Heartflow has announced new data for its artificial intelligence (AI)-enabled Heartflow Plaque Analysis, including final primary endpoint data from the DECIDE registry.
Data from the DECIDE registry showed Heartflow Plaque Analysis led to medical management change in over half of patients beyond coronary computed tomography angiography (CCTA) alone, regardless of traditional risk factors or CCTA findings. The DECIDE registry is the largest prospective study of its kind, enrolling approximately 20,000 patients at over 30 sites across the USA.
Data were presented at the Society of Cardiovascular Computed Tomography (SCCT) 2025 annual scientific meeting (17–20 July, Montreal, Canada) from a cohort of 972 patients across 15 sites by Sarah Rinehart Charleston Area Medical Center, Charleston, USA), co-lead principal investigator of the registry.
DECIDE registry investigator Cian McCarthy (Massachusetts General Hospital, Boston, USA) is the first-place recipient of the 2025 SCCT Clinical Trials and Registries Award, which was presented at the opening session of SCCT 2025.
For DECIDE registry patients, management changes informed by Heartflow Plaque Analysis with Plaque Staging led to an average LDL cholesterol decrease of 18.7mg/dL, which is associated with an estimated 15% decrease in risk of a cardiac event, the company reports in a press release. 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, the press release adds.
“These data confirm what we’re seeing in clinical practice—Heartflow Plaque Analysis provides individualised insights that go beyond what a traditional analysis of a patient’s risk factors or CCTA alone can show,” said Rinehart. “By quantifying plaque burden and characterising higher-risk non-calcified plaque types, Heartflow’s technology empowers physicians to personalise care and intervene earlier, which can change the trajectory of a patient’s coronary health.”
As part of the DECIDE registry, Heartflow’s recently introduced Plaque Staging framework is being used prospectively to translate advanced insights into simplified, actionable treatment plans.
The Heartflow Plaque Staging framework, which was developed by expert consensus and clinically validated using outcomes data from the FISH&CHIPS study, stratifies patients into one of four risk-based stages—mild, moderate, severe, or extensive—based on AI-quantified plaque volume and composition. With data from over 2,800 patients, Heartflow Plaque Staging is the leading tool for risk stratification based on AI-quantitative coronary plaque assessment.
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 (BSCI) annual scientific meeting (2–4 April, Leicester, UK).
“The results from the DECIDE registry clearly show how Heartflow Plaque Analysis can meaningfully change CAD care, with more than half of patients seeing their treatment plans altered after Heartflow Plaque Analysis,” said Campbell Rogers, chief medical officer of Heartflow. “We expect that tools like Plaque Staging will enhance the impact Heartflow Plaque Analysis is already making by providing a clearer framework for personalised patient care.”
