可生物降解聚合物药物洗脱支架与第一代耐用聚合物药物洗脱支架：12项随机对照试验的系统评价和荟萃分析

Biodegradable polymer drug-eluting stents versus first-generation durable polymer drug-eluting stents: A systematic review and meta-analysis of 12 randomized controlled trials.

作者信息

Bundhun Pravesh Kumar, Pursun Manish, Huang Feng

机构信息

Institute of Cardiovascular Diseases, the First Affiliated Hospital of Guangxi Medical University Guangxi Medical University Institute of Cardiovascular Diseases and Guangxi Key Laboratory Base of Precision Medicine in Cardio-cerebrovascular Diseases Control and Prevention, the First Affiliated Hospital of Guangxi Medical University, Nanning, Guangxi, P. R. China.

出版信息

Medicine (Baltimore). 2017 Nov;96(47):e8878. doi: 10.1097/MD.0000000000008878.

DOI:10.1097/MD.0000000000008878

PMID:29382011

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC5709010/

Abstract

BACKGROUND

Even if drug-eluting stents (DES) showed beneficial effects in patients with coronary artery diseases (CADs), limitations have been observed with the first-generation durable polymer DES (DP-DES). Recently, biodegradable polymer DES (BP-DES) have been approved to be used as an alternative to DP-DES, with potential benefits. We aimed to systematically compare BP-DES with the first-generation DP-DES using a large number of randomized patients.

METHODS

Electronic databases were searched for randomized controlled trials (RCTs) comparing BP-DES with first-generation DP-DES. The main endpoints were the long-term (≥2 years) adverse clinical outcomes that were reported with these 2 types of DES. We calculated odds ratios (ORs) with 95% confidence intervals (CIs) and the analysis was carried out by RevMan 5.3 software.

RESULTS

Twelve trials with a total number of 13,480 patients (7730 and 5750 patients were treated by BP-DES and first-generation DP-DES, respectively) were included. During a long-term follow-up period of ≥2 years, mortality, myocardial infarction (MI), target lesion revascularization (TLR), and major adverse cardiac events (MACEs) were not significantly different between these 2 groups with OR: 0.84, 95% CI: 0.66-1.07; P = .16, I = 0%, OR: 1.01, 95% CI: 0.45-2.27; P = .98, I = 0%, OR: 0.91, 95% CI: 0.75-1.11; P = .37, I = 0% and OR: 0.86, 95% CI: 0.44-1.67; P = .65, I = 0%, respectively. Long-term total stent thrombosis (ST), definite ST, and probable ST were also not significantly different between BP-DES and the first-generation DP-DES with OR: 0.77, 95% CI: 0.50-1.18; P = .22, I = 0%, OR: 0.71, 95% CI: 0.43-1.18; P = .19, I = 0% and OR: 1.31, 95% CI: 0.56-3.08; P = .53, I = 6%, respectively.

CONCLUSION

Long-term mortality, MI, TLR, MACEs, and ST were not significantly different between BP-DES and the first-generation DP-DES. However, the follow-up period was restricted to only 3 years in this analysis.

摘要

背景

尽管药物洗脱支架（DES）在冠状动脉疾病（CAD）患者中显示出有益效果，但第一代耐用聚合物DES（DP-DES）存在局限性。最近，可生物降解聚合物DES（BP-DES）已被批准用作DP-DES的替代品，并具有潜在益处。我们旨在使用大量随机患者系统地比较BP-DES与第一代DP-DES。

方法

检索电子数据库以查找比较BP-DES与第一代DP-DES的随机对照试验（RCT）。主要终点是这两种类型DES报告的长期（≥2年）不良临床结局。我们计算了比值比（OR）及其95%置信区间（CI），并使用RevMan 5.3软件进行分析。

结果

纳入了12项试验，共有13480名患者（分别有7730名和5750名患者接受了BP-DES和第一代DP-DES治疗）。在≥2年的长期随访期内，两组之间的死亡率、心肌梗死（MI）、靶病变血运重建（TLR）和主要不良心脏事件（MACE）无显著差异，OR分别为：0.84，95%CI：0.66 - 1.07；P = 0.16，I = 0%；OR：1.01，95%CI：0.45 - 2.27；P = 0.98，I = 0%；OR：0.91，95%CI：0.75 - 1.11；P = 0.37，I = 0%；OR：0.86，95%CI：0.44 - 1.67；P = 0.65，I = 0%。BP-DES与第一代DP-DES之间的长期总支架血栓形成（ST）、确定性ST和可能ST也无显著差异，OR分别为：0.77，95%CI：0.50 - 1.18；P = 0.22，I = 0%；OR：0.71，95%CI：0.43 - 1.18；P = 0.19，I = 0%；OR：1.31，95%CI：0.56 - 3.08；P = 0.53，I = 6%。