Randomized Controlled Trial of Conventional Versus MicroNet™-Covered Stent in Carotid Artery Revascularization – 12Month Outcomes
Publication
Author
Andrey Karpenko, Savr Bugurov, Pavel Ignatenko, Vladimir Starodubtsev, Irina Popova, Krzysztof Malinowski, Piotr Musialek,Focus
Prospective 1:1 randomized controlled study, independent investigator-initiated study, single-center, externally monitored, and imaging data evaluated by an independent core laboratory. 100 consecutive unselected patients randomized to 50 Acculink™ and 50 CGuard™. Primary endpoint: MRI identified new ischemic brain lesions after CAS within 24-48 hours and 30 days. Secondary endpoint: Technical success, major adverse events (death, stroke, myocardial infarction) during the procedure, post-procedural, 24-48 hours, 30 days, and 12 months @48hr DW-MRI CGuard™ vs. Acculink™ o significant fewer and smaller brain lesions in CGuard™: o the CGuard™ arm was observed to have a 78% reduction in the average volume of new cerebral lesions, a statistically significant improvement (p=0.007) @30-day CGuard™ vs. Acculink™: o persistent reduction of lesion number in CGuard™ o reduction of the total volume of permanent cerebral lesions by 92.3% (P < 0.001) in CGuard™ 12-months CGuard™ vs. Acculink™: •0 in stent restenoses (ISR), 0 occlusion in CGuard™ arm, 3 in-stent restenoses (ISR), 1 occlusion in Acculink™ arm.Highlights
• These data constitute level 1 evidence in favor of CGuard™ MicroNet™-covered stent in demonstrating the reduction of cerebral infarcts in neuroprotected CAS versus CREST Stent (Acculink™).
• The postprocedural embolism was totally eliminated with the CGuard stent; in contrast, it persisted with the Acculink stent.
• Thanks to MicroNet™-covered carotid stent CGuard™, lower periprocedural stroke rates and the elimination of postprocedural neurologic events by 30 days
• 12-month clinical outcomes from a randomized controlled trial of cerebral embolism in CAS using the CGuard vs the CREST trial stent suggest that MicroNet™-covered stent use may be associated with a clinical benefit.
• Consistency in terms of the 12-month CGuard™ and Acculink™ outcomes with the meta-analysis (112 CAS studies with a total of 68,422 patients).