1. Carotid artery stenting compared with endarterectomy in patients with symptomatic carotid stenosis (International Carotid Stenting Study): an interim analysis of a randomised controlled trial.
- Author
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Giroux M.-F., Prakash K.G., Serracino-Inglott F., Subramanian G., Symth J.V., Walker M.G., Clarke M., Davis M., Dixit S.A., Dorman P., Dyker A., Ford G., Golkar A., Jackson R., Jayakrishnan V., Lambert D., Lees T., Louw S., Mendelow A.D., 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., 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., Jager R., Kitchen N., Ashleigh R., Butterfield S., Gamble G.E., Nasim A., O'Neill P., Wong J., Edwards R.D., Lees K.R., MacKay A.J., Moss J., Rogers P., Ederle J., Dobson J., Featherstone R.L., Bonati L.H., van der Worp H.B., de Borst G.J., Hauw Lo T., Dorman P.J., Macdonald S., Lyrer P.A., McCollum C., Nederkoorn P.J., Brown M.M., Algra A., Bamford J., Bland M., Hacke W., Mas J.L., McGuire A.J., Sidhu P., Bradbury A., Collins R., Molyneux A., Naylor R., Warlow C., Ferro M., Thomas D., Featherstone R.F., Tindall H., McCabe D., Wallis A., Coward L., 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., Grigg M., New G., Bell R., Bower S., Chong W., Holt M., Saunder A., Than P.G., 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 J.M.H., 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., Verhelst R., DeJaegher L., Peeters A., Verbist J., Blair J.-F., Caron J.L., Daneault N., Guilbert F., Lanthier S., Lebrun L.-H., Oliva V., Raymond J., Roy D., Soulez G., Weill A., Hill M., Hu W., Hudion M., Morrish W., Sutherland G., 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 M.J.W., Reekers J.A.A., Roos Y.B.W.E.M., Hendriks J.M., Koudstaal P.J., Pattynama P.M.T., van der Lugt A., van Dijk L.C., van Sambeek M.R.H.M., van Urk H., Verhagen H.J.M., Bruijninckx C.M.A., de Bruijn S.F., Keunen R., Knippenberg B., Mosch A., Treurniet F., van Dijk L., van Overhagen H., Wever J., de Beer F.C., van den Berg J.S.P., van Hasselt B.A.A.M., Zeilstra D.J., Boiten J., de Mol van Otterloo J.C.A., de Vries A.C., Lycklama a Nijeholt G.J., van der Kallen B.F.W., Blankensteijn J.D., De Leeuw F.E., Schultze Kool L.J., van der Vliet J.A., de Kort G.A.P., Kapelle L.J., Lo T.H., Mali W.P.T.M., Moll F., Verhagen H., Barber P.A., Bourchier R., Hill A., Holden A., Stewart J., Bakke S.J., 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., Gimenez Gaibar A., Perendreu J., Bjorses K., Gottsater A., Ivancev K., Maetzsch T., Sonesson B., Berg B., Delle M., Formgren J., Gillgren P., Kall T.-B., Konrad P., Nyman N., Takolander R., Andersson T., Malmstedt J., Soderman M., Wahlgren C., Wahlgren N., Binaghi S., Hirt L., Michel P., Ruchat P., Engelter S.T., Fluri F., Guerke L., Jacob A.L., Kirsch E., Radue E.-W., Stierli P., Wasner M., Wetzel S., Bonvin C., Kalangos A., Lovblad K., Murith N., Ruefenacht D., Sztajzel R., Higgins N., Kirkpatrick P.J., Martin P., Adam D., Bell J., Bradbury A.W., Crowe P., Gannon M., Henderson M.J., Sandler D., Shinton R.A., Scriven J.M., Wilmink T., D'Souza S., Egun A., Guta R., Punekar S., Seriki D.M., Thomson G., Brennan J.A., Enevoldson T.P., Gilling-Smith G., Gould D.A., Harris P.L., McWilliams R.G., Nasser H.