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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| Published in | JACC. Cardiovascular interventions Vol. 14; no. 21; pp. 2377 - 2387 |
|---|---|
| Main Authors | , , , , , , |
| Format | Journal Article |
| Language | English |
| Published |
United States
Elsevier Inc
08.11.2021
|
| Subjects | |
| Online Access | Get full text |
| ISSN | 1936-8798 1876-7605 1876-7605 |
| DOI | 10.1016/j.jcin.2021.08.005 |
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| Abstract | 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 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.
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)
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| AbstractList | 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 < 0.001), with total permanent lesion volume 7,474 mm
vs 574 mm
(92.3% reduction with the CGuard). There were 6 vs 0 new ipsilateral lesions (P = 0.030) and 2 versus 0 strokes.
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). 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 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. 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) [Display omitted] 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).OBJECTIVESThe 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.BACKGROUNDThe 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).METHODSA 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 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.RESULTSThe 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.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).CONCLUSIONSThe 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). |
| Author | Bugurov, Savr Ignatenko, Pavel Popova, Irina Karpenko, Andrey Starodubtsev, Vladimir Malinowski, Krzysztof Musialek, Piotr |
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| BackLink | https://www.ncbi.nlm.nih.gov/pubmed/34736737$$D View this record in MEDLINE/PubMed |
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| Keywords | diffusion-weighted cerebral imaging DW-MRI CAS MRI MicroNet-covered carotid stent second-generation carotid stent MES cerebral embolism stroke prevention CEA DAPT neuroprotected carotid artery stenting |
| Language | English |
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| SubjectTerms | Angioplasty - adverse effects Carotid Arteries Carotid Stenosis - diagnostic imaging Carotid Stenosis - etiology Carotid Stenosis - therapy cerebral embolism Diffusion Magnetic Resonance Imaging diffusion-weighted cerebral imaging Humans Intracranial Embolism - diagnostic imaging Intracranial Embolism - etiology Intracranial Embolism - prevention & control MicroNet-covered carotid stent neuroprotected carotid artery stenting second-generation carotid stent Stents stroke prevention Treatment Outcome |
| Title | Randomized Controlled Trial of Conventional Versus MicroNet-Covered Stent in Carotid Artery Revascularization |
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