Carotid artery stenting compared with endarterectomy in patients with symptomatic carotid stenosis (International Carotid Stenting Study)

an interim analysis of a randomised controlled trial

Jörg Ederle, Joanna Dobson, Roland L. Featherstone, Leo H. Bonati, H. Bart van der Worp, Gert J. de Borst, T. Hauw Lo, Peter Gaines, Paul J. Dorman, Sumaira Macdonald, Philippe A. Lyrer, Johanna M. Hendriks, Charles McCollum, Paul J. Nederkoorn, Martin M. Brown, A. Algra, J. Bamford, M. Bland, W. Hacke, J. L. Mas & 331 others A. J. McGuire, P. Sidhu, A. Bradbury, R. Collins, A. Molyneux, R. Naylor, C. Warlow, M. Ferro, D. Thomas, R. F. Featherstone, H. Tindall, D. J H McCabe, A. Wallis, L. Coward, M. Brooks, B. Chambers, A. Chan, P. Chu, D. Clark, 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, A. Saunder, P. G. Than, S. Gett, D. Leggett, T. McGahan, J. Quinn, M. Ray, A. Wong, P. Woodruff, R. Foreman, D. Schultz, R. Scroop, B. Stanley, B. Allard, N. Atkinson, W. Cambell, S. Davies, P. Field, P. Milne, P. Mitchell, B. Tress, B. Yan, A. Beasley, D. Dunbabin, D. Stary, S. Walker, P. Cras, O. d'Archambeau, J. M H Hendriks, P. Van Schil, M. Bosiers, K. Deloose, E. van Buggenhout, J. De Letter, V. Devos, J. Ghekiere, G. Vanhooren, P. Astarci, F. Hammer, V. Lacroix, A. Peeters, R. Verhelst, L. DeJaegher, A. Peeters, J. Verbist, J. F. Blair, Jean-louis R Caron, N. Daneault, M. F. Giroux, F. Guilbert, S. Lanthier, L. H. Lebrun, V. Oliva, J. Raymond, D. Roy, G. Soulez, A. Weill, M. Hill, W. Hu, M. Hudion, W. Morrish, G. Sutherland, J. Wong, A. Albäck, H. Harno, P. Ijäs, M. Kaste, M. Lepäntalo, S. Mustanoja, T. Paananen, M. Porras, J. Putaala, M. Railo, T. Sairanen, L. Soinne, A. Vehmas, P. Vikatmaa, M. Goertler, Z. Halloul, M. Skalej, P. Brennan, C. Kelly, A. Leahy, J. Moroney, J. Thornton, M. J W Koelemay, J. A A Reekers, Y. B W E M Roos, J. M. Hendriks, P. J. Koudstaal, P. M T Pattynama, A. van der Lugt, L. C. van Dijk, M. R H M van Sambeek, H. van Urk, H. J M Verhagen, C. M A Bruijninckx, S. F. de Bruijn, R. Keunen, B. Knippenberg, A. Mosch, F. Treurniet, L. van Dijk, H. van Overhagen, J. Wever, F. C. de Beer, J. S P van den Berg, B. A A M van Hasselt, D. J. Zeilstra, J. Boiten, J. C A de Mol van Otterloo, A. C. de Vries, G. J. Lycklama a Nijeholt, B. F W van der Kallen, J. D. Blankensteijn, F. E. De Leeuw, L. J. Schultze Kool, J. A. van der Vliet, G. A P de Kort, L. J. Kapelle, T. H. Lo, W. P T M Mali, F. Moll, H. Verhagen, P. A. Barber, R. Bourchier, A. Hill, A. Holden, J. Stewart, S. J. Bakke, K. Krohg-Sørensen, M. Skjelland, B. Tennøe, P. Bialek, Z. Biejat, W. Czepiel, A. Czlonkowska, A. Dowzenko, J. Jedrzejewska, A. Kobayashi, M. Lelek, J. Polanski, J. Kirbis, Z. Milosevic, B. Zvan, J. Blasco, A. Chamorro, J. Macho, V. Obach, V. Riambau, L. San Roman, J. Branera, D. Canovas, Jordi Estela, A. Gimenez Gaibar, J. Perendreu, K. Björses, A. Gottsater, K. Ivancev, T. Maetzsch, B. Sonesson, B. Berg, M. Delle, J. Formgren, P. Gillgren, T. B. Kall, P. Konrad, N. Nyman, R. Takolander, T. Andersson, J. Malmstedt, M. Soderman, C. Wahlgren, N. Wahlgren, S. Binaghi, L. Hirt, P. Michel, P. Ruchat, S. T. Engelter, F. Fluri, L. Guerke, A. L. Jacob, E. Kirsch, E. W. Radue, P. Stierli, M. Wasner, S. Wetzel, C. Bonvin, A. Kalangos, K. Lovblad, N. Murith, D. Ruefenacht, R. Sztajzel, N. Higgins, P. J. Kirkpatrick, P. Martin, D. Adam, J. Bell, A. W. Bradbury, P. Crowe, M. Gannon, M. J. Henderson, D. Sandler, R. A. Shinton, J. M. Scriven, T. Wilmink, S. D'Souza, 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, H. C. Nasser, R. White, K. G. Prakash, F. Serracino-Inglott, G. Subramanian, J. V. Symth, M. G. Walker, M. Clarke, M. Davis, S. A. Dixit, P. Dorman, A. Dyker, G. Ford, A. Golkar, R. Jackson, V. Jayakrishnan, D. Lambert, T. Lees, S. Louw, A. D. Mendelow, H. Rodgers, J. Rose, G. Stansby, M. Wyatt, T. Baker, N. Baldwin, 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, P. Gaines, R. Lonsdale, R. Nair, A. Nassef, S. Nawaz, G. Venables, A. Belli, A. Clifton, G. Cloud, A. Halliday, H. Markus, R. McFarland, R. Morgan, A. Pereira, A. Thompson, J. Chataway, N. Cheshire, R. Gibbs, M. Hammady, M. Jenkins, I. Malik, J. Wolfe, M. Adiseshiah, C. Bishop, S. Brew, J. Brookes, R. Jäger, N. Kitchen, R. Ashleigh, S. Butterfield, G. E. Gamble, A. Nasim, P. O'Neill, J. Wong, R. D. Edwards, K. R. Lees, A. J. MacKay, J. Moss, P. Rogers

