BioMatrix Biolimus A9生物可降解支架治疗冠心病安全性和有效性的Meta分析

Meta-analysis of the security and effectiveness of BioMatrix Biolimus A9 Biodegradable stents in the treatment of coronary heart disease

目的 系统评价BioMatrix Biolimus A9生物可降解支架（BioMatrix BES）用于经皮冠状动脉介入术的安全性和有效性。方法 计算机检索Cochrane临床对照试验中心注册库、PubMed数据库,检索时限自2005年1月—2015年12月,搜集针对BioMatrix BES与金属裸支架（BMS）或第二代药物洗脱支架（DES）有效性和安全性比较的随机对照试验（RCT）。采用RevMan 5.2软件对纳入的试验结果 进行Meta分析。结果 共纳入4项研究计6 063例患者,术后随访9~12个月。Meta分析显示：BioMatrix BES在主要不良心血管事件发生率（OR=0.79,95%CI 0.55~1.13,P=0.20）、心源性病死率（OR=0.89,95%CI 0.62~1.28,P=0.53）、心肌梗死发生率（OR=0.94,95%CI 0.57~1.54,P=0.80）、靶血管血运重建率（OR=0.66,95%CI 0.36~1.23,P=0.19）、靶病变血运重建率（OR=0.64,95%CI 0.34~1.21,P=0.17）、支架内血栓形成率（OR=0.64,95%CI 0.37~1.11,P=0.11）等方面均与DES或BMS相似。结论 BioMatrix BES在冠状动脉介入术后1年内的安全性和有效性方面均不劣于传统的BMS或DES。

Objective To investigate the security and effectiveness of BioMatrix Biolimus A 9 Biodegradable stents （ BioMatrix BES） in the treatment of coronary heart disease .Methods The foreign literature of comparison of security and ef-fectiveness between BioMatrix Biolimus A 9 Biodegradable stents and drug eluting stents （ DES） or bare metal stents （ BMS） was searched by computer from electronic database of Cochrone controlled clinical trials data bank and PubMed .Also it was searched by hand as a supplement .All the data was processed by meta-analysis using Review manager 5.2.Results A total of four studies were included , and there were totally 6 063 patients in these studies .Meta-analysis of one year outcome indica-ted that：the occurrence of major adverse cardiovascular events （OR=0.79,95%CI 0.55 to 1.13, P =0.20）, cardiac death （OR=0.89,95%CI 0.62 to 1.28, P =0.53）, myocardial infarction （OR=0.94,95%CI 0.57 to 1.54, P =0.80）, target vessel revascularization （OR=0.66,95%CI 0.36 to 1.23, P =0.19）, target lesion revascularization （OR=0.64,95%CI 0.34 to 1.21, P =0.17）and intra stent thrombosis （OR=0.64,95%CI 0.37 to 1.11, P =0.11）were similar between Bi-oMatrix BES group and DES or BMS .Conclusion The security and effectiveness of BioMatrix BES was not inferior to the DES or BMS in the treatment of coronary heart disease .