TCT 2025 Late-Breaking Science: Quantitative Assessment of Non-Calcified Plaque Volume Drives Risk for Myocardial Infarction and Death

CONFIRM2 Registry Demonstrates Prognostic Value of AI-Based Plaque Characterization Beyond Stenosis Severity

Cleerly, a leader in AI-based cardiovascular imaging, presented new, late-breaking science from the international CONFIRM2 Registry at the Transcatheter Cardiovascular Therapeutics (TCT) 2025 Conference at the Moscone Center in San Francisco, CA.

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CONFIRM2 Registry Demonstrates Prognostic Value of AI-Based Plaque Characterization Beyond Stenosis Severity

The study, "AI-Guided Quantitative Plaque Evaluation from CT to Identify Patients with Future Myocardial Infarction or Death," analyzed 6,550 symptomatic patients (48% male, 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:

• Both non-calcified plaque (NCP) volume and diameter stenosis were powerful independent predictors of heart attack and death
• Patients who experienced events had nearly five times higher NCP volumes compared to those without events (254 mm³ vs 53 mm³)
• Those in the highest tertile of NCP volume faced nearly double the risk of adverse outcomes (HR 1.93, 95% CI 1.02-3.66) when adjusted for maximal stenosis severity

Notably, many events occurred in patients who did not have obstructive coronary artery disease (CAD), reinforcing the critical need to look beyond stenosis severity alone when assessing cardiovascular risk.

"These results challenge our traditional approach to cardiac risk assessment," said Alexander Van Rosendael, MD, PhD, the study's first author. "By identifying high-risk plaque features, particularly large non-calcified lesions, we can now detect vulnerable patients who would have been missed by conventional stenosis-focused evaluations."

The CONFIRM2 findings continue to highlight the value of AI-QCT technology in identifying patients with hidden disease, informing earlier intervention strategies, and helping enable more targeted therapeutic approaches. These results suggest that high-risk plaque features may represent important therapeutic targets for prevention and intervention, potentially transforming how clinicians approach cardiovascular risk stratification and management.

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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Many events occurred in patients who did not have obstructive coronary artery disease, reinforcing the critical need to look beyond stenosis severity alone when assessing cardiovascular risk.