Langhoff Ralf, Vajda Zsolt, Odrowąż-Pieniążek Piotr, Gjoreski Aleksandar, Beelen Roel, Deloose Koen, Nemes Balázs, Ruzsa Zoltán, Banos Jean-Luc, Castro Sérgio, Faurie Benjamin, Fuß Torsten, Piorkowski Michael, Király Istvan, Vulev Ivan, Schwindt Arne, Csécsei Péter, Tomasello Weitz Alejandro, Jonszta Tomáš, Latacz Paweł, Galván Fernández Jorge, Verbist Jürgen, Schröder Henrik, Pöckler-Schöniger Christiane, Kupcs Karlis, Lozano Vilardell Pascual, Rodríguez Carvajal Rubén, Daenens Kim, Tenholt Matthias, Blaško Peter, François Olivier, Diaz Valiño José Luis, Martínez Gámez Francisco Javier, Sesselmann Volker, Bárzo Pál, Kurre Wiebke, Terceño Izaga Mikel, Orgaz Pérez-Grueso Antonio, Suppan Karol, Lacman Jiří, Larrea Peña José Angel, Blasco Jordi, Bokkers Reinoud, Cvetić Vladimir, Till Viktor, Vallés González Heliodoro, Andrassy Martin, van den Heuvel Daniel, Köhler Jürgen, Müller-Hülsbeck Stefan, Kedev Sasko
Department of Angiology, Brandenburg Medical School Theodor Fontane, Campus Clinic Brandenburg, Brandenburg an der Havel and Sankt Gertrauden - Hospital, Berlin, Germany.
Neurovascular Unit, Moritz Kaposi Teaching Hospital, Kaposvár, Hungary.
Cardiovasc Intervent Radiol. 2025 Apr;48(4):427-437. doi: 10.1007/s00270-025-04003-z. Epub 2025 Mar 19.
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.
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.
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.
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 2, observational study (with dramatic effect).
与颈动脉内膜切除术相比，使用单层支架进行颈动脉支架置入术存在围手术期脑栓塞风险。双层微网支架旨在改善斑块覆盖并提供持续的栓子保护。本分析旨在在真实世界的颈动脉支架置入队列中确认Roadsaver双层微网支架的安全性。
Roadsaver是一项前瞻性、单臂、多中心观察性研究。符合择期支架置入条件的颈动脉狭窄患者在13个欧洲国家的52个地点入组。所有手术均遵循标准操作。主要结局是30天主要不良事件发生率，定义为任何死亡或中风的累积发生率。所有死亡、中风和颈动脉血管重建均由独立判定。
共分析了1965例患者（平均年龄70.6±8.8岁）。49.4%的参与者有脑缺血症状。26.3%的病例采用桡动脉/尺动脉入路，63.8%使用栓子保护装置。30天主要不良事件发生率为2.2%（无症状患者为1.6%，有症状患者为2.8%），任何中风发生率为1.9%，任何死亡发生率为0.8%，中风相关死亡率为0.5%。通过多变量建模确定的30天主要不良事件风险较高的预测因素包括残余狭窄≥30%、血栓栓塞性静脉疾病、既往心肌梗死、年龄≥75岁、动脉粥样硬化家族史、非胰岛素依赖型糖尿病、有症状的颈动脉狭窄和支架长度。
双层微网颈动脉支架置入术是安全的，在真实世界的无症状和有症状患者中30天主要不良事件发生率较低，支持持续栓子保护的设计理念。
2级，观察性研究（有显著效果）。
