Contemporary carotid artery stenting practices and peri-procedural outcomes in different European countries: ROADSAVER study multicentric insights

BACKGROUND: Regional variations in patient selection and procedural techniques for carotid artery stenting have been well documented. However, their impact on procedural outcomes, especially with the use of dual-layer micromesh stents, is not fully understood. METHODS: This prospective, multi-center observational study included 1965 patients with asymptomatic or symptomatic carotid artery stenosis treated with the Roadsaver dual-layer micromesh stent. The primary outcome measure was the 30-day rate of major adverse events, defined as any death or stroke occurring within 30 days post-procedure. This sub-analysis compared patient characteristics and procedural techniques across 13 participating countries and investigated differences in outcomes via logistic regression modelling. RESULTS: Patient demographics, comorbidities, and symptom presentation varied widely among countries. Similarly, the frequency of use of duplex ultrasound and diffusion-weighted magnetic resonance imaging at baseline and 30-day follow-up differed. Procedural approaches also varied, with differences in femoral access site selection (18.2% to 100.0%), use of embolic protection devices (0.0% to 100.0%), pre-dilatation (4.3% to 46.7%) and post-dilatation (66.7% to 100.0%). Although 30-day major adverse event rates differed across the compared countries, after adjusting for post-dilatation balloon pressure (categorized as no post-dilatation vs. ≤ 11atm vs. > 11atm), and the number of enrolled patients per study site, the difference became statistically non-significant. CONCLUSION: Our study reveals variability in patient selection, procedural carotid stenting practices and clinical outcomes across European countries. The differences in 30-day any death or stroke rates between countries may be attributed to differing post-dilatation practices and the number of enrolled patients per study site. LEVEL OF EVIDENCE: Level 3, observational study. TRIAL REGISTRATION: Clinicaltrials.gov identifier: NCT03504228.