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依维莫司生物可吸收血管支架与药物洗脱金属支架在冠状动脉疾病应用中临床结局比较的meta分析

《心脏杂志》[ISSN:1009-7236/CN:61-1268/R]

期数:
2018年第3期
页码:
309-318
栏目:
临床研究
出版日期:
2018-03-25

文章信息/Info

Title:
Mid-to-long term clinical outcomes with everolimus-eluting bioresorbable vascular scaffold versus everolimus-eluting metallic stent in coronary artery diseases: a meta-analysis of 7321 patients
作者:
吴献鹏; 陆 艺; 傅婷婷; 胡新央
（浙江大学医学院附属第二医院心血管内科，浙江 杭州 310009）
Author(s):
WU Xian-peng;  LU Yi;  FU Ting-ting;  HU Xin-yang
(Department of Cardiology, Second Affiliated Hospital, College of Medicine, Zhejiang University, Hangzhou 310009, Zhejiang, China)
关键词:
依维莫司生物可吸收血管支架; 依维莫司药物洗脱金属支架; 冠状动脉疾病; 支架内血栓; meta分析
Keywords:
Everolimus-Eluting Bioresorbable Vascular Scaffolds;  Everolimus-Eluting Metallic Stents;  Coronary artery diseases;  Stent
分类号:
R541.4
DOI:
-
文献标识码:
A
摘要:
目的 探讨生物可吸收血管支架（everolimus-eluting bioresorbable vascular scaffold，BVS）和依维莫司药物洗脱金属支架(everolimus-eluting metallic stents，EES)在冠状动脉疾病(coronary artery diseases,CAD)应用中的中长期临床结局的meta分析，为临床决策提供参考依据。方法 系统地检阅了电子数据库以及最新国际心血管会议记录，检索时间截止至2018年1月8日，收集已公布相关临床研究的最新随访数据并采用stata 12.0软件进行统计分析。结果 最终共纳入11项临床研究，包括7项随机对照试验，总计7 321位患者。meta分析结果显示，BVS组较EES组有更高的明确/极可能支架内血栓(stent/scaffold thrombosis,ST)发生率［比值比（OR）=3.08,95%CI：2.04-4.66,P<0.01］，其中早期(OR=2.26, 95%CI：1.26-4.03, P=0.006)及极晚期ST(OR=4.46,95%CI：2.01-9.89,P<0.01)发生率均显著高于EES组。BVS植入患者在靶病变失败(OR=1.34,95%CI：1.11 to 1.60,P<0.01)、靶血管心肌梗死(OR=1.71,95%CI：1.31-2.23,P<0.01)、有临床指征的靶病变血运重建(OR=1.51,95%CI：1.15-2.00,P<0.01)以及总心肌梗死(OR=1.52,95%CI：1.22-1.90,P<0.01)的发生率上均较EES组增多。然而，两组在面向患者的复合终点、心因死亡、全因死亡以及全血运重建等发生率上并无显著性差异。结论 BVS在冠状动脉疾病应用中的中长期临床结局劣于EES，但仍需更多大型长期临床随机对照试验进一步论证。
Abstract:
AIM To compare the mid-to-long term clinical outcomes between everolimus-eluting bioresorbable vascular scaffolds (BVS) and everolimus-eluting metallic stent (EES) in coronary artery diseases. METHODS The present investigation systematically searched electronic databases and abstracts or presentations from the latest international cardiovascular conferences up to January 8th 2018. RESULTS In total, 11 studies with 7321 patients were enrolled, including 7 randomized controlled trials and 4 propensity score-matched designs. Pooled analysis revealed that the patients undergoing BVS implantation had a higher rate of definite or probable stent/scaffold thrombosis (ST) (odds ratio (OR)=3.08, 95% confidence interval (CI): 2.04 to 4.66, P<0.01), which was mainly attributed to the higher risks of early ST (OR=2.26, 95%CI: 1.26 to 4.03, P=0.006) and very late ST (OR=4.46, 95%CI: 2.01 to 9.89, P<0.01). Also, target-lesion failure (TLF) was more frequent in BVS (OR=1.34, 95%CI: 1.11 to 1.60, P=0.002), which was related to the higher rates of target vessel myocardial infarction (OR=1.71, 95%CI: 1.31 to 2.23, P<0.01) and ischemia driven-target lesion revascularization (OR=1.51, 95%CI: 1.15 to 2.00, P=0.004) accompanied with BVS implantation. Myocardial infarction increased in BVS compared with EES (OR=1.52, 95%CI: 1.22 to 1.90, P<0.01), but there were no significant differences in patient-oriented composite endpoint, all death, and all revascularization between BVS and EES. CONCLUSION Our meta-analysis demonstrated that compared with EES, BVS is associated with compromised clinical outcomes. Additional clinical outcomes of long-term large-scale clinical trials are warranted to further evaluate the use of BVS.

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备注/Memo

备注/Memo:
收稿日期：2018-01-15.通讯作者：胡新央，主任医师，主要从事干细胞移植治疗心力衰竭的基础与临床转化研究 Email：hxy0507@zju.edu.cn 作者简介：吴献鹏，住院医师，硕士生 Email：wxpzju123@163.com
更新日期/Last Update: 1900-01-01