Ten Years of European Experience With Roadsaver Carotid Stent: A Systematic Review of Literature and Exploratory Meta-Analysis

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Abstract

BACKGROUND: Dual-layer micromesh (DLMM) carotid stents were developed to enhance plaque scaffolding and reduce peri-procedural embolization during carotid artery stenting (CAS). Although Roadsaver is widely used in contemporary European practice, comparative evidence against first-generation stents (FGSs) and other DLMM devices remains limited. This study systematically reviews the European experience with Roadsaver and performs an exploratory meta-analysis of 30-day clinical outcomes and in-stent restenosis (ISR). METHODS: A systematic search of PubMed, Embase, and Medline identified European studies published between January 1, 2014 and December 31, 2024 reporting transfemoral CAS using the Roadsaver stent. Adult patients with extracranial, de novo carotid stenosis-symptomatic or asymptomatic-were included. Comparative analyses were limited to studies reporting paired outcomes for Roadsaver versus FGSs or C-Guard. Primary endpoints were 30-day stroke and death; the secondary endpoint was ≥50% ISR at approximately 12 months, as defined by each study. Pooled effects were calculated using Peto odds ratios with random-effects DerSimonian-Laird models. RESULTS: Twenty-two studies comprising 3539 Roadsaver procedures were included in the qualitative review; 5 studies met criteria for quantitative pooling. Across all studies, 30-day stroke and death occurred in 1.6% and 0.5% of patients, respectively. Meta-analysis showed no statistically significant differences in 30-day stroke or death between Roadsaver and FGSs, with low heterogeneity. In-stent restenosis comparisons similarly demonstrated no significant differences between Roadsaver and FGSs or between Roadsaver and C-Guard; however, ISR analyses were limited by marked heterogeneity in definitions, imaging modalities, and follow-up timing. CONCLUSIONS: Roadsaver DLMM stenting in European practice is associated with low 30-day stroke and death rates. Exploratory pooled analyses did not identify significant differences between Roadsaver and FGSs or between DLMM devices; however, the small number of comparative studies, variability in ISR assessment, and predominantly observational evidence base substantially limit the certainty of these findings. Larger, rigorously designed comparative studies, and randomized trials are needed to determine whether clinically meaningful differences exist between carotid stent platforms.Clinical impactIn this paper, transfemoral CAS with the Roadsaver dual-layer micromesh stent was associated with low 30-day stroke and death rates in European practice. Comparative analyses did not demonstrate significant differences versus first-generation stents or between DLMM devices; however, the observed safety profile, combined with mechanistic data on enhanced plaque scaffolding and embolic protection, supports the use of Roadsaver in routine CAS, including complex anatomies. These findings reinforce DLMM technology as a contemporary standard option rather than an experimental alternative, while underscoring the need for standardized ISR assessment and adequately powered randomized trials to guide device selection in carotid revascularization.

Abstract as published, via PubMed.