1. Comprehensive Quality-of-Life Outcomes With Invasive Versus Conservative Management of Chronic Coronary Disease in ISCHEMIA
- Author
-
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, and Judith S, Hochman
- Subjects
Male ,Ischemia ,Physiology (medical) ,Chronic Disease ,Quality of Life ,Humans ,Coronary Disease ,Female ,Conservative Treatment ,Cardiology and Cardiovascular Medicine ,Aged ,Angina Pectoris - Abstract
Background: ISCHEMIA (International Study of Comparative Health Effectiveness with Medical and Invasive Approaches) compared an initial invasive treatment strategy (INV) with an initial conservative strategy in 5179 participants with chronic coronary disease and moderate or severe ischemia. The ISCHEMIA research program included a comprehensive quality-of-life (QOL) substudy. Methods: In 1819 participants (907 INV, 912 conservative strategy), we collected a battery of disease-specific and generic QOL instruments by structured interviews at baseline; at 3, 12, 24, and 36 months postrandomization; and at study closeout. Assessments included angina-related QOL (19-item Seattle Angina Questionnaire), generic health status (EQ-5D), depressive symptoms (Patient Health Questionnaire-8), and, for North American patients, cardiac functional status (Duke Activity Status Index). Results: Median age was 67 years, 19.2% were female, and 15.9% were non-White. The estimated mean difference for the 19-item Seattle Angina Questionnaire Summary score favored INV (1.4 points [95% CI, 0.2–2.5] over all follow-up). No differences were observed in patients with rare/absent baseline angina (SAQ Angina Frequency score >80). Among patients with more frequent angina at baseline (SAQ Angina Frequency score 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. Registration: URL: https://www.clinicaltrials.gov ; Unique identifier: NCT01471522.
- Published
- 2022
- Full Text
- View/download PDF