摘要
目的以随机对照试验(RCT)为依据,比较生物可吸收支架(BVS)对比依维莫司洗脱支架(EES)在冠状动脉粥样硬化性心脏病(冠心病)介入治疗中的安全性和有效性。方法计算机检索数据库PubMed、Embase、Web of Science和Cochrane Library,并追踪获取文献,查询时间从2008年1月至2017年9月,根据改良Jadad量表评价文献质量并提取资料,运用Review Manager 5.3软件进行Meta分析。结果通过检索共纳入7项对比BVS及EES的RCT,随访时间从9个月～3年,共5546例患者,其中BVS组3241例、EES组2305例。Meta分析结果显示,应用BVS的患者发生心肌梗死(OR=1.55,95%CI:1.22～1.96,P=0.0003)、靶血管心肌梗死(OR=1.73,95%CI:1.32～2.27,P<0.0001)、支架内血栓(OR=3.62,95%CI:2.12～6.18,P<0.0001)的风险高于应用EES患者,但在全因死亡(P=0.1)、心源性死亡(P=0.42)、所有血运重建(P=0.10)、靶病变血运重建(P=0.06)对比中两组差异无统计学意义。同时,在各项复合终点的对比中,BVS组的主要心血管不良事件(OR=1.37,P=0.0003)、面向患者的复合终点(OR=1.21,P=0.005)、面向装置的复合终点(OR=1.41,P=0.002)、靶病变失败(OR=1.44,P<0.0001)的发生率均高于EES组。结论在目前的冠心病介入治疗随访中,BVS的安全性和有效性无论是短期还是长期均不优于EES。临床应用BVS应当更加谨慎,在新一代BVS投入应用之前,现行的治疗方案仍需大量的、更长时间的随访来验证。
Objective The aim of this meta-analysis was to evaluate the efficacy and safety Bioresorbable Vascular Scaffold(BVS)versus Everolimus Eluting Stent(EES)for treating the patients with coronary artery disease,using the data available from randomized controlled trials(RCTs),with the focus on short and long-term outcomes.Methods We searched relevant literatures in PubMed,Embase,Web of science,and Cochrane Database from January,2008 to September,2017,collected published data and RCTs from websites to compare BVS and EES for patients.The clinical studies had 9-36 months of follow up results.The quality of literatures was assessed and extracted by modified Jadad score.RevMan 5.3 software was used to perform the meta-analysis.Results A total of 7 RCTs were eligible,including 5546 patients.Our meta-analysis showed that BVS had a higher rate of myocardial infarction(OR=1.55,95%CI:1.22~1.96,P=0.0003),target vessel myocardial infarction(OR=1.73,95%CI:1.32~2.27,P<0.0001)and stent thrombosis(OR=3.62,95%CI:2.12~6.18,P<0.0001)than EES group,but the rates of all death(OR=0.77,P=0.10),cardiac death(OR=0.83,P=0.42),all revascularization(OR=1.15,P=0.10),target vessel failure(OR=1.29,P=0.06)were not significantly different between BVS and EES.At the same time,in the comparison of the composite endpoints,the risk of major adverse cardiac events(OR=1.37,P=0.0003),patient-oriented composite endpoint(OR=1.41,P=0.002),device-oriented composite endpoint(OR=1.41,P=0.002),target lesion failure(OR=1.44,P<0.0001)was higher than EES.Conclusions Compared with EES,BVS is not superior to decrease the risk of target lesion failure driven by the increased rates of target vessel myocardial infarction and ischemia-driven target lesion revascularization patients after percutaneous coronary intervention.The risk of stent/scaffold thrombosis and very late stent/scaffold thrombosis seems to be higher with BVS.The clinical application of BVS should be more cautious.Until the new generation BVS is put into use,the existing treatment plans still need a large number of longer follow-up.
作者
梁宇博
林欣
车千秋
孙润民
王琼英
马俊丽
胡浩
常鹏
张春
余静
白锋
Liang Yubo;Lin Xin;Che Qianqiu;Sun Runmin;Wang Qiongying;Ma Junli;Hu Hao;Chang Peng;Zhang Chun;Yu Jing;Bai Feng(Department of Cardiology,Lanzhou University Second Hospital,Lanzhou 730030,China)
出处
《中国循证心血管医学杂志》
2019年第2期148-154,共7页
Chinese Journal of Evidence-Based Cardiovascular Medicine
基金
兰州大学第二医院院内基金(sdkyjj-10
ynbskyjj2015-1-11)
兰州市人才新创业项目(2016-RC-104
2016-RC-54)
甘肃省卫生行业科研计划项目(GSWSKY2016-53)
