Loading...
Although the use of percutaneous stenting for carotid artery stenosis is increasing, the procedure is FDA-approved only in patients at high risk for surgical complications. In direct comparisons with endarterectomy, stenting was associated with increased rates of periprocedural stroke, but questions remain about surgical complications, patient selection, timing of intervention, and operator experience. To address these issues, investigators from 50 centers in Europe, Australia, New Zealand, and Canada randomized 1713 patients with recently symptomatic carotid stenosis to undergo stenting or endarterectomy. Planned follow-up is 3 years; we now have results of an interim safety analysis.
At 120 days after randomization, the rate of disabling stroke or death was 4.0% in the stenting group and 3.2% in the endarterectomy group, a nonsignificant difference. However, the incidence of the primary endpoint — any stroke, death, or myocardial infarction (MI) — was 8.5% in the stenting group and 5.2% in the endarterectomy group (hazard ratio, 1.69; 95% confidence interval, 1.16–2.45; P=0·006). Cranial nerve palsy occurred in 1 patient in the stenting group compared with 45 in the endarterectomy group, and significantly fewer hematomas occurred in the stenting group than in the endarterectomy group.
In a substudy, 231 patients underwent preprocedural and postprocedural diffusion-weighted magnetic resonance imaging (DWI) to detect ischemic brain lesions. New postprocedural lesions were found in 50% of patients randomized to stenting and in 17% of those randomized to endarterectomy (odds ratio, 5.21; 95% CI, 2.78–9.79; P<0.001). Increasing DWI lesion volume was associated with subsequent symptomatic stroke. Moreover, DWI lesion rates were higher in centers where filter-based cerebral protection devices were used routinely during stenting than in centers where these devices were not routinely used.
ICSS Investigators. Carotid artery stenting compared with endarterectomy in patients with symptomatic carotid stenosis (International Carotid Stenting Study): An interim analysis of a randomised controlled trial. Lancet 2010 Mar 20; 375:985.
Bonati LH 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). Lancet Neurol 2010 Apr; 9:353.
Rothwell PM. Carotid stenting: More risky than endarterectomy and often no better than medical treatment alone. Lancet 2010 Mar 20; 375:957.
Comment
Although longer-term follow-up results of this trial are yet to come, the evidence increasingly supports endarterectomy as the first choice for patients with symptomatic carotid stenosis who are suitable candidates for surgery. The elevated stroke risk associated with stenting is underlined by the striking increase in new ischemic lesions on DWI that appeared to be somewhat related to the use of cerebral protection devices. Whether periprocedural strokes have a greater impact on a patient's quality of life than periprocedural MIs remains to be seen. Investigators from a U.S. trial (CREST) reported at a recent stroke meeting that stenting and endarterectomy were comparable in their trial, but we reserve judgment until their full published analysis is available.