Heartflow’s Plaque Analysis software is an effective tool for the diagnosis and management of coronary artery disease (CAD), according to a new retrospective analysis of more than three years of data. The findings were presented at the American Heart Association’s Scientific Sessions 2025 conference.
The FDA-cleared Plaque Analysis software was designed to evaluate coronary CT angiography (CCTA) results and provide cardiologists with an artificial intelligence (AI)-powered assessment of the patient’s coronary plaques. It delivers an interactive 3D model of the coronaries and identifies high-risk CAD patients who may benefit from immediate care.
This latest analysis included nearly 8,000 symptomatic CAD patients who participated in the FISH&CHIP study. All patients were treated with Plaque Analysis as well as Heartflow’s new Plaque Staging framework. Plaque Staging separates patients into one of four categories—mild, moderate, severe or extensive—based on AI-powered total plaque volume (TPV) measurements. According to Heartflow, this study represents the largest validation to date of the Plaque Staging framework.
Overall, after a median 3.3 years of follow-up, patients with higher plaque volume stages were independently associated with increased rates of cardiovascular death and myocardial infarction. In addition, this trend remained in place after adjustments were made for coronary stenosis, FFRCT values and various 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,” Timothy Fairbairn, PhD, principal investigator for the FISH&CHIPS study and a cardiologist with Liverpool Heart and Chest Hospital, said in a statement. “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 personalize treatment, in order to prevent heart attacks or death in the future.”
“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,” added Campbell Rogers, MD, chief medical officer with Heartflow.
Back in July, researchers presented additional positive data on Heartflow’s Plaque Analysis software at the SCCT 2025 Annual Meeting. The company raised $364 million and went public just a few weeks later.
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