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

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.