药物洗脱支架在糖尿病患者中的临床疗效：一项荟萃分析。

Clinical efficacy of drug-eluting stents in diabetic patients: a meta-analysis.

作者信息

Mahmud Ehtisham, Bromberg-Marin Guilherme, Palakodeti Vachaspathi, Ang Lawrence, Creanga Dana, Demaria Anthony N

机构信息

Division of Cardiovascular Medicine, University of California-San Diego Medical Center, San Diego, California 92103-8784, USA.

出版信息

J Am Coll Cardiol. 2008 Jun 24;51(25):2385-95. doi: 10.1016/j.jacc.2008.03.028.

DOI:10.1016/j.jacc.2008.03.028

PMID:18565394

Abstract

OBJECTIVES

The purpose of this study was to compare estimates for revascularization and major adverse cardiac events (MACE) (death, myocardial infarction, repeat revascularization) in diabetic patients treated with paclitaxel- and sirolimus-eluting stents (PES and SES).

BACKGROUND

Outcomes in diabetic patients treated with PES and SES have not been adequately evaluated.

METHODS

We searched MEDLINE/EMBASE from January 2002 to February 2007 and identified abstracts/presentations from this period at major cardiology conferences. Randomized controlled trials (RCTs) and registries were included if data for diabetic patients treated with PES or SES were available. Point estimates with 95% confidence intervals (CIs) were computed as summary statistics.

RESULTS

In RCTs (13 trials; n = 2,422) similar point estimates for target lesion revascularization (TLR) (PES: 8.6%, 95% CI 6.5% to 11.3%; SES: 7.6%, 95% CI 5.8% to 9.9%) and MACE (PES: 15.4%, 95% CI 12.4% to 19.1%; SES: 12.9%, 95% CI 8.5% to 19.2%) were observed. In head-to-head trials (4 RCTs), no difference in the likelihood of TLR (PES vs. SES) was observed (odds ratio [OR] 1.37, 95% CI 0.64 to 2.9, p = 0.42). In registries (16 registries; n = 10,156), point estimates for target vessel revascularization (TVR) (PES: 5.8%, 95% CI 3.9% to 8.5%; SES: 7.2%, 95% CI 4.6% to 11.2%) and MACE (PES: 10.1%, 95% CI 7.3% to 13.8%; SES: 11.9%, 95% CI 8.6% to 16.4%) were also similar. In registries reporting outcomes with both stents (8 registries for TVR and 7 registries for MACE), the likelihood of TVR (PES vs. SES) (OR 0.77, 95% CI 0.54 to 1.10, p = 0.15) and MACE (OR 0.83, 95% CI 0.68 to 1.01, p = 0.056) were nonsignificantly lower with PES.

CONCLUSIONS

This analysis of over 11,000 diabetic patients treated with drug-eluting stents demonstrates single-digit revascularization rates. Furthermore, revascularization and MACE estimates are similar with both PES and SES.

摘要

目的

本研究旨在比较接受紫杉醇洗脱支架（PES）和西罗莫司洗脱支架（SES）治疗的糖尿病患者的血运重建和主要不良心脏事件（MACE，包括死亡、心肌梗死、再次血运重建）的评估结果。

背景

接受PES和SES治疗的糖尿病患者的预后尚未得到充分评估。

方法

我们检索了2002年1月至2007年2月期间的MEDLINE/EMBASE数据库，并确定了同期在主要心脏病学会议上发表的摘要/报告。如果有接受PES或SES治疗的糖尿病患者的数据，则纳入随机对照试验（RCT）和登记研究。计算点估计值及其95%置信区间（CI）作为汇总统计量。

结果

在RCT（13项试验；n = 2422）中，观察到目标病变血运重建（TLR）的点估计值相似（PES：8.6%，95%CI 6.5%至11.3%；SES：7.6%，95%CI 5.8%至9.9%），MACE的点估计值也相似（PES：15.4%，95%CI 12.4%至19.1%；SES：12.9%，95%CI 8.5%至19.2%）。在头对头试验（4项RCT）中，未观察到TLR（PES与SES相比）可能性的差异（优势比[OR]1.37，95%CI 0.64至2.9，p = 0.42）。在登记研究（16项登记研究；n = 10156）中，目标血管血运重建（TVR）的点估计值（PES：5.8%，95%CI 3.9%至8.5%；SES：7.2%，95%CI 4.6%至11.2%）和MACE的点估计值（PES：10.1%，95%CI 7.3%至13.8%；SES：11.9%，95%CI 8.6%至16.4%）也相似。在报告两种支架预后的登记研究中（8项TVR登记研究和7项MACE登记研究），PES的TVR（PES与SES相比）可能性（OR 0.77，95%CI 0.54至1.10，p = 0.15）和MACE可能性（OR 0.83，95%CI 0.68至1.01，p = 0.056）无显著降低。