Research output: Contribution to journalArticle

911 Citations (Scopus)

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

Original languageEnglish (US)
Pages (from-to)985-997
Number of pages13
JournalThe Lancet
Volume375
Issue number9719
DOIs
StatePublished - 2010
Externally publishedYes

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Endarterectomy
Carotid Stenosis
Carotid Arteries
Randomized Controlled Trials
Carotid Endarterectomy
Stroke
Random Allocation
Intention to Treat Analysis
Myocardial Infarction
Safety
Telefacsimile
Outcome Assessment (Health Care)
Cranial Nerve Diseases
Kaplan-Meier Estimate
European Union
Therapeutics
Telephone
Hematoma
Stents
Biomedical Research

ASJC Scopus subject areas

  • Medicine(all)

Cite this

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, 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.; Peeters, A.; Verbist, J.; Blair, J. F.; Caron, Jean-louis R; 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.; Wong, J.; Edwards, R. D.; Lees, K. R.; MacKay, A. J.; Moss, J.; Rogers, P.

In: The Lancet, Vol. 375, No. 9719, 2010, p. 985-997.

Research output: Contribution to journalArticle

Ederle, J, Dobson, J, Featherstone, RL, Bonati, LH, van der Worp, HB, de Borst, GJ, Hauw Lo, T, Gaines, P, Dorman, PJ, Macdonald, S, Lyrer, PA, Hendriks, JM, McCollum, C, Nederkoorn, PJ, Brown, MM, Algra, A, Bamford, J, Bland, M, Hacke, W, Mas, JL, McGuire, AJ, Sidhu, P, Bradbury, A, Collins, R, Molyneux, A, Naylor, R, Warlow, C, Ferro, M, Thomas, D, Featherstone, RF, Tindall, H, McCabe, DJH, 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, 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, JR, 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, 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, MJW, 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, Bruijninckx, 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, de Mol van Otterloo, JCA, de Vries, AC, Lycklama a Nijeholt, GJ, van der Kallen, BFW, Blankensteijn, JD, De Leeuw, FE, Schultze Kool, LJ, van der Vliet, JA, de Kort, GAP, Kapelle, LJ, Lo, TH, Mali, WPTM, Moll, F, Verhagen, H, Barber, PA, Bourchier, R, Hill, A, Holden, A, Stewart, J, Bakke, SJ, 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, J, Gimenez Gaibar, A, Perendreu, J, Björses, 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, Engelter, ST, Fluri, F, Guerke, L, Jacob, AL, Kirsch, E, 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, JA, 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, Dorman, 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, 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, GE, Nasim, A, O'Neill, P, Wong, J, Edwards, RD, Lees, KR, MacKay, AJ, Moss, J & Rogers, P 2010, 'Carotid artery stenting compared with endarterectomy in patients with symptomatic carotid stenosis (International Carotid Stenting Study): an interim analysis of a randomised controlled trial', The Lancet, vol. 375, no. 9719, pp. 985-997. https://doi.org/10.1016/S0140-6736(10)60239-5
