经皮冠状动脉介入治疗围术期应用比伐芦定多中心、大样本回顾性研究

A large-scale, multicenter, retrospective study on efficacy of bivalirudin use during peri-percutaneous coronary intervention period for Chinese patients with coronary heart disease

目的 观察比伐芦定在中国冠心病患者经皮冠状动脉介入治疗（PCI）中应用的有效性和安全性.方法 回顾性纳入2013年7月至2015年10月间在国内88家中心接受PCI且在PCI围术期应用比伐芦定的连续病例共3 271例.主要观察指标为术后30 d内的净不良临床事件（NACE,包括死亡、心肌梗死、卒中、紧急靶血管血运重建和全部出血）,其他观察指标为30 d主要心脑血管不良事件（MACCE,包括死亡、心肌梗死、卒中和紧急靶血管血运重建）、全部出血以及支架内血栓.结果 入选患者平均年龄（65.12±12.44）岁,女性占27.4％（889/3 244）.稳定性冠心病、非ST段抬高型急性冠状动脉综合征和ST抬高型急性心肌梗死分别占5.0％（162/3 248）,44.6％（1 450/3 248）和50.4％（1 636/3 248）.经桡动脉介入治疗比例89.5％ （2 879/3 271）,围术期接受替格瑞洛和替罗非班治疗的比例分别为9.7％ （316/3 271）和34.1％（1 115/3 271）.69.3％（2 266/3 271）的患者接受术后比伐芦定持续静滴,其中46.3％（1 050/2 266）接受高剂量维持静滴,中位数时间为2.5（1.0,4.0）h.30 d随访时,NACE、MACCE、死亡和出血事件的发生率分别为3.45％（103/2 988）,2.17％ （65/2 994）,1.03％ （31/3 017）和1.37％ （41/2 996）.共4例（0.13％）发生支架内血栓,其中有3例（0.09％）为急性支架内血栓.结论 在当前中国PCI围术期治疗实践中,比伐芦定可安全有效地应用于不同PCI适应证的冠心病患者,在发挥良好抗凝疗效的同时,可将出血风险控制在较低水平.

Objective To observe the efficacy and safety of bivalirudin use in Chinese patients with coronary heart disease （CHD） during the peri-percutaneous coronary intervention（PCI） period.Methods A total of 3 271 patients who underwent PCI and received periprocedural bivalirudin treatment between July 2013 and October 2015 from 88 centers of China were involved in this study.The primary outcome was 30-day net adverse clinical events （NACE a composite of major adverse cardiac or cerebral events （MACE,all-cause death,reinfarction,urgent target vessel revascularization,or stroke） or bleeding）,the secondary outcome was stent thrombosis at 30 days.Results The mean age of enrolled patients was （65.12 ± 12.44） years old,27.4% （889/3 244） of them were female.Percent of stable coronary disease （SCD）,non-ST segment elevation acute coronary syndrome （NSTE-ACS） and ST elevation myocardial infarction （STEMI） was 5.0% （162/3 248）,44.6% （1 450/3 248） and 50.4% （1 636/3 248） respectively.Radial access was performed in 89.5% （2 879/3 271） patients,and 9.7% （316/3 271） and 34.1% （1 115/3 271） patients also received ticagrelor and tirofiban medication.69.3% （2 266/3 271） patients received post-procedural bivalirudin infusion,in which 46.3% （1 050/2 266） was treated at PCI-does,with a median duration of 2.5 （1.0,4.0） h.During the 30-day follow-up,NACE occurred in 3.45% （103/2 988） patients,the incidence of MACE,death was 2.17% （65/2 994） and 1.03% （31/3 017）,respectively and bleeding events were recorded in 1.37% （41/2 996） patients.Four cases （0.13%） of stent thrombosis （3 acute stent thrombosis） were recorded.Conclusion Peri-PCI Bivalirudin use is safe and related with low bleeding risk in Chinese CHD patients.