比较新一代药物洗脱支架和裸金属支架在急性 ST 段抬高型心肌梗死患者中的应用：EXAMINATION（急性心肌梗死中评价 Xience-V 支架的临床研究）和 COMFORTABLE-AMI（急性 ST 段抬高型心肌梗死中生物可降解涂层雷帕霉素洗脱支架与裸金属支架的比较研究）试验的汇总分析。

Comparison of newer-generation drug-eluting with bare-metal stents in patients with acute ST-segment elevation myocardial infarction: a pooled analysis of the EXAMINATION (clinical Evaluation of the Xience-V stent in Acute Myocardial INfArcTION) and COMFORTABLE-AMI (Comparison of Biolimus Eluted From an Erodible Stent Coating With Bare Metal Stents in Acute ST-Elevation Myocardial Infarction) trials.

机构信息

University Hospital Clinic, Institut d'Investigacions Biomèdiques August Pi i Sunyer (IDIBAPS), Barcelona, Spain.

Swiss Cardiovascular Center, Bern University Hospital, Bern, Switzerland.

出版信息

JACC Cardiovasc Interv. 2014 Jan;7(1):55-63. doi: 10.1016/j.jcin.2013.07.012. Epub 2013 Dec 11.

DOI:10.1016/j.jcin.2013.07.012

PMID:24332419

Abstract

OBJECTIVES

This study sought to study the efficacy and safety of newer-generation drug-eluting stents (DES) compared with bare-metal stents (BMS) in an appropriately powered population of patients with ST-segment elevation myocardial infarction (STEMI).

BACKGROUND

Among patients with STEMI, early generation DES improved efficacy but not safety compared with BMS. Newer-generation DES, everolimus-eluting stents, and biolimus A9-eluting stents, have been shown to improve clinical outcomes compared with early generation DES.

METHODS

Individual patient data for 2,665 STEMI patients enrolled in 2 large-scale randomized clinical trials comparing newer-generation DES with BMS were pooled: 1,326 patients received a newer-generation DES (everolimus-eluting stent or biolimus A9-eluting stent), whereas the remaining 1,329 patients received a BMS. Random-effects models were used to assess differences between the 2 groups for the device-oriented composite endpoint of cardiac death, target-vessel reinfarction, and target-lesion revascularization and the patient-oriented composite endpoint of all-cause death, any infarction, and any revascularization at 1 year.

RESULTS

Newer-generation DES substantially reduce the risk of the device-oriented composite endpoint compared with BMS at 1 year (relative risk [RR]: 0.58; 95% confidence interval [CI]: 0.43 to 0.79; p = 0.0004). Similarly, the risk of the patient-oriented composite endpoint was lower with newer-generation DES than BMS (RR: 0.78; 95% CI: 0.63 to 0.96; p = 0.02). Differences in favor of newer-generation DES were driven by both a lower risk of repeat revascularization of the target lesion (RR: 0.33; 95% CI: 0.20 to 0.52; p < 0.0001) and a lower risk of target-vessel infarction (RR: 0.36; 95% CI: 0.14 to 0.92; p = 0.03). Newer-generation DES also reduced the risk of definite stent thrombosis (RR: 0.35; 95% CI: 0.16 to 0.75; p = 0.006) compared with BMS.

CONCLUSIONS

Among patients with STEMI, newer-generation DES improve safety and efficacy compared with BMS throughout 1 year. It remains to be determined whether the differences in favor of newer-generation DES are sustained during long-term follow-up.

摘要

目的

本研究旨在探讨在适当数量的 ST 段抬高型心肌梗死（STEMI）患者中，与金属裸支架（BMS）相比，新一代药物洗脱支架（DES）的疗效和安全性。

背景

在 STEMI 患者中，早期一代 DES 改善了疗效，但安全性不如 BMS。新一代 DES，依维莫司洗脱支架和生物可吸收涂层雷帕霉素洗脱支架，已被证明可改善临床结局，优于早期一代 DES。

方法

对 2 项大规模随机临床试验中 2665 例 STEMI 患者的个体患者数据进行了汇总分析，这些患者被随机分为 2 组，分别接受新一代 DES（依维莫司洗脱支架或生物可吸收涂层雷帕霉素洗脱支架）或 BMS 治疗：1326 例患者接受了新一代 DES 治疗，1329 例患者接受了 BMS 治疗。采用随机效应模型评估两组患者在 1 年时的器械导向复合终点（心脏死亡、靶血管再梗死和靶病变血运重建）和患者导向复合终点（全因死亡、任何梗死和任何血运重建）的差异。

结果

与 BMS 相比，新一代 DES 可显著降低 1 年时的器械导向复合终点风险（相对风险 [RR]：0.58；95%置信区间 [CI]：0.43 至 0.79；p = 0.0004）。同样，新一代 DES 的患者导向复合终点风险也低于 BMS（RR：0.78；95% CI：0.63 至 0.96；p = 0.02）。新一代 DES 更有利的结果主要归因于靶病变血运重建的风险降低（RR：0.33；95% CI：0.20 至 0.52；p < 0.0001）和靶血管梗死的风险降低（RR：0.36；95% CI：0.14 至 0.92；p = 0.03）。与 BMS 相比，新一代 DES 还降低了明确支架血栓形成的风险（RR：0.35；95% CI：0.16 至 0.75；p = 0.006）。