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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. | Authors: | 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. | Institution: | (Ederle) Department of Brain Repair and Rehabilitation, UCL Institute of Neurology, University College London, United Kingdom (Dobson) Medical Statistics Unit, Department of Epidemiology and Population Health, London School of Hygiene and Tropical Medicine, London, United Kingdom (Featherstone) Department of Brain Repair and Rehabilitation, UCL Institute of Neurology, University College London, United Kingdom (Bonati) Department of Brain Repair and Rehabilitation, UCL Institute of Neurology, University College London, United Kingdom (van der Worp) Department of Neurology, Rudolf Magnus Institute of Neuroscience, University Medical Centre Utrecht, Netherlands (de Borst) Department of Vascular Surgery, University Medical Centre Utrecht, Netherlands (Hauw Lo) Department of Radiology, University Medical Centre Utrecht, Netherlands (Gaines) Sheffield Vascular Institute, Sheffield Teaching Hospitals NHS Foundation Trust, Sheffield, United Kingdom (Dorman) Department of Neurology, Newcastle General Hospital, Newcastle upon Tyne, United Kingdom (Macdonald) Department of Radiology, Freeman Hospital, Newcastle upon Tyne, United Kingdom (Lyrer) Department of Neurology and Stroke Unit, University Hospital Basel, Basel University, Switzerland (Hendriks) Department of Vascular Surgery, Erasmus Medical Center, Rotterdam, Netherlands (McCollum) Cardiovascular Medicine, School of Biomedicine, Manchester Academic Health Science Centre, University of Manchester, Manchester, United Kingdom (Nederkoorn) Department of Neurology, Academic Medical Centre, University of Amsterdam, Netherlands (Brown) Department of Brain Repair and Rehabilitation, UCL Institute of Neurology, University College London, Box 6, Queen Square, London WC1N 3BG, United Kingdom (Ederle, Dobson, Featherstone, Tindall, McCabe, Wallis, Coward) UCL Institute of Neurology, United Kingdom (Brooks, Chambers, Chan, Chu, Clark, Dewey, Donnan, Fell, Hoare, Molan, Roberts, Roberts) Australia Austin Health, Heidelberg, Germany (Fell, Beiles, Bladin, Clifford, Grigg, New) Box Hill Hospital, Monash University, Melbourne, Australia (Bell, Bower, Chong, Holt, Saunder, Than) Monash Medical Centre, Clayton, Germany (Gett, Leggett, McGahan, Quinn, Ray, Wong, Woodruff) Princess Alexandra Hospital, Brisbane, Australia (Foreman, Schultz, Scroop, Stanley) Repatriation General Hospital, Daw Park, Adelaide, Australia (Allard, Atkinson, Cambell, Davies, Field, Milne, Mitchell, Tress, Yan) Royal Melbourne Hospital, Melbourne, Australia (Beasley, Dunbabin, Stary, Walker) Royal Hobart Hospital, Hobart, Australia (Cras, d'Archambeau, Hendriks, Van Schil) Belgium Antwerp University Hospital, Antwerp, Belgium (Bosiers, Deloose, van Buggenhout) A Z St Blasius, Dendermonde, Belgium (De Letter, Devos, Ghekiere, Vanhooren) A Z Sint Jan Brugge-Oostende, Campus Brugge, Brugges, Belgium (Astarci, Hammer, Lacroix, Peeters, Verhelst) Cliniques Universitaires St Luc, Bruxelles, Belgium (DeJaegher, Peeters, Verbist) Imelda Ziekenhuis, Bonheiden, Belgium (Blair, Caron, Daneault, Giroux, Guilbert, Lanthier, Lebrun, Oliva, Raymond, Roy, Soulez, Weill) Canada CHUM Notre-Dame Hospital, Montreal, Canada (Hill, Hu, Hudion, Morrish, Sutherland, Wong) Foothills Medical Centre, Calgary, Canada (Alback, Harno, Ijas, Kaste, Lepantalo, Mustanoja, Paananen, Porras, Putaala, Railo, Sairanen, Soinne, Vehmas, Vikatmaa) Finland Helsinki University Central Hospital, Helsinki, Finland (Goertler, Halloul, Skalej) Germany Otto von Guericke University, Magdeburg, Germany (Brennan, Kelly, Leahy, Moroney, Thornton) Ireland Beaumont Hospital, Dublin, Ireland (Nederkoorn, Koelemay, Reekers, Roos) Netherlands Academic Medical Centre, Amsterdam, Netherlands (Hendriks, Koudstaal, Pattynama, van der Lugt, van Dijk, van Sambeek, van Urk, Verhagen) Erasmus Medical Centre, Rotterdam, Netherlands (Bruijninckx, de Bruijn, Keunen, Knippenberg, Mosch, Treurniet, van Dijk, van Overhagen, Wever) Haga Teaching Hospitals, The Hague, Netherlands (de Beer, van den Berg, van Hasselt, Zeilstra) Isala Klinieken, Zwolle, Netherlands (Boiten, de Mol van Otterloo, de Vries, Lycklama a Nijeholt, van der Kallen) Medical Centre Haaglanden, The Hague, Netherlands (Blankensteijn, De Leeuw, Schultze Kool, van der Vliet) UMC St Radboud, Nijmegen, Netherlands (de Borst, de Kort, Kapelle, Lo, Mali, Moll, Verhagen) University Medical Centre, Utrecht, Netherlands (Barber, Bourchier, Hill, Holden, Stewart) New Zealand Auckland City Hospital, Auckland, Netherlands (Bakke, Krohg-Sorensen, Skjelland, Tennoe) Norway Rikshospitalet University Hospital, Oslo, Norway (Bialek, Biejat, Czepiel, Czlonkowska, Dowzenko, Jedrzejewska, Kobayashi, Lelek, Polanski) Poland Institute of Psychiatry and Neurology, Department of Neurology and Department of Neuroradiology, Warsaw, Poland (Bialek, Biejat, Czepiel, Czlonkowska, Dowzenko, Jedrzejewska, Kobayashi, Lelek, Polanski) Medical University of Warsaw, Department of General, Vascular and Oncological Surgery, Warsaw, Poland (Kirbis, Milosevic, Zvan) Slovenia University Medical Centre, Ljubljana, Slovenia (Blasco, Chamorro, Macho, Obach, Riambau, San Roman) Spain Hospital Clinic, Barcelona, Spain (Branera, Canovas, Estela, Gimenez Gaibar, Perendreu) Parc Tauli Sabadell Hospital, Barcelona, Spain (Bjorses, Gottsater, Ivancev, Maetzsch, Sonesson) Sweden Malmo University Hospital, Malmo, Sweden (Berg, Delle, Formgren, Gillgren, Kall, Konrad, Nyman, Takolander) Sodersjukhuset, Stockholm, Sweden (Andersson, Malmstedt, Soderman, Wahlgren, Wahlgren) The Karolinska Institute, Stockholm, Sweden (Binaghi, Hirt, Michel, Ruchat) Switzerland Centre Hospitalier Universitaire Vaudois, Lausanne, Switzerland (Bonati, Engelter, Fluri, Guerke, Jacob, Kirsch, Radue, Stierli, Wasner, Wetzel) University Hospital Basel, Basel, Switzerland (Bonvin, Kalangos, Lovblad, Murith, Ruefenacht, Sztajzel) University Hospital of Geneva, Geneva, Switzerland (Higgins, Kirkpatrick, Martin) UK Addenbrookes Hospital, Cambridge, United Kingdom (Adam, Bell, Bradbury, Crowe, Gannon, Henderson, Sandler, Shinton, Scriven, Wilmink) K Varty Birmingham Heartlands Hospital, Birmingham, United Kingdom (D'Souza, Egun, Guta, Punekar, Seriki, Thomson) Lancashire Teaching Hospitals NHS Trust, Preston, United Kingdom (Brennan, Enevoldson, Gilling-Smith, Gould, Harris, McWilliams, Nasser, White) Liverpool Royal Infirmary 21 and the Walton Centre, Liverpool, United Kingdom (Prakash, Serracino-Inglott, Subramanian, Symth, Walker) Manchester Royal Infirmary, Manchester, United Kingdom (Clarke, Davis, Dixit, Dorman, Dyker, Ford, Golkar, Jackson, Jayakrishnan, Lambert, Lees, Louw, Mendelow, Rodgers, Rose, Stansby, Wyatt) Newcastle Acute Hospitals NHS Foundation Trust, Newcastle upon Tyne, United Kingdom (Baker, Baldwin, Jones, Mitchell, Munro, Thornton) North Bristol NHS Trust, Frenchay Hospital, Bristol, United Kingdom (McCabe, Baker, Davis, Hamilton, Platts, Tibballs) Royal Free Hospital, London, United Kingdom (Beard, Cleveland, Dodd, Gaines, Lonsdale, Nair, Nassef, Nawaz, Venables) Sheffield Teaching Hospitals NHS Foundation Trust, Sheffield, United Kingdom (Belli, Clifton, Cloud, Halliday, Markus, McFarland, Morgan, Pereira, Thompson) St George's University of London and St George's NHS Healthcare Trust, London, United Kingdom (Chataway, Cheshire, Gibbs, Hammady, Jenkins, Malik, Wolfe) St Mary's Hospital, Imperial College Healthcare NHS Trust, London, United Kingdom (Brown, Adiseshiah, Bishop, Brew, Brookes, Jager, Kitchen) University College London Hospitals NHS FoundationTrust, London, United Kingdom (McCollum, Ashleigh, Butterfield, Gamble, Nasim, O'Neill, Wong) University Hospital of South Manchester, Wythenshawe, Manchester, United Kingdom (Edwards, Lees, MacKay, Moss, Rogers) Western Infirmary, Glasgow, United Kingdom | Issue Date: | 14-Jun-2010 | Copyright year: | 2010 | Publisher: | Lancet Publishing Group (E-mail: cususerv@lancet.com) Elsevier B.V. (E-mail: cususerv@lancet.com) |
Place of publication: | United Kingdom | Publication information: | The Lancet. 375 (9719) (pp 985-997), 2010. Date of Publication: 01 May 2010. | Journal: | The Lancet | 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, 1.16-2.45, 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(s): 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(s): Medical Research Council, the Stroke Association, Sanofi-Synthelabo, European Union. © 2010 Elsevier Ltd. All rights reserved. | DOI: | http://monash.idm.oclc.org/login?url=http://dx.doi.org/10.1016/S0140-6736%2810%2960239-5 | PubMed URL: | 20189239 [http://www.ncbi.nlm.nih.gov/pubmed/?term=20189239] | ISSN: | 0140-6736 | URI: | https://repository.monashhealth.org/monashhealthjspui/handle/1/27326 | Type: | Article | Type of Clinical Study or Trial: | Randomised controlled trial |
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