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Randomized Controlled Trial
. 2022 Apr 26;145(17):1294-1307.
doi: 10.1161/CIRCULATIONAHA.121.057363. Epub 2022 Mar 9.

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

Daniel B Mark  1 , John A Spertus  2 , Robert Bigelow  1 , Sophia Anderson  1 , Melanie R Daniels  1 , Kevin J Anstrom  1 , Khaula N Baloch  1 , David J Cohen  3   4 , Claes Held  5 , Shaun G Goodman  6   7 , Sripal Bangalore  8 , Derek Cyr  1 , Harmony R Reynolds  8 , Karen P Alexander  1 , Yves Rosenberg  9 , Gregg W Stone  10 , David J Maron  11 , Judith S Hochman  8 ; ISCHEMIA Research Group
Affiliations
Randomized Controlled Trial

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

Daniel B Mark et al. Circulation. .

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 <80, 744 patients, 41%), those randomly assigned to INV had a mean 3.7-point higher 19-item Seattle Angina Questionnaire Summary score than conservative strategy (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 Duke Activity Status Index, no difference was estimated overall by treatment, but in patients with baseline SAQ Angina Frequency scores <80, Duke Activity Status Index 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%-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.

Registration: URL: https://www.

Clinicaltrials: gov; Unique identifier: NCT01471522.

Keywords: angina pectoris; coronary angiography; coronary artery bypass; coronary disease; health status; myocardial ischemia; myocardial revascularization; quality of life.

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Figures

Figure 1:
Figure 1:
Flow of Participants in the Comprehensive Quality of Life Substudy Cohort in ISCHEMIA
Figure 2:
Figure 2:
Treatment Differences in Seattle Angina Questionnaire Summary Scores in the ISCHEMIA Comprehensive Quality of Life Substudy
Figure 3:
Figure 3:
Treatment Differences in Seattle Angina Questionnaire Summary Scores Stratified by Seattle Angina Frequency Scores at Baseline in the ISCHEMIA Comprehensive Quality of Life Substudy
See this image and copyright information in PMC

Comment in

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