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

Abstract

SummaryBackgroundStents 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.MethodsThe 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.FindingsThe 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).InterpretationCompletion 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.FundingMedical Research Council, the Stroke Association, Sanofi-Synthélabo, European Union.

Carotid Plaque Surface Irregularity Predicts Cerebral Embolism during Carotid Artery Stenting

“…According to the results of recent randomized clinical trials on the safety and efficacy of endarterectomy versus CAS for symptomatic carotid stenosis, the risk of any periprocedural stroke or death is higher with CAS than with endarterectomy [11,12,13,14,15,16]. However, a head-to-head comparison of endarterectomy versus CAS to identify the best modality for the treatment of all patients may not comply with the demands for individual treatment decisions in clinical practice.…”

Predictors of Periprocedural Brain Lesions Associated with Carotid Stenting

“…Carotid stenting has emerged as a potential alternative to endarterectomy. The risk of periprocedural stroke is higher with stenting than with endarterectomy when done in patients judged suitable for either procedure [4,5,6,7]. However, the risks of both procedures vary with patient characteristics and may differ between specific groups of patients [8,9,10,11].…”

Timing of carotid intervention

“…CREST (Carotid Revascularization Endarterectomy versus Stenting Trial)10 reported the shortest median interval; this was still 22 days for CEA and 18 days for CAS. In all except two RCTs, the mean delay from the index event to revascularization was greater than 1 month9, 12, 14. Even in studies that mostly revascularized sooner after the index event, the mean delay was above the 2‐week threshold3, 10.…”

“…Of the 12 RCTs3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14 that have compared carotid endarterectomy (CEA) with carotid artery stenting (CAS) in patients with significant carotid stenosis, only five3, 9, 10, 12, 14 provided information on the time from the index event to revascularization. CREST (Carotid Revascularization Endarterectomy versus Stenting Trial)10 reported the shortest median interval; this was still 22 days for CEA and 18 days for CAS.…”