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

• DOI: 10.1161/circulationaha.121.057363
• Publication Date: 2022-03-09T10:00:11Z
• Authors: Daniel B. Mark; John A. Spertus; Robert Bigelow; Sophia Anderson; Melanie R. Daniels; Kevin J. Anstrom; Khaula N. Baloch; David J. Cohen; Claes Held; Shaun G. Goodman; Sripal Bangalore; Derek Cyr; Harmony R. Reynolds; Karen P. Alexander; Yves Rosenberg; Gregg W. Stone; David J. Maron; Judith S. Hochman
• Keywords: Coronary disease

Background: ISCHEMIA (International Study of Comparative Health Effectiveness with Medical and Invasive Approaches) compared an initial invasive treatment strategy (INV) conservative in 5179 participants chronic coronary disease moderate or severe ischemia. The research program included a comprehensive quality-of-life (QOL) substudy. Methods: In 1819 (907 INV, 912 strategy), we collected battery disease-specific generic QOL instruments by structured interviews at baseline; 3, 12, 24, 36 months postrandomization; study closeout. Assessments angina-related (19-item Seattle Angina Questionnaire), health status (EQ-5D), depressive symptoms (Patient Questionnaire-8), and, for North American patients, cardiac functional (Duke Activity Status Index). Results: Median age was 67 years, 19.2% were female, 15.9% non-White. estimated mean difference the 19-item Questionnaire Summary score favored INV (1.4 points [95% CI, 0.2–2.5] over all follow-up). No differences observed patients rare/absent baseline angina (SAQ Frequency >80). Among more frequent <80, 744 41%), those randomly assigned to had 3.7-point higher than (95% 1.6–5.8) consistent effects across SAQ subscales: Physical Limitations 3.2 0.2–6.1), 1.2–5.1), Quality Life/Health Perceptions 5.3 2.8–7.8). For Duke Index, no overall treatment, but scores Index (3.2 0.6–5.7]), whereas showed treatment-related differences. Moderate depression infrequent randomization (11.5%–12.8%) unaffected assignment. Conclusions: substudy, reported greater improvements symptom, physical functioning, psychological well-being dimensions when treated strategy, who Registration: URL: https://www.clinicaltrials.gov ; Unique identifier: NCT01471522.