BYPASS ANGIOPLASTY REVASCULARIZATION INVESTIG 2 DIABETES STUDY (BARI2D)

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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. Despite the well known poor prognosis of diabetic patients who have documented coronary artery disease, the best treatment strategy for this group has not been determined. Coronary revascularization, while increasingly used, has not been directly shown to be of additional benefit to simultaneous intensive medical management of coronary artery disease in addition to management of hyperglycemia, hypertension, dyslipidemia, and other risk factors. Furthermore, the optimal hyperglycemia management strategy and its relation to the manifestations of coronary artery disease is not known. BARI 2D, a multi center randomized trial is designed to determine the efficacy of initial elective coronary revascularization combined with aggressive medical therapy, compared to an initial strategy of aggressive medical therapy alone in Type 2 diabetic patients with stable CAD. The second primary objective of the trial is to examine the efficacy of a strategy of providing more insulin versus a strategy of increasing sensitivity to insulin in the management of hyperglycemia. The primary endpoint of this trial will be all cause mortality. Secondary study endpoints to be evaluated include cardiac-only mortality, myocardial infarction, composite clinical endpoints, angina, and quality of life. In addition to clinical endpoints, cumulative medical costs will be analyzed. "Diabetes-specific" complications including retinopathy, nephropathy, neuropathy and peripheral vascular disease will be monitored regularly. Patients will be followed closely for a period of 5 years from randomization to determine the ideal treatment pattern for diabetics with CAD.