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

Abstract

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 >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.

Improving Symptoms and Quality of Life in Stable Coronary Artery Disease: An Evolving Paradigm

“…Given that increase in coronary flow after revascularization is believed to be the primary mechanism driving the improvement in symptoms, it is conceivable that patients with significant amounts of myocardium jeopardized by ischemia may have greater improvement in symptoms with revascularization. The results of the ISCHEMIA trial (International Study of Comparative Health Effectiveness With Medical and Invasive Approaches) 3 and the present quality of life substudy 6 validate this hypothesis, showing greater improvement in angina and quality of life with invasive compared with conservative management in patients with stable CAD and moderate to severe ischemia on testing. As expected, this benefit in health status was a function of symptom burden at baseline, being primarily driven by patients who had more frequent symptoms at baseline.…”

“…In this issue of Circulation , the ISCHEMIA investigators present a detailed report of quality of life outcomes collected in 1819 of 5179 patients enrolled in the parent trial. 6 The authors provide a rich and broad assessment of patient-reported outcomes that capture diverse aspects of quality of life that are important from a patient perspective, including the disease-specific 19-item SAQ and many other general health status measures.…”

Role of percutaneous coronary intervention in the modern-day management of chronic coronary syndrome

“…In the correct circumstances, PCI can offer complete angina relief. In the ISCHEMIA EXTENDED study, there was no difference in all-cause mortality with an initial invasive strategy compared with an initial conservative strategy, but there was lower risk of cardiovascular mortality and higher risk of non-cardiovascular mortality with an initial invasive strategy during a median follow-up of 5.7 years 35…”

Sex-based Differences in Percutaneous Coronary Intervention Outcomes in Patients with Ischaemic Heart Disease

“…were more likely to have femoral artery access for the intervention, more frequently experienced major bleeding complications and less frequently had multivessel disease compared with men. 51,52 Several studies have shown that women who undergo PCI for angina have worse short-term MACE and all-cause mortality than men, although this may relate, in part, to differences in baseline characteristics (Table 1). [52][53][54] Yet, in an adjusted analysis of British and Swedish registry data (n=458,261; 26% female; 33% angina diagnosis), female sex was independently associated with all-cause mortality at 30 days and at 1 year following PCI.…”