Abstract P173: Risk Factor Analysis of Clinically Significant Improvements in Quality of Life Measures for Stable Coronary Patients

Abstract

Background: The COURAGE trial compared percutaneous coronary intervention (PCI) plus optimal medical therapy (OMT) to OMT alone in reducing the risk of cardiovascular events in 2287 patients with stable coronary disease. We examined the impact of PCI and other risk factors on clinically significant improvements in quality of life measures. Methods: Angina-specific and overall health status were assessed with the Seattle Angina Questionnaire (SAQ) and RAND-36 respectively, at baseline and at 1, 3, 6 and 12 months followed by annual evaluations. Scores range from 0 to 100; higher scores indicate better health status. Clinically significant improvement from baseline within individual patients was defined as score increases of ≥8, ≥25, ≥20, ≥12, and ≥16 for physical limitation, angina stability, angina frequency, treatment satisfaction, and quality of life domains respectively in SAQ and ≥ 10 for each domain in RAND-36. Results: Adjusted for other demographic and comorbidity risk factors, adding PCI to OMT resulted in clinically significant improvements in physical limitation from 1 to 6 months, angina stability from 1 to 3 months, angina frequency from 1 to 36 months, treatment satisfaction no time, and quality of life from 1 to 6 months in SAQ (p-value<0.05); For RAND-36, adding PCI to OMT resulted in clinically significant improvements in physical functioning from 1 to 6 months, energy/fatigue from 1 to 3 months, emotional well-being from 1 month to 3 months, pain at 1 month, but no time in other domains. Overall important interactions between treatment (adding PCI to OMT) and follow-up time were found in all domains of SAQ except in angina stability, but not found in all domains of RAND-36, indicating that the impact of PCI on angina specific health varies over time. Age and historic clinical events such as previous diabetes, congestive heart failure, or myocardial infarction previous were also shown to be important risk factors for clinically significant improvements, especially after loss of the influence of PCI. Conclusions: Adding PCI to OMT significantly improved angina-related health clinically from 3 to 6 or 12 months, but less for overall general health status. There was no advantage to PCI after about 1 year in any clinically significant improvement.