A randomized trial of therapies for type 2 diabetes and coronary artery disease.
A randomized trial of therapies for type 2 diabetes and coronary artery disease.
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DOI：
10.1056/nejmoa0805796
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发表时间：
2009-06-11
期刊：
影响因子：
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通讯作者：
Sobel BE
中科院分区：
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作者：
BARI 2D Study Group;Frye RL;August P;Brooks MM;Hardison RM;Kelsey SF;MacGregor JM;Orchard TJ;Chaitman BR;Genuth SM;Goldberg SH;Hlatky MA;Jones TL;Molitch ME;Nesto RW;Sako EY;Sobel BE
2 型糖尿病和稳定型缺血性心脏病患者的最佳治疗方案尚未确定。我们随机分配 2368 名患有 2 型糖尿病和心脏病的患者接受立即血运重建联合强化药物治疗或单独强化药物治疗，并接受胰岛素增敏或胰岛素供给治疗。主要终点是死亡率以及死亡、心肌梗死或中风（主要心血管事件）的复合终点。根据选择经皮冠状动脉介入治疗（PCI）或冠状动脉旁路移植术（CABG）作为更合适的干预措施，对随机分组进行分层。 5年时，血运重建组（88.3%）和药物治疗组（87.8%，P=0.97）或胰岛素增敏组（88.2%）和胰岛素提供组（87.9%，P=0.89）之间的生存率没有显着差异。各组之间无重大心血管事件发生率也没有显着差异：血运重建组为 77.2%，药物治疗组为 75.9%（P=0.70）；胰岛素增敏组为 77.7%，胰岛素提供组为 75.4%（P=0.13）。在 PCI 层中，血运重建组和药物治疗组之间的主要终点没有显着差异。在CABG分层中，血运重建组的主要心血管事件发生率（22.4%）显着低于药物治疗组（30.5%，P=0.01；分层与研究组之间的交互作用P=0.002）。尽管严重低血糖在胰岛素提供组（9.2%）比胰岛素增敏组（5.9%，P=0.003）更常见，但各组之间的不良事件和严重不良事件总体相似。总体而言，接受立即血运重建的患者和接受药物治疗的患者之间，或者胰岛素增敏和胰岛素供应策略之间，死亡率和主要心血管事件的发生率没有显着差异。 （ClinicalTrials.gov 编号，NCT00006305。）
Optimal treatment for patients with both type 2 diabetes mellitus and stable ischemic heart disease has not been established. We randomly assigned 2368 patients with both type 2 diabetes and heart disease to undergo either prompt revascularization with intensive medical therapy or intensive medical therapy alone and to undergo either insulin-sensitization or insulin-provision therapy. Primary end points were the rate of death and a composite of death, myocardial infarction, or stroke (major cardiovascular events). Randomization was stratified according to the choice of percutaneous coronary intervention (PCI) or coronary-artery bypass grafting (CABG) as the more appropriate intervention. At 5 years, rates of survival did not differ significantly between the revascularization group (88.3%) and the medical-therapy group (87.8%, P=0.97) or between the insulin-sensitization group (88.2%) and the insulin-provision group (87.9%, P=0.89). The rates of freedom from major cardiovascular events also did not differ significantly among the groups: 77.2% in the revascularization group and 75.9% in the medical-treatment group (P=0.70) and 77.7% in the insulin-sensitization group and 75.4% in the insulin-provision group (P=0.13). In the PCI stratum, there was no significant difference in primary end points between the revascularization group and the medical-therapy group. In the CABG stratum, the rate of major cardiovascular events was significantly lower in the revascularization group (22.4%) than in the medical-therapy group (30.5%, P=0.01; P=0.002 for interaction between stratum and study group). Adverse events and serious adverse events were generally similar among the groups, although severe hypoglycemia was more frequent in the insulin-provision group (9.2%) than in the insulin-sensitization group (5.9%, P=0.003). Overall, there was no significant difference in the rates of death and major cardiovascular events between patients undergoing prompt revascularization and those undergoing medical therapy or between strategies of insulin sensitization and insulin provision. (ClinicalTrials.gov number, NCT00006305.)