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依维莫司洗脱支架植入术治疗无保护左主干冠状动脉狭窄。PRECOMBAT-2(左主干冠状动脉疾病患者中使用依维莫司洗脱支架的旁路手术与血管成形术的随机比较的初步结果)研究。

Everolimus-eluting stent implantation for unprotected left main coronary artery stenosis. The PRECOMBAT-2 (Premier of Randomized Comparison of Bypass Surgery versus Angioplasty Using Sirolimus-Eluting Stent in Patients with Left Main Coronary Artery Disease) study.

机构信息

University of Ulsan College of Medicine, Asan Medical Center, Seoul, Korea.

出版信息

JACC Cardiovasc Interv. 2012 Jul;5(7):708-17. doi: 10.1016/j.jcin.2012.05.002.

DOI:10.1016/j.jcin.2012.05.002
PMID:22814775
Abstract

OBJECTIVES

This study sought to evaluate the safety and efficacy of second-generation drug-eluting stents (DES) for patients with unprotected left main coronary artery (ULMCA) stenosis.

BACKGROUND

The clinical benefit of second-generation DES for ULMCA stenosis has not been determined.

METHODS

The authors assessed 334 consecutive patients who received everolimus-eluting stents (EES) for ULMCA stenosis between 2009 and 2010. The 18-month incidence rates of major adverse cardiac or cerebrovascular events (MACCE), including death, myocardial infarction (MI), stroke, or ischemia-driven target vessel revascularization (TVR), were compared with those of a randomized study comparing patients who received sirolimus-eluting stents (SES) (n = 327) or coronary artery bypass grafts (CABG) (n = 272).

RESULTS

EES (8.9%) showed a comparable incidence of MACCE as SES (10.8%; adjusted hazard ratio [aHR] of EES: 0.84; 95% confidence interval [CI]: 0.51 to 1.40; p = 0.51) and CABG (6.7%, aHR of EES: 1.40; 95% CI: 0.78 to 2.54; p = 0.26). The composite incidence of death, MI, or stroke also did not differ among patients receiving EES (3.3%), SES (3.7%; aHR of EES: 0.63; 95% CI: 0.27 to 1.47; p = 0.29), and CABG (4.8%; aHR of EES: 0.67; 95% CI: 0.29 to 1.54; p = 0.34). However, the incidence of ischemia-driven TVR in the EES group (6.5%) was higher than in the CABG group (2.6%, aHR of EES: 2.77; 95% CI: 1.17 to 6.58; p = 0.02), but comparable to SES (8.2%, aHR of EES: 1.14; 95% CI: 0.64 to 2.06; p = 0.65). Angiographic restenosis rates were similar in the SES and EES groups (13.8% vs. 9.2%, p = 0.16).

CONCLUSIONS

Second-generation EES had a similar 18-month risk of MACCE for ULMCA stenosis as first-generation SES or CABG.

摘要

目的

本研究旨在评估第二代药物洗脱支架(DES)治疗无保护左主干冠状动脉(ULMCA)狭窄患者的安全性和疗效。

背景

第二代 DES 治疗 ULMCA 狭窄的临床获益尚未确定。

方法

作者评估了 2009 年至 2010 年间 334 例接受依维莫司洗脱支架(EES)治疗 ULMCA 狭窄的连续患者。比较了 18 个月时主要不良心脑血管事件(MACCE)的发生率,包括死亡、心肌梗死(MI)、卒中和缺血驱动的靶血管血运重建(TVR),并与接受西罗莫司洗脱支架(SES)(n = 327)或冠状动脉旁路移植术(CABG)(n = 272)的随机研究患者进行比较。

结果

EES(8.9%)的 MACCE 发生率与 SES(10.8%;EES 的调整后危险比 [aHR]:0.84;95%置信区间 [CI]:0.51 至 1.40;p = 0.51)和 CABG(6.7%,EES 的 aHR:1.40;95%CI:0.78 至 2.54;p = 0.26)相似。接受 EES(3.3%)、SES(3.7%;EES 的 aHR:0.63;95%CI:0.27 至 1.47;p = 0.29)和 CABG(4.8%;EES 的 aHR:0.67;95%CI:0.29 至 1.54;p = 0.34)的患者复合死亡率、MI 或卒中等的发生率也无差异。然而,EES 组缺血驱动的 TVR 发生率(6.5%)高于 CABG 组(2.6%,EES 的 aHR:2.77;95%CI:1.17 至 6.58;p = 0.02),但与 SES 相似(8.2%,EES 的 aHR:1.14;95%CI:0.64 至 2.06;p = 0.65)。SES 和 EES 组的血管造影再狭窄率相似(13.8%比 9.2%,p = 0.16)。

结论

第二代 EES 治疗 ULMCA 狭窄的 18 个月 MACCE 风险与第一代 SES 或 CABG 相似。

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