Management of Diabetes Mellitus in Patients With Cardiovascular Disease in the Bypass Angioplasty Revascularization Investigation 2 Diabetes (BARI 2D) Trial
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Cardiovascular disease is the leading cause of morbidity and mortality for patients with type 2 diabetes mellitus (T2DM), accounting for two thirds of patient deaths. In addition to traditional cardiovascular risk factors, hyperglycemia and multiple other factors associated with T2DM such as obesity, insulin resistance, and inflammation play significant roles in cardiovascular disease risk.1 Patients with diabetes mellitus have derived less benefit from multiple preventive and interventional advances. Indeed, in the Bypass Angioplasty Revascularization Investigation (BARI) trial, angioplasty appeared to provide very little benefit for patients with diabetes mellitus,2 a finding supported by a meta-analysis of randomized interventional trials,3 although modern revascularization techniques with the use of drug-eluting stents were not yet widely utilized.
Therefore, the questions addressed in the BARI 2 Diabetes (BARI 2D) trial are of particular importance in determining optimal treatments to prevent mortality and major cardiovascular events in patients with T2DM and stable ischemic heart disease. Both prompt revascularization compared with intensive medical therapy alone or with delayed revascularization, and insulin-sensitization compared with insulin-provisional therapeutic strategies were evaluated in 2368 patients over 5 years with the use of a 2×2 randomized factorial trial design.4 With recognition of the cardiovascular benefits of optimal management of diabetes mellitus and cardiovascular risk factors in patients with diabetes mellitus,5 the BARI 2D study was performed with guideline-driven targets for lipids, blood pressure, and aspirin use.
Medical Therapy Compared With Prompt Revascularization
First, in a comparison of prompt revascularization with intensive medical therapy alone or with delayed revascularization, similar survival (88.3% versus 87.8%; P=0.97) and freedom from cardiovascular event rates (77.2% versus 75.9%; P=0.70) were demonstrated. However, a high proportion (42%) of subjects initially randomized to medical intervention received delayed revascularization. These findings extend those of the Clinical Outcomes Utilizing Revascularization and Aggressive Drug Evaluation (COURAGE) trial, in which an …