比伐卢定与肝素用于STEMI患者经皮冠状动脉介入术的疗效Meta分析

Bivalirudin versus heparin in patients with ST segment elevation myocardial infarction undergoing percutaneous coronary intervention: a Meta-analysis

目的系统评价比伐卢定与肝素制剂在ST段抬高心肌梗死(STEMI)患者经皮冠状动脉介入(PCI)治疗的有效性及安全性。方法计算机检索中国知网(CNKI)、Cochrane图书馆数据库、MEDLINE、Elsevier、Pub Med、Embase、及中国万方数据库,收集STEMI患者PCI过程中应用比伐卢定与肝素的随机对照试验(RCT),数据的统计学处理由两名独立的研究者分别检索和评价相关文献,应用RevM an 5.3软件进行分析。主要观察术后1 d至术后30 d的主要不良心血管事件(MACEs,包括再次血运重建、再次心肌梗死、死亡),同时观察术后急性支架血栓、亚急性血栓与出血并发症。结果初检出相关文献543篇,最终纳入6个RCT,共14364例患者。Meta分析结果显示,比伐卢定组与肝素组(无论单用肝素或者肝素联用血小板膜糖蛋白GPⅡb/Ⅲa受体拮抗剂)相比,两组再次血运重建(RR=1.46,95%CI:1.10~1.94,P=0.009)、再次心肌梗死(RR=1.36,95%CI:1.01~1.84,P=0.04)、全因死亡(RR=0.85,95%CI:0.70~1.03,P=0.11)、30d内支架血栓(RR=1.69,95%CI:1.06~2.68,P=0.03)、亚急性支架血栓(24h^30d)(RR=0.99,95%CI:0.64~1.54,P=0.97)、发生率差异均无统计学意义;比伐卢定组24h内急性支架内血栓的发生率高于肝素组(RR=3.04,95%CI:1.92~4.83,P<0.00001)、而短期出血风险比伐卢定组较肝素组显著降低(RR=0.65,95%CI:0.47~0.91,P=0.01)。结论 STEMI患者急诊行直接PCI时,比伐卢定与肝素在再次血运重建、心肌梗死、全因死亡、30d内支架血栓及24h^30d支架血栓的结局相似,24 h内急性支架血栓形成的风险在比伐卢定组增加,术后出血风险在比伐卢定组降低,较肝素更有优势。

Objective To evaluate the impact of bivalirudin versus heparin on efficacy and safety of patients with ST segment elevation myocardial infarction undergoing percutaneous coronary intervention（PCI）. Methods The randomized controlled trials（RCTs）about the bivalirudin versus heparin in patients with STEMI Undergoing PCI were retrieved from the databases of CNKI Pub Med, Cochrane Library, MEDLINE, Embase, Elsevier, and Wan Fang Database. 2 reviewers were retrieved and evaluated all materials independently, and then a Meta-analysis were done by using RevM an 5.3 software. MACE（revascularisation, myocardial infarction, all-cause death）, major bleeding, acute and subacute stent thrombosis were observed. Results There were finally 6 RCT including 14364 cases. The results of Meta-analysis showed that revascularisation was that RR was 1.46 and 95%CI was 1.10～1.94,（P=0.009）, myocardial infarction was that RR was 1.36 and 95%CI was 1.01～1.84,（P=0.04）, all-cause death was that RR was 0.85 and 95%CI was 0.70～1.03,（P=0.11）, stent thrombosis in 30 d was that RR was 1.69 and 95%CI was 1.06～2.68,（P=0.03）, subacute stent thrombosis from 24 h to 30 days was that RR was 0.99 and 95%CI was 0.64～1.54,（P=0.97）. There were not significantly different compared to heparin with or without GlycoproteinⅡb/Ⅲa Inhibitors. Compared to heparin,the risk of acute stent thrombosis was increased by Bivalirudin（RR=3.04,95%CI：1.92～4.83,P〈0.00001）, but bivalirudin reduced major bleeding（RR=0.65,95%CI：0.47～0.91,P=0.01）. Conclusion The outcomes of Bivalirudin versus heparin on revascularisation, myocardial infarction, all-cause death, stent thrombosis in 30 d, subacute stent thrombosis are similar In patients with STEMI Undergoing PPCI. But the rate of acute stent thrombosis were increasing in bivalirudin group, bivalirudin is superior to heparin preparation in reducing bleeding risk after PCI.