IYSC07 - Safety and Durability of Dual-Layer Stents in Carotid Artery Stenting

Objectives: Carotid artery stenting (CAS) has emerged as a valid alternative to carotid endarterectomy (CEA) for the treatment of extracranial carotid artery stenosis in both symptomatic and asymptomatic patients. Recent evidence suggests that the use of new-generation dual-layer carotid stents is safe and associated with a very low rate of neurological complications at short-term follow-up. However, data on mid- and long-term outcomes remain limited. The aim of this study was to evaluate the safety and efficacy of dual-layer stents in carotid artery stenting over a mid- to long-term follow-up period.

Methods: A total of 310 patients with symptomatic (13 patients, 4.2%) or asymptomatic carotid artery stenosis underwent CAS using the C-Guard dual-layer stent between January 2015 and December 2024. The primary endpoint was stent patency at 4 years and during annual follow-up thereafter. Secondary endpoints included neurological events, rates of in-stent restenosis or occlusion, external carotid artery occlusion, and identification of potential predictive factors. Follow-up was based on duplex ultrasound examinations performed at 1 month, 1 year, and annually thereafter.

Results: The study population has a mean age of 73±8 years old and was predominantly male (84%). A total of 38 (12.3%) peri- and post-procedural adverse events were recorded, including 9 (2.9%) transient ischemic attacks, 1 (0.3%) minor stroke and no major strokes. All adverse neurological events occurred within 72 hours of the procedure. At 30 day duplex ultrasound follow-up, 2 patients (0.65%) treated for asymptomatic carotid stenosis had internal carotid artery occlusion: 1 patient presented a minor stroke and was treated with carotid-carotid bypass and 1 patient remained asymptomatic. In 10 patients was detected external carotid artery occlusion without any neurological symptoms (3.2%). No independent predictors of carotid occlusion were identified. At a mean follow-up time of 4 years, all patients showed 100% stent patency.

Conclusions: In this real-world cohort, dual-layer carotid stents demonstrated excellent mid- and long-term durability, with sustained patency and a very low rate of neurological complications. All adverse neurological events occurred within 72 hours of the procedure. These findings support the long-term safety of dual-layer stents in CAS.