Abstract 2983: Sex Differences in Quality of Life and Health Status in the COURAGE Trial
Purpose: The Clinical Outcomes Utilizing Revascularization and Aggressive DruG Evaluation (COURAGE) trial randomized 2,287 patients to percutaneous coronary intervention (PCI) plus optimal medical treatment (OMT) or OMT alone. The purpose of this study was to assess sex differences in quality of life (QOL) and health status between randomized initial management strategies over the trial follow-up period.
Methods: Of the 2,287 patients, 979 males and 169 females were randomized to PCI, and 968 males and 169 females were randomized to OMT. Quality of life was assessed with the Seattle Angina Questionnaire (SAQ) and health status with the RAND-36 at baseline, 1, 3, 6, 12 months and annually thereafter. SAQ and RAND-36 scores were assessed by analysis of variance (ANOVA), and linear mixed effects models.
Results: There were no significant sex by treatment group interactions indicating PCI vs. OMT differences were similar for the 1,947 men (85%) and 338 women (15%). Men had significantly higher SAQ Physical Functioning scores at baseline and 1 month post-treatment (p < 0.004) and a trend of higher means thereafter (Figure 1A⇓) and significantly higher RAND-36 Physical Functioning scores over 3 years of follow-up (p < 0.001, Figure 1B⇓). Men also had significantly higher RAND-36 Energy/Fatigue means scores (p < 0.05, Figure 1C⇓). RAND-36 scores for the other domains were similar fbetween the two groups (Figure 1D⇓).
Conclusions: Men and women in both arms experienced improvement in quality of life and health status over time. Men had significantly higher physical functioning as well as energy/fatigue scores, but were similar to women in other quality of life and health status domains.