Methods:

Data from the BARI 2D trial, an international multicenter randomized clinical trial that evaluated the optimal treatment for patients with diabetes mellitus and documented CAD, were used. Between January 1, 2001, and March 31, 2005, 2,368 participants were enrolled from 49 clinical sites in the United States, Canada, Brazil, Mexico, Czech Republic, and Austria. Patients were excluded if they had unstable symptoms necessitating revascularization, severe left main disease (≥50% stenosis), percutaneous coronary intervention (PCI), or coronary artery bypass grafting (CABG) in the preceding 12 months or a history of chronic kidney disease with a serum creatinine above 2.0 mg/dl. Physicians were queried before randomization with regard to the recommended method of revascularization, and patients entered into either the PCI or CABG stratum. Patients were then randomized in a 2 x 2 factorial design to a strategy of prompt revascularization plus intensive medical therapy versus initial intensive medical therapy alone with clinically indicated revascularization for treatment of CAD. Subjects were randomly assigned to an insulin-providing or an insulin-sensitizing strategy for glycemic control. The primary endpoint of the BARI 2D trial was the rate of death from any cause. The principal secondary endpoint was a composite of death, myocardial infarction (MI), or stroke (cerebrovascular accident [CVA]) at 5 years of follow-up. Baseline variables, study interventions, and outcomes were compared between women and men randomized to aggressive medical therapy alone or aggressive medical therapy with prompt revascularization.