Cardiac outcomes after screening for asymptomatic coronary artery disease in patients with type 2 diabetes: the DIAD study: a randomized controlled trial

Abstract

Context: Coronary artery disease (CAD) is the major cause of mortality and morbidity in patients with type 2 diabetes. But the utility of screening patients with type 2 diabetes for asymptomatic CAD is controversial.

Objective: To assess whether routine screening for CAD identifies patients with type 2 diabetes as being at high cardiac risk and whether it affects their cardiac outcomes.

Design, setting, and patients: The Detection of Ischemia in Asymptomatic Diabetics (DIAD) study is a randomized controlled trial in which 1123 participants with type 2 diabetes and no symptoms of CAD were randomly assigned to be screened with adenosine-stress radionuclide myocardial perfusion imaging (MPI) or not to be screened. Participants were recruited from diabetes clinics and practices and prospectively followed up from August 2000 to September 2007.

Main outcome measure: Cardiac death or nonfatal myocardial infarction (MI).

Results: The cumulative cardiac event rate was 2.9% over a mean (SD) follow-up of 4.8 (0.9) years for an average of 0.6% per year. Seven nonfatal MIs and 8 cardiac deaths (2.7%) occurred among the screened group and 10 nonfatal MIs and 7 cardiac deaths (3.0%) among the not-screened group (hazard ratio [HR], 0.88; 95% confidence interval [CI], 0.44-1.88; P = .73). Of those in the screened group, 409 participants with normal results and 50 with small MPI defects had lower event rates than the 33 with moderate or large MPI defects; 0.4% per year vs 2.4% per year (HR, 6.3; 95% CI, 1.9-20.1; P = .001). Nevertheless, the positive predictive value of having moderate or large MPI defects was only 12%. The overall rate of coronary revascularization was low in both groups: 31 (5.5%) in the screened group and 44 (7.8%) in the unscreened group (HR, 0.71; 95% CI, 0.45-1.1; P = .14). During the course of study there was a significant and equivalent increase in primary medical prevention in both groups.

Conclusion: In this contemporary study population of patients with diabetes, the cardiac event rates were low and were not significantly reduced by MPI screening for myocardial ischemia over 4.8 years.

Trial registration: clinicaltrials.gov Identifier: NCT00769275.

Figure 1

Flow of Study Participants

Figure 2. Cumulative Incidence of Cardiac Events in Participants With Type 2 Diabetes Without Symptomatic or Previously Diagnosed Coronary Artery Disease

A, Cumulative incidence of cardiac events in 561 participants randomized to systematic baseline screening with stress myocardial perfusion imaging (MPI) and 562 participants randomized to receive no screening. B, Cumulative incidence of cardiac events according to results of systematic screening with stress MPI: normal, small defect, moderate or large defect, and nonperfusion abnormality. No cardiac events occurred in participants who were randomized to but did not complete screening MPI. The y-axis scale in blue indicates range from 0 to 0.06.