Dual-layered micromesh stent technology for embolic prevention in carotid revascularization: technical experience and clinical outcomes from a high-volume interventional radiology center.

ABSTRACT

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) first generation stents (FGS) demonstrated a higher risk of periprocedural cerebrovascular events compared to surgery. Dual-layer mesh-covered stents (DLSs) showed promising results in terms of 30-day embolic events in initial studies; larger-scale evidence is accumulating. This study aims to evaluate 30-day clinical efficacy of DLS against a closed-cell 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 eneterd into a prospectively collected database. Our The primary endpoint was survival free of death, stroke, and myocardial infarction (MI) at 30 days. In addition, technical success and periprocedural major adverse clinical event rate (with a focus on stroke) were also evaluated. RESULTS: Over a total of 1101 CAS procedures (745 males; mean age 79±7.8 years), 48.6% were symptomatic. Majority (80.2%) were treated with DLSs. Technical success was achieved in 98.9%. The FGSs group showed a significantly higher peri-procedural stroke rate when compared with CGuard and Roadsaver DLS 4.59% vs. 1.18% vs. 2.63% (P=0.008); minor stroke rates were 4.13% vs. 0.83% and 0% P=0.01). The cumulative stroke, MI and death - free survival at 30 days was 97.46%. A statistically significant higher cumulative 30-day death/stroke/MI rate occurred in FGSs-treated patients compared to the CGuard and Roadsaver DLS-treated (6.42% vs. 1.42% and 2.63%, P=0.001). 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.