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

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). The MicroNet-covered stent may reduce periprocedural cerebral embolism in CAS, bu...

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Bibliographic Details
Published in:JACC. Cardiovascular interventions 2021-11, Vol.14 (21), p.2377-2387
Main Authors: Karpenko, Andrey, Bugurov, Savr, Ignatenko, Pavel, Starodubtsev, Vladimir, Popova, Irina, Malinowski, Krzysztof, Musialek, Piotr
Format: Article
Language:English
Subjects:
Angioplasty - adverse effects
Carotid Arteries
Carotid Stenosis - diagnostic imaging
Carotid Stenosis - etiology
Carotid Stenosis - therapy
Diffusion Magnetic Resonance Imaging
Humans
Intracranial Embolism - diagnostic imaging
Intracranial Embolism - etiology
Intracranial Embolism - prevention & control
Stents
Treatment Outcome
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Summary: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). The MicroNet-covered stent may reduce periprocedural cerebral embolism in CAS, but level 1 evidence is lacking. 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). The baseline characteristics of the study groups were similar. Eighty-two (total volume = 18,212 mm ) diffusion-weighted magnetic resonance imaging postprocedural cerebral lesions occurred in 26 Acculink-treated patients and 45 lesions (total volume = 3,930 mm ; 78.4% reduction) in 25 CGuard-treated patients. New cerebral lesion average volume was 171 mm vs 73 mm (P = 0.017) per affected patient and 222 mm vs 84 mm (P = 0.038) per lesion (Acculink vs CGuard). In lesion-affected patients, the average sum of lesion volumes was 701 mm vs 157 mm (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 
ISSN:1936-8798
1876-7605
DOI:10.1016/j.jcin.2021.08.005