Discovering PRECISE-ly what our patients need:
Learnings from the randomized PRECISE trial

All truths are easy to understand once they are discovered; the point is to discover them.

– Galileo Galilei

Discovery drives clinical research. Whether we are testing a potential breakthrough therapy or the impact of a long-standing care practice, the chance to chart a path toward better heart health is why substantial effort and resources are regularly invested in cardiovascular trials.

The search for a better path is what motivated the PRECISE trial, presented at AHA 2022. This randomized trial delivered strong evidence that a diagnostic pathway centered on coronary CTA + FFRCT, which was recommended in the 2021 AHA/ACC Chest Pain Guideline for the Evaluation and Diagnosis of Chest Pain, provides clinicians and patients with a better pathway for assessing and managing coronary artery disease (CAD).

This global RCT enrolled 2,103 stable symptomatic patients with suspected CAD who were randomized between two pathways:

  • Precision Pathway: Risk scoring (using the PROMISE Minimal Risk Score) to defer testing in the lowest-risk patients, and coronary CTA with selective FFRCT for elevated risk patients or low-risk patients if necessary after initial deferral

  • Traditional Testing: Functional stress testing or invasive coronary angiography (ICA)

At one year, a 70% reduction in the primary composite endpoint (all-cause death, non-fatal MI, or ICA without obstructive CAD) was found in the Precision Pathway arm, as compared to the Traditional Testing arm.

Moreover, PRECISE allows us to better understand the signals observed in previous trials. Specifically, PRECISE clarifies that, when compared to traditional testing, a diagnostic pathway centered on coronary CTA + FFRCT leads to:

 Total ICAs (see PLATFORM)
 Preventive medical therapies (see SCOT-HEART)
 Cath lab efficiency (PCI-to-ICA ratio) (see PLATFORMFORECAST)
 Identification of patients requiring revasc (see Parikh, et al. VA FFR study)
 Comparable safety (see FORECAST)

In an effort to better understand the PRECISE trial, I spoke with Dr. James Udelson, the chief of cardiology at Tufts Medical Center and a lead investigator in the PRECISE trial. He shared his perspective, both as a practicing cardiologist and as a clinical trialist.

You can watch this video (7 minutes) of our discussion or you can click on any of the discussed topics below.

PRECISE confirms that a better path exists for our patients. And from Dr. Udelson’s comments, it is clear that in the coming months and years this trial will provide more discoveries to inform our daily clinical decisions.

— A perspective from HeartFlow Chief Medical Officer, Campbell Rogers, MD
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Campbell Rogers, M.D., F.A.C.C.

Executive Vice President and Chief Medical Officer

Campbell brings a wealth of experience to HeartFlow, where he serves as the Chief Medical Officer. Prior to joining HeartFlow, he was the Chief Scientific Officer and Global Head of Research and Development at Cordis Corporation, Johnson & Johnson, where he was responsible for leading investments and research in cardiovascular devices. Prior to Cordis, he was Associate Professor of Medicine at Harvard Medical School and the Harvard-M.I.T. Division of Health Sciences and Technology, and Director of the Cardiac Catheterization and Experimental Cardiovascular Interventional Laboratories at Brigham and Women’s Hospital. He served as Principal Investigator for numerous interventional cardiology device, diagnostic, and pharmacology trials, is the author of numerous journal articles, chapters, and books in the area of coronary artery and other cardiovascular diseases, and was the recipient of research grant awards from the NIH and AHA.

He received his A.B. from Harvard College and his M.D. from Harvard Medical School.