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

摘要: Background Stents are an alternative treatment to carotid endarterectomy for symptomatic stenosis, but previous trials have not established equivalent safety and efficacy. We compared the of artery stenting with that endarterectomy. Methods The International Carotid Stenting Study (ICSS) is a multicentre, international, randomised controlled trial blinded adjudication outcomes. Patients recently stenosis were randomly assigned in 1:1 ratio receive or Randomisation was by telephone call fax central computerised service stratified centre minimisation sex, age, contralateral occlusion, side artery. investigators masked assignment. followed up independent clinicians directly involved delivering treatment. primary outcome measure 3-year rate fatal disabling stroke any territory, which has been analysed yet. main interim analysis 120-day stroke, death, procedural myocardial infarction. Analysis intention treat (ITT). This study registered, number ISRCTN25337470. Findings enrolled 1713 patients (stenting group, n=855; n=858). Two group one withdrew immediately after randomisation, included ITT analysis. Between randomisation 120 days, there 34 (Kaplan-Meier estimate 4.0%) events death 27 (3.2%) (hazard [HR] 1.28, 95% CI 0.77-2.11). incidence infarction 8.5% 5.2% (72 vs 44 events; HR 1.69, 1.16-2.45, p=0.006), Risks (65 35 1.92, 1.27-2.89) all-cause (19 seven 2.76, 1.16-6.56) higher than group. Three infarctions recorded all fatal, four, non-fatal, There event cranial nerve palsy 45 also fewer haematomas severity (31 50 p=0.0197). Interpretation Completion long-term follow-up needed establish efficacy In meantime, should remain choice suitable surgery.