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30-Day Outcomes of Real-World Elective Carotid Stenosis Treatment Using a Dual-Layer Micromesh Stent (ROADSAVER Study)
R. Langhoff, Z. Vajda, P. Odrowąż-Pieniążek, A. Gjoreski, R. Beelen, K. Deloose, B. Nemes, Z. Ruzsa, JL. Banos, S. Castro, B. Faurie, T. Fuß, M. Piorkowski, I. Király, I. Vulev, A. Schwindt, P. Csécsei, A. Tomasello Weitz, T. Jonszta, P. Latacz,...
Jazyk angličtina Země Spojené státy americké
Typ dokumentu časopisecké články, multicentrická studie, pozorovací studie
- MeSH
- cévní mozková příhoda prevence a kontrola etiologie MeSH
- lidé středního věku MeSH
- lidé MeSH
- prospektivní studie MeSH
- protézy - design MeSH
- senioři MeSH
- stenóza arteria carotis * terapie chirurgie diagnostické zobrazování MeSH
- stenty * MeSH
- výsledek terapie MeSH
- Check Tag
- lidé středního věku MeSH
- lidé MeSH
- mužské pohlaví MeSH
- senioři MeSH
- ženské pohlaví MeSH
- Publikační typ
- časopisecké články MeSH
- multicentrická studie MeSH
- pozorovací studie MeSH
- Geografické názvy
- Evropa MeSH
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).
Angiology and Vascular Surgery Department Hospital Universitari Son Espases Palma Spain
Cardioangiologisches Centrum Bethanien at Agaplesion Bethanien Hospital Frankfurt Germany
Center of Radiology Clinical Centre of Vojvodina Novi Sad Serbia
Centre de Cardiologie et d'Exploration de la Côte Basque Bayonne France
Centre of Vasculare Medicine Elblandklinikum Radebeul Radebeul Germany
Clinic of Vascular and Internal Diseases Dr Jan Biziel University Hospital No 2 Bydgoszcz Poland
Department of Interventional Cardiology Kardiocentrum Nitra s r o Nitra Slovakia
Department of Interventional Neuroradiology Hospital Clinic of Barcelona Barcelona Spain
Department of Interventional Radiology CINRE s r o Bratislava Slovakia
Department of Medical Imaging AZ Groeninge Kortrijk Belgium
Department of Radiology and Neuroradiology Klinikum Passau Passau Germany
Department of Radiology Military University Hospital Prague Prague Czech Republic
Department of Radiology Riga Stradiņš University Riga Latvia
Department of Radiology St Antonius Hospital Nieuwegein The Netherlands
Department of Radiology University Hospital Ostrava Ostrava Czech Republic
Department of Vascular and Thoracic Surgery Imelda Hospital Bonheiden Bonheiden Belgium
Department of Vascular and Thoracic Surgery O L 5 Aalst Aalst Belgium
Department of Vascular Surgery and Angiology Brothers of Mercy St John of God Hospital Kraków Poland
Department of Vascular Surgery AZ Sint Blasius Dendermonde Belgium
Department of Vascular Surgery St Franziskus Hospital Münster Germany
Department of Vascular Surgery University Hospitals Leuven Leuven Belgium
Diagnostische Radiologie Neuroradiologie SRH Klinikum Karlsbad Langensteinbach Karlsbad Germany
Division of Invasive Cardiology Department of Internal Medicine University of Szeged Szeged Hungary
Division on Endovascular Therapy Department of Vascular Surgery John Paul 2 Hospital Kraków Poland
Faculty of Medicine Riga Stradiņš University Riga Latvia
Faculty of Medicine University of Ostrava Ostrava Czech Republic
Fuerst Stirum Hospital Cardiology and Vascular Medicine Bruchsal Germany
Infirmerie Protestante de Lyon Caluire et Cuire France
Központi Radiológiai Osztály Markusovszky Egyetemi Oktatókórház Szombathely Szombathely Hungary
Neuroendovascular Division Department of Neurosurgery University of Pécs Pécs Hungary
Neuroradiology Department Hospital Universitario A Coruña A Coruña Spain
Neurosurgery Clinic University of Szeged Hospital Szeged Hungary
Neurovascular Unit Moritz Kaposi Teaching Hospital Kaposvár Hungary
Servicio de Angiología y Cirugía Vascular Hospital Universitario de Toledo Toledo Spain
SRH Zentralklinikum Suhl Klinik Für Innere Medizin 1 Suhl Germany
Citace poskytuje Crossref.org
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