soderman, C Wahlgren, N Wahlgren, S Binaghi, L Hirt, P Michel, P Ruchat, L H Bonati, S T Engelter, A L Jacob, E Kirsch, P A Lyrer, C Bonvin, A Kalangos, K Lovblad, R Sztajzel, N Higgins, P J Kirkpatrick, P Martin, K Varty, D Adam, J Bell, A W Bradbury, P Crowe, M Gannon, M J Henderson, D Sandler, R A Shinton, J M Scriven, T Wilmink, A Egun, R Guta, S Punekar, D M Seriki, G Thomson, J A Brennan, T P Enevoldson, G Gilling-Smith, D A Gould, P L Harris, R G McWilliams, R White, K G Prakash, F Serracino-Inglott, G Subramanian, M G Walker, M Clarke, M Davis, S A Dixit, P Dorman, A Dyker, G Ford, A Golkar, D Lambert, T Lees, S Louw, S Macdonald, A D Mendelow, H Rodgers, G Stansby, M Wyatt, T Baker, L Jones, D Mitchell, E Munro, M Thornton, D Baker, N Davis, G Hamilton, D McCabe, A Platts, J Tibballs, J Beard, T Cleveland, D Dodd, R Nair, A Nassef, S Nawaz, G Venables, A Belli, A Clifton, A Halliday, H Markus, R McFarland, R Morgan, A Pereira, J Chataway, N Cheshire, R Gibbs, M Hammady, M Jenkins, I Malik, J Wolfe, M Adiseshiah, C Bishop, S Brew, R Jäger, N Kitchen, R Ashleigh, S Butterfield, G E Gamble, C McCollum, A Nasim, P O'Neill, J Wong, R D Edwards, K R Lees, A J MacKay, J Moss, P Rogers

Abstract

Background: Stenting is an alternative to endarterectomy for treatment of carotid artery stenosis, but long-term efficacy is uncertain. We report long-term data from the randomised International Carotid Stenting Study comparison of these treatments.

Methods: Patients with symptomatic carotid stenosis were randomly assigned 1:1 to open treatment with stenting or endarterectomy at 50 centres worldwide. Randomisation was computer generated centrally and allocated by telephone call or fax. Major outcomes were assessed by an independent endpoint committee unaware of treatment assignment. The primary endpoint was fatal or disabling stroke in any territory after randomisation to the end of follow-up. Analysis was by intention to treat ([ITT] all patients) and per protocol from 31 days after treatment (all patients in whom assigned treatment was completed). Functional ability was rated with the modified Rankin scale. This study is registered, number ISRCTN25337470.

Findings: 1713 patients were assigned to stenting (n=855) or endarterectomy (n=858) and followed up for a median of 4·2 years (IQR 3·0-5·2, maximum 10·0). Three patients withdrew immediately and, therefore, the ITT population comprised 1710 patients. The number of fatal or disabling strokes (52 vs 49) and cumulative 5-year risk did not differ significantly between the stenting and endarterectomy groups (6·4% vs 6·5%; hazard ratio [HR] 1·06, 95% CI 0·72-1·57, p=0·77). Any stroke was more frequent in the stenting group than in the endarterectomy group (119 vs 72 events; ITT population, 5-year cumulative risk 15·2% vs 9·4%, HR 1·71, 95% CI 1·28-2·30, p<0·001; per-protocol population, 5-year cumulative risk 8·9% vs 5·8%, 1·53, 1·02-2·31, p=0·04), but were mainly non-disabling strokes. The distribution of modified Rankin scale scores at 1 year, 5 years, or final follow-up did not differ significantly between treatment groups.

Interpretation: Long-term functional outcome and risk of fatal or disabling stroke are similar for stenting and endarterectomy for symptomatic carotid stenosis.

Funding: Medical Research Council, Stroke Association, Sanofi-Synthélabo, European Union.

Copyright © 2015 Bonati et al. Open Access article distributed under the terms of CC BY. Published by Elsevier Ltd. All rights reserved.

