BYPASS ANGIOPLASTY REVASCULARIZATION 2 DIABETES (BARI 2D)

这个子项目是许多研究子项目中利用 资源由NIH/NCRR资助的中心拨款提供。子项目和 调查员(PI)可能从NIH的另一个来源获得了主要资金， 并因此可以在其他清晰的条目中表示。列出的机构是 该中心不一定是调查人员的机构。 有充分证据表明，II型糖尿病患者的心血管死亡率和发病率都有所增加。Bari I试验发现，接受冠状动脉搭桥术(CABG)(包括内乳动脉移植)治疗的糖尿病患者的预后明显好于最初接受经皮冠状动脉腔内成形术(PTCA)治疗的患者。BARI I试验研究了不稳定冠脉综合征患者。然而，随机Bari I试验结果和Bari I登记结果之间的显著差异表明接受CABG和PTCA的糖尿病患者的预后没有差异，这引发了问题。对于结果中的差异，有许多看似合理的解释。其中之一是登记处的患者可能没有那么严重的冠心病。这是BARI II将要招募的人群。BARI II将最佳治疗的问题扩大到大量有记录的冠心病但非紧急症状的人。这项研究将为医学界提供有用的信息，为这些患者选择最佳的治疗策略。最近的AVERT试验显示，与血管成形术和常规护理相比，接受积极降脂治疗的稳定性冠状动脉疾病患者的缺血事件发生率相似。这增加了确定糖尿病合并稳定性冠状动脉病变患者的最佳治疗策略的重要性。虽然AVERT试验并不是专门针对糖尿病患者的，但在其他降脂试验的糖尿病试验中，已经看到了由于积极降低胆固醇而降低心血管发病率的好处。 这是一项多中心、随机、临床试验，采用2×2析因设计。在降低冠心病和2型糖尿病(DM)患者死亡率方面，首次选择性冠状动脉血运重建术加积极药物治疗与单纯积极药物治疗的效果进行了比较。血糖控制策略是否影响这些患者的预后也将得到确定。胰岛素增敏策略将与增强胰岛素的策略进行比较。共有2600名患者将从30个临床中心进入。受试者将在药物治疗和血管重建术之间随机分配，同时随机分配到胰岛素提供或胰岛素增敏的血糖控制策略。两组都将积极管理危险因素，并将糖化血红蛋白(HbA1C)的目标定为7.5。患者将被跟踪5年，主要结果将是通过意向治疗分析的总死亡率，以及心脏死亡率、心肌梗死、综合临床终点、心绞痛和生活质量的次级终点。

This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. There is ample evidence that patients with Type II diabetes mellitus have increased cardiovascular mortality and morbidity. The BARI I trial found that patients with treated diabetes mellitus had a significantly better outcome when treated with coronary artery bypass graft (CABG) (involving internal mammary artery graft) than if treated initially with percutaneous transluminal coronary angioplasty (PTCA). The BARI I trial studied patients with unstable coronary syndrome. However, the marked difference in results between the randomized BARI I trial results and the BARI I registry that showed no difference in outcome between diabetic patients receiving CABG vs. PTCA has raised questions. There are many plausible explanations for the difference in the results. One of these is that the patients in the Registry had potentially less severe CAD. This is the population to be recruited for BARI II. BARI II extends the question of optimum therapy to the large number who have documented coronary disease but non-urgent symptomatology. This study will provide information useful to the medical community on the optimum choice of treatment strategy for these patients. The recent AVERT trial showing a similar incidence of ischemic events in patients with stable coronary artery disease treated with aggressive lipid lowering compared to angioplasty and usual care. This increases the importance of determining the optimum strategy for management of diabetic patients with stable coronary artery disease. Although the AVERT trial was not specifically in diabetic patients, the benefit of reduced cardiovascular morbidity as a result of aggressive cholesterol lowering has been seen in the diabetic subsets of other lipid lowering trials. This is a multicenter, randomized, clinical trial with a 2 x 2 factorial design. The effect of initial elective coronary revascularization with aggressive medical therapy is compared to aggressive medical therapy of ischemia alone in reducing mortality in patients with CAD and Type 2 diabetes mellitus (DM). Whether the strategy of glucose control affects the prognosis of these patients will also be determined. The strategies of insulin sensitization will be compared with a strategy of augmenting insulin. A total of 2,600 patients will be entered from 30 clinical centers. Subjects will be randomized between medical therapy versus revascularization and simultaneously be assigned at random to an insulin providing or insulin sensitizing strategy of glycemic control. Aggressive management of risk factors and a goal of HbA1C (glycosylated hemoglobin) of 7.5 will be followed in both groups. Patients will be followed for 5 years and the primary outcome will be total mortality analyzed by intention-to-treat with secondary endpoints of cardiac mortality, myocardial infarction, composite clinical endpoint, angina, and quality of life.