Carotid artery stenting compared with endarterectomy in patients with symptomatic carotid stenosis (International Carotid Stenting Study): an interim analysis of a randomised controlled trial

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dc.contributor.author Ederle, J en
dc.contributor.author Dobson, J en
dc.contributor.author Featherstone, RL en
dc.contributor.author Bonati, LH en
dc.contributor.author van der Worp, HB en
dc.contributor.author de Borst, GJ en
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dc.contributor.author Gaines, P en
dc.contributor.author Hacke, W en
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dc.contributor.author Venables, G en
dc.contributor.author Bradbury, A en
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dc.contributor.author Dobson, J en
dc.contributor.author Ederle, J en
dc.contributor.author Featherstone, RF en
dc.contributor.author Tindall, H en
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dc.contributor.author Wallis, A en
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dc.date.accessioned 2012-05-09T21:31:47Z en
dc.date.issued 2010-03-20 en
dc.identifier.citation LANCET 375(9719):985-997 20 Mar 2010 en
dc.identifier.issn 0140-6736 en
dc.identifier.uri http://hdl.handle.net/2292/17810 en
dc.description.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. en
dc.language English en
dc.publisher Elsevier en
dc.relation.ispartofseries Lancet en
dc.rights Items in ResearchSpace are protected by copyright, with all rights reserved, unless otherwise indicated. Previously published items are made available in accordance with the copyright policy of the publisher. Details obtained from http://www.sherpa.ac.uk/romeo/issn/0140-6736/ en
dc.rights.uri https://researchspace.auckland.ac.nz/docs/uoa-docs/rights.htm en
dc.subject Science & Technology en
dc.subject Life Sciences & Biomedicine en
dc.subject Medicine, General & Internal en
dc.subject General & Internal Medicine en
dc.subject ANGIOPLASTY en
dc.subject SURGERY en
dc.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 en
dc.type Journal Article en
dc.identifier.doi 10.1016/S0140-6736(10)60239-5 en
pubs.issue 9719 en
pubs.begin-page 985 en
pubs.volume 375 en
dc.rights.holder Copyright: Elsevier en
dc.identifier.pmid 20189239 en
pubs.author-url http://gateway.webofknowledge.com/gateway/Gateway.cgi?GWVersion=2&SrcApp=PARTNER_APP&SrcAuth=LinksAMR&KeyUT=000276110700031&DestLinkType=FullRecord&DestApp=ALL_WOS&UsrCustomerID=6e41486220adb198d0efde5a3b153e7d en
pubs.end-page 997 en
dc.rights.accessrights http://purl.org/eprint/accessRights/RestrictedAccess en
pubs.subtype Article en
pubs.elements-id 119154 en
pubs.org-id Medical and Health Sciences en
pubs.org-id School of Medicine en
pubs.org-id Medicine Department en
pubs.record-created-at-source-date 2012-05-10 en
pubs.dimensions-id 20189239 en


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