不同欧洲国家当代颈动脉支架置入术的实践及围手术期结局：ROADSAVER研究的多中心见解
Contemporary carotid artery stenting practices and peri-procedural outcomes in different European countries: ROADSAVER study multicentric insights.
作者信息
Müller-Hülsbeck Stefan, Vajda Zsolt, Odrowąż-Pieniążek Piotr, Ruzsa Zoltán, Beelen Roel, Gjoreski Aleksandar, Deloose Koen, Castro Sérgio, Faurie Benjamin, Tomasello Weitz Alejandro, Schwindt Arne, Latacz Paweł, Orgaz Pérez-Grueso Antonio, Cvetić Vladimir, Langhoff Ralf, Kedev Sasko
机构信息
Department of Diagnostic and Interventional Radiology and Neuroradiology, DIAKO Hospital GmbH, Academic Teaching Hospital Christian-Albrechts-University Kiel - Faculty of Medicine, Deaconess Hospital Flensburg, Knuthstraße 1, 24939, Flensburg, Germany.
Neurovascular Unit, Moritz Kaposi Teaching Hospital, Kaposvár, Hungary.
出版信息
CVIR Endovasc. 2025 Apr 12;8(1):29. doi: 10.1186/s42155-025-00528-z.
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.
背景
颈动脉支架置入术在患者选择和手术技术方面的区域差异已有充分记录。然而，它们对手术结果的影响，尤其是在使用双层微网支架时，尚未完全明确。
方法
这项前瞻性、多中心观察性研究纳入了1965例接受Roadsaver双层微网支架治疗的无症状或有症状颈动脉狭窄患者。主要结局指标是30天主要不良事件发生率，定义为术后30天内发生的任何死亡或卒中。这项亚分析比较了13个参与国家的患者特征和手术技术，并通过逻辑回归模型研究了结局差异。
结果
各国患者的人口统计学特征、合并症和症状表现差异很大。同样，基线和30天随访时使用双功超声和扩散加权磁共振成像的频率也有所不同。手术方法也各不相同，在股动脉入路部位选择（18.2%至100.0%）、使用栓塞保护装置（0.0%至100.0%）、预扩张（4.3%至46.7%）和后扩张（66.7%至100.0%）方面存在差异。尽管比较的国家之间30天主要不良事件发生率有所不同，但在调整后扩张球囊压力（分为无后扩张、≤11个大气压和>11个大气压）以及每个研究地点的入组患者数量后，差异在统计学上变得不显著。
结论
我们的研究揭示了欧洲各国在患者选择、颈动脉支架置入手术操作和临床结局方面的差异。各国之间30天任何死亡或卒中发生率的差异可能归因于不同的后扩张操作和每个研究地点的入组患者数量。
证据水平
3级，观察性研究。
试验注册
Clinicaltrials.gov标识符：NCT03504228。
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