The prospective randomized trial of the optimal evaluation of cardiac symptoms and revascularization: Rationale and design of the PRECISE trial

Michael G Nanna, Sreekanth Vemulapalli, Christopher B Fordyce, Daniel B Mark, Manesh R Patel, Hussein R Al-Khalidi, Michelle Kelsey, Beth Martinez, Eric Yow, Sarah Mullen, Gregg W Stone, Ori Ben-Yehuda, James E Udelson, Campbell Rogers, Pamela S Douglas, Michael G Nanna, Sreekanth Vemulapalli, Christopher B Fordyce, Daniel B Mark, Manesh R Patel, Hussein R Al-Khalidi, Michelle Kelsey, Beth Martinez, Eric Yow, Sarah Mullen, Gregg W Stone, Ori Ben-Yehuda, James E Udelson, Campbell Rogers, Pamela S Douglas

Abstract

Background: Clinicians vary widely in their preferred diagnostic approach to patients with non-acute chest pain. Such variation exposes patients to potentially avoidable risks, as well as inefficient care with increased costs and unresolved patient concerns.

Methods: The Prospective Randomized Trial of the Optimal Evaluation of Cardiac Symptoms and Revascularization (PRECISE) trial (NCT03702244) compares an investigational "precision" diagnostic strategy to a usual care diagnostic strategy in participants with stable chest pain and suspected coronary artery disease (CAD).

Results: PRECISE randomized 2103 participants with stable chest pain and a clinical recommendation for testing for suspected CAD at 68 outpatient international sites. The investigational precision evaluation strategy started with a pre-test risk assessment using the PROMISE Minimal Risk Tool. Those at lowest risk were assigned to deferred testing (no immediate testing), and the remainder received coronary computed tomographic angiography (cCTA) with selective fractional flow reserve (FFRCT) for any stenosis meeting a threshold of ≥30% and <90%. For participants randomized to usual care, the clinical care team selected the initial noninvasive or invasive test (diagnostic angiography) according to customary practice. The use of cCTA as the initial diagnostic strategy was proscribed by protocol for the usual care strategy. The primary endpoint is time to a composite of major adverse cardiac events (MACE: all-cause death or non-fatal myocardial infarction) or invasive cardiac catheterization without obstructive CAD at 1 year. Secondary endpoints include health care costs and quality of life.

Conclusions: PRECISE will determine whether a precision approach comprising a strategically deployed combination of risk-based deferred testing and cCTA with selective FFRCT improves the clinical outcomes and efficiency of the diagnostic evaluation of stable chest pain over usual care.

Conflict of interest statement

Conflict of interest Nanna MG: Dr Nanna is supported by the National Institutes of Health/National Institute on Aging award number R03AG074067. Vemulapalli S: Grants/contracts: American College of Cardiology, Society of Thoracic Surgeons, National Institutes of Health, Food and Drug Administration (NESTcc), Abbott Vascular, Boston Scientific. Consulting/Advisory Board: HeartFlow, Janssen, American College of Physicians, Boston Scientific. Fordyce CB: Reports Consultant/Honorarium: Bayer, Novo Nordisk, Boehringer Ingelheim, Sanofi, Pfizer, Amgen, Novartis; Research Grant: Bayer; Steering Committee: HeartFlow. Mark DB: Research support from HeartFlow and Merck. Patel MR: Research Grants/Advisory Board: Amgen, Bayer, Janssen, Heartflow; Research Grants; NHLBI, Novartis. Al-Khalidi HR: No disclosures to report. Kelsey M: Dr Kelsey is supported by 5T32HL069749-18. Martinez B: No disclosures to report. Yow E: No disclosures to report. Mullen S: Employee of HeartFlow: Salary and equity. Stone GW: Speaker or other honoraria from Cook, Infraredx; consultant to Valfix, TherOx, Robocath, HeartFlow, Ablative Solutions, Vectorious, Miracor, Neovasc, Abiomed, Ancora, Elucid Bio, Occlutech, CorFlow, Apollo Therapeutics, Reva, MAIA Pharmaceuticals, Vascular Dynamics, Shockwave, V-Wave, Cardiomech, Gore; equity/options from Ancora, Cagent, Applied Therapeutics, Biostar family of funds, SpectraWave, Orchestra Biomed, Aria, Cardiac Success, Valfix, MedFocus family of funds. Ben-Yehuda O: CRF is the recipient of research grants from HeartFlow. Udelson JE: Research funding from HeartFlow. Rogers C: Employee of HeartFlow: Salary and equity. Douglas PS: Grant support from HeartFlow.

Copyright © 2021. Published by Elsevier Inc.

Figures

Figure 1.. Study Design.
Figure 1.. Study Design.
Figure 1 presents a diagrammatic representation of the study design of the PRECISE trial.

