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Background: The International Study of Comparative Health Effectiveness with Medical and Invasive Approaches (ISCHEMIA) compared an initial invasive treatment strategy (INV) with an initial conservative strategy (CON) in 5,179 participants with chronic coronary disease (CCD) and moderate or severe ischemia. The ISCHEMIA research program included a comprehensive quality of life (QOL) substudy.Methods: In 1,819 participants (907 INV, 912 CON), we collected a battery of disease-specific and generic QOL instruments by structured interviews at baseline; at 3, 12, 24, and 36 months post-randomization; and at study close-out. Assessments included angina-related QOL (19-item Seattle Angina Questionnaire [SAQ-19]), generic health status (EQ-5D), depressive symptoms (Patient Health Questionnaire-8), and, for North American patients, cardiac functional status (Duke Activity Status Index [DASI]).Results: Median age was 67 years, 19.2% were female, and 15.9% were non-white. The estimated mean difference for the SAQ-19 Summary score favored INV (1.4 points, 95% confidence interval [CI] 0.2, 2.5 over all follow-up). No differences were observed in patients with rare/absent baseline angina (SAQ Angina Frequency [AF] score &gt;80). Among patients with more frequent angina at baseline (SAQ AF score ≤80, 744 patients, 41%), those randomized to INV had a mean 3.7-point higher SAQ-19 Summary score than CON (95% CI 1.6, 5.8) with consistent effects across SAQ subscales: Physical Limitations 3.2 points (95% CI 0.2, 6.1), Angina Frequency 3.2 points (95% CI 1.2, 5.1), Quality of Life/Health Perceptions 5.3 points (95% CI 2.8, 7.8). For the DASI, no difference was estimated overall by treatment, but in patients with baseline SAQ AF scores ≤80, DASI scores were higher for INV (3.2 points, 95% CI 0.6, 5.7), whereas patients with rare/absent baseline angina showed no treatment-related differences. Moderate to severe depression was infrequent at randomization (11.5% to 12.8%) and was unaffected by treatment assignment.Conclusions: In the ISCHEMIA comprehensive QOL substudy, patients with more frequent baseline angina reported greater improvements in the symptom, physical functioning, and psychological well-being dimensions of QOL when treated with an invasive strategy, whereas patients who had rare/absent angina at baseline reported no consistent treatment-related QOL differences.

Comprehensive Quality-of-Life Outcomes With Invasive Versus Conservative Management of Chronic Coronary Disease in ISCHEMIA