经导管主动脉瓣植入术后血管通路闭合策略的比较：ACCESS-TAVI随机试验

Comparison of strategies for vascular ACCESS closure after Transcatheter Aortic Valve Implantation: the ACCESS-TAVI randomized trial.

作者信息

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

机构信息

Department of Cardiovascular Diseases, German Heart Center Munich, Technical University Munich University Hospital, Lazarettstrasse 36, 80636 Munich, Germany.

Department of Cardiovascular Surgery, Institute Insure, German Heart Center Munich, School of Medicine & Health, Technical University of Munich, Lazarettstrasse 36, 80636 Munich, Germany.

出版信息

Eur Heart J. 2025 Feb 14;46(7):635-645. doi: 10.1093/eurheartj/ehae784.

DOI:10.1093/eurheartj/ehae784

PMID:39474906

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 haemostasis after TF-TAVI were compared.

METHODS

The ACCESS-TAVI (Comparison of Strategies for Vascular ACCESS Closure after Transcatheter Aortic Valve Implantation) is a prospective, multicentre 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 ProGlide™/ProStyle™ (Abbott Vascular) and one Angio-Seal® (Terumo) vs. a suture-based VCD strategy (suture-only group) using two ProGlides™/ProStyles™. The primary endpoint was a composite of major or minor access site-related vascular complications during index hospitalization according to Valve Academic Research Consortium 3 criteria. Key secondary endpoints included time to haemostasis, 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 .55 (95% confidence interval: .44, .68); P < .001]. Time to haemostasis was significantly shorter in the suture/plug group compared with the suture-only group (108 ± 208 s vs. 206 ± 171 s; P < .001). At 30 days, bleeding type ≥ 2 occurred less often in the suture/plug group compared with the suture-only group [6.2% vs. 12.1%, relative risk .66 (.43, 1.02); P = .032], with no significant difference in mortality.

CONCLUSIONS

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

摘要

背景与目的

关于经股动脉经导管主动脉瓣植入术（TF-TAVI）后不同血管闭合策略的随机试验数据仍然稀少。在本研究中，比较了TF-TAVI术后实现止血的两种血管闭合装置（VCD）策略。

方法

ACCESS-TAVI（经导管主动脉瓣植入术后血管通路闭合策略比较）是一项前瞻性、多中心试验，接受TF-TAVI的患者被随机分配至使用一个ProGlide™/ProStyle™（雅培血管）和一个Angio-Seal®（泰尔茂）的基于缝线/封堵器的联合VCD策略组（缝线/封堵器组），与使用两个ProGlides™/ProStyles™的基于缝线的VCD策略组（仅缝线组）。主要终点是根据瓣膜学术研究联盟3标准，在首次住院期间与穿刺部位相关的主要或次要血管并发症的复合终点。关键次要终点包括止血时间、≥2级出血类型以及30天内的全因死亡率。

结果

在2022年9月至2024年4月期间，454例患者被随机分组。缝线/封堵器组主要终点发生率为27%（62/230），仅缝线组为54%（121/224）[相对风险0.55（95%置信区间：0.44，0.68）；P<0.001]。与仅缝线组相比，缝线/封堵器组的止血时间显著缩短（108±208秒对206±171秒；P<0.001）。在30天时，缝线/封堵器组≥2级出血类型的发生率低于仅缝线组[6.2%对12.1%，相对风险0.66（0.43，1.02）；P = 0.032]，死亡率无显著差异。