Risk reduction of cardiac events by screening of unknown asymptomatic coronary artery disease in subjects with type 2 diabetes mellitus at high cardiovascular risk: An open-label randomized pilot study

Background Evaluated the efficacy of reducing the risk of cardiac events by a preclinical diagnosis of CAD in subjects with type 2 diabetes mellitus with 2 or more cardiovascular risk factors. Methods One hundred forty-one subjects with type 2 diabetes mellitus without known cardiac disease and asymptomatic, aged >45 to <76 years, were randomized into the screening arm for CAD (71 patients) or to the control arm (70 patients). The screening consisted in performing an exercise electrocardiogram test and dipyridamole stress echocardiography; if 1 test was abnormal, coronary angiography is done. Screening was positive in 15 subjects (21.4%). At coronary angiography, which was performed in 14 of 15 patients, stenoses ≥50% of vessel diameter were present in 9 patients, of these 4 underwent coronary artery bypass grafting and 4 underwent percutaneous transluminal coronary angioplasty. Stenoses <50% of vessel diameter were present in 5 patients. Results Mean follow-up was 53.5 months (range, 42-54 months). During this period, 1 major (myocardial infarction) and 3 minor events (angina) occurred in the screening arm. Eleven major and 4 minor events occurred in the control arm. In the screened arm, the proportion of all events was significantly less (P = .018) (RR .226, 95% CI 0.707-0.719, P = .012); the proportion of major to minor events was significantly less (P = .006) (RR .07, 95% CI 0.0087-0.565, P = .013). Conclusions The preclinical diagnosis of CAD is effective in reducing the risk of cardiac events, especially major events, in subjects with type 2 diabetes mellitus at high cardiovascular risk.