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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

Ederle, Joerg; Dobson, Joanna; Featherstone, Roland L.; Bonati, Leo H.; van der Worp, H. Bart; de Borst, Gert J.; Lo, T. Hauw; Gaines, Peter; Dorman, Paul J. and Macdonald, Sumaira, et al. (2010) In The Lancet 375(9719). p.985-997
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... (More)
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. (Less)
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The Lancet
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375
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9719
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985 - 997
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Elsevier Limited
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  • wos:000276110700031
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1474-547X
DOI
10.1016/S0140-6736(10)60239-5
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English
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@article{231f2838-a27c-4ae3-bbe5-7c6a1b65e788,
  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.},
  author       = {Ederle, Joerg and Dobson, Joanna and Featherstone, Roland L. and Bonati, Leo H. and van der Worp, H. Bart and de Borst, Gert J. and Lo, T. Hauw and Gaines, Peter and Dorman, Paul J. and Macdonald, Sumaira and Lyrer, Philippe A. and Hendriks, Johanna M. and McCollum, Charles and Nederkoorn, Paul J. and Brown, Martin M. and Algra, A. and Bamford, J. and Beard, J. and Bland, M. and Bradbury, A. W. and Brown, M. M. and Clifton, A. and Gaines, P. and Hacke, W. and Halliday, A. and Malik, I. and Mas, J. L. and McGuire, A. J. and Sidhu, P. and Venables, G. and Bradbury, A. and Brown, M. M. and Clifton, A. and Gaines, P. and Collins, R. and Molynewc, A. and Naylor, R. and Warlow, C. and Ferro, J. M. and Thomas, D. and Bonati, L. H. and Coward, L. and Dobson, J. and Ederle, J. and Featherstone, R. F. and Tindall, H. and McCabe, D. J. H. and Wallis, A. and Brooks, M. and Chambers, B. and Chan, A. and Chu, P. and Clark, D. and Dewey, H. and Donnan, G. and Fell, G. and Hoare, M. and Molan, M. and Roberts, A. and Roberts, N. and Beiles, B. and Bladin, C. and Clifford, C. and Fell, G. and Grigg, M. and New, G. and Bell, R. and Bower, S. and Chong, W. and Holt, M. and Saunder, A. and Than, P. G. and Gett, S. and Leggett, D. and McGahan, T. and Quinn, J. and Ray, M. and Wong, A. and Woodruff, P. and Foreman, R. and Schultz, D. and Scroop, R. and Stanley, B. and Allard, B. and Atkinson, N. and Cambell, W. and Davies, S. and Field, P. and Milne, P. and Mitchell, P. and Tress, B. and Yan, B. and Beasley, A. and Dunbabin, D. and Stary, D. and Walker, S. and Cras, P. and d'Archambeau, O. and Hendriks, J. M. H. and Van Schil, P. and Bosiers, M. and Deloose, K. and van Buggenhout, E. and De Letter, J. and Devos, V. and Ghekiere, J. and Vanhooren, G. and Astarci, P. and Hammer, F. and Lacroix, V. and Peeters, A. and Verhelst, R. and DeJaegher, L. and Peeters, A. and Verbist, J. and Blair, J-F and Caron, J. L. and Daneault, N. and Giroux, M-F and Guilbert, F. and Lanthier, S. and Lebrun, L-H and Oliva, V. and Raymond, J. and Roy, D. and Soulez, G. and Weill, A. and Hill, M. and Hu, W. and Hudion, M. and Morrish, W. and Sutherland, G. and Wong, J. and Alback, A. and Harno, H. and Ijas, P. and Kaste, M. and Lepantalo, M. and Mustanoja, S. and Paananen, T. and Porras, M. and Putaala, J. and Railo, M. and Sairanen, T. and Soinne, L. and Vehmas, A. and Vikatmaa, P. and Goertler, M. and Halloul, Z. and Skalej, M. and Brennan, P. and Kelly, C. and Leahy, A. and Moroney, J. and Thornton, J. and Koelemay, M. J. W. and Nederkoorn, P. J. and Reekers, J. A. A. and Roos, Y. B. W. E. M. and Hendriks, J. M. and Koudstaal, P. J. and Pattynama, P. M. T. and van der Lugt, A. and van Dijk, L. C. and van Sambeek, M. R. H. M. and van Urk, H. and Verhagen, H. J. M. and Bruininckx, C. M. A. and de Bruijn, S. F. and