Managing Stable Coronary Disease in Patients With Diabetes: The BARI 2D Trial

Abstract

The BARI 2D Study Group: A randomized trial of therapies for type 2 diabetes and coronary artery disease. N Engl J Med 360:2503-2515, 2009 Design. BARI 2D is a multicenter, randomized, controlled trial. Subjects. A total of 2,368 adults (average age 62 years) with diabetes (average A1C 7.2%) and coronary artery disease (CAD; based on angiography with > 50% blockage in a major epicardial artery and a positive stress test, or > 70% blockage with anginal symptoms) participated. Patients who required immediate revascularization or had left main disease, a creatinine level > 2.0 mg/dl, an A1C level > 13%, class IV heart failure, liver dysfunction, or revascularization within the previous 12 months were excluded. Methods. The BARI 2D trial was designed to test and compare benefits of coronary revascularization and medical therapy, as well as insulin sensitization versus insulin provisional therapy for CAD in patients with diabetes. Enrolled patients underwent categorization to coronary artery bypass grafting (CABG) or percutaneous coronary intervention (PCI) groups based on the clinical judgment of their treating physician. Two independent randomizations then occurred, in a two-by-two factorial design. In both the CABG and PCI groups, patients were randomized to primary revascularization plus medical therapy versus medical therapy alone. Independent of these results, both groups were also randomized to insulin provisional therapy (insulin and sulfonylureas) or insulin sensitization therapy (mainly metformin and thiazolidinediones). All patients had goals of A1C < 7%, LDL cholesterol < 100 mg/dl, blood pressure < 130/80 mmHg, counseling for tobacco …