Interventional Cardiology Unit, Department of Cardiology, Complejo Hospitalario Universitario A Coruña, A Coruña, Spain.
Am Heart J. 2011 Jun;161(6):1207-13. doi: 10.1016/j.ahj.2011.03.009. Epub 2011 May 11.
The use of vascular closure devices (VCDs) for the reduction of access site complications following percutaneous coronary intervention (PCI) remains controversial. Patients undergoing primary PCI for acute ST-segment elevation myocardial infarction (STEMI) are at high risk of femoral artery complications. A lack of information exists regarding the use of VCDs in this group of patients because they have been routinely excluded from randomized trials. This study sought to evaluate the safety and efficacy of the routine use of VCDs after primary PCI.
A total of 558 consecutive patients undergoing primary PCI for STEMI via femoral route were studied for in-hospital outcomes through a prospective registry from January 2003 to December 2008. The primary end point was the presence of major vascular complication (MVC) defined as a composite of fatal access site bleeding, access site complication requiring interventional or surgical correction, or access site bleeding with ≥3 g/dL drop in hemoglobin or requiring blood transfusion.
Of the total patients, 464 (83.2%) received a VCD; and manual compression was used in 94 patients (16.8%). Major vascular complication occurred in 5.2% of patients. The risk of MVC was significantly lower with VCDs compared with manual compression (4.3% vs 9.6%, P = .036). Multivariable logistic regression analysis determined that VCD use remained an independent predictor of lower rate of MVC (odds ratio 0.38, 95% CI 0.17-0.91).
The use of VCDs in patients undergoing primary PCI for STEMI is safe and is associated with lower rates of MVC compared with manual compression.
经皮冠状动脉介入治疗（PCI）后使用血管闭合装置（VCD）减少介入部位并发症仍存在争议。接受急性 ST 段抬高型心肌梗死（STEMI）的患者行直接 PCI 术时，股动脉并发症风险较高。由于这些患者通常被排除在随机试验之外，因此缺乏关于使用 VCD 的信息。本研究旨在评估直接 PCI 术后常规使用 VCD 的安全性和疗效。
2003 年 1 月至 2008 年 12 月，通过前瞻性登记研究，对 558 例连续接受股动脉途径直接 PCI 术治疗的 STEMI 患者进行了住院期间结局评估。主要终点是主要血管并发症（MVC）的发生，定义为致命性入路部位出血、需要介入或手术矫正的入路部位并发症或血红蛋白下降≥3 g/dL 并需要输血的入路部位出血的复合终点。
在所有患者中，464 例（83.2%）接受了 VCD，94 例（16.8%）采用了手动压迫。5.2%的患者发生主要血管并发症。与手动压迫相比，VCD 降低 MVC 的风险显著（4.3%比 9.6%，P=0.036）。多变量逻辑回归分析确定，VCD 使用仍然是 MVC 发生率较低的独立预测因素（比值比 0.38，95%置信区间 0.17-0.91）。
在接受直接 PCI 术治疗的 STEMI 患者中，使用 VCD 是安全的，与手动压迫相比，VCD 可降低 MVC 的发生率。
