比伐卢定与肝素制剂在PCI患者中疗效与出血风险比较的Meta分析

Comparison in curative effect and bleeding risk between bivalirudin and heparin preparation in patients after having PCI:A Meta-analysis

目的系统评价比伐卢定与肝素制剂(普通肝素及低分子肝素)在经皮冠状动脉介入治疗(PCI)患者中的疗效与出血风险。方法计算机检索PubMed、Embase、Elsevier、Cochrane图书馆数据库及中国万方、中国知网(CNKI)数据库,收集比伐卢定与肝素制剂治疗PCI患者的随机对照试验(RCTs),由两名研究者独立检索和评价相关文献,利用RevMan5.1及Stata软件进行数据统计学处理。分别观察近期(术后30d内)及远期(术后1年)的主要不良心血管事件(MACEs)及术后出血风险。结果共纳入12项研究,37024例患者,Meta分析显示:比伐卢定与肝素制剂无论单用或者联用血小板膜糖蛋白GPⅡb/Ⅲa受体拮抗剂,短期(RR=0.96,95%CI:0.78～1.18,P=0.26)及1年时(RR=0.94,95%CI:0.81～1.08,P=0.15)死亡率的比较两组均无统计学差异;短期(RR=1.00,95%CI:0.91～1.09,P=0.19)及1年时(RR=1.06,95%CI:0.95～1.18,P=0.25)心肌梗死发生率两组均无统计学差异;短期(RR=1.04,95%CI:0.89～1.23,P=0.21)及1年时(RR=1.03,95%CI:0.94～1.12,P=0.07)再次血运重建发生率两组均无统计学差异;而比伐卢定组短期出血风险较肝素制剂组显著降低(RR=0.58,95%CI:0.48～0.69,P=0.02)。结论对PCI治疗患者,比伐卢定与肝素制剂在死亡率、心肌梗死、再次血运重建等主要不良心血管事件的结局相似,但比伐卢定在降低术后出血风险较肝素制剂更有优势。

Objective To review systematically the curative of bivalirudin and heparin preparation （ unfraetionated heparin and low molecular heparin ） and bleeding risk in the patients after having percutaneous coronary intervention （PCI）. Methods The databases of PubMed, Embase, Elsevier, Cochrane Library, WanFang Database and CNKI were retrieved with computer for collecting the randomized controlled trials （RCTs） about bivalirudin and heparin preparation used for treating the patients after PCI. The relative literature was retrieved and reviewed by two independent researchers, and the data was processed by using softwares of RevMan 5.1 and Stata. The occurrence of major adverse cardiovascular events （MACE） and bleeding risk were observed after a short-term period （within 30 days） and a long-term period （ after one year ） . Results There were 12 RCTs included involving 37024 patients. The Meta-analysis showed that mortality had no statistical difference between two groups after using bivalirudin and heparin preparation singly or combined with platelet membrane glyeoprotein GP Ⅱ b/ma receptor antagonists after a short-term period （RR=0.96, 95%CI： 0.78-1.18, P=0.26） and a long-term period （RR=0.94, 95%CI： 0.81-1.08, P=0.15）. The occurrence rate of myocardial infarction had no statistical difference between two groups after a short-term period （RR=1.00, 95%CI： 0.91-1.09, P=0.19） and a long-term period （RR=1.06, 95%CI： 0.95-1.18, P=0.25）. The occurrence rate of revascularization had no statistical difference between two groups after a short-term period （RR=1.04, 95%CI： 0.89-1.23, P=0.21） and a long-term period （RR=1.03, 95%CI： 0.94-1.12, P=0.07）. The bleeding risk decreased significantly in bivalirudin group compared with heparin group （RR=0.58, 95%CI： 0.48-0.69, P=0.02）. Conclusion In the patients after having PCI, bivalirudin and hepafin preparation have the similar outcomes on MACE including mortality, myocardial infarction and revascularization, but bivalirudin is superior to heparin preparation in reducing bleeding risk after PCI.