国产比伐卢定用于冠状动脉介入治疗术中抗凝的疗效和安全性评价

Evaluation of Anticoagulant Efficacy and Safety for Domestic Bivalirudin During Percutaneous Coronary Intervention

目的:评估国产比伐卢定应用于择期冠状动脉介入治疗术(PCI)中抗凝治疗的疗效及安全性。方法:采用随机、单盲、多中心临床试验设计,随机将接受择期PCI的患者分为比伐卢定组和肝素组,在PCI术中分别采用比伐卢定或普通肝素抗凝治疗,主要疗效评价指标为术中测定激活的全血凝固时间(ACT)、手术成功率(靶病变术后狭窄程度小于20%并24 h内无冠状动脉事件发生)及30天无心血管事件生存率,主要安全性评价指标为轻度及重度出血。结果:共有218例患者入选,实际入组完成试验207例,比伐卢定组(n=105)和肝素组(n=102)。用药后5 min除肝素组2例需要追加剂量外,其余两组患者PCI术中均能维持ACT>225 s,两组差异无统计学意义(P>0.05);比伐卢定组和肝素组PCI手术成功率和30天无心脏事件生存率均分别为100%和98.04%(P>0.05),差异无统计学意义。比伐卢定组和肝素组24 h内轻度出血的发生率分别为0.95%和6.86%(P<0.05)、30天内轻度出血发生率分别为1.9%和8.8%(P<0.05),肝素组有1例发生严重消化道出血。结论:国产比伐卢定能安全有效地应用于择期PCI术中抗凝治疗,疗效不劣于肝素且出血副作用低于肝素。

Objective：To evaluate the anticoagulant efficacy and safety of domestic bivalirudin during elective percutaneous coronary in- tervention （PCI）. Methods：A total of 218 elective PCI candidates were enrolled in this randomized, single-blind multi center clinical trial and 207 patients finished the trail. The patients were divided into two groups, Bivalirudin group, n = 105 and Heparin group, n = 102, they received either bivalirudin or heparin during PCI procedure. We compared the activated coagulation time（ ACT）, procedural success rate（residual stenosis〈20% in target lesion, no coronary artery related adverse events within 24 hours of PCI）and the survival rate（without major adverse cardiac events within 30 days of PCI）between two groups. The major safety evaluation was based on mild or severe bleeding. Results： Most patients had ACT〉225s at 5 min after the medication during PCI procedure in both groups ,P〉0. 05. The pro- cedural success rate and the survival rate in Bivalirudin group and in Heparin group were both 100% and 98.04% ,P〉0. 05 re- spectively. The mild bleeding rate within 24 hours in Bivalirudin group and in Heparin group were 0.95% and 6. 86% ,P〈0. 05, within 30 days were 1.9% and 8.8% ,P〈0.05. There was 1 severe gastrointestinal bleeding in Heparin group. Conclusion： Domestic bivalidurin could be used as an effective and safe anticoagulant during elective PCI procedure, it has less bleeding side effect than heparin.