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9. Surpass flow diverter in the treatment of intracranial aneurysms: a prospective multicenter study

Author

Wakhloo, A.K., Lylyk, P., Vries, J. de, Taschner, C., Lundquist, J., Biondi, A., Hartmann, M., Szikora, I., Pierot, L., Sakai, N., Imamura, H., Sourour, N., Rennie, I., Skalej, M., Beuing, O., Bonafe, A., Mery, F., Turjman, F., Brouwer, P., Boccardi, E., Valvassori, L., Derakhshani, S., Litzenberg, M.W., Gounis, M.J., Wakhloo, A.K., Lylyk, P., Vries, J. de, Taschner, C., Lundquist, J., Biondi, A., Hartmann, M., Szikora, I., Pierot, L., Sakai, N., Imamura, H., Sourour, N., Rennie, I., Skalej, M., Beuing, O., Bonafe, A., Mery, F., Turjman, F., Brouwer, P., Boccardi, E., Valvassori, L., Derakhshani, S., Litzenberg, M.W., and Gounis, M.J.

Abstract

Item does not contain fulltext, BACKGROUND AND PURPOSE: Incomplete occlusion and recanalization of large and wide-neck brain aneurysms treated by endovascular therapy remains a challenge. We present preliminary clinical and angiographic results of an experimentally optimized Surpass flow diverter for treatment of intracranial aneurysms in a prospective, multicenter, nonrandomized, single-arm study. MATERIALS AND METHODS: At 24 centers, 165 patients with 190 intracranial aneurysms of the anterior and posterior circulations were enrolled. The primary efficacy end point was the percentage of intracranial aneurysms with 100% occlusion on 6-month DSA. The primary safety end point was neurologic death and any stroke through a minimum follow-up of 6 months. Results : Successful flow-diverter delivery was achieved in 161 patients with 186 aneurysms (98%); the mean number of devices used per aneurysm was 1.05. Clinical follow-up (median, 6 months) of 150 patients (93.2%), showed that the primary safety end point occurred in 18 subjects. Permanent neurologic morbidity and mortality were 6% and 2.7%, respectively. Morbidity occurred in 4% and 7.4% of patients treated for aneurysms of the anterior and posterior circulation, respectively. Neurologic death during follow-up was observed in 1.6% and 7.4% of patients with treated intracranial aneurysms of the anterior and posterior circulation, respectively. Ischemic stroke at 30 days or SAH at >7 days occurred. New or worsening cranial nerve deficit was observed in 2.7%. Follow-up angiography available in 158 (86.8%) intracranial aneurysms showed 100% occlusion in 75%. CONCLUSIONS: Clinical outcomes of the Surpass flow diverter in the treatment of intracranial aneurysms show a safety profile that is comparable with that of stent-assisted coil embolization. Angiographic results showed a hig

Published
2015

10. Surpass flow diverter in the treatment of intracranial aneurysms: a prospective multicenter study

Author

Wakhloo, A.K., Lylyk, P., Vries, J. de, Taschner, C., Lundquist, J., Biondi, A., Hartmann, M., Szikora, I., Pierot, L., Sakai, N., Imamura, H., Sourour, N., Rennie, I., Skalej, M., Beuing, O., Bonafe, A., Mery, F., Turjman, F., Brouwer, P., Boccardi, E., Valvassori, L., Derakhshani, S., Litzenberg, M.W., Gounis, M.J., Wakhloo, A.K., Lylyk, P., Vries, J. de, Taschner, C., Lundquist, J., Biondi, A., Hartmann, M., Szikora, I., Pierot, L., Sakai, N., Imamura, H., Sourour, N., Rennie, I., Skalej, M., Beuing, O., Bonafe, A., Mery, F., Turjman, F., Brouwer, P., Boccardi, E., Valvassori, L., Derakhshani, S., Litzenberg, M.W., and Gounis, M.J.

