Comparison of strategies for vascular ACCESS closure after transcatheter aortic valve implantation: the ACCESS-TAVI randomized trial.

IF 37.6 1区医学 Q1 CARDIAC & CARDIOVASCULAR SYSTEMS European Heart Journal Pub Date : 2024-10-29 DOI:10.1093/eurheartj/ehae784

Tobias Rheude, Hendrik Ruge, Niklas Altaner, Costanza Pellegrini, Hector Alvarez Covarrubias, N Patrick Mayr, Salvatore Cassese, Sebastian Kufner, Yousuke Taniguchi, Christian Thilo, Markus Klos, Magdalena Erlebach, Simon Schneider, Martin Jurisic, Karl-Ludwig Laugwitz, Rüdiger Lange, Heribert Schunkert, Adnan Kastrati, Markus Krane, Erion Xhepa, Michael Joner

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Abstract

Background and aims: Data from randomized trials investigating different access closure strategies after transfemoral transcatheter aortic valve implantation (TF-TAVI) remain scarce. In this study, two vascular closure device (VCD) strategies to achieve hemostasis after TF-TAVI were compared.

Methods: The ACCESS-TAVI (Comparison of Strategies for Vascular ACCESS Closure after Transcatheter Aortic Valve Implantation) is a prospective, multicenter trial in which patients undergoing TF-TAVI were randomly assigned to a strategy with a combined suture-/plug-based VCD strategy (suture/plug group) using one ProGlideTM/ProStyleTM (Abbott Vascular) and one Angio-Seal® (Terumo) versus a suture-based VCD strategy (suture-only group) using two ProGlidesTM/ProStylesTM. The primary endpoint was a composite of major or minor access site-related vascular complications during index hospitalization according to Valve Academic Research Consortium (VARC)-3 criteria. Key secondary endpoints included time to hemostasis, VARC-3 bleeding type ≥2 and all-cause mortality over 30 days.

Results: Between September 2022 and April 2024, 454 patients were randomized. The primary endpoint occurred in 27% (62/230) in the suture/plug group and 54% (121/224) in the suture-only group (relative risk [RR] 0.55 [95% confidence interval: 0.44;0.68]; p<0.001). Time to hemostasis was significantly shorter in the suture/plug group compared to the suture-only group (108±208 s vs. 206±171 s; p <0.001). At 30 days, bleeding type ≥2 occurred less often in the suture/plug group compared to the sutureonly group (6.2% vs. 12.1%, RR 0.66 [0.43;1.02]; p=0.032), with no significant difference in mortality.

Conclusions: With regard to the composite of major or minor access-related vascular complications, a combined suture-/plug-based VCD strategy was superior to a suturebased VCD strategy for vascular access closure in patients undergoing TF-TAVI.

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经导管主动脉瓣植入术后血管 ACCESS 关闭策略的比较：ACCESS-TAVI 随机试验。

背景和目的：研究经股动脉经导管主动脉瓣植入术（TF-TAVI）后不同入路闭合策略的随机试验数据仍然很少。本研究比较了两种血管闭合器（VCD）策略，以实现 TF-TAVI 术后止血：ACCESS-TAVI（经导管主动脉瓣植入术后血管ACCESS闭合策略比较）是一项前瞻性多中心试验、在这项多中心试验中，接受经导管主动脉瓣置换术的患者被随机分配到使用一个 ProGlideTM/ProStyleTM （雅培血管公司）和一个 Angio-Seal®（泰瑞茂公司）的缝合/塞子联合 VCD 策略（缝合/塞子组）和使用两个 ProGlideTM/ProStylesTM 的缝合 VCD 策略（仅缝合组）。主要终点是根据瓣膜学术研究联盟 (Valve Academic Research Consortium，VARC)-3 标准得出的指数住院期间与入路部位相关的主要或次要血管并发症的综合结果。主要次要终点包括止血时间、VARC-3出血类型≥2和30天内全因死亡率：2022年9月至2024年4月期间，454名患者接受了随机治疗。主要终点发生率：缝合/塞子组为 27%（62/230），单纯缝合组为 54%（121/224）（相对风险 [RR] 0.55 [95% 置信区间：0.44;0.68]；P结论：该研究的主要终点发生率为 0.55[95% 置信区间：0.44;0.68]：在TF-TAVI患者的血管通路闭合方面，就与通路相关的主要或次要血管并发症的复合情况而言，基于缝合/塞子的联合VCD策略优于基于缝合的VCD策略。

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来源期刊

European Heart Journal 医学-心血管系统

CiteScore

39.30

自引率

6.90%

发文量

3942

审稿时长

1 months

期刊介绍： The European Heart Journal is a renowned international journal that focuses on cardiovascular medicine. It is published weekly and is the official journal of the European Society of Cardiology. This peer-reviewed journal is committed to publishing high-quality clinical and scientific material pertaining to all aspects of cardiovascular medicine. It covers a diverse range of topics including research findings, technical evaluations, and reviews. Moreover, the journal serves as a platform for the exchange of information and discussions on various aspects of cardiovascular medicine, including educational matters. In addition to original papers on cardiovascular medicine and surgery, the European Heart Journal also presents reviews, clinical perspectives, ESC Guidelines, and editorial articles that highlight recent advancements in cardiology. Additionally, the journal actively encourages readers to share their thoughts and opinions through correspondence.