Heartflow, Inc. Announces Late-Breaking Data Validating AI-Driven Plaque Analysis for Coronary Risk

Heartflow presents compelling new data from the FISH&CHIPS Study confirming its AI-powered Plaque Analysis as a robust predictor of coronary risk, enabling personalized, precise treatment to reduce cardiovascular events.

Nov 10, 2025
Heartflow, Inc. Announces Late-Breaking Data Validating AI-Driven Plaque Analysis for Coronary Risk

Heartflow, Inc., a leader in artificial intelligence technology for coronary artery disease (CAD), revealed late-breaking data at the American Heart Association (AHA) Scientific Sessions 2025, reinforcing the prognostic power of its AI-driven Heartflow Plaque Analysis and Plaque Staging framework. The findings stem from the FISH&CHIPS Study, a multicenter retrospective analysis involving nearly 8,000 symptomatic patients.

This study provides the largest validation to date of Heartflow’s Plaque Staging based on total plaque volume (TPV) measurements, establishing it as a powerful independent predictor of major cardiovascular events such as heart attacks and cardiovascular death. Patients with the highest TPV stage experienced more than a fivefold increase in risk compared to those with the lowest stage (hazard ratio 5.10, p-value < 0.0001). These associations persisted even after adjusting for traditional cardiovascular risk factors and imaging markers like coronary stenosis and fractional flow reserve.

Dr. Timothy Fairbairn, principal investigator for the FISH&CHIPS Study, highlighted the clinical significance: “Accurately measuring plaque burden with Heartflow’s AI-enabled technology enables cardiologists to identify patients at greatest risk beyond traditional risk scoring, guiding more tailored and potentially life-saving interventions.”

Heartflow’s AI system leverages the world’s largest coronary imaging dataset, trained on over 110 million annotated CT angiography images, delivering highly precise and reproducible insights across diverse populations. The technology is FDA-cleared and used by more than 1,400 healthcare institutions globally.

Complementing this latest validation, earlier studies such as the DECIDE Registry demonstrated that medical management changes guided by Heartflow Plaque Staging led to meaningful LDL cholesterol reductions and estimated a 15% decrease in cardiac event risks.

Dr. Campbell Rogers, Heartflow’s Chief Medical Officer, emphasized the transformational potential: “Integrating AI-powered plaque insights directly into diagnostic pathways fundamentally changes CAD management, allowing physicians to make more confident, personalized treatment decisions.”

Heartflow’s groundbreaking AI-driven tools represent a critical advancement in precision cardiovascular care, promising to improve outcomes for millions of patients worldwide by enabling earlier, more accurate risk stratification and management.