Deferred Testing in Stable Outpatients With Suspected Coronary Artery Disease
James E. Udelson, Michelle D. Kelsey, Michael G. Nanna, Christopher B. Fordyce, Eric Yow, Robert M. Clare, Daniel B. Mark, Manesh R. Patel, Campbell Rogers, Nick Curzen, Gianluca Pontone, Pál Maurovich-Horvat, Bernard De Bruyne, John P. Greenwood, Victor Marinescu, Jonathon Leipsic, Gregg W. Stone, Ori Ben-Yehuda, Colin Berry, Shea E. Hogan, Bjorn Redfors, Ziad A. Ali, Robert A. Byrne, Christopher M. Kramer, Robert W. Yeh, Beth Martinez, Sarah Mullen, Whitney Huey, Kevin J. Anstrom, Hussein R. Al-Khalidi, Karen Chiswell, Sreekanth Vemulapalli, Pamela S. Douglas, Michael Barry, Stephen Bloom, David Buck, Jane Cao, Jeffrey Carstens, Justin Carter, Benjamin Chow, George Chrysant, Jason Cole, Derek Connolly, Ryan Daly, Sorin Danciu, Melissa Daubert, Roderick Deano, Peter Fail, Timothy Fairbairn, Maros Ferencik, Thomas Hauser, Peter Haworth, Mohammad Hojjati, Angela Hoye, Mark Ibrahim, Fuad Jan, Clemens Kadalie, Dinesh Kalra, Ronald Karlsberg, Steven Kindsvater, John Kobayashi, David Landers, James Lee, Diana Litmanovich, Scott Matson, David McAllister, Gerald McCann, Mark Meier, Nicolai Mejevoi, Bela Merkely, Jamaluddin Moloo, Michael Morris, Darra Murphy, Nasar Nallamothu, Anna Narezkina, Katarina Nelson, Tuan Nguyen, Koen Nieman, Prabhjot Nijjar, Peter O'Kane, Amit Patel, Hena Patel, Thomas Phiambolis, Amit Pursnani, Mark Rabbat, Steven Raible, Frederic Resnic, Michael Salerno, Daniel Sauri, Uwe O.P.J. Schoepf, Moneal Shah, Vincent Sorrell, Michael Turner, Michael Walls, Jonathan Weir-McCall, Frederick Welt, Andrew Zurick,- Cardiology and Cardiovascular Medicine
Importance
Guidelines recommend deferral of testing for symptomatic people with suspected coronary artery disease (CAD) and low pretest probability. To our knowledge, no randomized trial has prospectively evaluated such a strategy.
Objective
To assess process of care and health outcomes in people identified as minimal risk for CAD when testing is deferred.
Design, Setting, and Participants
This randomized, pragmatic effectiveness trial included prespecified subgroup analysis of the PRECISE trial at 65 North American and European sites. Participants identified as minimal risk by the validated PROMISE minimal risk score (PMRS) were included.
Intervention
Randomization to a precision strategy using the PMRS to assign those with minimal risk to deferred testing and others to coronary computed tomography angiography with selective computed tomography-derived fractional flow reserve, or to usual testing (stress testing or catheterization with PMRS masked). Randomization was stratified by PMRS risk.
Main Outcome
Composite of all-cause death, nonfatal myocardial infarction (MI), or catheterization without obstructive CAD through 12 months.
Results
Among 2103 participants, 422 were identified as minimal risk (20%) and randomized to deferred testing (n = 214) or usual testing (n = 208). Mean age (SD) was 46 (8.6) years; 304 were women (72%). During follow-up, 138 of those randomized to deferred testing never had testing (64%), whereas 76 had a downstream test (36%) (at median [IQR] 48 [15-78] days) for worsening (30%), uncontrolled (10%), or new symptoms (6%), or changing clinician preference (19%) or participant preference (10%). Results were normal for 96% of these tests. The primary end point occurred in 2 deferred testing (0.9%) and 13 usual testing participants (6.3%) (hazard ratio, 0.15; 95% CI, 0.03-0.66; P = .01). No death or MI was observed in the deferred testing participants, while 1 noncardiovascular death and 1 MI occurred in the usual testing group. Two participants (0.9%) had catheterizations without obstructive CAD in the deferred testing group and 12 (5.8%) with usual testing (P = .02). At baseline, 70% of participants had frequent angina and there was similar reduction of frequent angina to less than 20% at 12 months in both groups.
Conclusion and Relevance
In symptomatic participants with suspected CAD, identification of minimal risk by the PMRS guided a strategy of initially deferred testing. The strategy was safe with no observed adverse outcome events, fewer catheterizations without obstructive CAD, and similar symptom relief compared with usual testing.
Trial Registration
ClinicalTrials.gov Identifier: