Randomized Controlled Trial of Conventional Versus MicroNet-Covered Stent in Carotid Artery Revascularization

OBJECTIVES The aim of this study was to compare procedure-related ipsilateral cerebral embolism with a conventional (Acculink, Abbott Vascular) versus a MicroNet-covered (CGuard, InspireMD) stent in carotid artery stenting (CAS). BACKGROUND The MicroNet-covered stent may reduce periprocedural cerebral embolism in CAS, but level 1 evidence is lacking. METHODS A total of 100 consecutive patients were randomized 1:1 to filter-protected CAS using the Acculink or the CGuard device. The study was powered for its primary endpoint of at least 50% reduction in ipsilateral diffusion-weighted magnetic resonance imaging lesion average volume 48 hours postprocedure (blinded external core laboratory analysis). RESULTS The baseline characteristics of the study groups were similar. Eighty-two (total volume = 18,212 mm(3)) diffusion-weighted magnetic resonance imaging postprocedural cerebral lesions occurred in 26 Acculink-treated patients and 45 lesions (total volume = 3,930 mm(3); 78.4% reduction) in 25 CGuard-treated patients. New cerebral lesion average volume was 171 mm(3) vs 73 mm(3) (P = 0.017) per affected patient and 222 mm(3) vs 84 mm(3) (P = 0.038) per lesion (Acculink vs CGuard). In lesion-affected patients, the average sum of lesion volumes was 701 mm(3) vs 157 mm(3) (P = 0.007). The Acculink significantly increased the risk for multiple (>= 5) cerebral lesions (relative risk: 7.8; 95% CI: 1.3-14.9; P = 0.021). At 30 days, new permanent (fluid-attenuated inversion recovery) lesion prevalence was 3:1 (P < 0.001), with total permanent lesion volume 7,474 mm(3) vs 574 mm(3) (92.3% reduction with the CGuard). There were 6 vs 0 new ipsilateral lesions (P = 0.030) and 2 versus 0 strokes. CONCLUSIONS The MicroNet-covered stent significantly reduced periprocedural and abolished postprocedural cerebral embolism in relation to a conventional carotid stent. This is consistent with the MicroNet-covered stent's sustained embolism prevention, translating into cerebral protection not only during but also after CAS. The present findings may influence decision making in carotid revascularization. (C) 2021 The Authors. Published by Elsevier on behalf of the American College of Cardiology Foundation.