比伐卢定在急性心肌梗塞患者介入治疗中抗凝的疗效及安全性评估

Evaluation of anticoagulant efficacy and safety for domestic bivalirudin during Percutaneous Coronary Intervention in patients with acute myocardio infarction

目的 评估比伐卢定用于急性ST段抬高型心肌梗塞（STEMI）患者急诊经皮冠状动脉介入治疗（PCI）中抗凝疗效及出血风险.方法 2013年9月～2014年3月武警后勤学院附属医院确诊STEMI患者87例行直接PCI治疗,随机分为肝素组（n=42例）和比伐卢定组（n=45例）.术中监测激活的全血凝固时间（ACT）,并测定术前及术后1h凝血指标,分析比较两组间各项指标.术后随访30 d观察两组主要心血管不良事件（MACE）及出血事件发生率.主要试验终点为严重出血及MACE事件包括（死亡、再梗、缺血性靶血管血运重建、卒中）.结果 两组患者基线资料相当,术中两组抗凝效果相当,无明显统计学差异,P＞0.05;术后30dMACE事件发生率两组无明显差异P＞0.05;比伐卢定组2例牙龈出血,肝素组牙龈出血3例,血尿1例,消化道出血1例,两组比较存在统计学差异,P ＜0.05.此外肝素组1例出现肝素诱导的血小板减少症（heparin-induced thrombicytopenia,HIT）.结论 比伐卢定可安全的应用于STEMI患者急诊PCI术中抗凝,抗凝效果不劣于普通肝素,但出血的风险更低,且避免了HIT的发生.

Objective To evaluate the safety and efficacy of bivalirudin during percutaneous coronary intervention （PCI） in patients with acute myocardial infarction （AMI）. Methods A total of 87 patients who were diagnosed ST-elevation myocardial infarction （STEMI） were randomly divided into two groups for PCI, and respectively received heparin （n=42）, or bivalirudin （n=45）. The activated coagulation time （ACT） were monitored during the PCI procedure and the blood clotting related parameter were detected and compared before administration and 1 hour after PCI. The primary composite end point was the incidence of death in 30 days, remyocardial infarction, urgent repeat revascularization, stroke and bleeding. Results The baseline data of the two groups were similar, and the anticoagulant efficiency reflected no significant difference,P 〉0.05. The incidence of MACE was not significantly different between the two groups,P 〉0.05.while a lower bleed incidence was observed in the bivalirudin group,P 〈0.05.Conclusion Bivalirudin carries the feature of comparable anticoagulation effect as heparin during PCI in the patients of STEMI with a lower risk of bleeding.