Figures

Figure 1
Figure 1
Trial profile Numbers at screening and excluded before enrolment were not recorded. ITT=intention to treat. *Excluded from the restenosis analysis. † Excluded from per-protocol analysis and restenosis analysis. ‡Excluded from per-protocol analysis.
Figure 2
Figure 2
Kaplan-Meier estimates of cumulative incidence for major outcomes (A) Fatal or disabling stroke. (B) Any stroke. (C) Procedural stroke or procedural death or ipsilateral stroke during follow-up. (D) All-cause death. (E) Any stroke more than 30 days after treatment. (F) Ipsilateral stroke more than 30 days after treatment. (G) Contralateral carotid or vertebrobasilar stroke more than 30 days after treatment. (H) Ipsilateral severe (at least 70%) carotid stenosis after completed treatment, generated by life-table analysis. Panels A–D show results for the intention-to-treat population, E–G for the per-protocol population from 30 days after treatment, and H for the per-protocol population from treatment. Percentage values are the estimated cumulative incidence at 1 year and 5 years. Graphs stop at 7 years' follow-up because numbers beyond that time were less than 100, but analyses were based on all follow-up data (maximum 10 years). HR=hazard ratio. CAS=carotid stenting. CEA=carotid endarterectomy.
Figure 3
Figure 3
Functional ability measured by the modified Rankin scale at the end of follow-up* A permutation test was done to compare scores at the end of follow-up between the two groups: unadjusted, p=0·49; adjusted for baseline modified Rankin scale score, p=0·24. CAS=carotid stenting. CEA=carotid endarterectomy. *Excludes seven patients (three CAS and four CEA) who had no scores recorded during follow-up and were still alive at their final visit.