-C., White R., Giroux M.-F., Prakash K.G., Serracino-Inglott F., Subramanian G., Symth J.V., Walker M.G., Clarke M., Davis M., Dixit S.A., Dorman P., Dyker A., Ford G., Golkar A., Jackson R., Jayakrishnan V., Lambert D., Lees T., Louw S., Mendelow A.D., 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., 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., Jager R., Kitchen N., Ashleigh R., Butterfield S., Gamble G.E., Nasim A., O'Neill P., Wong J., Edwards R.D., Lees K.R., MacKay A.J., Moss J., Rogers P., Ederle J., Dobson J., Featherstone R.L., Bonati L.H., van der Worp H.B., de Borst G.J., Hauw Lo T., Dorman P.J., Macdonald S., Lyrer P.A., McCollum C., Nederkoorn P.J., Brown M.M., Algra A., Bamford J., Bland M., Hacke W., Mas J.L., McGuire A.J., Sidhu P., Bradbury A., Collins R., Molyneux A., Naylor R., Warlow C., Ferro M., Thomas D., Featherstone R.F., Tindall H., McCabe D., Wallis A., Coward L., 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., Grigg M., New G., Bell R., Bower S., Chong W., Holt M., Saunder A., Than P.G., 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 J.M.H., 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., Verhelst R., DeJaegher L., Peeters A., Verbist J., Blair J.-F., Caron J.L., Daneault N., Guilbert F., Lanthier S., Lebrun L.-H., Oliva V., Raymond J., Roy D., Soulez G., Weill A., Hill M., Hu W., Hudion M., Morrish W., Sutherland G., 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 M.J.W., Reekers J.A.A., Roos Y.B.W.E.M., Hendriks J.M., Koudstaal P.J., Pattynama P.M.T., van der Lugt A., van Dijk L.C., van Sambeek M.R.H.M., van Urk H., Verhagen H.J.M., Bruijninckx C.M.A., de Bruijn S.F., Keunen R., Knippenberg B., Mosch A., Treurniet F., van Dijk L., van Overhagen H., Wever J., de Beer F.C., van den Berg J.S.P., van Hasselt B.A.A.M., Zeilstra D.J., Boiten J., de Mol van Otterloo J.C.A., de Vries A.C., Lycklama a Nijeholt G.J., van der Kallen B.F.W., Blankensteijn J.D., De Leeuw F.E., Schultze Kool L.J., van der Vliet J.A., de Kort G.A.P., Kapelle L.J., Lo T.H., Mali W.P.T.M., Moll F., Verhagen H., Barber P.A., Bourchier R., Hill A., Holden A., Stewart J., Bakke S.J., 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., Gimenez Gaibar A., Perendreu J., Bjorses K., Gottsater A., Ivancev K., Maetzsch T., Sonesson B., Berg B., Delle M., Formgren J., Gillgren P., Kall T.-B., Konrad P., Nyman N., Takolander R., Andersson T., Malmstedt J., Soderman M., Wahlgren C., Wahlgren N., Binaghi S., Hirt L., Michel P., Ruchat P., Engelter S.T., Fluri F., Guerke L., Jacob A.L., Kirsch E., Radue E.-W., Stierli P., Wasner M., Wetzel S., Bonvin C., Kalangos A., Lovblad K., Murith N., Ruefenacht D., Sztajzel R., Higgins N., Kirkpatrick P.J., Martin P., Adam D., Bell J., Bradbury A.W., Crowe P., Gannon M., Henderson M.J., Sandler D., Shinton R.A., Scriven J.M., Wilmink T., D'Souza S., Egun A., Guta R., Punekar S., Seriki D.M., Thomson G., Brennan J.A., Enevoldson T.P., Gilling-Smith G., Gould D.A., Harris P.L., McWilliams R.G., Nasser H.-C., and White R.
- 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. Method(s): 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. Finding(s): 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.
- Published
- 2010