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Carotid artery stenting compared with endarterectomy in patients with symptomatic carotid stenosis (International Carotid Stenting Study): an interim analysis of a randomised controlled trial

Lookup NU author(s): Dr Paul Milne, Patrick Mitchell, Dr Alexander Dyker, Professor Gary Ford, Dr Richard Jackson, David Lambert, Tim Lees, Dr Sumaira MacDonald, Emeritus Professor David Mendelow, Emerita Professor Helen Rodgers, Dr John Rose, Professor Gerard Stansby, Michael Wyatt

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Abstract

Background Stents are an alternative treatment to carotid endarterectomy for symptomatic carotid stenosis, but previous trials have not established equivalent safety and efficacy. We compared the safety of carotid artery stenting with that of carotid endarterectomy. Methods The International Carotid Stenting Study (ICSS) is a multicentre, international, randomised controlled trial with blinded adjudication of outcomes. Patients with recently symptomatic carotid artery stenosis were randomly assigned in a 1:1 ratio to receive carotid artery stenting or carotid endarterectomy. Randomisation was by telephone call or fax to a central computerised service and was stratified by centre with minimisation for sex, age, contralateral occlusion, and side of the randomised artery. Patients and investigators were not masked to treatment assignment. Patients were followed up by independent clinicians not directly involved in delivering the randomised treatment. The primary outcome measure of the trial is the 3-year rate of fatal or disabling stroke in any territory, which has not been analysed yet. The main outcome measure for the interim safety analysis was the 120-day rate of stroke, death, or procedural myocardial infarction. Analysis was by intention to treat (ITT). This study is registered, number ISRCTN25337470. Findings The trial enrolled 1713 patients (stenting group, n=855; endarterectomy group, n=858). Two patients in the stenting group and one in the endarterectomy group withdrew immediately after randomisation, and were not included in the ITT analysis. Between randomisation and 120 days, there were 34 (Kaplan-Meier estimate 4.0%) events of disabling stroke or death in the stenting group compared with 27 (3.2%) events in the endarterectomy group (hazard ratio [HR] 1.28, 95% CI 0.77-2.11). The incidence of stroke, death, or procedural myocardial infarction was 8.5% in the stenting group compared with 5.2% in the endarterectomy group (72 vs 44 events; HR 1.69, 1.16-2.45, p=0.006), Risks of any stroke (65 vs 35 events; HR 1.92, 1.27-2.89) and all-cause death (19 vs seven events; HR 2.76, 1.16-6.56) were higher in the stenting group than in the endarterectomy group. Three procedural myocardial infarctions were recorded in the stenting group, all of which were fatal, compared with four, all non-fatal, in the endarterectomy group. There was one event of cranial nerve palsy in the stenting group compared with 45 in the endarterectomy group. There were also fewer haematomas of any severity in the stenting group than in the endarterectomy group (31 vs 50 events; p=0.0197). Interpretation Completion of long-term follow-up is needed to establish the efficacy of carotid artery stenting compared with endarterectomy. In the meantime, carotid endarterectomy should remain the treatment of choice for patients suitable for surgery.

