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.

中文翻译：

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


背景和目的 来自调查经股动脉经导管主动脉瓣植入术 （TF-TAVI） 后不同通路关闭策略的随机试验的数据仍然稀缺。在本研究中，比较了 TF-TAVI 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，其中接受 TF-TAVI 的患者被随机分配到一种策略，该策略具有基于缝合/栓子的组合 VCD 策略（缝合/栓组），使用一个 ProGlideTM/ProStyleTM（雅培血管）和一个血管密封® （Terumo） 与基于缝合的 VCD 策略（仅缝合组）使用两个 ProGlidesTM/ProStylesTM。主要终点是根据 Valve 学术研究联盟 （VARC）-3 标准，指数住院期间主要或次要入路部位相关血管并发症的复合。关键的次要终点包括止血时间、VARC-3 出血类型 ≥2 和 30 天内的全因死亡率。结果 2022 年 9 月至 2024 年 4 月期间，454 例患者被随机分组。主要终点发生在缝合/栓塞组为 27% （62/230），仅缝合组为 54% （121/224）（相对风险 [RR] 0.55 [95% 置信区间：0.44;0.68];p<0.001）。与仅缝合组相比，缝合/塞组的止血时间显著缩短 （108±208 s vs. 206±171 s;p <0.001）。30 天时，与仅缝合组相比，缝合/塞组出血类型 ≥2 的发生率较低 （6.2% vs. 12.1%，RR 0.66 [0.43;1.02];p=0.032），死亡率无显著差异。 结论 关于主要或次要通路相关血管并发症的复合情况，对于接受 TF-TAVI 的患者，基于缝合/塞子的联合 VCD 策略优于基于缝合的 VCD 策略。