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. ; Peeters, A. ; Verbist, J. ; Blair, J. F. ; Caron, Jean-louis R ; 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. ; Wong, J. ; Edwards, R. D. ; Lees, K. R. ; MacKay, A. J. ; Moss, J. ; Rogers, P. / Carotid artery stenting compared with endarterectomy in patients with symptomatic carotid stenosis (International Carotid Stenting Study) : an interim analysis of a randomised controlled trial. In: The Lancet. 2010 ; Vol. 375, No. 9719. pp. 985-997.
@article{d09a538c25cb4d3a8fd152e9847b36c8,
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",
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. Funding: Medical Research Council, the Stroke Association, Sanofi-Synth{\'e}labo, European Union.",
author = "J{\"o}rg Ederle and Joanna Dobson and Featherstone, {Roland L.} and Bonati, {Leo H.} and {van der Worp}, {H. Bart} and {de Borst}, {Gert J.} and {Hauw Lo}, T. and Peter Gaines and Dorman, {Paul J.} and Sumaira Macdonald and Lyrer, {Philippe A.} and Hendriks, {Johanna M.} and Charles McCollum and Nederkoorn, {Paul J.} and Brown, {Martin M.} and A. Algra and J. Bamford and M. Bland and W. Hacke and Mas, {J. L.} and McGuire, {A. J.} and P. Sidhu and A. Bradbury and R. Collins and A. Molyneux and R. Naylor and C. Warlow and M. Ferro and D. Thomas and Featherstone, {R. F.} and H. Tindall and McCabe, {D. J H} and A. Wallis and L. Coward and M. Brooks and B. Chambers and A. Chan and P. Chu and D. Clark and H. Dewey and G. Donnan and G. Fell and M. Hoare and M. Molan and A. Roberts and N. Roberts and B. Beiles and C. Bladin and C. Clifford and M. Grigg and G. New and R. Bell and S. Bower and W. Chong and M. Holt and A. Saunder and Than, {P. G.} and S. Gett and D. Leggett and T. McGahan and J. Quinn and M. Ray and A. Wong and P. Woodruff and R. Foreman and D. Schultz and R. Scroop and B. Stanley and B. Allard and N. Atkinson and W. Cambell and S. Davies and P. Field and P. Milne and P. Mitchell and B. Tress and B. Yan and A. Beasley and D. Dunbabin and D. Stary and S. Walker and P. Cras and O. d'Archambeau and Hendriks, {J. M H} and {Van Schil}, P. and M. Bosiers and K. Deloose and {van Buggenhout}, E. and {De Letter}, J. and V. Devos and J. Ghekiere and G. Vanhooren and P. Astarci and F. Hammer and V. Lacroix and A. Peeters and R. Verhelst and L. DeJaegher and A. Peeters and J. Verbist and Blair, {J. F.} and Caron, {Jean-louis R} and N. Daneault and Giroux, {M. F.} and F. Guilbert and S. Lanthier and Lebrun, {L. H.} and V. Oliva and J. Raymond and D. Roy and G. Soulez and A. Weill and M. Hill and W. Hu and M. Hudion and W. Morrish and G. Sutherland and J. Wong and A. Alb{\"a}ck and H. Harno and P. Ij{\"a}s and M. Kaste and M. Lep{\"a}ntalo and S. Mustanoja and T. Paananen and M. Porras and J. Putaala and M. Railo and T. Sairanen and L. Soinne and A. Vehmas and P. Vikatmaa and M. Goertler and Z. Halloul and M. Skalej and P. Brennan and C. Kelly and A. Leahy and J. Moroney and J. Thornton and Koelemay, {M. J W} 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 Bruijninckx, {C. M A} and {de Bruijn}, {S. F.} and R. Keunen and B. Knippenberg and A. Mosch and F. Treurniet and {van Dijk}, L. and {van Overhagen}, H. and J. Wever and {de Beer}, {F. C.} and {van den Berg}, {J. S P} and {van Hasselt}, {B. A A M} and Zeilstra, {D. J.} and J. Boiten and {de Mol van Otterloo}, {J. C A} and {de Vries}, {A. C.