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Randomized Controlled Trial
. 2025 Feb;18(2):e011414.
doi: 10.1161/CIRCOUTCOMES.124.011414. Epub 2025 Feb 3.

Quality of Life Outcomes With a Risk-Based Precision Testing Strategy Versus Usual Testing in Stable Patients With Suspected Coronary Disease: Results From the PRECISE Randomized Trial

Daniel B Mark  1   2 , Yanhong Li  1 , Michael G Nanna  3 , Michelle D Kelsey  1   2 , Melanie R Daniels  1 , Campbell Rogers  4 , Manesh R Patel  1   2 , Khaula N Baloch  1 , Benjamin J W Chow  5 , Kevin J Anstrom  6 , Sreekanth Vemulapalli  1   2 , Jonathan R Weir-McCall  7 , Gregg W Stone  8 , Derek S Chew  9 , Pamela S Douglas  1   2 ; PRECISE Investigators
Affiliations
Randomized Controlled Trial

Quality of Life Outcomes With a Risk-Based Precision Testing Strategy Versus Usual Testing in Stable Patients With Suspected Coronary Disease: Results From the PRECISE Randomized Trial

Daniel B Mark et al. Circ Cardiovasc Qual Outcomes. 2025 Feb.

Abstract

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.

Keywords: chest pain; coronary artery disease; health status; prospective studies; quality of life.

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Conflict of interest statement

Dr Mark received grant support from HeartFlow Inc during the conduct of this study, Merck and Novo Nordisk outside the submitted work, grants or research support from National Institutes of Health/National Heart, Lung, and Blood Institute and American Heart Association, consulting fees from CeleCor, Novartis, and Boehringer Ingelheim outside the submitted work, and honoraria from Elsevier outside the submitted work. Dr Nanna received consulting fees from HeartFlow Inc, Novo Nordisk, and Merck, research support from the National Institute on Aging/National Institutes of Health (R03AG074067), the American College of Cardiology Foundation supported by the George F. and Ann Harris Bellows Foundation, the Patient-Centered Outcomes Research Institute, and the Yale Claude D. Pepper Older Americans Independence Center (P30AG021342). Dr Kelsey is a member of the Advisory Board for Bayer and the Consultant/Speaker for Heartflow Inc. M.R. Daniels received honoraria from Elsevier outside the submitted work, and consulting fees from CeleCor outside the submitted work. Dr Rogers reported receiving salary and equity as an employee of HeartFlow Inc during the conduct of the study, in addition, Dr Rogers reported having a patent for HeartFlow Inc issued. Dr M.R. Patel received grants from HeartFlow during the conduct of the study and Bayer, Janssen, and Novartis outside the submitted work. Dr B.J.W. Chow receives research support from TD Bank and Artrya. He is a consultant for and has an equity interest in Artrya. Dr Anstrom received grants from Merck, Bayer, and the National Institutes of Health during the conduct of the study. Dr Vemulapalli received grants/contracts from the National Institutes of Health, Food and Drug Administration, American College of Cardiology, Cytokinetics, Edwards Lifesciences, Abbott Vascular, consulting/advisory: Astra Zeneca, Boehringer-Ingelheim, Cytokinetics, Edwards Lifesciences, Medtronic, Total CME, Ikon, and Veralox Therapeutics. Dr Weir-McCall is supported by the National Institute for Health and Care Research (NIHR) Cambridge Biomedical Research Center (BRC-1215-20014). Dr Stone reported receiving speaker fees from Medtronic, Pulnovo, Infraredx, Abiomed, Abbott, Amgen, and Boehringer Ingelheim, consultant fees from Daiichi Sankyo, Ablative Solutions, CorFlow, Apollo Therapeutics, Cardiomech, Gore, Robocath, Miracor, Vectorious, Abiomed, Valfix, TherOx, HeartFlow Inc, Neovasc, Ancora, Elucid Bio, Occlutech, Impulse Dynamics, Adona Medical, Millennia Biopharma, and Oxitope, equity or stock options from Ancora, Cagent, Applied Therapeutics, Biostar family of funds, SpectraWave, Orchestra Biomed, Aria, Cardiac Success, Valfix, Xenter; and grants from Abbott, Abiomed, Bioventrix, Cardiovascular Systems Inc, Phillips, Biosense-Webster, Shockwave, Vascular Dynamics, Pulnovo, and V-wave outside the submitted work. Dr Stone’s daughter is an employee at IQVIA. Dr Chew received research support from the Heart and Stroke Foundation of Canada and the Canadian Institutes of Health Research. Dr Douglas received grants from HeartFlow Inc during the conduct of the study. Full Trial Protocol at: https://jamanetwork.com/journals/jamacardiology/fullarticle/2808765. The other authors report no conflicts.

