Andrey Karpenko1, Savr Bugurov2, Pavel Ignatenko2, Vladimir Starodubtsev2, Irina Popova2, Krzysztof Malinowski3, Piotr Musialek4. 1. Centre of Vascular and Hybrid Surgery, E.N. Meshalkin National Medical Research Center, Novosibirsk, Russia. Electronic address: andreikarpenko@rambler.ru. 2. Centre of Vascular and Hybrid Surgery, E.N. Meshalkin National Medical Research Center, Novosibirsk, Russia. 3. KCRI Department of Statistics, Krakow, Poland. 4. Jagiellonian University, Department of Cardiac and Vascular Diseases, John Paul II Hospital, Krakow, Poland. Electronic address: pmusialek@szpitaljp2.krakow.pl.
Abstract
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 mm3) diffusion-weighted magnetic resonance imaging postprocedural cerebral lesions occurred in 26 Acculink-treated patients and 45 lesions (total volume = 3,930 mm3; 78.4% reduction) in 25 CGuard-treated patients. New cerebral lesion average volume was 171 mm3 vs 73 mm3 (P = 0.017) per affected patient and 222 mm3 vs 84 mm3 (P = 0.038) per lesion (Acculink vs CGuard). In lesion-affected patients, the average sum of lesion volumes was 701 mm3 vs 157 mm3 (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 mm3 vs 574 mm3 (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. (The SIBERIA Trial [Acculink™ Versus CGuard™]; NCT03488199).
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 mm3) diffusion-weighted magnetic resonance imaging postprocedural cerebral lesions occurred in 26 Acculink-treated patients and 45 lesions (total volume = 3,930 mm3; 78.4% reduction) in 25 CGuard-treated patients. New cerebral lesion average volume was 171 mm3 vs 73 mm3 (P = 0.017) per affected patient and 222 mm3 vs 84 mm3 (P = 0.038) per lesion (Acculink vs CGuard). In lesion-affected patients, the average sum of lesion volumes was 701 mm3 vs 157 mm3 (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 mm3 vs 574 mm3 (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. (The SIBERIA Trial [Acculink™ Versus CGuard™]; NCT03488199).
Authors: Adam Mazurek; Krzysztof Malinowski; Kenneth Rosenfield; Laura Capoccia; Francesco Speziale; Gianmarco de Donato; Carlo Setacci; Christian Wissgott; Pasqualino Sirignano; Lukasz Tekieli; Andrey Karpenko; Waclaw Kuczmik; Eugenio Stabile; David Christopher Metzger; Max Amor; Adnan H Siddiqui; Antonio Micari; Piotr Pieniążek; Alberto Cremonesi; Joachim Schofer; Andrej Schmidt; Piotr Musialek Journal: J Clin Med Date: 2022-08-17 Impact factor: 4.964
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