} and {Lycklama a Nijeholt}, {G. J.} and {van der Kallen}, {B. F W} and Blankensteijn, {J. D.} and {De Leeuw}, {F. E.} and {Schultze Kool}, {L. J.} and {van der Vliet}, {J. A.} and {de Kort}, {G. A P} and Kapelle, {L. J.} and Lo, {T. H.} and Mali, {W. P T M} and F. Moll and H. Verhagen and Barber, {P. A.} and R. Bourchier and A. Hill and A. Holden and J. Stewart and Bakke, {S. J.} and K. Krohg-S{\o}rensen and M. Skjelland and B. Tenn{\o}e and P. Bialek and Z. Biejat and W. Czepiel and A. Czlonkowska and A. Dowzenko and J. Jedrzejewska and A. Kobayashi and M. Lelek and J. Polanski and J. Kirbis and Z. Milosevic and B. Zvan and J. Blasco and A. Chamorro and J. Macho and V. Obach and V. Riambau and {San Roman}, L. and J. Branera and D. Canovas and Jordi Estela and {Gimenez Gaibar}, A. and J. Perendreu and K. Bj{\"o}rses and A. Gottsater and K. Ivancev and T. Maetzsch and B. Sonesson and B. Berg and M. Delle and J. Formgren and P. Gillgren and Kall, {T. B.} and P. Konrad and N. Nyman and R. Takolander and T. Andersson and J. Malmstedt and M. Soderman and C. Wahlgren and N. Wahlgren and S. Binaghi and L. Hirt and P. Michel and P. Ruchat and Engelter, {S. T.} and F. Fluri and L. Guerke and Jacob, {A. L.} and E. Kirsch and Radue, {E. W.} and P. Stierli and M. Wasner and S. Wetzel and C. Bonvin and A. Kalangos and K. Lovblad and N. Murith and D. Ruefenacht and R. Sztajzel and N. Higgins and Kirkpatrick, {P. J.} and P. Martin and D. Adam and J. Bell and Bradbury, {A. W.} and P. Crowe and M. Gannon and Henderson, {M. J.} and D. Sandler and Shinton, {R. A.} and Scriven, {J. M.} and T. Wilmink and S. D'Souza and A. Egun and R. Guta and S. Punekar and Seriki, {D. M.} and G. Thomson and Brennan, {J. A.} and Enevoldson, {T. P.} and G. Gilling-Smith and Gould, {D. A.} and Harris, {P. L.} and McWilliams, {R. G.} and Nasser, {H. C.} and R. White and Prakash, {K. G.} and F. Serracino-Inglott and G. Subramanian and Symth, {J. V.} and Walker, {M. G.} and M. Clarke and M. Davis and Dixit, {S. A.} and P. Dorman and A. Dyker and G. Ford and A. Golkar and R. Jackson and V. Jayakrishnan and D. Lambert and T. Lees and S. Louw and Mendelow, {A. D.} and H. Rodgers and J. Rose and G. Stansby and M. Wyatt and T. Baker and N. Baldwin and L. Jones and D. Mitchell and E. Munro and M. Thornton and D. Baker and N. Davis and G. Hamilton and D. McCabe and A. Platts and J. Tibballs and J. Beard and T. Cleveland and D. Dodd and P. Gaines and R. Lonsdale and R. Nair and A. Nassef and S. Nawaz and G. Venables and A. Belli and A. Clifton and G. Cloud and A. Halliday and H. Markus and R. McFarland and R. Morgan and A. Pereira and A. Thompson and J. Chataway and N. Cheshire and R. Gibbs and M. Hammady and M. Jenkins and I. Malik and J. Wolfe and M. Adiseshiah and C. Bishop and S. Brew and J. Brookes and R. J{\"a}ger and N. Kitchen and R. Ashleigh and S. Butterfield and Gamble, {G. E.} and A. Nasim and P. O'Neill and J. Wong and Edwards, {R. D.} and Lees, {K. R.} and MacKay, {A. J.} and J. Moss and P. Rogers",
year = "2010",
doi = "10.1016/S0140-6736(10)60239-5",
language = "English (US)",
volume = "375",
pages = "985--997",
journal = "The Lancet",
issn = "0140-6736",
publisher = "Elsevier Limited",
number = "9719",

