摘要
目的在真实世界中对比经皮冠状动脉介入治疗(PCI)围术期应用比伐芦定和肝素的有效性和安全性。方法连续入选北部战区总医院心血管内科2016年1月至2018年11月间接受PCI的冠心病患者13097例,按PCI围术期抗凝治疗方案分为比伐芦定组和肝素组。主要终点为术后30 d净临床不良事件(NACE)发生率,NACE定义为包括全因死亡、心肌梗死、卒中、紧急靶病变再次血运重建(uTLR)和全部出血的复合终点。次要终点为30 d主要不良心脑血管事件(MACCE),定义为由全因死亡、心肌梗死、卒中和uTLR组成的复合事件。其他观察指标还包括支架内血栓发生率。依据人口学特征和临床危险因素计算倾向性评分,以1∶2的比例匹配两组患者。匹配前、后均比较两组的终点事件发生率。结果最终纳入13097例患者,年龄(61±10)岁,其中女性3421例(26.1%)。比伐芦定组2734例,肝素组10363例;倾向评分匹配后比伐芦定组2734例,肝素组5468例。匹配前与肝素组比较,比伐芦定组中患者的年龄偏大,CRUSADE出血风险评分更高,合并高血压和诊断为急性心肌梗死的患者比例更高(P均<0.05)。经倾向性评分匹配后,比伐芦定组在PCI术后30 d内NACE[(3.8%(103/2734)比5.0%(271/5468),P=0.015]和全部出血事件[2.0%(54/2734)比2.8%(151/5468),P=0.032]发生率均低于肝素组,但两组的MACCE[1.9%(51/2734)比2.3%(127/5468),P=0.180]和支架内血栓[0.1%(2/2734)比0.1%(3/5468),P=1.000]发生率差异无统计学意义。结论与肝素相比,比伐芦定可显著减少出血和NACE事件发生率,且不增加缺血事件发生风险。
Objective To compare the safety and efficacy of bivalirudin versus unfractionated heparin during perioperative period of percutaneous coronary intervention(PCI)in real-world.Methods A total of 13097 serial patients who underwent PCI from January 2016 to November 2018 in the Northern Theater Command were enrolled in the present study.Patients were stratified as the bivalirudin group or the heparin group according to antithrombotic therapy during PCI.The primary efficiency endpoint was 30-day net adverse clinical event(NACE),defined as all-cause death,re-infarction,urgent target lesion revascularization(uTLR),stroke or any bleeding.The second efficiency endpoint was 30-day major cardiac and cerebral events(MACCE),defined as all-cause death,re-infarction,uTLR and stroke.Additional end points included the rates of stent thrombosis at 30 days.Propensity scores included clinical and demographic variables,with 1∶2 matching.Compared the incidence of events above between the two groups before and after matching.Results Among the 13097 included patients(age was(61±10)years old),3421(26.1%)were female.And 2734 patients were divided into the bivalirudin group,and 10363 patients to the heparin group(5468 after matching).Before propensity score matching,patients in bivalirudin group were older and received higher levels of CRUSADE score than heparin group.These patients were more likely to have hypertension and more with ST-segment elevation acute coronary syndromes(all P<0.05).After propensity score matching,the incidence of 30-day NACE(3.8%(103/2734)vs.5.0%(271/5468),P=0.015)and any bleeding(2.0%(54/2734)vs.2.8%(151/5468),P=0.032)in the bivalirudin group were lower than that in the heparin group,but the incidence of MACCE(1.9%(51/2734)vs.2.3%(127/5468),P=0.180)and stent thrombosis(0.1%(2/2734)vs.0.1%(3/5468),P=1.000)were comparable between the two groups.Conclusion The risk of bleeding and the incidence of NACE are significantly lower for patients using bivalirudin during perioperative period of PCI compared to heparin,wi
作者
李晶
程龙
王贺阳
赵昕
梁振洋
韩雅玲
李毅
Li Jing;Cheng Long;Wang Heyang;Zhao Xin;Liang Zhenyang;Han Yaling;Li Yi(Department of Cardiology,General Hospital of Northern Theater Command,Shenyang 110016,China)
出处
《中华心血管病杂志》
CAS
CSCD
北大核心
2020年第8期648-654,共7页
Chinese Journal of Cardiology
基金
国家重点研发计划(2016YFC1301300)
立信扬帆优化抗栓研究基金(BJUHFCSOARF201801-07)。