References

    1. Newby DE, Adamson PD, Berry C et al. CT coronary angiography in patients with suspected angina due to coronary heart disease (SCOT-HEART): an open-label, parallel-group, multicentre trial. Lancet (London, England) 2015;385:2383–91.
    1. Douglas PS, Hoffmann U, Patel MR et al. Outcomes of anatomical versus functional testing for coronary artery disease. The New England journal of medicine 2015;372:1291–300.
    1. Patel MR, Peterson ED, Dai D et al. Low diagnostic yield of elective coronary angiography. The New England journal of medicine 2010;362:886–95.
    1. Pagidipati NJ, Hemal K, Coles A et al. Sex Differences in Functional and CT Angiography Testing in Patients With Suspected Coronary Artery Disease. Journal of the American College of Cardiology 2016;67:2607–16.
    1. Finkelstein DM, Schoenfeld DA. Combining mortality and longitudinal measures in clinical trials. Stat Med 1999;18:1341–54.
    1. Pocock SJ, Ariti CA, Collier TJ, Wang D. The win ratio: a new approach to the analysis of composite endpoints in clinical trials based on clinical priorities. European heart journal 2012;33:176–82.
    1. Fordyce CB, Douglas PS, Roberts RS et al. Identification of Patients With Stable Chest Pain Deriving Minimal Value From Noninvasive Testing: The PROMISE Minimal-Risk Tool, A Secondary Analysis of a Randomized Clinical Trial. JAMA cardiology 2017;2:400–408.
    1. Gibbons RJ, Balady GJ, Bricker JT et al. ACC/AHA 2002 guideline update for exercise testing: summary article. A report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (Committee to Update the 1997 Exercise Testing Guidelines). Journal of the American College of Cardiology 2002;40:1531–40.
    1. Pellikka PA, Nagueh SF, Elhendy AA, Kuehl CA, Sawada SG. American Society of Echocardiography Recommendations for Performance, Interpretation, and Application of Stress Echocardiography. Journal of the American Society of Echocardiography 2007;20:1021–1041.
    1. Tilkemeier PL, Bourque J, Doukky R, Sanghani R, Weinberg RL. ASNC imaging guidelines for nuclear cardiology procedures. Journal of Nuclear Cardiology 2017;24:2064–2128.
    1. Henzlova MJ, Duvall WL, Einstein AJ, Travin MI, Verberne HJ. ASNC imaging guidelines for SPECT nuclear cardiology procedures: Stress, protocols, and tracers. Journal of nuclear cardiology : official publication of the American Society of Nuclear Cardiology 2016;23:606–39.
    1. Henzlova MJ, Duvall WL, Einstein AJ, Travin MI, Verberne HJ. Erratum to: ASNC imaging guidelines for SPECT nuclear cardiology procedures: Stress, protocols, and tracers. Journal of nuclear cardiology : official publication of the American Society of Nuclear Cardiology 2016;23:640–642.
    1. Dilsizian V, Bacharach SL, Beanlands RS et al. ASNC imaging guidelines/SNMMI procedure standard for positron emission tomography (PET) nuclear cardiology procedures. Journal of nuclear cardiology : official publication of the American Society of Nuclear Cardiology 2016;23:1187–1226.
    1. Hundley WG, Bluemke DA, Finn JP et al. ACCF/ACR/AHA/NASCI/SCMR 2010 expert consensus document on cardiovascular magnetic resonance: a report of the American College of Cardiology Foundation Task Force on Expert Consensus Documents. Circulation 2010;121:2462–508.
    1. Leipsic J, Abbara S, Achenbach S et al. SCCT guidelines for the interpretation and reporting of coronary CT angiography: a report of the Society of Cardiovascular Computed Tomography Guidelines Committee. Journal of cardiovascular computed tomography 2014;8:342–58.
    1. Abbara S, Blanke P, Maroules CD et al. SCCT guidelines for the performance and acquisition of coronary computed tomographic angiography: A report of the society of Cardiovascular Computed Tomography Guidelines Committee: Endorsed by the North American Society for Cardiovascular Imaging (NASCI). Journal of cardiovascular computed tomography 2016;10:435–449.
    1. Elbez Y, Cheong AP, Fassa A-A et al. Clinical outcomes in patients with stable coronary artery disease with vs. without a history of myocardial revascularization. European Heart Journal - Quality of Care and Clinical Outcomes 2015;2:23–32.
    1. Patel MR, Dai D, Hernandez AF et al. Prevalence and predictors of nonobstructive coronary artery disease identified with coronary angiography in contemporary clinical practice. American heart journal 2014;167:846–52.e2.
    1. Bradley SM, Maddox TM, Stanislawski MA et al. Normal coronary rates for elective angiography in the Veterans Affairs Healthcare System: insights from the VA CART program (veterans affairs clinical assessment reporting and tracking). Journal of the American College of Cardiology 2014;63:417–26.