}

TY - JOUR

T1 - Carotid artery stenting compared with endarterectomy in patients with symptomatic carotid stenosis (International Carotid Stenting Study)

T2 - an interim analysis of a randomised controlled trial

AU - Ederle, Jörg

AU - Dobson, Joanna

AU - Featherstone, Roland L.

AU - Bonati, Leo H.

AU - van der Worp, H. Bart

AU - de Borst, Gert J.

AU - Hauw Lo, T.

AU - Gaines, Peter

AU - Dorman, Paul J.

AU - Macdonald, Sumaira

AU - Lyrer, Philippe A.

AU - Hendriks, Johanna M.

AU - McCollum, Charles

AU - Nederkoorn, Paul J.

AU - Brown, Martin M.

AU - Algra, A.

AU - Bamford, J.

AU - Bland, M.

AU - Hacke, W.

AU - Mas, J. L.

AU - McGuire, A. J.

AU - Sidhu, P.

AU - Bradbury, A.

AU - Collins, R.

AU - Molyneux, A.

AU - Naylor, R.

AU - Warlow, C.

AU - Ferro, M.

AU - Thomas, D.

AU - Featherstone, R. F.

AU - Tindall, H.

AU - McCabe, D. J H

AU - Wallis, A.

AU - Coward, L.

AU - Brooks, M.

AU - Chambers, B.

AU - Chan, A.

AU - Chu, P.

AU - Clark, D.

AU - Dewey, H.

AU - Donnan, G.

AU - Fell, G.

AU - Hoare, M.

AU - Molan, M.

AU - Roberts, A.

AU - Roberts, N.

AU - Beiles, B.

AU - Bladin, C.

AU - Clifford, C.

AU - Grigg, M.

AU - New, G.

AU - Bell, R.

AU - Bower, S.

AU - Chong, W.

AU - Holt, M.

AU - Saunder, A.

AU - Than, P. G.

AU - Gett, S.

AU - Leggett, D.

AU - McGahan, T.

AU - Quinn, J.

AU - Ray, M.

AU - Wong, A.

AU - Woodruff, P.

AU - Foreman, R.

AU - Schultz, D.

AU - Scroop, R.

AU - Stanley, B.

AU - Allard, B.

AU - Atkinson, N.

AU - Cambell, W.

AU - Davies, S.

AU - Field, P.

AU - Milne, P.

AU - Mitchell, P.

AU - Tress, B.

AU - Yan, B.

AU - Beasley, A.

AU - Dunbabin, D.

AU - Stary, D.

AU - Walker, S.

AU - Cras, P.

AU - d'Archambeau, O.

AU - Hendriks, J. M H

AU - Van Schil, P.

AU - Bosiers, M.

AU - Deloose, K.

AU - van Buggenhout, E.

AU - De Letter, J.

AU - Devos, V.

AU - Ghekiere, J.

AU - Vanhooren, G.

AU - Astarci, P.

AU - Hammer, F.

AU - Lacroix, V.

AU - Peeters, A.

AU - Verhelst, R.

AU - DeJaegher, L.

AU - Peeters, A.

AU - Verbist, J.

AU - Blair, J. F.

AU - Caron, Jean-louis R

AU - Daneault, N.

AU - Giroux, M. F.

AU - Guilbert, F.

AU - Lanthier, S.

AU - Lebrun, L. H.

AU - Oliva, V.

AU - Raymond, J.

AU - Roy, D.

AU - Soulez, G.

AU - Weill, A.

AU - Hill, M.

AU - Hu, W.

AU - Hudion, M.

AU - Morrish, W.

AU - Sutherland, G.

AU - Wong, J.

AU - Albäck, A.

AU - Harno, H.

AU - Ijäs, P.

AU - Kaste, M.

AU - Lepäntalo, M.

AU - Mustanoja, S.

AU - Paananen, T.

AU - Porras, M.

AU - Putaala, J.

AU - Railo, M.

AU - Sairanen, T.

AU - Soinne, L.

AU - Vehmas, A.

AU - Vikatmaa, P.

AU - Goertler, M.

