Related Experiment Video
Updated: Jun 13, 2025
Signal Acquisition, Score Interpretation, and Economics of a Non-Invasive Point-of-Care Test for Coronary Artery Disease
Published on: August 9, 2024
Quality of Life Outcomes With a Risk-Based Precision Testing Strategy Versus Usual Testing in Stable Patients With
Daniel B Mark1,2, Yanhong Li1, Michael G Nanna3
1Duke Clinical Research Institute, Duke University, Durham, NC (D.B.M., Y.L., M.D.K., M.R.D., M.R.P., K.N.B., S.V., P.S.D.).
Background:
The PRECISE (Prospective Randomized Trial of the Optimal Evaluation of Cardiac Symptoms and Revascularization) trial compared an investigational precision diagnostic testing strategy (n=1057) with usual testing (n=1046) in patients with stable chest pain and suspected coronary artery disease. Quality of life (QOL) outcomes were a prespecified secondary end point.
Methods:
We assessed QOL by structured interviews in all trial participants at baseline and 45 days, 6 months, and 12 months postrandomization. QOL assessments included angina-related QOL (19-item Seattle Angina Questionnaire [SAQ-19]), generic health status (EQ-5D), and a 4-item care satisfaction survey (at 45 days only). The prespecified primary comparison was the 6-month SAQ Summary score outcomes (scale, 0 to 100; higher scores indicate greater health status). QOL data collection rates were high, with 99% complete baseline SAQ scores and 86.5% complete at the 6-month primary comparison follow-up. All comparisons were made as randomized.
Results:
At baseline, mean SAQ Summary scores were 70.9 in the Precision Strategy group (n=1050) and 70.4 in the Usual Testing group (n=1042). By 6 months, mean SAQ Summary scores had improved to 89.9 in the Precision Strategy group and 89.2 in the Usual Testing group, with a mean adjusted difference of 0.8 (95% CI, -0.3 to 2.0). The SAQ component scores showed similar improvement from baseline in both groups and no statistically significant or clinically meaningful differences between the 2 groups at any follow-up time point. By 6 months, 66% of patients in both groups were chest pain-free. EQ-5D visual analog scores also improved from baseline and showed no difference between groups during follow-up. Care satisfaction scores were high and similar at 45 days.
Conclusions:
In stable patients with symptoms suggesting coronary artery disease, angina-related and overall QOL improved substantially over the initial 6 months independent of the testing strategy assigned.
Registration:
URL: https://www.clinicaltrials.gov; Unique identifier: NCT03702244.
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