比伐卢定对比肝素加血小板膜糖蛋白Ⅱb/Ⅲa受体抑制剂在PCI治疗中的安全性与有效性

Efficacy and safety of bivalirudin versus heparin plus glycoproteinⅡb/Ⅲa inhibitors in patients undergoing percutaneous coronary intervention:a meta-analysis

目的:在接受经皮冠状动脉介入(PCI)治疗的冠心病患者中,比较使用比伐卢定与使用肝素加血小板膜糖蛋白Ⅱb/Ⅲa受体拮抗剂(GPI)的疗效和安全性,并进行系统评价。方法:检索MEDLINE、EMBASE、PubMed、ScienceDirect数据库、中国生物医学文献数据库和Cochrane图书馆中2000-01-2012-12公开发表的国内外文献,收集在接受PCI的冠心病患者中比较比伐卢定对比肝素加GPI的随机对照试验资料。按Cochrane系统评价方法,由2名评价者独立评价所纳入研究的文献质量,提取有效数据后,分为近期随访(≤30d)及长期随访(>30d)两个亚组进行分析,采用RevMan 5.1软件进行荟萃分析。结果:纳入10项随机临床试验共计21 699例患者,其中比伐卢定组10 736例(49.5%),肝素加GPI组10 963例(50.5%)。近期随访分析显示:与肝素加GPI组相比,比伐卢定组网状心血管不良事件的发生率较低(P=0.004);主要出血及轻微出血均显著减少(均P<0.000 01)。长期随访分析显示:比伐卢定组具有较低的死亡率(P=0.02);主要出血及轻微出血方面均优于对照组(P分别为<0.000 01和0.008);比伐卢定组靶血管再次血运重率高于对照组(P=0.02),且总体血运重建也有增高的趋势(P=0.07)。其余主要不良心血管事件、再发心肌梗死、短期死亡率两组间均无明显差异。结论:在接受PCI治疗的患者中,相比于肝素加GPI,比伐卢定具有显著的低出血风险及死亡率,且不增加主要不良心血管事件、再发心肌梗死率及总体血运重建率,但有相对较高的靶血管再次血运重建率。

Objective：To perform an up-to-date meta-analysis of randomized trials on the effectiveness and safety of bivalirudin versus heparin plus glycoprotein Ⅱb/Ⅲa inhibitors（GPI）in patients undergoing percutaneous coronary intervention（PCI）.Method：We searched the MEDLINE,EMBASE,PubMed,ScienceDirect,CBM databases and the Cochrane Library to identify all randomized trials published from January 2000to December 2011 that compared of bivalirudin versus heparin plus GPI in patients undergoing PCI.According to the Cochrane Handbook for systematic reviews,quality assessment and data extraction were conducted by two reviewers independently.Two subgroups were chose to analysis：short-term follow up（≤30days）and long-term follow up（ 30days）.All data were analyzed by using Review Manager 5.1.Result：We included a total of ten randomized trials enrolling 21 699patients,who were randomized to bivalirudin group（n=10 736,49.5%）and heparin plus glycoproteinⅡb/Ⅲa inhibitors group（n=10 963,50.5%）.The short-term subgroup analysis showed,compared with heparin plus GPI,anticoagulation with bivalirudin have a significantly lower rates of net clinical adverse events（P=0.004）and major bleeding（P0.000 01）,as well as minor bleeding（P0.000 01）.The long-term subgroup analysis found that Bivalirudin resulted in a lower rates of death（P=0.02）and major bleeding,as well as minor bleeding（P0.000 01,P=0.008,respectively）.Bivalirudin administration resulted in a higher incidence of target vessel revascularization（P=0.02）and a high trend in individual definition of revascularization（P=0.07）.There was no difference in major adverse cardiovascular events,myocardial reinfarction,or short-term death event.Conclusion：Compared with using heparin plus GPI during the PCI precedure,anticoagulation with bivalirudin results in significantly lower rates of bleeding,long-term mortality and short-term net clinical adverse events.There is a higher long-term risk of target vessel revascularization in the group of using bivalirudin,but there are no different in MACE,MI,and total vessel revascularization events between the two groups.