阿根廷随机研究：多支血管病变患者冠状动脉血管成形术加支架置入术与冠状动脉搭桥手术的比较（ERACI II）：30天和1年随访结果。ERACI II研究人员。

Argentine Randomized Study: Coronary Angioplasty with Stenting versus Coronary Bypass Surgery in patients with Multiple-Vessel Disease (ERACI II): 30-day and one-year follow-up results. ERACI II Investigators.

作者信息

Rodriguez A, Bernardi V, Navia J, Baldi J, Grinfeld L, Martinez J, Vogel D, Grinfeld R, Delacasa A, Garrido M, Oliveri R, Mele E, Palacios I, O'Neill W

机构信息

Otamendi Hospital, Buenos Aires, Argentina.

出版信息

J Am Coll Cardiol. 2001 Jan;37(1):51-8. doi: 10.1016/s0735-1097(00)01052-4.

DOI:10.1016/s0735-1097(00)01052-4

PMID:11153772

Abstract

OBJECTIVE

The purpose of this study was to compare percutaneous transluminal coronary revascularization (PTCR) employing stent implantation to conventional coronary artery bypass graft surgery (CABG) in symptomatic patients with multivessel coronary artery disease.

BACKGROUND

Previous randomized studies comparing balloon angioplasty versus CABG have demonstrated equivalent safety results. However, CABG was associated with significantly fewer repeat revascularization procedures.

METHODS

A total of 2,759 patients with coronary artery disease were screened at seven clinical sites, and 450 patients were randomly assigned to undergo either PTCR (225 patients) or CABG (225 patients). Only patients with multivessel disease and indication for revascularization were enrolled.

RESULTS

Both groups had similar clinical demographics: unstable angina in 92%; 38% were older than 65 years, and 23% had a history of peripheral vascular disease. During the first 30 days, PTCR patients had lower major adverse events (death, myocardial infarction, repeat revascularization procedures and stroke) compared with CABG patients (3.6% vs. 12.3%, p = 0.002). Death occurred in 0.9% of PTCR patients versus 5.7% in CABG patients, p < 0.013, and Q myocardial infarction (MI) occurred in 0.9% PTCR versus 5.7% of CABG patients, p < 0.013. At follow-up (mean 18.5 +/- 6.4 months), survival was 96.9% in PTCR versus 92.5% in CABG, p < 0.017. Freedom from MI was also better in PTCR compared to CABG patients (97.7% vs. 93.4%, p < 0.017). Requirements for new revascularization procedures were higher in PTCR than in CABG patients (16.8% vs. 4.8%, p < 0.002).

CONCLUSIONS

In this selected high-risk group of patients with multivessel disease, PTCR with stent implantation showed better survival and freedom from MI than did conventional surgery. Repeat revascularization procedures were higher in the PTCR group.

摘要

目的

本研究旨在比较采用支架植入的经皮腔内冠状动脉血管重建术（PTCR）与传统冠状动脉旁路移植术（CABG）在有症状的多支冠状动脉疾病患者中的疗效。

背景

既往比较球囊血管成形术与CABG的随机研究显示了相当的安全性结果。然而，CABG相关的再次血管重建手术显著更少。

方法

在7个临床地点共筛查了2759例冠状动脉疾病患者，450例患者被随机分配接受PTCR（225例患者）或CABG（225例患者）。仅纳入有多支血管病变且有血管重建指征的患者。

结果

两组患者的临床特征相似：92%为不稳定型心绞痛；38%年龄大于65岁，23%有外周血管疾病史。在最初30天内，PTCR组患者的主要不良事件（死亡、心肌梗死、再次血管重建手术和中风）低于CABG组患者（3.6%对12.3%，p = 0.002）。PTCR组患者的死亡率为0.9%，而CABG组为5.7%，p < 0.013；PTCR组患者的Q波心肌梗死（MI）发生率为0.9%，而CABG组为5.7%，p < 0.013。在随访期（平均18.5±6.4个月），PTCR组的生存率为96.9%，而CABG组为92.5%，p < 0.017。与CABG组患者相比，PTCR组患者无MI的情况也更好（97.7%对93.4%，p < 0.017）。PTCR组患者新的血管重建手术需求高于CABG组患者（16.8%对4.8%，p < 0.002）。