Deutsches Herzzentrum München, Technische Universität, Munich, Germany2DZHK, Partner Site Munich Heart Alliance, Munich, Germany.
Deutsches Herzzentrum München, Technische Universität, Munich, Germany.
JAMA. 2014 Nov 19;312(19):1981-7. doi: 10.1001/jama.2014.15305.
The role of vascular closure devices (VCD) for the achievement of hemostasis in patients undergoing transfemoral coronary angiography remains controversial.
To compare outcomes with the use of 2 hemostasis strategies after diagnostic coronary angiography performed via transfemoral access-a VCD-based strategy with 2 types of devices, an intravascular device and an extravascular device, vs standard manual compression. The primary hypothesis to be tested was that femoral hemostasis achieved through VCD is noninferior to manual compression in terms of vascular access-site complications. A secondary objective was the comparison of the 2 types of VCD.
DESIGN, SETTING, AND PARTICIPANTS: Randomized, large-scale, multicenter, open-label clinical trial. We enrolled 4524 patients undergoing coronary angiography with a 6 French sheath via the common femoral artery from April 2011 through May 2014 in 4 centers in Germany. Last 30-day follow-up was performed in July 2014.
After angiography of the access site, patients were randomized to hemostasis with an intravascular VCD, extravascular VCD, or manual compression in a 1:1:1 ratio.
Primary end point: the composite of access site-related vascular complications at 30 days after randomization with a 2% noninferiority margin. Secondary end points: time to hemostasis, repeat manual compression, and VCD failure. An α-level of .025 was chosen for primary and secondary comparisons.
Of the 4524 enrolled patients, 3015 were randomly assigned to a VCD group (1509 received intravascular VCD and 1506 received extravascular VCD) and 1509 patients were randomly assigned to the manual compression group. Before hospital discharge, duplex sonography of the access site was performed in 4231 (94%) patients. The primary end point was observed in 208 patients (6.9%) assigned to receive a VCD and 119 patients (7.9%) assigned to manual compression (difference, -1.0% [1-sided 97.5% CI, 0.7%]; P for noninferiority<.001). Time to hemostasis was significantly shorter in patients with VCD (1 minute [interquartile range {IQR}, 0.5-2.0]), vs manual compression (10 minutes [IQR, 10-15]; P < .001). Time to hemostasis was significantly shorter among patients with intravascular VCD (0.5 minute [IQR, 0.2-1.0]), vs extravascular VCD (2.0 minutes [IQR, 1.0-2.0]; P <.001) and closure device failure was also significantly lower among those with intravascular vs extravascular VCD (80 patients [5.3%], vs 184 patients [12.2%]; P < .001).
In patients undergoing transfemoral coronary angiography, VCDs were noninferior to manual compression in terms of vascular access-site complications and reduced time to hemostasis.
clinicaltrials.gov Identifier: NCT01389375.
在经股冠状动脉造影术中，血管闭合装置（VCD）在实现止血方面的作用仍存在争议。
比较经股入路行诊断性冠状动脉造影后两种止血策略的结果 - 一种是基于 VCD 的策略，包括两种设备，即血管内装置和血管外装置，另一种是标准的手动压迫。要检验的主要假设是，通过 VCD 实现的股动脉止血在血管通路部位并发症方面不劣于手动压迫。次要目标是比较两种 VCD。
设计、地点和参与者：这是一项随机、大规模、多中心、开放性临床试验。我们在德国的 4 个中心共纳入了 4524 例 6 法国鞘经股总动脉行冠状动脉造影的患者。2014 年 7 月进行最后 30 天的随访。
血管造影后，患者随机分为血管内 VCD、血管外 VCD 或手动压迫组，比例为 1:1:1。
主要终点：随机分组后 30 天血管相关并发症的复合发生率，以 2%的非劣效性边界为指标。次要终点：止血时间、重复手动压迫和 VCD 失败。主要和次要比较的 α 水平选择为 0.025。
在纳入的 4524 例患者中，3015 例随机分配至 VCD 组（1509 例接受血管内 VCD，1506 例接受血管外 VCD），1509 例随机分配至手动压迫组。在出院前，4231 例（94%）患者接受了血管通路部位的双功超声检查。在接受 VCD 的 208 例患者（6.9%）和接受手动压迫的 119 例患者（7.9%）中观察到主要终点（差异，-1.0%[1 侧 97.5%置信区间，0.7%]；P<0.001 为非劣效性）。VCD 组的止血时间明显短于手动压迫组（1 分钟[四分位距 {IQR}，0.5-2.0]，vs 手动压迫组 10 分钟[IQR，10-15]；P<0.001）。血管内 VCD 组的止血时间明显短于血管外 VCD 组（0.5 分钟[IQR，0.2-1.0]，vs 血管外 VCD 组 2.0 分钟[IQR，1.0-2.0]；P<0.001），血管内 VCD 组的器械失效也明显低于血管外 VCD 组（80 例[5.3%]，vs 血管外 VCD 组 184 例[12.2%]；P<0.001）。
在经股冠状动脉造影患者中，VCD 在血管通路部位并发症和缩短止血时间方面不劣于手动压迫。
clinicaltrials.gov 标识符：NCT01389375。