AU - Halloul, Z.

AU - Skalej, M.

AU - Brennan, P.

AU - Kelly, C.

AU - Leahy, A.

AU - Moroney, J.

AU - Thornton, J.

AU - Koelemay, M. J W

AU - Reekers, J. A A

AU - Roos, Y. B W E M

AU - Hendriks, J. M.

AU - Koudstaal, P. J.

AU - Pattynama, P. M T

AU - van der Lugt, A.

AU - van Dijk, L. C.

AU - van Sambeek, M. R H M

AU - van Urk, H.

AU - Verhagen, H. J M

AU - Bruijninckx, C. M A

AU - de Bruijn, S. F.

AU - Keunen, R.

AU - Knippenberg, B.

AU - Mosch, A.

AU - Treurniet, F.

AU - van Dijk, L.

AU - van Overhagen, H.

AU - Wever, J.

AU - de Beer, F. C.

AU - van den Berg, J. S P

AU - van Hasselt, B. A A M

AU - Zeilstra, D. J.

AU - Boiten, J.

AU - de Mol van Otterloo, J. C A

AU - de Vries, A. C.

AU - Lycklama a Nijeholt, G. J.

AU - van der Kallen, B. F W

AU - Blankensteijn, J. D.

AU - De Leeuw, F. E.

AU - Schultze Kool, L. J.

AU - van der Vliet, J. A.

AU - de Kort, G. A P

AU - Kapelle, L. J.

AU - Lo, T. H.

AU - Mali, W. P T M

AU - Moll, F.

AU - Verhagen, H.

AU - Barber, P. A.

AU - Bourchier, R.

AU - Hill, A.

AU - Holden, A.

AU - Stewart, J.

AU - Bakke, S. J.

AU - Krohg-Sørensen, K.

AU - Skjelland, M.

AU - Tennøe, B.

AU - Bialek, P.

AU - Biejat, Z.

AU - Czepiel, W.

AU - Czlonkowska, A.

AU - Dowzenko, A.

AU - Jedrzejewska, J.

AU - Kobayashi, A.

AU - Lelek, M.

AU - Polanski, J.

AU - Kirbis, J.

AU - Milosevic, Z.

AU - Zvan, B.

AU - Blasco, J.

AU - Chamorro, A.

AU - Macho, J.

AU - Obach, V.

AU - Riambau, V.

AU - San Roman, L.

AU - Branera, J.

AU - Canovas, D.

AU - Estela, Jordi

AU - Gimenez Gaibar, A.

AU - Perendreu, J.

AU - Björses, K.

AU - Gottsater, A.

AU - Ivancev, K.

AU - Maetzsch, T.

AU - Sonesson, B.

AU - Berg, B.

AU - Delle, M.

AU - Formgren, J.

AU - Gillgren, P.

AU - Kall, T. B.

AU - Konrad, P.

AU - Nyman, N.

AU - Takolander, R.

AU - Andersson, T.

AU - Malmstedt, J.

AU - Soderman, M.

AU - Wahlgren, C.

AU - Wahlgren, N.

AU - Binaghi, S.

AU - Hirt, L.

AU - Michel, P.

AU - Ruchat, P.

AU - Engelter, S. T.

AU - Fluri, F.

AU - Guerke, L.

AU - Jacob, A. L.

AU - Kirsch, E.

AU - Radue, E. W.

AU - Stierli, P.

AU - Wasner, M.

AU - Wetzel, S.

AU - Bonvin, C.

AU - Kalangos, A.

AU - Lovblad, K.

AU - Murith, N.

AU - Ruefenacht, D.

AU - Sztajzel, R.

AU - Higgins, N.

AU - Kirkpatrick, P. J.

AU - Martin, P.

AU - Adam, D.

AU - Bell, J.

AU - Bradbury, A. W.

AU - Crowe, P.

AU - Gannon, M.

AU - Henderson, M. J.

AU - Sandler, D.

AU - Shinton, R. A.

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PY - 2010

Y1 - 2010

N2 - 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. Funding: Medical Research Council, the Stroke Association, Sanofi-Synthélabo, European Union.

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

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U2 - 10.1016/S0140-6736(10)60239-5

DO - 10.1016/S0140-6736(10)60239-5

M3 - Article

VL - 375

SP - 985

EP - 997

JO - The Lancet

JF - The Lancet

SN - 0140-6736

IS - 9719

ER -