Abstract

Item does not contain fulltext, BACKGROUND AND PURPOSE: Incomplete occlusion and recanalization of large and wide-neck brain aneurysms treated by endovascular therapy remains a challenge. We present preliminary clinical and angiographic results of an experimentally optimized Surpass flow diverter for treatment of intracranial aneurysms in a prospective, multicenter, nonrandomized, single-arm study. MATERIALS AND METHODS: At 24 centers, 165 patients with 190 intracranial aneurysms of the anterior and posterior circulations were enrolled. The primary efficacy end point was the percentage of intracranial aneurysms with 100% occlusion on 6-month DSA. The primary safety end point was neurologic death and any stroke through a minimum follow-up of 6 months. RESULTS: Successful flow-diverter delivery was achieved in 161 patients with 186 aneurysms (98%); the mean number of devices used per aneurysm was 1.05. Clinical follow-up (median, 6 months) of 150 patients (93.2%), showed that the primary safety end point occurred in 18 subjects. Permanent neurologic morbidity and mortality were 6% and 2.7%, respectively. Morbidity occurred in 4% and 7.4% of patients treated for aneurysms of the anterior and posterior circulation, respectively. Neurologic death during follow-up was observed in 1.6% and 7.4% of patients with treated intracranial aneurysms of the anterior and posterior circulation, respectively. Ischemic stroke at 30 days or SAH at >7 days occurred. New or worsening cranial nerve deficit was observed in 2.7%. Follow-up angiography available in 158 (86.8%) intracranial aneurysms showed 100% occlusion in 75%. CONCLUSIONS: Clinical outcomes of the Surpass flow diverter in the treatment of intracranial aneurysms show a safety profile that is comparable with that of stent-assisted coil embolization. Angiographic results showed a high

Published
2015

11. Surpass flow diverter in the treatment of intracranial aneurysms: a prospective multicenter study

Author

Wakhloo, A.K., Lylyk, P., Vries, J. de, Taschner, C., Lundquist, J., Biondi, A., Hartmann, M., Szikora, I., Pierot, L., Sakai, N., Imamura, H., Sourour, N., Rennie, I., Skalej, M., Beuing, O., Bonafe, A., Mery, F., Turjman, F., Brouwer, P., Boccardi, E., Valvassori, L., Derakhshani, S., Litzenberg, M.W., Gounis, M.J., Wakhloo, A.K., Lylyk, P., Vries, J. de, Taschner, C., Lundquist, J., Biondi, A., Hartmann, M., Szikora, I., Pierot, L., Sakai, N., Imamura, H., Sourour, N., Rennie, I., Skalej, M., Beuing, O., Bonafe, A., Mery, F., Turjman, F., Brouwer, P., Boccardi, E., Valvassori, L., Derakhshani, S., Litzenberg, M.W., and Gounis, M.J.

Abstract

Item does not contain fulltext, BACKGROUND AND PURPOSE: Incomplete occlusion and recanalization of large and wide-neck brain aneurysms treated by endovascular therapy remains a challenge. We present preliminary clinical and angiographic results of an experimentally optimized Surpass flow diverter for treatment of intracranial aneurysms in a prospective, multicenter, nonrandomized, single-arm study. MATERIALS AND METHODS: At 24 centers, 165 patients with 190 intracranial aneurysms of the anterior and posterior circulations were enrolled. The primary efficacy end point was the percentage of intracranial aneurysms with 100% occlusion on 6-month DSA. The primary safety end point was neurologic death and any stroke through a minimum follow-up of 6 months. RESULTS: Successful flow-diverter delivery was achieved in 161 patients with 186 aneurysms (98%); the mean number of devices used per aneurysm was 1.05. Clinical follow-up (median, 6 months) of 150 patients (93.2%), showed that the primary safety end point occurred in 18 subjects. Permanent neurologic morbidity and mortality were 6% and 2.7%, respectively. Morbidity occurred in 4% and 7.4% of patients treated for aneurysms of the anterior and posterior circulation, respectively. Neurologic death during follow-up was observed in 1.6% and 7.4% of patients with treated intracranial aneurysms of the anterior and posterior circulation, respectively. Ischemic stroke at 30 days or SAH at >7 days occurred. New or worsening cranial nerve deficit was observed in 2.7%. Follow-up angiography available in 158 (86.8%) intracranial aneurysms showed 100% occlusion in 75%. CONCLUSIONS: Clinical outcomes of the Surpass flow diverter in the treatment of intracranial aneurysms show a safety profile that is comparable with that of stent-assisted coil embolization. Angiographic results showed a high