References

    1. North American Symptomatic Carotid Endarterectomy Trial Collaborators Beneficial effect of carotid endarterectomy in symptomatic patients with high-grade carotid stenosis. N Engl J Med. 1991;325:445–453.
    1. European Carotid Surgery Trialists' Collaborative Group Randomised trial of endarterectomy for recently symptomatic carotid stenosis: final results of the MRC European Carotid Surgery Trial (ECST) Lancet. 1998;351:1379–1387.
    1. Mas JL, Chatellier G, Beyssen B. Endarterectomy versus stenting in patients with symptomatic severe carotid stenosis. N Engl J Med. 2006;355:1660–1671.
    1. The SPACE Collaborative Group 30 day results from the SPACE trial of stent-protected angioplasty versus carotid endarterectomy in symptomatic patients: a randomised non-inferiority trial. Lancet. 2006;368:1239–1247.
    1. International Carotid Stenting Study investigators 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;375:985–997.
    1. Brott TG, Hobson RW, Howard G. Stenting versus endarterectomy for treatment of carotid-artery stenosis. N Engl J Med. 2010;363:11–23.
    1. Bonati LH, Lyrer P, Ederle J, Featherstone R, Brown MM. Percutaneous transluminal balloon angioplasty and stenting for carotid artery stenosis. Cochrane Database Syst Rev. 2012;9 CD000515.
    1. Featherstone RL, Brown MM, Coward LJ. International carotid stenting study: protocol for a randomised clinical trial comparing carotid stenting with endarterectomy in symptomatic carotid artery stenosis. Cerebrovasc Dis. 2004;18:69–74.
    1. van Swieten JC, Koudstaal PJ, Visser MC, Schouten HJ, van Gijn J. Interobserver agreement for the assessment of handicap in stroke patients. Stroke. 1988;19:604–607.
    1. Bonati LH, Ederle J, McCabe DJ, for the CAVATAS Investigators Long-term risk of carotid restenosis in patients randomly assigned to endovascular treatment or endarterectomy in the Carotid and Vertebral Artery Transluminal Angioplasty Study (CAVATAS): long-term follow-up of a randomised trial. Lancet Neurol. 2009;8:908–917.
    1. Collet D. Modelling survival data in medical research. 2nd edn. Chapman & Hall/CRC; London: 2003. pp. 286–296.
    1. Howard G, Waller JL, Voeks JH. A simple, assumption-free, and clinically interpretable approach for analysis of modified Rankin outcomes. Stroke. 2012;43:664–669.
    1. Mas JL, Trinquart L, Leys D, Albucher JF, for the EVA-3S investigators Endarterectomy Versus Angioplasty in Patients with Symptomatic Severe Carotid Stenosis (EVA-3S) trial: results up to 4 years from a randomised, multicentre trial. Lancet Neurol. 2008;7:885–892.
    1. Eckstein HH, Ringleb P, Allenberg JR. Results of the Stent-Protected Angioplasty versus Carotid Endarterectomy (SPACE) study to treat symptomatic stenoses at 2 years: a multinational, prospective, randomised trial. Lancet Neurol. 2008;7:893–902.
    1. Halliday A, Harrison M, Hayter E, for the Asymptomatic Carotid Surgery Trial (ACST) Collaborative Group 10-year stroke prevention after successful carotid endarterectomy for asymptomatic stenosis (ACST-1): a multicentre randomised trial. Lancet. 2010;376:1074–1084.
    1. Ederle J, Bonati LH, Dobson J, for the CAVATAS Investigators Endovascular treatment with angioplasty or stenting versus endarterectomy in patients with carotid artery stenosis in the Carotid and Vertebral Artery Transluminal Angioplasty Study (CAVATAS): long-term follow-up of a randomised trial. Lancet Neurol. 2009;8:898–907.
    1. Bost RB, Hendrikse J, Algra A. Effects of carotid endarterectomy or stenting on arterial diameters in the circle of Willis. J Stroke Cerebrovasc Dis. 2014;23:699–705.
    1. Arquizan C, Trinquart L, Touboul PJ. Restenosis is more frequent after carotid stenting than after endarterectomy: the EVA-3S study. Stroke. 2011;42:1015–1020.
    1. Silver FL, Mackey A, Clark WM, for the CREST Investigators Safety of stenting and endarterectomy by symptomatic status in the Carotid Revascularization Endarterectomy Versus Stenting Trial (CREST) Stroke. 2011;42:675–680.
    1. Nederkoorn PJ, Brown MM. Optimal cut-off criteria for duplex ultrasound for the diagnosis of restenosis in stented carotid arteries: review and protocol for a diagnostic study. BMC Neurol. 2009;9:36.
    1. Carotid Stenting Trialists' Collaboration Short-term outcome after stenting versus endarterectomy for symptomatic carotid stenosis: a preplanned meta-analysis of individual patient data. Lancet. 2010;376:1062–1073.
    1. Calvet D, Dobson J, Algra A. Long term outcome after stenting versus endarterectomy for symptomatic carotid stenosis: a preplanned meta-analysis of individual patient data. Cerebrovasc Dis. 2014;37(suppl 1):192.
    1. Ederle J, Davagnanam I, van der Worp HB, for the ICSS investigators Effect of white-matter lesions on the risk of periprocedural stroke after carotid artery stenting versus endarterectomy in the International Carotid Stenting Study (ICSS): a prespecified analysis of data from a randomised trial. Lancet Neurol. 2013;12:866–872.
    1. Calvet D, Mas JL, Algra A. Carotid stenting: is there an operator effect? A pooled analysis from the carotid stenting trialists' collaboration. Stroke. 2014;45:527–532.
    1. Castro-Afonso LH, Abud LG, Rolo JG. Flow reversal versus filter protection: a pilot carotid artery stenting randomized trial. Circ Cardiovasc Interv. 2013;6:552–559.
    1. Kennedy F, Dobson J, Doig DD, Featherstone RL, Richards T, Brown MM, for the ICSS and CAVATAS Investigators The risks of carotid endarterectomy have declined: an analysis of two trials with similar protocols. Cerebrovasc Dis. 2013;35(suppl 3):463.
    1. Higgins JPT, Altman DG, Sterne JAC, eds, for the Cochrane Statistical Methods Group and the Cochrane Bias Methods Group. Assessing risk of bias in included Studies. In: Higgins JPT, Green S, eds. Cochrane handbook for systematic reviews of interventions: version 5.1.0. (accessed Aug 20, 2014).

Source: PubMed

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