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

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.

[1]  T. Brott,et al.  The Carotid Revascularization Endarterectomy vs. Stenting Trial completes randomization: lessons learned and anticipated results. , 2009, Journal of vascular surgery.

[2]  P. Rothwell,et al.  A Systematic Review of the Associations between Age and Sex and the Operative Risks of Carotid Endarterectomy , 2005, Cerebrovascular Diseases.

[3]  M. Eliasziw,et al.  Endarterectomy for symptomatic carotid stenosis in relation to clinical subgroups and timing of surgery , 2004, The Lancet.

[4]  S. Pendlebury,et al.  Prevalence, incidence, and factors associated with pre-stroke and post-stroke dementia: a systematic review and meta-analysis , 2009, The Lancet Neurology.

[5]  P. Sandercock,et al.  Endovascular treatment with angioplasty or stenting versus endarterectomy in patients with carotid artery stenosis in the Carotid And Vertebral Artery Transluminal Angioplasty Study (CAVATAS): long-term follow-up of a randomised trial , 2009, The Lancet Neurology.

[6]  J M Bland,et al.  Endovascular versus surgical treatment in patients with carotid stenosis in the Carotid and Vertebral Artery Transluminal Angioplasty Study (CAVATAS): a randomised trial , 2001, The Lancet.

[7]  C. Meuleman.  Endarterectomy versus stenting in patients with symptomatic severe carotid stenosis. , 2006 .

[8]  L. Trinquart,et al.  Endarterectomy Versus Angioplasty in Patients with Symptomatic Severe Carotid Stenosis (EVA-3S) trial: results up to 4 years from a randomised, multicentre trial , 2008, The Lancet Neurology.

[9]  D. Sackett,et al.  Benefit of carotid endarterectomy in patients with symptomatic moderate or severe stenosis. North American Symptomatic Carotid Endarterectomy Trial Collaborators. , 1998, The New England journal of medicine.

[10]  W. Hacke,et al.  Results of the Stent-Protected Angioplasty versus Carotid Endarterectomy (SPACE) study to treat symptomatic stenoses at 2 years: a multinational, prospective, randomised trial , 2008, The Lancet Neurology.

[11]  P. Rothwell,et al.  Stenosis and carotid endarterectomy - Reply , 2003 .

[12]  T. Hölzenbein,et al.  Protected carotid-artery stenting versus endarterectomy in high-risk patients , 2005, European Surgery.

[13]  J. Slattery,et al.  Clinical and angiographic predictors of stroke and death from carotid endarterectomy: systematic review , 1997, BMJ.

[14]  M. Brown,et al.  International Carotid Stenting Study: Protocol for a Randomised Clinical Trial Comparing Carotid Stenting with Endarterectomy in Symptomatic Carotid Artery Stenosis , 2004, Cerebrovascular Diseases.

[15]  H. Jäger,et al.  New ischaemic brain lesions on MRI after stenting or endarterectomy for symptomatic carotid stenosis: a substudy of the International Carotid Stenting Study (ICSS) , 2010, Lancet Neurology.

[16]  M. Brown,et al.  Percutaneous transluminal angioplasty and stenting for carotid artery stenosis. , 2004, The Cochrane database of systematic reviews.