Keunen, R. and Knippenberg, B. and Mosch, A. and Treurniet, F. and van Dijk, L. and van Overhagen, H. and Wever, J. and de Beer, F. C. and van den Berg, J. S. P. and van Hasselt, B. A. A. M. and Zeilstra, D. J. and Boiten, J. and van Otterloo, J. C. A. de Mol and de Vries, A. C. and Nieholt, G. J. Lycklama A. and van der Kallen, B. F. W. and Blankensteijn, J. D. and De Leeuw, F. E. and Kool, L. J. Schultze and van der Vliet, J. A. and de Borst, G. J. and de Kort, G. A. P. and Kapelle, L. J. and Lo, T. H. and Mali, W. P. Th M. and Moll, F. and van der Worp, H. B. and Verhagen, H. and Barber, P. A. and Bourchier, R. and Hill, A. and Holden, A. and Stewart, J. and Bakke, S. J. and Krohg-Sorensen, K. and Skjelland, M. and Tennoe, B. and Bialek, P. and Biejat, Z. and Czepiel, W. and Czlonkowska, A. and Dowzenko, A. and Jedrzejewska, J. and Kobayashi, A. and Lelek, M. and Polanski, J. and Kirbis, J. and Milosevic, Z. and Zvan, B. and Blasco, J. and Chamorro, A. and Macho, J. and Obach, V. and Riambau, V. and San Roman, L. and Branera, J. and Canovas, D. and Estela, Jordi and Gimenez Gaibar, A. and Perendreu, J. and Björses, Katarina and Gottsäter, Anders and Ivancev, Krassi and Mätzsch, Thomas and Sonesson, Björn and Berg, B. and Delle, M. and Formgren, J. and Gillgren, P. and Kall, T-B and Konrad, P. and Nyman, N. and Takolander, R. and Andersson, T. and Malmstedt, J. and Soderman, M. and Wahlgren, C. and Wahlgren, N. and Binaghi, S. and Hirt, L. and Michel, P. and Ruchat, P. and Bonati, L. H. and Engelter, S. T. and Fluri, F. and Guerke, L. and Jacob, A. L. and Kirsch, E. and Lyrer, P. A. and Radue, E-W and Stierli, P. and Wasner, M. and Wetzel, S. and Bonvin, C. and Kalangos, A. and Lovblad, K. and Murith, N. and Ruefenacht, D. and Sztajzel, R. and Higgins, N. and Kirkpatrick, P. J. and Martin, P. and Adam, D. and Bell, J. and Bradbury, A. W. and Crowe, P. and Gannon, M. and Henderson, M. J. and Sandler, D. and Shinton, R. A. and Scriven, J. M. and Wilmink, T. and D'Souza, S. and Egun, A. and Guta, R. and Punekar, S. and Seriki, D. M. and Thomson, G. and Brennan, A. and Enevoldson, T. P. and Gilling-Smith, G. and Gould, D. A. and Harris, P. L. and McWilliams, R. G. and Nasser, H-C and White, R. and Prakash, K. G. and Serracino-Inglott, F. and Subramanian, G. and Symth, J. V. and Walker, M. G. and Clarke, M. and Davis, M. and Dixit, S. A. and Dolman, P. and Dyker, A. and Ford, G. and Golkar, A. and Jackson, R. and Jayakrishnan, V. and Lambert, D. and Lees, T. and Louw, S. and Macdonald, S. and Mendelow, A. D. and Rodgers, H. and Rose, J. and Stansby, G. and Wyatt, M. and Baker, T. and Baldwin, N. and Jones, L. and Mitchell, D. and Munro, E. and Thornton, M. and Baker, D. and Davis, N. and Hamilton, G. and McCabe, D. and Platts, A. and Tibballs, J. and Beard, J. and Cleveland, T. and Dodd, D. and Gaines, P. and Lonsdale, R. and Nair, R. and Nassef, A. and Nawaz, S. and Venables, G. and Belli, A. and Clifton, A. and Cloud, G. and Halliday, A. and Markus, H. and McFarland, R. and Morgan, R. and Pereira, A. and Thompson, A. and Chataway, J. and Cheshire, N. and Gibbs, R. and Hammady, M. and Jenkins, M. and Malik, I. and Wolfe, J. and Adiseshiah, M. and Bishop, C. and Brew, S. and Brookes, J. and Brown, M. M. and Jaeger, R. and Kitchen, N. and Ashleigh, R. and Butterfield, S. and Gamble, G. E. and McCollum, C. and Nasim, A. and O'Neill, P. and Wong, J. and Edwards, R. D. and Lees, K. R. and MacKay, A. J. and Moss, J. and Rogers, P.},
  issn         = {1474-547X},
  language     = {eng},
  number       = {9719},
  pages        = {985--997},
  publisher    = {Elsevier Limited},
  series       = {The Lancet},
  title        = {Carotid artery stenting compared with endarterectomy in patients with symptomatic carotid stenosis (International Carotid Stenting Study): an interim analysis of a randomised controlled trial},
  url          = {http://dx.doi.org/10.1016/S0140-6736(10)60239-5},
  volume       = {375},
  year         = {2010},
}