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Purpose <p>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.</p> Materials and Methods <p>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.</p> Results <p>In total, 1965 patients were analysed (mean age 70.6 ± 8.8&#xa0;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&#xa0;years, family history of atherosclerosis, non-insulin-dependent diabetes mellitus, symptomatic carotid stenosis, and stent length.</p> Conclusion <p>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.</p> Level of Evidence <p>Level 2, observational study (with dramatic effect).</p> Graphical Abstract <p></p>

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

  • 期刊论文

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  • 发表日期：

    2025年3月19日

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  • Ralf Langhoff,
  • Zsolt Vajda,
  • Piotr Odrowąż-Pieniążek,
  • Aleksandar Gjoreski,
  • Roel Beelen,
  • Koen Deloose,
  • Balázs Nemes,
  • Zoltán Ruzsa,
  • Jean-Luc Banos,
  • Sérgio Castro,
  • Benjamin Faurie,
  • Torsten Fuß,
  • Michael Piorkowski,
  • Istvan Király,
  • Ivan Vulev,
  • Arne Schwindt,
  • Péter Csécsei,
  • Alejandro Tomasello Weitz,
  • Tomáš Jonszta,
  • Paweł Latacz,
  • Jorge Galván Fernández,
  • Jürgen Verbist,
  • Henrik Schröder,
  • Christiane Pöckler-Schöniger,
  • Karlis Kupcs,
  • Pascual Lozano Vilardell,
  • Rubén Rodríguez Carvajal,
  • Kim Daenens,
  • Matthias Tenholt,
  • Peter Blaško,
  • Olivier François,
  • José Luis Diaz Valiño,
  • Francisco Javier Martínez Gámez,
  • Volker Sesselmann,
  • Pál Bárzo,
  • Wiebke Kurre,
  • Mikel Terceño Izaga,
  • Antonio Orgaz Pérez-Grueso,
  • Karol Suppan,
  • Jiří Lacman,
  • José Angel Larrea Peña,
  • Jordi Blasco,
  • Reinoud Bokkers,
  • Vladimir Cvetić,
  • Viktor Till,
  • Heliodoro Vallés González,
  • Martin Andrassy,
  • Daniel van den Heuvel,
  • Jürgen Köhler,
  • Stefan Müller-Hülsbeck,
  • Sasko Kedev

摘要

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).

Graphical Abstract