生物可吸收支架与药物洗脱支架在急性心肌梗死治疗中的安全性和有效性Meta分析

Meta-analysis of effi cacy and safety of the bioresorbable vascular scaff old versus drug-eluting stents treating acute myocardial infarction

目的系统评价生物可吸收支架(BVS)与药物洗脱支架(DES)在治疗急性心肌梗死(AMI)中的安全性和有效性。方法计算机检索PubMed、Cochrane Library、Embase、Web of Science及相关网站(www.clinicaltrials.gov)。纳入2006年1月至2020年1月关于BVS与DES治疗AMI安全性与有效性的研究。主要有效终点为靶病变血运重建,主要安全终点为明确/可能的支架内血栓形成。由两名研究者按照纳入与排除标准筛选文献,提取资料和评价文献质量。采用Stata 12.0统计软件进行Meta分析。结果最终纳入4个临床研究,其中2个为随机对照研究,2个为观察性研究,共1335例患者,其中BVS组709例,DES组626例。随访时间为12~36个月。Meta分析结果:BVS组与DES组靶病变血运重建(RR 1.59,95%CI 0.82~3.10,P=0.337)、明确/可能的支架内血栓形成(RR 1.56,95%CI 0.70~3.46,P=0.685)的差异均无统计学意义。两组靶血管心肌梗死(RR 1.05,95%CI 0.41~2.67,P=0.667)、全因死亡(RR 1.35,95%CI 0.52~3.45,P=0.871)、心原性死亡(RR 1.29,95%CI 0.59~2.80,P=0.778)、设备相关的复合终点(RR 1.37,95%CI 0.87~2.16,P=0.425)的差异均无统计学意义。结论BVS治疗AMI的安全性与有效性可能不劣于DES。

Objective To evaluate the effi cacy and safety of bioresorbable vascular scaff old(BVS)and drug-eluting stents(DES)in treating acute myocardial infarction(AMI)patients.Methods PubMed,Cochrane Library,Embase,Web of Science,and relevant websites(www.clinicaltrials.gov/)were systematically searched for relevant articles.Studies on the safety and effectiveness of BVS vs.DES in AMI from January 2006 to January 2020 were included.The primary effi cacy outcome measure was the target lesion revascularization(TLR)and the primary safety outcome measure was defi nite/probable scaff old thrombosis(ST).A Two researchers screened the literature according to the inclusion and exclusion criteria,extracted the data,and evaluated the quality of the literature.A meta-analysis was performed using Stata 12.0 statistical software.Results Four studies were enrolled,including two randomized controlled trials and two observational studies,with a total of 1329 patients(BVS,n=703;DES,n=626).Follow-up period was 12 to 36 months.The results showed no signifi cant diff erences between the BVS group and the DES group in the incidence of TLR(RR 1.59,95%CI 0.82-3.10,P=0.337)and definite/probable ST(RR 1.56,95%CI 0.70-3.46,P=0.685).The risk for target vessel myocardial infarction(RR 1.05,95%CI 0.41-2.67,P=0.667),all-cause death(RR 1.35,95%CI 0.52-3.45,P=0.871),cardiac death(RR 1.29,95%CI 0.59-2.80,P=0.778),and deviceoriented composite endpoint(RR 1.37,95%CI 0.87-2.16,P=0.425)did not differ between BVS and DES groups.Conclusions The safety and effi cacy of BVS in the treatment of AMI may not be inferior to DES.