Background: Carotid artery stenting (CAS) has become a cornerstone of carotid revascularization for stroke prevention. Despite the advantages of CAS, large-scale randomized trials involving prior (single-layer) generation of carotid stents demonstrated its higher risk of periprocedural cerebrovascular events compared to carotid endarterectomy (CEA). Dual-layer mesh-covered stents (DLSs) showed promising results in terms of 30-day embolic events. This study aims to evaluate 30-day clinical efficacy of DLS against a closed-cell single-layer stent, based on large-volume data.
Methods: The study center is part of the Italian National Outcomes Evaluation Program (PNE). CAS procedures performed between November 2017 and September 2023 were retrospectively analyzed. Our primary endpoint was 30-day survival free of death, stroke, and myocardial infarction (MI). Periprocedural stroke rate, technical success and restenosis rate of CAS procedures performed with DLSs and first-generation stents (FGSs) were also evaluated.
Results: Over a total of 1101 CAS procedures (55 men; 745 males; mean age of 79±7.8 years), 80.2% were treated with DLS and 48.6% were symptomatic. The cumulative stroke-, MI- and death-free 30-day survival was 98.9%, Technical success was achieved in 98.9% of cases. The DLS group showed significantly lower 30-day death, stroke and death+stroke and periprocedural minor stroke rates compared to FGS group (P=0.04; P=0.04; P=0.003 and P=0.0002, respectively).
Conclusions: The use of DLS in patients undergoing CAS in our large-volume center showed a high technical success rate and minimal cerebral embolic complications by 30 days. High volumes and an experienced interventional team may contribute to these favorable outcomes.