股动脉穿刺后Angioseal血管闭合器与人工压迫止血的并发症研究

Complications of applying Angioseal arterial closure device versus and manual compression homeostasis after common femoral artery puncture in coronary intervention

目的:比较经股动脉穿刺行冠状动脉介入诊治术后Angioseal血管闭合器和人工压迫止血的安全性。方法:采用随机双盲对照研究,从2008年1月至2011年11月经股动脉穿刺行冠状动脉介入诊治的病例611人次,分为Angioseal血管闭合器组和人工压迫组,比较2组并发症的发生率。结果:2组总的并发症发生率差异无统计学意义(P>0.05),但在24 h后Angioseal血管闭合器组的并发症发生率有增加的趋势(P<0.05)。结论:使用Angioseal血管闭合器不能减少股动脉穿刺并发症的发生率,尤其在24 h后并发症有增加的趋势,不推荐股动脉穿刺后常规使用Angioseal血管闭合器。

Objective ：To compare the safety between Angioseal closure device and manual compression homeostasis after performing coronary intervention through femoral artery puncture. Methods：Randomized double blind controlled trial was used. Totally 611 patients treated with coronary intervention through femoral artery puncture from January 2008 to November 2011 were enrolled and di- vided into Angioseal closure device group and manual compression homeostasis group. Complications were compared between the two groups. Results：There was no difference in the overall complication rate between the two groups （P〉0.05）. However, the compli- cation rate of Angioseal closure device group tended to increase at 24 h after the treatment（P〈0.05）. Conclusio~：Angiosea! clo- sure device can not decrease complications because delayed complications may occur significantly after 24 h. Angioseal closure device is not recommended to use after performing coronary intervention through femoral artery puncture.