Deutsches Herzzentrum München, Technische Universität München, Germany (S.M.G., S.M.H., K.M., I.O., J.H., T.M., R.A.B., S.K., S.C., M.F., H.S., A.K., S.S.).
Klinikum Landkreis Erding, Abteilung Kardiologie und Pneumologie, Germany (S.M.H., L.B.-F.).
Circ Cardiovasc Interv. 2018 Aug;11(8):e006074. doi: 10.1161/CIRCINTERVENTIONS.117.006074.
The value of vascular closure devices (VCD) in women undergoing transfemoral catheterization has not been sufficiently investigated.
This is a sex-specific analysis of 1395 women enrolled in a large-scale, randomized, multicenter trial, in which patients undergoing transfemoral diagnostic coronary angiography were randomly assigned in a 1:1:1 ratio to arteriotomy closure with an intravascular VCD, extravascular VCD, or manual compression (MC). Primary objective was to assess the safety and efficacy of 2 different VCD compared with MC regarding vascular access-site complications at 30 days. A secondary comparison was between 2 different types of contemporary VCD. Overall, women were at higher risk for vascular access-site complications compared with men (9.0% versus 6.4%; P=0.002). Vascular access-site complications were comparable in women assigned to VCD and MC (8.6% versus 9.8%; P=0.451). There was no interaction of treatment effect and sex ( P=0.970). Time to hemostasis was significantly shortened with VCD compared with MC (1 [interquartile range, 0.5-2.0] minutes) versus 11 [interquartile range, 10-15] minutes; P<0.001); however, more women with VCD required repeat MC (2.4% versus 0.6%; P=0.018). The use of the intravascular compared with the extravascular VCD was associated with a numerical reduction in vascular access-site complications (6.6% versus 10.7%; P=0.027) and significant reductions in time to hemostasis and VCD failure.
In women undergoing diagnostic coronary angiography via the common femoral artery, VCD and MC provided comparable safety, while time to hemostasis was reduced with VCD.
URL: https://www.clinicaltrials.gov . Unique identifier: NCT01389375.
经股动脉行导管插入术的女性患者中，血管闭合装置（VCD）的价值尚未得到充分研究。
这是一项对 1395 名女性进行的大规模、随机、多中心试验的性别特异性分析，其中接受经股动脉诊断性冠状动脉造影的患者以 1:1:1 的比例随机分配接受血管内 VCD、血管外 VCD 或手动压迫（MC）闭合动脉切开部位。主要目的是评估与 MC 相比，两种不同的 VCD 在 30 天内对血管入路部位并发症的安全性和有效性。次要比较是两种不同类型的现代 VCD 之间的比较。总体而言，女性发生血管入路部位并发症的风险高于男性（9.0%比 6.4%；P=0.002）。接受 VCD 和 MC 治疗的女性血管入路部位并发症发生率相似（8.6%比 9.8%；P=0.451）。治疗效果与性别之间无交互作用（P=0.970）。与 MC 相比，VCD 可显著缩短止血时间（1 [四分位距，0.5-2.0] 分钟）与 11 [四分位距，10-15] 分钟；P<0.001）；然而，更多的 VCD 女性需要重复 MC（2.4%比 0.6%；P=0.018）。与血管外 VCD 相比，使用血管内 VCD 与血管入路部位并发症的发生率降低（6.6%比 10.7%；P=0.027）和止血时间及 VCD 失败显著减少相关。
在经股总动脉行诊断性冠状动脉造影的女性患者中，VCD 和 MC 的安全性相似，而 VCD 可缩短止血时间。
网址：https://www.clinicaltrials.gov。唯一标识符：NCT01389375。
