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与生物可降解聚合物药物洗脱支架和耐用聚合物依维莫司洗脱支架相关的不良心血管事件:对10项随机对照试验的系统评价和荟萃分析。

Adverse cardiovascular events associated with biodegradable polymer drug-eluting stents and durable polymer everolimus-eluting stents: A systematic review and meta-analysis of 10 randomized controlled trials.

作者信息

Bundhun Pravesh Kumar, Janoo Girish, Yanamala Chandra Mouli, Huang Feng

机构信息

Institute of Cardiovascular Diseases, The First Affiliated Hospital of Guangxi Medical University Guangxi Medical University, Nanning, Guangxi, P.R. China Department of Internal Medicine, Ealing Hospital, University of Buckingham, Southall, London, United Kingdom.

出版信息

Medicine (Baltimore). 2017 Jul;96(28):e7510. doi: 10.1097/MD.0000000000007510.

Abstract

BACKGROUND

Controversies have been observed among network meta-analyses comparing biodegradable polymer drug-eluting stents (BP-DES) with durable polymer drug-eluting stents (DP-DES). We aimed to compare the adverse cardiovascular events associated with BP-DES and durable polymer everolimus-eluting stents (DP-EES) using a large number of patients obtained from randomized controlled trials (RCTs).

METHODS

Electronic databases were searched for randomized trials comparing BP-DES with DP-EES. Adverse cardiovascular outcomes observed between 6 months and 3 years were considered as the clinical endpoints in this analysis. Odds ratios (ORs) with 95% confidence intervals (CIs) were calculated and the pooled analyses were performed with RevMan 5.3 software. All authors had full access to the data, and they have read and agreed to the manuscript as written.

RESULTS

Ten trials involving a total number of 13,218 patients (7451 patients treated by BP-DES and 5767 patients treated by DP-EES) were included. No significant difference was observed when analyzing mortality and myocardial infarction between BP-DES and DP-EES with OR 1.08, 95% CI 0.87-1.34, P = .47 and OR 1.04, 95% CI 0.84-1.28, P = .72 respectively. Target vessel revascularization, target lesion revascularization, major adverse cardiac events, and stroke were also not significantly different with OR 1.11, 95% CI 0.92-1.33, P = .28; OR 1.11, 95% CI 0.94-1.33, P = .22; OR 1.12, 95% CI 0.99-1.27; P = .07; and OR 1.13, 95% CI 0.69-1.84; P = .62 respectively. In addition, total stent thrombosis (ST) was similarly reported between BP-DES and DP-EES with OR 0.85, 95% CI 0.59-1.21; P = .37. However, even if BP-DES were associated with a higher rate of definite ST with OR 1.69, 95% CI 0.92-3.08, P = .09 and DP-EES were associated with a higher rate of probable ST with OR 0.67, 95% CI 0.38-1.17, P = .16, these results were not statistically significant.

CONCLUSIONS

Between 6 months and 3 years, BP-DES were similar in terms of cardiovascular outcomes compared to DP-EES. However, further long-term follow-up research is recommended.

摘要

背景

在比较生物可降解聚合物药物洗脱支架(BP-DES)与耐用聚合物药物洗脱支架(DP-DES)的网络荟萃分析中存在争议。我们旨在通过从随机对照试验(RCT)中获取的大量患者,比较与BP-DES和耐用聚合物依维莫司洗脱支架(DP-EES)相关的不良心血管事件。

方法

检索电子数据库中比较BP-DES与DP-EES的随机试验。本分析将6个月至3年期间观察到的不良心血管结局视为临床终点。计算比值比(OR)及其95%置信区间(CI),并使用RevMan 5.3软件进行汇总分析。所有作者都能完全获取数据,并已阅读并同意本文稿。

结果

纳入了10项试验,共13218例患者(7451例接受BP-DES治疗,5767例接受DP-EES治疗)。分析BP-DES与DP-EES之间的死亡率和心肌梗死时,未观察到显著差异,OR分别为1.08,95%CI为0.87-1.34,P = 0.47;OR为1.04,95%CI为0.84-1.28,P = 0.72。靶血管重建、靶病变重建、主要不良心脏事件和中风也无显著差异,OR分别为1.11,95%CI为0.92-1.33,P = 0.28;OR为1.11,95%CI为0.94-1.33,P = 0.22;OR为1.12,95%CI为0.99-1.27,P = 0.07;OR为1.13,95%CI为0.69-1.84,P = 0.62。此外,BP-DES和DP-EES之间报告的总支架血栓形成(ST)相似,OR为0.85,95%CI为0.59-1.21,P = 0.37。然而,即使BP-DES与较高的明确ST发生率相关,OR为1.69,95%CI为0.92-3.0

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/d209/5515774/5d652bc825ad/medi-96-e7510-g003.jpg

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