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Author(s): 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, Brown MM, Algra A, Bamford J, Beard J, Bland M, Bradbury AW, Brown MM, Clifton A, Gaines P, Hacke W, Halliday A, Malik I, Mas JL, McGuire AJ, Sidhu P, Venables G, Bradbury A, Brown MM, Clifton A, Gaines P, Collins R, Molynewc A, Naylor R, Warlow C, Ferro JM, Thomas D, Bonati LH, Coward L, Dobson J, Ederle J, Featherstone RF, Tindall H, McCabe DJH, Wallis A, Brooks M, Chambers B, Chan A, Chu P, Clark D, Dewey H, Donnan G, Fell G, Hoare M, Molan M, Roberts A, Roberts N, Beiles B, Bladin C, Clifford C, Fell G, Grigg M, New G, Bell R, Bower S, Chong W, Holt M, Saunder A, Than PG, Gett S, Leggett D, McGahan T, Quinn J, Ray M, Wong A, Woodruff P, Foreman R, Schultz D, Scroop R, Stanley B, Allard B, Atkinson N, Cambell W, Davies S, Field P, Milne P, Mitchell P, Tress B, Yan B, Beasley A, Dunbabin D, Stary D, Walker S, Cras P, d'Archambeau O, Hendriks JMH, Van Schil P, Bosiers M, Deloose K, van Buggenhout E, De Letter J, Devos V, Ghekiere J, Vanhooren G, Astarci P, Hammer F, Lacroix V, Peeters A, Verhelst R, DeJaegher L, Peeters A, Verbist J, Blair JF, Caron JL, Daneault N, Giroux MF, Guilbert F, Lanthier S, Lebrun LH, Oliva V, Raymond J, Roy D, Soulez G, Weill A, Hill M, Hu W, Hudion M, Morrish W, Sutherland G, Wong J, Alback A, Harno H, Ijas P, Kaste M, Lepantalo M, Mustanoja S, Paananen T, Porras M, Putaala J, Railo M, Sairanen T, Soinne L, Vehmas A, Vikatmaa P, Goertler M, Halloul Z, Skalej M, Brennan P, Kelly C, Leahy A, Moroney J, Thornton J, Koelemay MJW, Nederkoorn PJ, Reekers JAA, Roos YBWEM, Hendriks JM, Koudstaal PJ, Pattynama PMT, van der Lugt A, van Dijk LC, van Sambeek MRHM, van Urk H, Verhagen HJM, Bruininckx CMA, de Bruijn SF, Keunen R, Knippenberg B, Mosch A, Treurniet F, van Dijk L, van Overhagen H, Wever J, de Beer FC, van den Berg JSP, van Hasselt BAAM, Zeilstra DJ, Boiten J, van Otterloo JCAD, de Vries AC, Nieholt GJLA, van der Kallen BFW, Blankensteijn JD, De Leeuw FE, Kool LJS, van der Vliet JA, de Borst GJ, de Kort GAP, Kapelle LJ, Lo TH, Mali WPTM, Moll F, van der Worp HB, Verhagen H, Barber PA, Bourchier R, Hill A, Holden A, Stewart J, Bakke SJ, Krohg-Sorensen K, Skjelland M, Tennoe B, Bialek P, Biejat Z, Czepiel W, Czlonkowska A, Dowzenko A, Jedrzejewska J, Kobayashi A, Lelek M, Polanski J, Kirbis J, Milosevic Z, Zvan B, Blasco J, Chamorro A, Macho J, Obach V, Riambau V, San Roman L, Branera J, Canovas D, Estela J, Gaibar AG, Perendreu J, Bjorses K, Gottsater A, Ivancev K, Maetzsch T, Sonesson B, Berg B, Delle M, Formgren J, Gillgren P, Kall TB, Konrad P, Nyman N, Takolander R, Andersson T, Malmstedt J, Soderman M, Wahlgren C, Wahlgren N, Binaghi S, Hirt L, Michel P, Ruchat P, Bonati LH, Engelter ST, Fluri F, Guerke L, Jacob AL, Kirsch E, Lyrer PA, Radue EW, Stierli P, Wasner M, Wetzel S, Bonvin C, Kalangos A, Lovblad K, Murith N, Ruefenacht D, Sztajzel R, Higgins N, Kirkpatrick PJ, Martin P, Adam D, Bell J, Bradbury AW, Crowe P, Gannon M, Henderson MJ, Sandler D, Shinton RA, Scriven JM, Wilmink T, D'Souza S, Egun A, Guta R, Punekar S, Seriki DM, Thomson G, Brennan A, Enevoldson TP, Gilling-Smith G, Gould DA, Harris PL, McWilliams RG, Nasser HC, White R, Prakash KG, Serracino-Inglott F, Subramanian G, Symth JV, Walker MG, Clarke M, Davis M, Dixit SA, Dolman P, Dyker A, Ford G, Golkar A, Jackson R, Jayakrishnan V, Lambert D, Lees T, Louw S, Macdonald S, Mendelow AD, Rodgers H, Rose J, Stansby G, Wyatt M, Baker T, Baldwin N, Jones L, Mitchell D, Munro E, Thornton M, Baker D, Davis N, Hamilton G, McCabe D, Platts A, Tibballs J, Beard J, Cleveland T, Dodd D, Gaines P, Lonsdale R, Nair R, Nassef A, Nawaz S, Venables G, Belli A, Clifton A, Cloud G, Halliday A, Markus H, McFarland R, Morgan R, Pereira A, Thompson A, Chataway J, Cheshire N, Gibbs R, Hammady M, Jenkins M, Malik I, Wolfe J, Adiseshiah M, Bishop C, Brew S, Brookes J, Brown MM, Jager R, Kitchen N, Ashleigh R, Butterfield S, Gamble GE, McCollum C, Nasim A, O'Neill P, Wong J, Edwards RD, Lees KR, MacKay AJ, Moss J, Rogers P, International Carotid Stenting Study Group

Publication type: Article

Publication status: Published

Journal: The Lancet

Year: 2010

Volume: 375

Issue: 9719

Pages: 985-997

Print publication date: 25/02/2010

ISSN (print): 0140-6736

ISSN (electronic): 1474-547X

Publisher: The Lancet Publishing Group

URL: http://dx.doi.org/10.1016/S0140-6736(10)60239-5

DOI: 10.1016/S0140-6736(10)60239-5

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