BYPASS ANGIOPLASTY REVASCULARIZATION 2 DIABETES (BARI 2D)

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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.