    1. David C. Modelling Binary Data (Second Edition). Texts in Statistical Science. Second Edition ed: Chapman and Hall/CRC, 2002.
    1. Kalbenfleisch JD P RL. The Statistical Analysis of Failure Time Data. Second Edition ed. Canada: John Wiley & Sons Inc., 2002.
    1. Cox DR. Regression Models and Life-Tables. Journal of the Royal Statistical Society Series B (Methodological) 1972;34:187–220.
    1. Kaplan EL, Meier P. Nonparametric Estimation from Incomplete Observations. Journal of the American Statistical Association 1958;53:457–481.
    1. Fine JP, Gray RJ. A Proportional Hazards Model for the Subdistribution of a Competing Risk. Journal of the American Statistical Association 1999;94:496–509.
    1. Lan KKG, DeMets, D.L. Discrete sequential boundaries for clinical trials. Biometrika 1983;70:649–653.
    1. Chen YH, DeMets DL, Lan KK. Increasing the sample size when the unblinded interim result is promising. Stat Med 2004;23:1023–38.
    1. Goff DC Jr., Lloyd-Jones DM, Bennett G et al. 2013 ACC/AHA guideline on the assessment of cardiovascular risk: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines. Circulation 2014;129:S49–73.
    1. Woodward M, Brindle P, Tunstall-Pedoe H. Adding social deprivation and family history to cardiovascular risk assessment: the ASSIGN score from the Scottish Heart Health Extended Cohort (SHHEC). Heart (British Cardiac Society) 2007;93:172–176.
    1. Roifman I, Wijeysundera HC, Austin PC, Rezai MR, Wright GA, Tu JV. Comparison of Anatomic and Clinical Outcomes in Patients Undergoing Alternative Initial Noninvasive Testing Strategies for the Diagnosis of Stable Coronary Artery Disease. Journal of the American Heart Association 2017;6:e005462.
    1. Coronary CT Angiography and 5-Year Risk of Myocardial Infarction . New England Journal of Medicine 2018;379:924–933.
    1. Ladapo JA, Hoffmann U, Lee KL et al. Changes in Medical Therapy and Lifestyle After Anatomical or Functional Testing for Coronary Artery Disease. Journal of the American Heart Association 2016;5.
    1. Fordyce CB, Newby DE, Douglas PS. Diagnostic Strategies for the Evaluation of Chest Pain: Clinical Implications From SCOT-HEART and PROMISE. Journal of the American College of Cardiology 2016;67:843–52.
    1. Chow BJ, Small G, Yam Y et al. Prognostic and therapeutic implications of statin and aspirin therapy in individuals with nonobstructive coronary artery disease: results from the CONFIRM (COronary CT Angiography EvaluatioN For Clinical Outcomes: An InteRnational Multicenter registry) registry. Arteriosclerosis, thrombosis, and vascular biology 2015;35:981–9.
    1. Schulman-Marcus J, Hartaigh BO, Giambrone AE et al. Effects of cardiac medications for patients with obstructive coronary artery disease by coronary computed tomographic angiography: results from the multicenter CONFIRM registry. Atherosclerosis 2015;238:119–25.
    1. Guidance MT. HeartFlow FFRCT for estimating fractional flow reserve from coronary CT angiography. NICE (National Institute for Health and Care Excellence), 2021.
    1. Moss AJ, Williams MC, Newby DE, Nicol ED. The Updated NICE Guidelines: Cardiac CT as the First-Line Test for Coronary Artery Disease. Current cardiovascular imaging reports 2017;10:15.
    1. Knuuti J, Wijns W, Saraste A et al. 2019 ESC Guidelines for the diagnosis and management of chronic coronary syndromes: The Task Force for the diagnosis and management of chronic coronary syndromes of the European Society of Cardiology (ESC). European heart journal 2019;41:407–477.
    1. Gulati M, Levy PD, Mukherjee D, 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(22):e368–e454. doi:doi:10.1161/CIR.0000000000001029.
    1. Koo BK, Erglis A, Doh JH et al. Diagnosis of ischemia-causing coronary stenoses by noninvasive fractional flow reserve computed from coronary computed tomographic angiograms. Results from the prospective multicenter DISCOVER-FLOW (Diagnosis of Ischemia-Causing Stenoses Obtained Via Noninvasive Fractional Flow Reserve) study. Journal of the American College of Cardiology 2011;58:1989–97.
    1. Min JK, Leipsic J, Pencina MJ et al. Diagnostic accuracy of fractional flow reserve from anatomic CT angiography. Jama 2012;308:1237–45.
    1. Norgaard BL, Leipsic J, Gaur S et al. Diagnostic performance of noninvasive fractional flow reserve derived from coronary computed tomography angiography in suspected coronary artery disease: the NXT trial (Analysis of Coronary Blood Flow Using CT Angiography: Next Steps). Journal of the American College of Cardiology 2014;63:1145–1155.
