AHA 2025 Late-Breaking Science: Cleerly’s AI Atherosclerosis Quantification Outperforms Traditional Risk Scoring

New Data from the CONFIRM2 International Registry Shows AI-QCT Improves Prediction of Major Cardiovascular Events from 62% to 75%

Cleerly, a leader in AI-based cardiovascular imaging, presented new, late-breaking science from the international CONFIRM2 Registry at the American Heart Association (AHA) Scientific Sessions 2025 at the Ernest N. Morial Convention Center in New Orleans, LA.

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New data from the CONFIRM2 International Registry shows AI-QCT improves prediction of major cardiovascular events from 62% to 75%.

The study, "Risk stratification by AI guided CT atherosclerosis quantification according to the clinical likelihood of obstructive stenosis," analyzed 6,550 patients (51.6% female, mean age 59) over 4.4 years who underwent coronary computed tomography angiography (CCTA) with AI-based quantitative coronary CT analysis (AI-QCT) across international sites.

The findings indicated:

• AI-guided atherosclerosis quantification significantly improved cardiovascular risk prediction: The addition of AI-QCT to European Society of Cardiology Risk Factor-weighted Clinical Likelihood (ESC RF-CL) scores improved prediction of major adverse cardiovascular events (MACE) with Area Under the Curve (AUC) increasing from 0.62 to 0.75 (p<0.001), and death/MI prediction from AUC 0.60 to 0.71 (p<0.001).
• Most symptomatic patients have very-low or low likelihood of obstructive stenosis, AI is able to identify those at risk: While 78.4% of patients presenting with chest pain were classified as very-low (35.7%) or low (42.7%) likelihood for obstructive Coronary Artery Disease (CAD) (with true obstruction rates of only 5.8% and 14.2% respectively), AI-guided quantification of non-obstructive atherosclerosis successfully stratified these patients for future cardiovascular events.
• AI performance remains consistent across all risk levels: AI-QCT maintained strong and consistent predictive accuracy (AUC 0.71-0.73) across included ESC risk categories.

"This is another step towards earlier identification and treatment for patients," said Ibrahim Danad, MD, PhD, the study's principal investigator. "In this case, it challenges what we know about obstructive disease and further validates the abilities of AI-QCT. This is another fascinating learning we’ve gained from the CONFIRM2 Registry."

The findings demonstrate that AI-guided atherosclerosis quantification provides valuable prognostic information for MACE and MI/death beyond traditional clinical risk assessment. Given that 78.4% of symptomatic patients in this study had very-low or low likelihood of obstructive disease, the ability of AI-QCT to risk-stratify these patients for future events addresses an important clinical gap.

About Cleerly

Cleerly is the company on a mission to eliminate heart attacks by creating a new standard of care for heart disease. Through its FDA-cleared solutions driven by artificial intelligence, Cleerly supports comprehensive phenotyping of coronary artery disease, as determined from advanced noninvasive CT imaging. Cleerly’s approach is grounded in science, based on millions of images from over 40,000 patients. Led by a world-class clinical and technical team, Cleerly enhances health literacy for each and every stakeholder in the coronary care pathway. For more information, please visit: cleerlyhealth.com.

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"This is another step towards earlier identification and treatment for patients," said Ibrahim Danad, MD, PhD, the study's principal investigator.