Abstract 3511: Quality of Life in COURAGE Trial Patients with Diabetes

Abstract

Background: The COURAGE trial randomized 2,287 patients to percutaneous coronary intervention (PCI) plus optimal medical therapy (OMT) or OMT alone. We hypothesized that patients with diabetes would have lower quality of life (QOL) at baseline and benefit less from PCI than patients without diabetes. Methods: Angina frequency and QOL were assessed with the Seattle Angina Questionnaire (SAQ) at baseline, 1, 2, and 3 years. Diabetes and treatment group differences were assessed by analysis of variance and linear mixed effects models. Results: (See Table .) Diabetes status could be determined in 2,234 patients. Of these, 766 (34%) had diabetes. There were no significant baseline differences in SAQ scores for angina frequency and QOL for patients with and without diabetes. All patients experienced significant (p<0.001) improvement in these SAQ scores from baseline through 3 years post-randomization in both treatment arms, however patients without diabetes had significantly greater improvement (p<0.001 for both scores). The addition of PCI to OMT produced a small but statistically significant advantage for patients without diabetes that persisted for 2 years for angina frequency and 1 year for QOL; a similar advantage for PCI was observed for patients with diabetes, but this was not statistically significant, due in part to the smaller sample size. Comparison of SAQ Scores by Diabetes Status and Treatment Conclusions: COURAGE patients with and without diabetes had similar baseline angina frequency and QOL, and experienced marked improvement in these parameters in both treatment groups. Diabetic patients had less improvement in these health status scores than non-diabetic patients. The addition of PCI to OMT produced a small incremental benefit compared with OMT alone that lasted for 1–2 years, after which there were no between-group differences for patients with or without diabetes.