30-Day Outcomes of Real-World Elective Carotid Stenosis Treatment Using a Dual-Layer Micromesh Stent (ROADSAVER Study)

Abstract

Carotid artery disease; Cerebrovascular embolic protection; Stroke prevention

Enfermedad de la arteria carótida; Protección embólica cerebrovascular; Prevención de accidentes cerebrovasculares

Malaltia de l'artèria caròtida; Protecció embòlica cerebrovascular; Prevenció d'accidents cerebrovasculars

Purpose Carotid artery stenting with single-layer stents carries a risk of periprocedural cerebral embolization compared to carotid endarterectomy. Dual-layer micromesh stents were designed for improved plaque coverage and sustained embolic protection. This analysis aimed to confirm the Roadsaver dual-layer micromesh stent safety in a real-world carotid artery stenting cohort. Materials and Methods ROADSAVER was a prospective, single-arm, multicenter, observational study. Patients with carotid artery stenosis, eligible for elective stenting, were enrolled at 52 sites across 13 European countries. All procedures followed standard practice. The primary outcome was the 30-day major adverse event rate, defined as the cumulative incidence of any death or stroke. All deaths, strokes, and carotid artery revascularizations were independently adjudicated. Results In total, 1965 patients were analysed (mean age 70.6 ± 8.8 years). Cerebral ischaemia symptoms were present in 49.4% of participants. Radial/ulnar access was used in 26.3% of cases and embolic protection in 63.8%. The 30-day major adverse event incidence was 2.2% (1.6% in asymptomatic and 2.8% in symptomatic patients), with any stroke at 1.9%, any death at 0.8%, and stroke-related death at 0.5%. Predictors of higher 30-day major adverse event risk, identified through multivariable modelling, included residual stenosis ≥ 30%, thromboembolic venous disease, previous myocardial infarction, age ≥ 75 years, family history of atherosclerosis, non-insulin-dependent diabetes mellitus, symptomatic carotid stenosis, and stent length. Conclusion Dual-layer micromesh carotid artery stenting is safe, with a low 30-day major adverse event incidence in real-world asymptomatic and symptomatic patients, supporting the sustained embolic protection design concept. Level of Evidence Level 2, observational study (with dramatic effect).

The ROADSAVER study was funded by Terumo Europe N.V. and designed in collaboration with the study's Steering Committee members. The sponsor managed the study conduct, including data collection and analyses, consulting the Steering Committee members on relevant topics. The sponsor also supported manuscript drafting, with editorial assistance provided by the external agency CCN17 Ltd, UK.