Implications of Contemporary Clinical Trials Management of Diabetes Mellitus in Patients With Cardiovascular Disease in the Bypass Angioplasty

Cardiovascular disease is the leading cause of morbidityand mortality for patients with type 2 diabetes mellitus (T2DM), accounting for two thirds of patient deaths. In addition to traditional cardiovascular risk factors, hypergly-cemia and multiple other factors associated with T2DM such as obesity, insulin resistance, and inflammation play signifi-cant 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-anal-ysis 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 cardiovas-cular events in patients with T2DM and stable ischemic heart disease. Both prompt revascularization compared with inten-sive 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 22 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