Abstract Body (Do not enter title and authors here): Background: Despite a lesser extent and severity of coronary artery disease (CAD), women had a higher burden of angina than men in the ISCHEMIA trial, suggesting that other factors may explain symptom severity in women. We aim to describe demographic and clinical characteristics, as well as differences in care patterns, associated with health status differences in women, as compared with men, in the conservative and invasive treatment groups of the ISCHEMIA trial.
Methods: The ISCHEMIA trial randomized participants with moderate or severe ischemia to a routine invasive strategy of cardiac catheterization with complete revascularization plus guideline-directed medical therapy (GDMT), or an initial conservative strategy of GDMT alone with catheterization reserved for GDMT failure. Health status was a key secondary outcome. Using linear regression models we compared raw and adjusted Seattle Angina Questionnaire (SAQ) scores in women and men at baseline and at 1 year, stratified by randomized treatment strategy. Within the invasive strategy, sex differences were adjusted for completeness of revascularization among those with ≥1 coronary stenosis ≥70%.
Results: Of 4,617 ISCHEMIA participants with valid SAQ data, women had lower (worse) baseline SAQ summary scores (SS) throughout follow up (Figure) after adjustment for demographics and clinical characteristics, including severity of CAD (difference 5.4 points, 95% CI 4.0-6.7). Women had lower SAQ SS after adjustment for post-randomization treatment (i.e., medical therapy, achievement of risk factor goals and, in the invasive strategy, complete revascularization), 2.4 points lower (95% CI 0.7-4.1) in the conservative group (Figure), and 1.9 points lower than in men (95% CI 0.1-3.7) in the invasive group. Findings were similar for all SAQ subscales.
Conclusions: Women with chronic coronary disease in ISCHEMIA had worse health status than men at baseline and 1 year later, which was not explained by demographic or clinical characteristics, intensity of medical therapy, or completeness of revascularization.