Published
2015

15. 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

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

16. 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

Ederle, Jörg, Dobson, Joanna, Featherstone, Roland L., Bonati, Leo H., van der Worp, H. Bart, de Borst, Gert J., Hauw Lo, T., Gaines, Peter, Dorman, Paul J., Macdonald, Sumaira, Lyrer, Philippe A., Hendriks, Johanna M., McCollum, Charles, Nederkoorn, Paul J., Brown, Martin 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.J.H., 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., Peeters, A., Verhelst, R., DeJaegher, L., Verbist, J., Blair, J.-F., Caron, J.L., Daneault, N., Giroux, M.-F., 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., Wong, J., Albäck, A., Harno, H., Ijäs, P., Kaste, M., Lepäntalo, 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-Sørensen, K., Skjelland, M., Tennøe, 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, Jordi, Gimenez Gaibar, A., Perendreu, J., Björses, 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., 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., 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., Jäger, R., Kitchen, N., Ashleigh, R., Butterfield, S., Gamble, G.E., Nasim, A., O'Neill, P., Edwards, R.D., Lees, K.R., MacKay, A.J., Moss, J., Rogers, P., Ederle, Jörg, Dobson, Joanna, Featherstone, Roland L., Bonati, Leo H., van der Worp, H. Bart, de Borst, Gert J., Hauw Lo, T., Gaines, Peter, Dorman, Paul J., Macdonald, Sumaira, Lyrer, Philippe A., Hendriks, Johanna M., McCollum, Charles, Nederkoorn, Paul J., Brown, Martin 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.J.H., 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., Peeters, A., Verhelst, R., DeJaegher, L., Verbist, J., Blair, J.-F., Caron, J.L., Daneault, N., Giroux, M.-F., 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., Wong, J., Albäck, A., Harno, H., Ijäs, P., Kaste, M., Lepäntalo, 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-Sørensen, K., Skjelland, M., Tennøe, 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, Jordi, Gimenez Gaibar, A., Perendreu, J., Björses, 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., 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., 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., Jäger, R., Kitchen, N., Ashleigh, R., Butterfield, S., Gamble, G.E., Nasim, A., O'Neill, P., Edwards, R.D., Lees, K.R., MacKay, A.J., Moss, J., and Rogers, P.

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

Published
2010

17. 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

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

42. 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

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, Clifton, A, Hacke, W, Halliday, A, Malik, I, Mas, JL, McGuire, AJ, Sidhu, P, Venables, G, Bradbury, A, Collins, R, Molynewc, A, Naylor, R, Warlow, C, Ferro, JM, Thomas, D, Coward, L, 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, 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, Verbist, J, Blair, J-F, Caron, JL, Daneault, N, Giroux, M-F, 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, 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, Reekers, JAA, Roos, YBWEM, 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, JCADM, de Vries, AC, Nieholt, GJLA, van der Kallen, BFW, Blankensteijn, JD, De Leeuw, FE, Kool, LJS, van der Vliet, JA, de Kort, GAP, Kapelle, LJ, Mali, WPTM, Moll, F, 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, 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, ST, Fluri, F, Guerke, L, Jacob, AL, 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, PJ, Martin, P, Adam, D, Bell, J, 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, H-C, 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, 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, Cleveland, T, Dodd, D, Lonsdale, R, Nair, R, Nassef, A, Nawaz, S, Belli, A, Cloud, G, Markus, H, McFarland, R, Morgan, R, Pereira, A, Thompson, A, Chataway, J, Cheshire, N, Gibbs, R, Hammady, M, Jenkins, M, Wolfe, J, Adiseshiah, M, Bishop, C, Brew, S, Brookes, J, Jaeger, R, Kitchen, N, Ashleigh, R, Butterfield, S, Gamble, GE, Nasim, A, O'Neill, P, Edwards, RD, Lees, KR, MacKay, AJ, Moss, J, Rogers, P, 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, Clifton, A, Hacke, W, Halliday, A, Malik, I, Mas, JL, McGuire, AJ, Sidhu, P, Venables, G, Bradbury, A, Collins, R, Molynewc, A, Naylor, R, Warlow, C, Ferro, JM, Thomas, D, Coward, L, 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, 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, Verbist, J, Blair, J-F, Caron, JL, Daneault, N, Giroux, M-F, 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, 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, Reekers, JAA, Roos, YBWEM, 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, JCADM, de Vries, AC, Nieholt, GJLA, van der Kallen, BFW, Blankensteijn, JD, De Leeuw, FE, Kool, LJS, van der Vliet, JA, de Kort, GAP, Kapelle, LJ, Mali, WPTM, Moll, F, 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, 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, ST, Fluri, F, Guerke, L, Jacob, AL, 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, PJ, Martin, P, Adam, D, Bell, J, 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, H-C, 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, 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, Cleveland, T, Dodd, D, Lonsdale, R, Nair, R, Nassef, A, Nawaz, S, Belli, A, Cloud, G, Markus, H, McFarland, R, Morgan, R, Pereira, A, Thompson, A, Chataway, J, Cheshire, N, Gibbs, R, Hammady, M, Jenkins, M, Wolfe, J, Adiseshiah, M, Bishop, C, Brew, S, Brookes, J, Jaeger, R, Kitchen, N, Ashleigh, R, Butterfield, S, Gamble, GE, Nasim, A, O'Neill, P, Edwards, RD, Lees, KR, MacKay, AJ, Moss, J, and Rogers, P

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

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