Carotid artery stenting with Roadsaver stent. Early and four-year results from a single-center registry

Introduction: Prevention of peri- and postprocedural complications is still a challenge in carotid artery stenting (CAS). Aim: To assess immediate and long-term safety and effectiveness of CAS using the Roadsaver double-nitinol-layer-micromesh stent. Material and methods: Since 2014, 298 CAS procedures in 287 non-consecutive patients (203 men, mean age 70.5 +/- 8.6 years, 100% symptomatic/high risk lesions) have been performed using the Roadsaver stent and proximal (40%) or distal (60%) neuroprotection system. Clinical and neurological examinations as well as duplex ultrasound were completed before CAS, before discharge, at 1, 6 and 12 months, then annually. Results: All CAS procedures were successful. Carotid stenosis was reduced from 84.9 +/- 9.9% to 11.0 +/- 9.4% (p < 000.1). In hospital, 1 ipsilateral periprocedural major (0.3%) and 3 minor (1.34%) ischemic strokes occurred, 2 (0.7%) patients died due to a cerebral hemorrhage on day 9 and 21. Three (1.0%) additional ipsilateral minor strokes within 30 consecutive days occurred. Thus, 30-day complications were observed in 9 (3.0%) patients. Two minor strokes were associated with in-stent thrombosis (0.7%). The 4-year follow-up showed 82% overall survival (95% CI: 69-91%) with no significant difference between asymptomatic (77%) and symptomatic patients (97%; p = 0.076). The stroke-free survival was 89% (95% CI: 77-95%), 84% asymptomatic vs. 98% symptomatic (p = 0.187). Seven (2.3%) patients developed > 50% in-stent restenosis. Conclusions: Carotid artery stenting using the Roadsaver stent for symptomatic patients and high risk lesions showed to be safe and effective, with a low complication rate and acceptable in-stent restenosis risk in 4-year follow-up.