冠脉内注射比伐芦定对急性ST段抬高型心肌梗死直接PCI术中冠脉血流及临床事件影响

目的探讨在直接经皮冠状动脉介入(PPCI)术中,冠脉内注射比伐芦定对急性ST段抬高型心肌梗死(STEMI)患者罪犯冠脉血流恢复情况,以及术后30 d内临床事件的影响。方法本研究为前瞻性、随机对照探索性临床研究,选择2015年7月至2015年12月收治的拟行PPCI的急性STEMI患者84例,将患者随机分为对照组(n=40)和比伐芦定组(n=44)。经冠状动脉插入指引导丝或小直径球囊导管预扩张,使冠状动脉恢复前向血流≥TIMI 1级后,对照组不予冠脉内注射比伐芦定,正常进行PPCI常规操作;比伐芦定组经指引导管或微导管一次性冠脉内推注50%静脉负荷剂量的比伐芦定,此后按照PPCI常规正常操作。主要观察终点为PPCI术终靶血管校正的TIMI血流帧数(CTFC);次要观察终点为患者30 d内不良心脑血管事件(MACCE)发生率(包括死亡、再次心肌梗死、靶血管血运重建、脑卒中)、支架内血栓及出血学术研究会(BARC)定义的出血事件。结果两组患者靶血管PPCI术后,最终CTFC比较,差异无统计学意义(P>0.05);两组术后30 d内,MACCE事件发生率、支架内血栓及出血事件发生率比较,差异无统计学意义(P>0.05)。结论比伐芦定组与对照组比较,在改善冠脉血流方面无显著作用;冠脉内应用比伐芦定对术后30 d的临床缺血及出血事件均无明显影响。

The effect of intra-coronary bivalirudin injection during primary PCI on coronary blood flow and clinical events in patients with acute ST segment elevation myocardial infarction:a pilot study

Objective To explore the effect of bivalirudin by intracoronary injection during primary PCI on coronary blood flow and 30 days clinical events in patients with acute ST segment elevation myocardial infarction. Methods This was a prospective, randomly controlled pilot trial. A total of 84 patients with acute ST segment elevation myocardial infarction were enrolled into this study,and then patients were randomly divided to control group and Bivalirudin intracoronary injection group(Biv. ic group)at the ratio of 1:1(40 ca-ses in control group and 44 cases in Biv. ic group) . All patients were given intravenous maintaining does-bivalirudin by body weight. After restoring coronary blood flow(TIMI≥1) via guide wire or micro catheter,intracoronary bivalirudin was pushed via guide wire or micro catheter for half-does group;while intracoronary bivalirudin was not given for control group then following the normal operation. The primary endpoint was the Corrected TIMI Frame Count( CTFC);the secondary endpoints were major adverse cardiac and cerebro-vascular events(MACCE combined with death,re-infarction,TVR,stroke),stent thrombosis and bleeding were according to BARC grade. Results No statistical difference was observed on the CTFC between the two groups at the end of PPCI(P>0. 05). There was no statistical difference on the clinical events( MACCE,stent thrombosis and bleeding events) between the two groups within 30 days (P>0. 05). Conclusion Comparing with control group,there are not significantly statistical differences on CTFC for intracoronary bivalirudin group;and there is no effect of intracoronary bivalirudin on the clinical ischemic events and bleeding events within 30 days after PPCI.