Heartflow’s Plaque Analysis for CAD Management Evaluated in DECIDE Registry

July 21, 2025—Heartflow, Inc. recently announced new data, including final primary endpoint data from the DECIDE registry, for its Heartflow Plaque Analysis.

DECIDE is a prospective study enrolling approximately 20,000 patients at more than 30 sites across the United States. The primary endpoint for the registry is changes in medical management after Heartflow Plaque Analysis. Clinical outcomes and biomarkers are the secondary endpoints. Safety endpoints include major adverse cardiovascular events, such as myocardial infarction and urgent hospitalization leading to revascularization.

According to the company, data from the DECIDE registry showed that its Plaque Analysis led to medical management change in more than half of patients beyond coronary CT angiography (CCTA) alone, regardless of traditional risk factors or CCTA findings.

Data from a cohort of 972 patients across 15 sites in the registry were presented by colead Principal Investigator Sarah Rinehart, MD, at SCCT2025, the Society of Cardiovascular Computed Tomography’s annual scientific meeting.

As summarized in the company’s press release, the data showed that management changes informed by the Heartflow Plaque Analysis with Plaque Staging led to an average decrease of 18.7 mg/dL in low-density lipoprotein cholesterol, which is associated with an estimated 15% decrease in risk of a cardiac event. Additionally, 30% of patients with a calcified plaque volume of zero had a change in management.

These findings suggest Heartflow Plaque Analysis can deliver clinically meaningful impact by helping clinicians identify which patients require changes to their treatment plans, stated the company.

“These data confirm what we’re seeing in clinical practice—Heartflow Plaque Analysis provides individualized insights that go beyond what a traditional analysis of a patient’s risk factors or CCTA alone can show,” commented Dr. Rinehart in the company’s press release. “By quantifying plaque burden and characterizing higher-risk noncalcified plaque types, Heartflow’s technology empowers physicians to personalize care and intervene earlier, which can change the trajectory of a patient’s coronary health.”

Dr. Rinehart is Medical Director of Cardiovascular Imaging at Charleston Area Medical Center in Charleston, West Virginia.

As part of the DECIDE Registry, Heartflow’s Plaque Staging framework is being used prospectively to help translate these insights into simplified, actionable treatment plans. The Heartflow Plaque Staging framework stratifies patients into one of four risk-based stages—mild, moderate, severe, or extensive— based on AI-quantified plaque volume and composition.

The company noted that the FISH&CHIPS study data showed higher coronary plaque-based stages, measured by Heartflow Plaque Analysis, were associated with up to five-times higher risk of cardiovascular event rates at 3.3 years. The data were presented at the British Society of Cardiovascular Imaging annual scientific meeting in April 2025. The study abstract was published in the meeting supplement in Heart.