Background:Transcatheter aortic valve replacement is an established treatment option for patients with severe symptomatic aortic stenosis and is most commonly performed through the transfemoral access route. Percutaneous access site closure can be achieved using dedicated plug-based or suture-based vascular closure device (VCD) strategies, but randomized comparative studies are scarce.Methods:The CHOICE-CLOSURE trial (Randomized Comparison of Catheter-based Strategies for Interventional Access Site Closure during Transfemoral Transcatheter Aortic Valve Implantation) is an investigator-initiated, multicenter study, in which patients undergoing transfemoral transcatheter aortic valve replacement were randomly assigned to vascular access site closure using either a pure plug-based technique (MANTA, Teleflex) with no additional VCDs or a primary suture-based technique (ProGlide, Abbott Vascular) potentially complemented by a small plug. The primary end point consisted of access site– or access-related major and minor vascular complications during index hospitalization, defined according to the Valve Academic Research Consortium-2 criteria. Secondary end points included the rate of access site– or access-related bleeding, VCD failure, and time to hemostasis.Results:A total of 516 patients were included and randomly assigned. The mean age of the study population was 80.5±6.1 years, 55.4% were male, 7.6% of patients had peripheral vascular disease, and the mean Society of Thoracic Surgeons score was 4.1±2.9%. The primary end point occurred in 19.4% (50/258) of the pure plug-based group and 12.0% (31/258) of the primary suture-based group (relative risk, 1.61 [95% CI, 1.07–2.44], P=0.029). Access site– or access-related bleeding occurred in 11.6% versus 7.4% (relative risk, 1.58 [95%CI: 0.91–2.73], P=0.133) and device failure in 4.7% versus 5.4% (relative risk, 0.86, [95% CI, 0.40–1.82], P=0.841) in the respective groups. Time to hemostasis was significantly shorter in the pure plug-based group (80 [32–180] versus 240 [174–316] seconds, P<0.001).Conclusions:Among patients treated with transfemoral transcatheter aortic valve replacement, a pure plug-based vascular closure technique using the MANTA VCD is associated with a higher rate of access site– or access-related vascular complications but a shorter time to hemostasis compared with a primary suture-based technique using the ProGlide VCD.Registration:URL: https://www.clinicaltrials.gov; Unique identifier: NCT04459208.

中文翻译：

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经股动脉经导管主动脉瓣置换术中纯栓塞与主要缝合血管闭合装置策略的比较：CHOICE-CLOSURE 随机临床试验

背景：经导管主动脉瓣置换术是严重症状性主动脉瓣狭窄患者的既定治疗选择，最常通过经股动脉通路进行。可以使用专用的基于栓塞或基于缝合的血管闭合装置 (VCD) 策略来实现经皮通路部位的闭合，但随机比较研究很少。方法：CHOICE-CLOSURE 试验（基于导管的介入部位策略的随机比较经股动脉经导管主动脉瓣植入术期间的闭合）是一项由研究者发起的多中心研究，其中接受经股动脉经导管主动脉瓣置换术的患者被随机分配到使用纯栓塞技术（MANTA，Teleflex）没有额外的 VCD 或基于主要缝合的技术（ProGlide，Abbott Vascular）可能由一个小塞子补充。主要终点包括根据 Valve Academic Research Consortium-2 标准定义的初次住院期间的通路部位或通路相关的主要和次要血管并发症。次要终点包括通路部位或通路相关出血率、VCD 失败和止血时间。结果：共纳入并随机分配了 516 名患者。研究人群的平均年龄为 80.5±6.1 岁，55.4% 为男性，7.6% 的患者患有外周血管疾病，平均胸外科医师协会评分为 4.1±2.9%。主要终点发生在 19.4% (50/258) 的纯栓塞组和 12 个。P = 0.029）。通路部位或通路相关的出血发生率为 11.6% 和 7.4%（相对风险，1.58 [95%CI：0.91-2.73]，P = 0.133），设备故障分别为 4.7% 和 5.4%（相对风险，0.86，[ 95% CI, 0.40–1.82], P = 0.841) 在各组中。纯栓塞组的止血时间显着缩短（80 [32-180] 秒对 240 [174-316] 秒，P<0.001).结论：在接受经股动脉经导管主动脉瓣置换术治疗的患者中，使用 MANTA VCD 的纯栓塞血管闭合技术与更高的进入部位或进入相关的血管并发症发生率相关，但止血时间更短与使用 ProGlide VCD.Registration:URL: https://www.clinicaltrials.gov 的主要缝合技术相比；唯一标识符：NCT04459208。