    1. Min JK, Taylor CA, Achenbach S et al. Noninvasive Fractional Flow Reserve Derived From Coronary CT Angiography: Clinical Data and Scientific Principles. JACC Cardiovascular imaging 2015;8:1209–22.
    1. Taylor CA, Fonte TA, Min JK. Computational fluid dynamics applied to cardiac computed tomography for noninvasive quantification of fractional flow reserve: scientific basis. Journal of the American College of Cardiology 2013;61:2233–41.
    1. Zimmermann FM, Pijls NHJ, Gould KL, Johnson NP. Stenting “Vulnerable” But Fractional Flow Reserve–Negative Lesions: Potential Statistical Limitations of Ongoing and Future Trials. JACC: Cardiovascular Interventions 2021;14:461–467.
    1. De Bruyne B, Fearon WF, Pijls NH et al. Fractional flow reserve-guided PCI for stable coronary artery disease. The New England journal of medicine 2014;371:1208–17.
    1. De Bruyne B, Pijls NH, Kalesan B et al. Fractional flow reserve-guided PCI versus medical therapy in stable coronary disease. The New England journal of medicine 2012;367:991–1001.
    1. Douglas PS, De Bruyne B, Pontone G et al. 1-Year Outcomes of FFRCT-Guided Care in Patients With Suspected Coronary Disease: The PLATFORM Study. Journal of the American College of Cardiology 2016;68:435–445.
    1. Patel MR, Nørgaard BL, Fairbairn TA et al. 1-Year Impact on Medical Practice and Clinical Outcomes of FFR(CT): The ADVANCE Registry. JACC Cardiovascular imaging 2020;13:97–105.
    1. Services DoHaH. Medicare program: Hospital Outpatient Prospective Payment and Ambulatory Surgical Center Payment Systems and Quality Reporting Programs. In: Services CfMM, editor 42 CFR Parts 414, 416 and 419. : Federal Register, December 14, 2017:282.
    1. Wolk MJ, Bailey SR, Doherty JU et al. ACCF/AHA/ASE/ASNC/HFSA/HRS/SCAI/SCCT/SCMR/STS 2013 multimodality appropriate use criteria for the detection and risk assessment of stable ischemic heart disease: a report of the American College of Cardiology Foundation Appropriate Use Criteria Task Force, American Heart Association, American Society of Echocardiography, American Society of Nuclear Cardiology, Heart Failure Society of America, Heart Rhythm Society, Society for Cardiovascular Angiography and Interventions, Society of Cardiovascular Computed Tomography, Society for Cardiovascular Magnetic Resonance, and Society of Thoracic Surgeons. Journal of the American College of Cardiology 2014;63:380–406.
    1. Curzen N, Nicholas Z, Stuart B et al. Fractional flow reserve derived from computed tomography coronary angiography in the assessment and management of stable chest pain: the FORECAST randomized trial. European heart journal 2021.
    1. Boden WE, O'Rourke RA, Teo KK et al. Optimal medical therapy with or without PCI for stable coronary disease. The New England journal of medicine 2007;356:1503–16.
    1. Al-Lamee R, Thompson D, Dehbi HM et al. Percutaneous coronary intervention in stable angina (ORBITA): a double-blind, randomised controlled trial. Lancet (London, England) 2018;391:31–40.
    1. Maron DJ, Hochman JS, Reynolds HR et al. Initial Invasive or Conservative Strategy for Stable Coronary Disease. New England Journal of Medicine 2020;382:1395–1407.
    1. Mesnier J, Ducrocq G, Danchin N et al. International Observational Analysis of Evolution and Outcomes of Chronic Stable Angina: The Multinational Observational CLARIFY Study. Circulation;0.
    1. Adamson PD, Fordyce CB, McAllister DA, Udelson JE, Douglas PS, Newby DE. Identification of patients with stable chest pain deriving minimal value from coronary computed tomography angiography: An external validation of the PROMISE minimal-risk tool. International journal of cardiology 2018;252:31–34.
    1. Fordyce CB, Douglas PS, Roberts RS et al. Identification of Patients With Stable Chest Pain Deriving Minimal Value From Noninvasive Testing: The PROMISE Minimal-Risk Tool, A Secondary Analysis of a Randomized Clinical Trial. JAMA cardiology 2017;2:400–408.
    1. Rasmussen LD, Nissen L, Westra J et al. Validation and update of the minimal risk tool in patients suspected of chronic coronary syndrome. The International Journal of Cardiovascular Imaging 2020.
    1. Nanna MG, Wang TY, Chiswell K et al. Estimating the real-world performance of the PROMISE minimal-risk tool. American heart journal 2021;239:100–109.

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