糖尿病患者与非糖尿病患者的多支冠状动脉血运重建：ARTS-II（动脉血运重建治疗研究 - 第二部分）试验的3年随访

Multivessel coronary revascularization in patients with and without diabetes mellitus: 3-year follow-up of the ARTS-II (Arterial Revascularization Therapies Study-Part II) trial.

作者信息

Daemen Joost, Kuck Karl Heinz, Macaya Carlos, LeGrand Victor, Vrolix Maarten, Carrie Didier, Sheiban Imad, Suttorp Maarten Jan, Vranckx Pascal, Rademaker Tessa, Goedhart Dick, Schuijer Monique, Wittebols Kristel, Macours Nathalie, Stoll Hans Peter, Serruys Patrick W

机构信息

Thoraxcenter, Erasmus Medical Center, Rotterdam, the Netherlands.

出版信息

J Am Coll Cardiol. 2008 Dec 9;52(24):1957-67. doi: 10.1016/j.jacc.2008.09.010.

DOI:10.1016/j.jacc.2008.09.010

PMID:19055986

Abstract

OBJECTIVES

The purpose of this study was to assess the 3-year outcome of coronary artery bypass graft surgery (CABG) and percutaneous coronary intervention (PCI) using sirolimus-eluting stents (SES) in patients who had multivessel coronary artery disease with and without diabetes mellitus.

BACKGROUND

The optimal method of revascularization in diabetic patients remains in dispute.

METHODS

The ARTS-II (Arterial Revascularization Therapies Study-Part II) trial is a single-arm study (n = 607) that included 159 diabetic patients treated with SES whose 3-year clinical outcome was compared with that of the historical diabetic and nondiabetic arms of the randomized ARTS-I trial (n = 1,205, including 96 diabetic patients in the CABG arm and 112 in the PCI arm).

RESULTS

At 3 years, among nondiabetic patients, the incidence of the primary composite of death, CVA, myocardial infarction (MI), and repeat revascularization (major adverse cardiac and cerebrovascular events [MACCE]), was significantly lower in ARTS-II than in ARTS-I PCI (adjusted odds ratio [OR]: 0.41; 95% confidence interval [CI]: 0.26 to 0.64) and similar to ARTS-I CABG. The ARTS-II patients were at significantly lower risk for death, CVA, and MI as compared with both the ARTS-I PCI (adjusted OR: 0.55; 95% CI: 0.34 to 0.91) and ARTS-I CABG patients (adjusted OR: 0.56; 95% CI: 0.35 to 0.92). Among diabetic patients, the incidence of MACCE in ARTS-II was similar to that of both PCI and CABG in ARTS-I. Conversely, the incidence of death, CVA, and MI was significantly lower in ARTS-II than in ARTS-I PCI (adjusted OR: 0.67; 95% CI: 0.27 to 1.65) and was similar to that of ARTS-I CABG.

CONCLUSIONS

At 3 years, PCI using SES for patients with multivessel coronary artery disease seems to be safer and more efficacious than PCI using bare-metal stents, irrespective of the diabetic status of the patient. Hence, PCI using SES appears to be a valuable alternative to CABG for both diabetic and nondiabetic patients.

摘要

目的

本研究旨在评估在患有或未患有糖尿病的多支冠状动脉疾病患者中，冠状动脉旁路移植术（CABG）和使用西罗莫司洗脱支架（SES）的经皮冠状动脉介入治疗（PCI）的3年结局。

背景

糖尿病患者中最佳的血运重建方法仍存在争议。

方法

ARTS-II（动脉血运重建治疗研究 - 第二部分）试验是一项单臂研究（n = 607），其中包括159例接受SES治疗的糖尿病患者，其3年临床结局与随机化ARTS-I试验的历史糖尿病和非糖尿病组（n = 1,205，包括CABG组中的96例糖尿病患者和PCI组中的112例）进行比较。

结果

3年时，在非糖尿病患者中，ARTS-II组中死亡、卒中、心肌梗死（MI）和再次血运重建（主要不良心脑血管事件[MACCE]）的主要复合事件发生率显著低于ARTS-I PCI组（调整后的优势比[OR]：0.41；95%置信区间[CI]：0.26至0.64），且与ARTS-I CABG组相似。与ARTS-I PCI组（调整后的OR：0.55；95%CI：0.34至0.91）和ARTS-I CABG组患者（调整后的OR：0.56；95%CI：0.35至0.92）相比，ARTS-II组患者死亡、卒中和MI的风险显著更低。在糖尿病患者中，ARTS-II组中MACCE的发生率与ARTS-I中PCI和CABG组的发生率相似。相反，ARTS-II组中死亡、卒中和MI的发生率显著低于ARTS-I PCI组（调整后的OR：0.67；95%CI：0.27至1.65），且与ARTS-I CABG组相似。