Covered versus bare self-expanding stents for endovascular treatment of carotid artery stenosis: a stopped randomized trial.

PURPOSE: To investigate whether filter-protected carotid artery stenting (CAS) using a covered self-expanding stent reduces the risk of cerebral embolization. METHODS: Fourteen asymptomatic patients (13 men; median age 77 years, IQR 73-83) were enrolled in a randomized pilot trial comparing the rates of cerebral microembolism during and after filter-protected CAS using either a self-expanding covered (n=8) or a bare (n=6) carotid stent. Transcranial Doppler (TCD) monitoring was done during and for 90 minutes after the procedure. Diffusion-weighted magnetic resonance imaging (DW-MRI) was performed before and 24 hours after CAS. Patients were followed for 6 months for neurological events and occurrence of restenosis. RESULTS: A significant reduction in ipsilateral microembolic signals by TCD was observed with the covered (median 1, IQR 0-4) versus the bare stent (median 6, IQR 3-8; p=0.043). Comparison of the preprocedural and 24-hour postprocedural DW-MRI images showed no new ipsilateral lesions but 1 new lesion in the contralateral hemisphere in the covered stent group, resulting in an overall 7% (95% CI 0%-20%) rate of new ischemic lesions. No neurological complications occurred up to 6 months. Restenosis (>70%) occurred in 3 (38%) of 8 patients with the covered versus none of the bare stents (p=0.21). The trial was stopped when the third restenosis of a covered stent was detected. CONCLUSION: Self-expanding covered stents potentially reduce the risk of cerebral microembolism during and after carotid stenting. However, the problem of in-stent restenosis has to be resolved before these devices can be considered for further investigation.