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

被引：971

作者：

Ederle, Joerg

Dobson, Joanna ^{[2
]}

Featherstone, Roland L.

Bonati, Leo H.

van der Worp, H. Bart ^{[3
]}

de Borst, Gert J. ^{[4
]}

Lo, T. Hauw ^{[5
]}

Gaines, Peter ^{[6
]}

Dorman, Paul J. ^{[7
,56
]}

Macdonald, Sumaira ^{[8
]}

Lyrer, Philippe A. ^{[9
,10
]}

Hendriks, Johanna M. ^{[11
]}

McCollum, Charles ^{[12
]}

Nederkoorn, Paul J. ^{[13
]}

Brown, Martin M. ^{[1
]}

Algra, A.

Bamford, J.

Beard, J. ^{[59
]}

Bland, M.

Bradbury, A. W. ^{[51
]}

Brown, M. M. ^{[63
]}

Clifton, A. ^{[60
,61
]}

Gaines, P. ^{[59
]}

Hacke, W.

Halliday, A. ^{[60
,61
]}

Malik, I. ^{[62
]}

Mas, J. L.

McGuire, A. J.

Sidhu, P.

Venables, G. ^{[59
]}

Bradbury, A.

Brown, M. M. ^{[63
]}

Clifton, A. ^{[60
,61
]}

Gaines, P. ^{[59
]}

Collins, R.

Molynewc, A.

Naylor, R.

Warlow, C.

Ferro, J. M. ^{[14
]}

Thomas, D. ^{[14
]}

Bonati, L. H. ^{[48
]}

Coward, L.

Dobson, J.

Ederle, J.

Featherstone, R. F.

Tindall, H.

McCabe, D. J. H.

Wallis, A.

Brooks, M. ^{[15
]}

Chambers, B. ^{[15
]}

机构：

[1] UCL, Inst Neurol, Natl Hosp Neurol & Neurosurg, Dept Brain Repair & Rehabil, London WC1N 3BG, England

[2] London Sch Hyg & Trop Med, Dept Epidemiol & Populat Hlth, Med Stat Unit, London WC1, England

[3] Univ Med Ctr Utrecht, Rudolf Magnus Inst Neurosci, Dept Neurol, Utrecht, Netherlands

[4] Univ Med Ctr Utrecht, Dept Vasc Surg, Utrecht, Netherlands

[5] Univ Med Ctr Utrecht, Dept Radiol, Utrecht, Netherlands

[6] Sheffield Teaching Hosp NHS Fdn Trust, Sheffield Vasc Inst, Sheffield, S Yorkshire, England

[7] Newcastle Gen Hosp, Dept Neurol, Newcastle Upon Tyne NE4 6BE, Tyne & Wear, England

[8] Freeman Rd Hosp, Dept Radiol, Newcastle Upon Tyne, Tyne & Wear, England

[9] Univ Basel, Univ Basel Hosp, Dept Neurol, CH-4003 Basel, Switzerland

[10] Univ Basel, Univ Basel Hosp, Stroke Unit, CH-4003 Basel, Switzerland

[11] Erasmus MC, Dept Vasc Surg, Rotterdam, Netherlands

[12] Univ Manchester, Sch Biomed, Manchester Acad Hlth Sci Ctr, Manchester, Lancs, England

[13] Univ Amsterdam, Acad Med Ctr, Dept Neurol, NL-1012 WX Amsterdam, Netherlands

[14] UCL, Inst Neurol, Cent Off Staff, London WC1N 3BG, England

[15] Australia Austin Hlth, Heidelberg, Germany

[16] Monash Univ, Box Hill Hosp, Melbourne, Vic, Australia

[17] Monash Med Ctr, Clayton, Vic 3168, Australia

[18] Princess Alexandra Hosp, Brisbane, Qld 4102, Australia

[19] Repatriat Gen Hosp, Adelaide, SA, Australia

[20] Royal Melbourne Hosp, Melbourne, Vic, Australia

[21] Royal Hobart Hosp, Hobart, Tas, Australia

[22] Belgium Antwerp Univ Hosp, Antwerp, Belgium

[23] AZ Sint Jan Brugge Oostende, Brugges, Belgium

[24] Clin Univ St Luc, B-1200 Brussels, Belgium

[25] Imelda Ziekenhuis, Bonheiden, Belgium

[26] Canada CHUM Notre Dame Hosp, Montreal, PQ, Canada

[27] Foothills Med Ctr, Calgary, AB, Canada

[28] Finland Helsinki Univ, Cent Hosp, Helsinki, Finland

[29] Germany Otto von Guericke Univ, Magdeburg, Germany

[30] Ireland Beaumont Hosp, Dublin, Ireland

[31] Netherlands Acad Med Ctr, Amsterdam, Netherlands

[32] Haga Teaching Hosp, The Hague, Netherlands

[33] Med Ctr Haaglanden, The Hague, Netherlands

[34] Radboud Univ Nijmegen Med Ctr, Nijmegen, Netherlands

[35] Univ Med Ctr, Utrecht, Netherlands

[36] New Zealand Auckland City Hosp, Auckland, New Zealand

[37] Univ Hosp, Norway Rikshosp, Oslo, Norway

[38] Poland Inst Psychiat & Neurol, Dept Neurol 2, Warsaw, Poland

[39] Poland Inst Psychiat & Neurol, Dept Neuroradiol, Warsaw, Poland

[40] Med Univ Warsaw, Dept Gen Vasc & Oncol Surg 2, Warsaw, Poland

[41] Slovenia Univ, Med Ctr, Ljubljana, Slovenia

[42] Spain Hosp Clin, Barcelona, Spain

[43] Parc Tauli Sabadell Hosp, Barcelona, Spain

[44] Sweden Malmo Univ Hosp, Malmo, Sweden

[45] Soder Sjukhuset, S-10064 Stockholm, Sweden

[46] Karolinska Inst, Stockholm, Sweden

[47] Switzerland Ctr Hosp Univ Vaudois, Lausanne, Switzerland

[48] Univ Basel Hosp, CH-4031 Basel, Switzerland

[49] Univ Hosp Geneva, Geneva, Switzerland

[50] UK Addenbrookes Hosp, Cambridge, England

来源：

LANCET | 2010年 / 375卷 / 9719期

基金：

瑞士国家科学基金会; 英国医学研究理事会;

关键词：

ANGIOPLASTY;

D O I：

10.1016/S0140-6736(10)60239-5

中图分类号：

R5 [内科学];

学科分类号：

1002 ; 100201 ;

摘要：

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.

引用

页码：985 / 997

页数：13

共 19 条

[1] Benefit of carotid endarterectomy in patients with symptomatic moderate or severe stenosis [J].