左主干和/或 3 支血管病变的糖尿病和非糖尿病患者：心脏手术与紫杉醇洗脱支架治疗结果的比较。

Diabetic and nondiabetic patients with left main and/or 3-vessel coronary artery disease: comparison of outcomes with cardiac surgery and paclitaxel-eluting stents.

机构信息

Cardiology Department, John Radcliffe Hospital, Oxford, UK.

出版信息

J Am Coll Cardiol. 2010 Mar 16;55(11):1067-75. doi: 10.1016/j.jacc.2009.09.057. Epub 2010 Jan 14.

DOI:10.1016/j.jacc.2009.09.057

PMID:20079596

Abstract

OBJECTIVES

This study was designed to compare contemporary surgical revascularization (coronary artery bypass graft surgery [CABG]) versus TAXUS Express (Boston Scientific, Natick, Massachusetts) paclitaxel-eluting stents (PES) in diabetic and nondiabetic patients with left main and/or 3-vessel disease.

BACKGROUND

Although the prevalence of diabetes mellitus is increasing, the optimal coronary revascularization strategy in diabetic patients with complex multivessel disease remains controversial.

METHODS

The SYNTAX (SYNergy between percutaneous coronary intervention with TAXus and cardiac surgery) study randomly assigned 1,800 patients (452 with medically treated diabetes) to receive PES or CABG.

RESULTS

The overall 1-year major adverse cardiac and cerebrovascular event rate was higher among diabetic patients treated with PES compared with CABG, but the revascularization method did not impact the death/stroke/myocardial infarction rate for nondiabetic patients (6.8% CABG vs. 6.8% PES, p = 0.97) or for diabetic patients (10.3% CABG vs. 10.1% PES, p = 0.96). The presence of diabetes was associated with significantly increased mortality after either revascularization treatment. The incidence of stroke was higher among nondiabetic patients after CABG (2.2% vs. PES 0.5%, p = 0.006). Compared with CABG, mortality was higher after PES use for diabetic patients with highly complex lesions (4.1% vs. 13.5%, p = 0.04). Revascularization with PES resulted in higher repeat revascularization for nondiabetic patients (5.7% vs. 11.1%, p < 0.001) and diabetic patients (6.4% vs. 20.3%, p < 0.001).

CONCLUSIONS

Subgroup analyses suggest that the 1-year major adverse cardiac and cerebrovascular event rate is higher among diabetic patients with left main and/or 3-vessel disease treated with PES compared with CABG, driven by an increase in repeat revascularization. However, the composite safety end point (death/stroke/myocardial infarction) is comparable between the 2 treatment options for diabetic and nondiabetic patients. Although further study is needed, these exploratory results may extend the evidence for PES use in selected patients with less complex left main and/or 3-vessel lesions. (SYNergy Between PCI With TAXus and Cardiac Surgery [SYNTAX]; NCT00114972).

摘要

目的

本研究旨在比较当代手术血运重建（冠状动脉旁路移植术[CABG]）与 TAXUS Express（波士顿科学公司，马萨诸塞州纳提克）紫杉醇洗脱支架（PES）在合并左主干和/或 3 支血管病变的糖尿病和非糖尿病患者中的疗效。

背景

尽管糖尿病的患病率在不断增加，但合并复杂多支血管病变的糖尿病患者的最佳冠状动脉血运重建策略仍存在争议。

方法

SYNTAX 研究将 1800 例患者（452 例经药物治疗的糖尿病患者）随机分为 PES 组或 CABG 组。

结果

与 CABG 相比，糖尿病患者接受 PES 治疗的 1 年主要不良心脑血管事件发生率更高，但血运重建方法对非糖尿病患者（CABG 组 6.8% vs. PES 组 6.8%，p=0.97）或糖尿病患者（CABG 组 10.3% vs. PES 组 10.1%，p=0.96）的死亡率/卒中和心肌梗死发生率没有影响。接受任何一种血运重建治疗后，糖尿病的存在均与死亡率显著升高相关。CABG 术后非糖尿病患者的卒中发生率更高（2.2% vs. PES 组 0.5%，p=0.006）。与 CABG 相比，糖尿病患者高度复杂病变患者接受 PES 治疗后死亡率更高（4.1% vs. 13.5%，p=0.04）。PES 治疗的非糖尿病患者再次血运重建的发生率更高（5.7% vs. 11.1%，p<0.001）和糖尿病患者（6.4% vs. 20.3%，p<0.001）。

结论

亚组分析表明，与 CABG 相比，合并左主干和/或 3 支血管病变的糖尿病患者接受 PES 治疗的 1 年主要不良心脑血管事件发生率更高，这主要是由于再次血运重建增加所致。然而，对于糖尿病和非糖尿病患者，两种治疗方法的复合安全性终点（死亡/卒中和心肌梗死）相当。尽管还需要进一步研究，但这些探索性结果可能为在病变复杂性较低的左主干和/或 3 支血管病变患者中选择使用 PES 提供更多证据。（经皮冠状动脉介入治疗与心脏手术的协同作用[SYNTAX]；NCT00114972）。