Heartflow has announced late-breaking data from the FISH&CHIPS study presented at the American Heart Association (AHA) 2025 scientific sessions (7–10 November, New Orleans, USA), supporting its artificial intelligence (AI)-powered Heartflow Plaque Analysis with Plaque Staging.
The retrospective analysis, which evaluated nearly 8,000 symptomatic patients from a cohort of the FISH&CHIPS study, represents the largest validation to date of the Heartflow Plaque Staging framework based on total plaque volume (TPV) measurement.
Findings indicate that patients in the highest TPV stage experienced more than a fivefold greater risk of major cardiovascular events compared with patients in the lowest stage (hazard ratio [HR] 5.10, p-value <0.0001). Higher plaque volume stages were independently associated with significantly increased rates of cardiovascular death and myocardial infarction over a median 3.3 years of follow-up.
Associations remained significant after adjustment for coronary stenosis, fractional flow reserve computed tomography (FFRCT) values and cardiovascular risk factors.
“This study provides strong validation of TPV-based staging measured with Heartflow Plaque Analysis as a predictor of future heart attacks or cardiovascular death,” said Timothy Fairbairn (Liverpool Heart and Chest Hospital, Liverpool, UK), principal investigator for the FISH&CHIPS study. “The ability to accurately measure plaque will enable cardiologists to better predict which patients are most at risk above the traditional risk factors, and thus personalise treatment, in order to prevent heart attacks or death in the future.”
The findings add to results from the DECIDE registry presented at the Society of Cardiovascular Computed Tomography (SCCT) 2025 annual scientific meeting (17–20 July, Montreal, Canada). DECIDE data showed that Heartflow Plaque Analysis with Plaque Staging led to changes in medical management for more than half of patients, resulting in an average reduction in LDL cholesterol of 18.7mg/dL at 90 days. These results indicate management changes guided by Heartflow Plaque Staging result in an expected 15% decrease in risk of a cardiac event, Heartflow says in a press release.
“We are demonstrating how AI-powered Heartflow Plaque Analysis with Heartflow Plaque Staging can fundamentally change the way we manage coronary artery disease,” said Campbell Rogers, chief medical officer at Heartflow. “These latest findings show that by embedding plaque insights directly into the diagnostic pathway, we can help physicians make more confident decisions to guide personalized and precise treatment for their patients.”
Heartflow Plaque Analysis is a US Food and Drug Administration (FDA)-cleared device. Heartflow Plaque Staging is an investigational-only framework, and its safety and effectiveness have not been reviewed by the FDA.