Figures

Figure 1.
Figure 1.
Adjusted mean differences with 95% CIs in Seattle Angina Questionnaire summary score by subgroups. The choice of which approach to use if randomized to Usual Testing (ie, invasive or initial noninvasive) was prespecified by the investigators before randomization.
Figure 2.
Figure 2.
Adjusted mean differences with 95% CIs in Seattle Angina Questionnaire Angina Frequency by subgroups. The choice of which approach to use if randomized to Usual Testing (ie, invasive or initial noninvasive) was prespecified by the investigators before randomization.
Figure 3.
Figure 3.
Adjusted mean differences with 95% CIs in Seattle Angina Questionnaire quality of life by subgroups. The choice of which approach to use if randomized to Usual Testing (ie, invasive or initial noninvasive) was prespecified by the investigators before randomization.
Figure 4.
Figure 4.
Adjusted mean differences with 95% CIs in Seattle Angina Questionnaire physical limitations by subgroups. The choice of which approach to use if randomized to Usual Testing (ie, invasive or initial noninvasive) was prespecified by the investigators before randomization.
Figure 5.
Figure 5.
Adjusted mean differences with 95% CIs in EQ-5D Visual Analog Scale by subgroups. The choice of which approach to use if randomized to Usual Testing (ie, invasive or initial noninvasive) was prespecified by the investigators before randomization.
See this image and copyright information in PMC

Comment in

  • Asking a More PRECISE Question?
    Hulten EA, Di Carli MF. Hulten EA, et al. Circ Cardiovasc Qual Outcomes. 2025 Feb;18(2):e011650. doi: 10.1161/CIRCOUTCOMES.124.011650. Epub 2025 Feb 3. Circ Cardiovasc Qual Outcomes. 2025. PMID: 39895491 No abstract available.

References

    1. Gulati M, Levy PD, Mukherjee D, Amsterdam E, Bhatt DL, Birtcher KK, Blankstein R, Boyd J, Bullock-Palmer RP, Conejo T, et al. . 2021 AHA/ACC/ASE/CHEST/SAEM/SCCT/SCMR guideline for the evaluation and diagnosis of chest pain: a report of the American College of Cardiology/American Heart Association Joint Committee on Clinical Practice Guidelines. Circulation. 2021;144:e368–e454. doi: 10.1161/CIR.0000000000001030 - PubMed
    1. Douglas PS, Hoffmann U, Patel MR, Mark DB, Al-Khalidi HR, Cavanaugh B, Cole J, Dolor RJ, Fordyce CB, Huang M, et al. ; PROMISE Investigators. Outcomes of anatomical versus functional testing for coronary artery disease. N Engl J Med. 2015;372:1291–1300. doi: 10.1056/NEJMoa1415516 - PMC - PubMed
    1. SCOT-HEART Investigators. CT coronary angiography in patients with suspected angina due to coronary heart disease (SCOT-HEART): an open-label, parallel-group, multicentre trial. Lancet. 2015;385:2383–2391. doi: 10.1016/S0140-6736(15)60291-4 - PubMed
    1. Mark DB, Federspiel JJ, Cowper PA, Anstrom KJ, Hoffmann U, Patel MR, Davidson-Ray L, Daniels MR, Cooper LS, Knight JD, et al. ; PROMISE Investigators. Economic outcomes with anatomical versus functional diagnostic testing for coronary artery disease. Ann Intern Med. 2016;165:94–102. doi: 10.7326/M15-2639 - PMC - PubMed
    1. Mark DB, Anstrom KJ, Sheng S, Baloch KN, Daniels MR, Hoffmann U, Patel MR, Cooper LS, Lee KL, Douglas PS; PROMISE Investigators. Quality-of-life outcomes with anatomic versus functional diagnostic testing strategies in symptomatic patients with suspected coronary artery disease: results from the PROMISE randomized trial. Circulation. 2016;133:1995–2007. doi: 10.1161/CIRCULATIONAHA.115.020259 - PMC - PubMed

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