生物可降解与非可降解涂层支架临床应用的meta分析

Efficacy and safety of biodegradable and permanent polymer drug eluting stents: a meta-analysis

关键词:  冠心病  生物可降解多聚物涂层支架  meta分析

Key words:  coronary artery disease  biodegradable polymer stent  meta-analysis

摘要:

目的 对生物可降解聚合物涂层药物支架与非可降解药物洗脱支架应用于我国冠心病人群的安全有效性进行meta分析。方法 通过计算机搜索国内外电子数据库,并结合文献追溯方式,收集已公开发表与生物可降解聚合物涂层药物支架（biodegradable polymer drug eluting stent,BPS）与永久聚合物涂层支架（permanent polymerdrug eluting stent,PPS）相关的临床对照研究资料,对随访末期主要不良心血管事件（major adverse cardiac events,MACE）、支架内血栓事件（stent thrombosis,ST）及支架内晚期管腔丢失（late lumen loss,LLL）情况进行meta分析,探讨BPS在我国冠心病人群中晚期应用的安全性及有效性。结果 共纳入国内公开发表的研究共7篇文献,共有2 533名患者分别植入BPS及PPS。BPS与PPS两组之间,1年随访末期MACE发生差异无统计学意义（OR=0.94,95%CI：0.68~1.32,Z=0.34,P=0.74＞0.05）,1年支架内血栓事件发生差异无统计学意义（OR=1.73,95%CI：0.59~5.04,Z=1.00,P=0.32＞0.05）,随访末期血管造影支架内LLL发生无统计学差异（WMD=-0.02,95%CI：-0.24~0.19,Z=0.22,P=0.83＞0.05）。结论 根据目前研究结果,BPS应用于中国人群其安全性并不劣于PPS,而以支架内LLL作为评价标准,BPS早期也并未表现出预期降低管腔丢失的优势。BPS的理论优越性尚需要随访时间更长、规模更大的临床研究来证实。

Abstract:

Objective To compare the efficacy and safety of biodegradable polymer drug eluting stent with permanent polymer drug eluting stent by meta-analysis.Methods CNKI,VIP,Wanfang, PubMed,Elsevier database were searched for the clinic study on comparison between biodegradable polymer drug eluting stent(BPS) and permanent polymer drug eluting stent(PPS).All studies were strictly evaluated and screened according to including criteria and the mate-analysis was performed using RevMan 4.2 software.Results Seven studies involving 1360 cases with BPS and 1173 with PPS were included.There was no significant difference between two groups in major adverse cardiac events(OR=0.94,95%CI:0.68～1.32,Z=0.34,P=0.74) and stent thrombosis events(OR=1.73, 95%CI:0.59~5.04,Z=1.00,P=0.32) during 1 year clinical follow-up.There was no difference between two groups in in-stent late lumen loses(LLL) during CAG follow-up(WMD=-0.02,95%CI: -0.24~0.19,Z=0.22,P=0.83).Conclusion BPS showed similar efficacy and safety as PPS applied to patients with coronary artery disease.