HeartFlow’s Plaque Analysis Tool to Be Evaluated for Patient Management for Suspected CAD in DECIDE Registry

March 26, 2024—HeartFlow, Inc. announced the launch of the prospective DECIDE registry. The large, prospective registry will collect multisite, real-world information on how the company’s Plaque Analysis product provides enhanced patient insights to inform physicians’ medical management decisions for patients with suspected coronary artery disease.

HeartFlow Plaque Analysis is an FDA-cleared artificial intelligence–enabled plaque quantification tool that was validated in a prospective international trial against the gold standard of invasive imaging, with a reported 95% agreement.

According to the company, the DECIDE registry will evaluate changes in treatment management decisions made by clinicians using HeartFlow Plaque Analysis derived from coronary CTA (CCTA) in comparison to decisions made with CCTA alone.

Cone Health Care in Greensboro, North Carolina, is the first site initiated in the registry.

Thomas Stuckey, MD, Medical Director and Cofounder of the LeBauer-Brodie Center for Cardiovascular Research and Education at Cone Health, commented on the Plaque Analysis tool and the DECIDE registry in HeartFlow’s press release.

“When treating patients with coronary artery disease, the more information we have at our fingertips the better,” said Dr. Stuckey. “Use of Plaque Analysis provides more complete data on the type and amount of coronary plaque present. We are excited to continue our partnership with HeartFlow as the first initiated site in the DECIDE registry and to build a collection of real-world data that could revolutionize decision-making in cardiology.”

The real-world, prospective registry aims to further the work highlighted in the retrospective DECODE study, which has just been published by Sarah Rinehart, MD, et al online in JSCAI, the journal of the Society for Cardiovascular Angiography & Interventions.

The company reported that the DECODE study showed that clinicians using the HeartFlow Plaque Analysis changed their management decisions for 66% of patients compared to CCTA alone across various patient presentations and disease stages.

Furthermore, approximately 50% of patients with a calcium score of 0 were reclassified after clinician review of the HeartFlow Plaque Analysis, demonstrating the importance of quantifying total plaque beyond just calcium score, noted the company.

The DECIDE registry, which aims to include 10,000 patients from approximately 25 sites across the United States, represents HeartFlow’s clinical evidence investment at the forefront of cardiovascular therapy. The primary endpoint for this registry will highlight change in medical management after HeartFlow Plaque Analysis compared to after CCTA alone. Observed outcomes and biomarkers are secondary endpoints. Safety endpoints include major adverse cardiovascular events—death, myocardial infarction, and urgent hospitalization leading to revascularization.

The lead principal investigators of the DECIDE Registry are Leslee Shaw, PhD, and Dr. Rinehart.

Dr. Shaw is Director of the Blavatnik Family Women’s Health Research Institute at the Icahn School of Medicine at Mount Sinai in New York, New York. Dr. Rinehart is Medical Director of CV Imaging, Computed Tomography and Nuclear, at Charleston Area Medical Center in Charleston, West Virginia.

“Coronary artery disease remains one of the leading causes of death in the United States,” commented Dr. Shaw in the HeartFlow press release. “While treatment options for the disease have improved over time, the complexity of the disease still leaves opportunity to enhance diagnostic and treatment protocols.

“The DECIDE Registry has the potential to improve how coronary artery disease is diagnosed and set a new standard of care in cardiovascular care driving positive change in population health overall.”