A randomized trial of therapies for type 2 diabetes and coronary artery disease.

BACKGROUND: Optimal treatment for patients with both type 2 diabetes mellitus and stable ischemic heart disease has not been established. METHODS: 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. RESULTS: 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). CONCLUSIONS: 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.)

Gated SPECT perfusion imaging for the simultaneous assessment of myocardial perfusion and ventricular function in the BARI 2D trial: an initial report from the Nuclear Core Laboratory.

BACKGROUND: The BARI 2D (Bypass Angioplasty Revascularization Investigation 2 Diabetes) trial, a National Heart, Lung, and Blood Institute-sponsored study in type 2 diabetic patients with coronary artery disease, completed patient recruitment in March 2005. This trial had a nuclear substudy in addition to many other substudies. METHODS AND RESULTS: After patient enrollment, adenosine gated single photon emission computed tomography perfusion imaging is performed at years 1 and 3. The images are interpreted at the core laboratory. Among the objectives of the nuclear substudy are (1) to determine the impact of the mode of therapy on left ventricular function, extent of ischemia, and scar; (2) to determine the impact of therapy on the progression/regression of ischemia/scar and changes in left ventricular function between years 1 and 3; and (3) to determine the independent and incremental prognostic value of ischemia, scar, and left ventricular function on the primary and secondary endpoints of the trial in the entire patient population and specified subgroups such as women, elderly patients, and minorities. CONCLUSIONS: This article describes the methodology and the initial experience of the nuclear core laboratory in this large multicenter trial and provides a summary of variables that are available for future analysis by the working group.