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

Abstract 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...

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Main Authors: Stefan Müller-Hülsbeck, Zsolt Vajda, Piotr Odrowąż-Pieniążek, Zoltán Ruzsa, Roel Beelen, Aleksandar Gjoreski, Koen Deloose, Sérgio Castro, Benjamin Faurie, Alejandro Tomasello Weitz, Arne Schwindt, Paweł Latacz, Antonio Orgaz Pérez-Grueso, Vladimir Cvetić, Ralf Langhoff, Sasko Kedev, all ROADSAVER study investigators
Format: Article
Language:English
Published: SpringerOpen 2025-04-01
Series:CVIR Endovascular
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Online Access:https://doi.org/10.1186/s42155-025-00528-z
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author Stefan Müller-Hülsbeck
Zsolt Vajda
Piotr Odrowąż-Pieniążek
Zoltán Ruzsa
Roel Beelen
Aleksandar Gjoreski
Koen Deloose
Sérgio Castro
Benjamin Faurie
Alejandro Tomasello Weitz
Arne Schwindt
Paweł Latacz
Antonio Orgaz Pérez-Grueso
Vladimir Cvetić
Ralf Langhoff
Sasko Kedev
all ROADSAVER study investigators
author_facet Stefan Müller-Hülsbeck
Zsolt Vajda
Piotr Odrowąż-Pieniążek
Zoltán Ruzsa
Roel Beelen
Aleksandar Gjoreski
Koen Deloose
Sérgio Castro
Benjamin Faurie
Alejandro Tomasello Weitz
Arne Schwindt
Paweł Latacz
Antonio Orgaz Pérez-Grueso
Vladimir Cvetić
Ralf Langhoff
Sasko Kedev
all ROADSAVER study investigators
author_sort Stefan Müller-Hülsbeck
collection DOAJ
description Abstract 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. Visual Abstract
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spelling doaj-art-bd7d02a0740043b3afd2fedf7aa5d3e02025-08-20T02:28:04ZengSpringerOpenCVIR Endovascular2520-89342025-04-01811910.1186/s42155-025-00528-zContemporary carotid artery stenting practices and peri-procedural outcomes in different European countries: ROADSAVER study multicentric insightsStefan Müller-Hülsbeck0Zsolt Vajda1Piotr Odrowąż-Pieniążek2Zoltán Ruzsa3Roel Beelen4Aleksandar Gjoreski5Koen Deloose6Sérgio Castro7Benjamin Faurie8Alejandro Tomasello Weitz9Arne Schwindt10Paweł Latacz11Antonio Orgaz Pérez-Grueso12Vladimir Cvetić13Ralf Langhoff14Sasko Kedev15all ROADSAVER study investigatorsDepartment of Diagnostic and Interventional Radiology and Neuroradiology, DIAKO Hospital GmbH, Academic Teaching Hospital Christian-Albrechts-University Kiel – Faculty of Medicine, Deaconess Hospital FlensburgNeurovascular Unit, Moritz Kaposi Teaching HospitalDepartment of Interventional Cardiology, Institute of Cardiology, Jagiellonian University, Medical CollegeBács-Kiskun County Hospital, Teaching Hospital of the Szent-Györgyi Albert Medical UniversityDepartment of Vascular and Thoracic Surgery, O.L.V. AalstDepartment for Diagnostic and Interventional Radiology, Clinical Hospital “Acibadem Sistina”Department of Vascular Surgery, AZ-Sint BlasiusDepartment of Imagiology, Interventional Neuroradiology Unit, Centro Hospitalar Vila Nova de Gaia/EspinhoInfirmerie Protestante de LyonInterventional Neuroradiology Section, Department of Radiology, Vall d’Hebron University HospitalDepartment of Vascular Surgery, St. Franziskus-HospitalDepartment of Vascular Surgery and Angiology, Brothers of Mercy St. John of God HospitalServicio de Angiología y Cirugía Vascular, Hospital Universitario de ToledoCardiovascular Radiology Department, Clinic for Vascular and Endovascular Surgery, University Clinical Centre of SerbiaDepartment of Angiology, Brandenburg Medical School Theodor Fontane, Campus Clinic Brandenburg, Brandenburg an der Havel & Sankt Gertrauden – HospitalDepartment of Cardiology, Faculty of Medicine, University Clinic of Cardiology, University of St. Cyril & MethodiusAbstract 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. Visual Abstracthttps://doi.org/10.1186/s42155-025-00528-zCarotid arteryCarotid stenosisAngioplastyStentsStroke preventionGeographical variation
spellingShingle Stefan Müller-Hülsbeck
Zsolt Vajda
Piotr Odrowąż-Pieniążek
Zoltán Ruzsa
Roel Beelen
Aleksandar Gjoreski
Koen Deloose
Sérgio Castro
Benjamin Faurie
Alejandro Tomasello Weitz
Arne Schwindt
Paweł Latacz
Antonio Orgaz Pérez-Grueso
Vladimir Cvetić
Ralf Langhoff
Sasko Kedev
all ROADSAVER study investigators
Contemporary carotid artery stenting practices and peri-procedural outcomes in different European countries: ROADSAVER study multicentric insights
CVIR Endovascular
Carotid artery
Carotid stenosis
Angioplasty
Stents
Stroke prevention
Geographical variation
title Contemporary carotid artery stenting practices and peri-procedural outcomes in different European countries: ROADSAVER study multicentric insights
title_full Contemporary carotid artery stenting practices and peri-procedural outcomes in different European countries: ROADSAVER study multicentric insights
title_fullStr Contemporary carotid artery stenting practices and peri-procedural outcomes in different European countries: ROADSAVER study multicentric insights
title_full_unstemmed Contemporary carotid artery stenting practices and peri-procedural outcomes in different European countries: ROADSAVER study multicentric insights
title_short Contemporary carotid artery stenting practices and peri-procedural outcomes in different European countries: ROADSAVER study multicentric insights
title_sort contemporary carotid artery stenting practices and peri procedural outcomes in different european countries roadsaver study multicentric insights
topic Carotid artery
Carotid stenosis
Angioplasty
Stents
Stroke prevention
Geographical variation
url https://doi.org/10.1186/s42155-025-00528-z
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