Cleerly, a pioneer in AI-driven cardiovascular imaging, unveiled significant advancements in predicting cardiovascular risk at the European Society of Cardiology (ESC) Congress 2025, held August 29 to September 1 at IFEMA in Madrid, Spain. The company presented a late-breaking analysis from the CONFIRM2 registry demonstrating that its AI-powered quantitative Coronary CT Angiography (AI-QCT) provides substantial prognostic value beyond traditional clinical assessment methods in predicting Major Adverse Cardiovascular Events (MACE). The study, titled Prognostic Value of AI-based Quantitative Coronary CT Evaluation Versus Standard Qualitative Evaluation, analyzed data from a symptomatic subset of the CONFIRM2 cohort, which includes over 8,000 patients across multiple international centers. CONFIRM2 is a large-scale, multicenter observational registry designed to enroll up to 30,000 patients, aiming to comprehensively quantify CT angiography findings and link them to clinical outcomes. In this analysis, AI-QCT was used to objectively assess plaque burden, morphology, composition, and luminal narrowing across the entire coronary tree. The results showed that incorporating AI-QCT metrics—specifically quantitative diameter stenosis and non-calcified plaque volume—significantly improved risk prediction compared to models based on standard clinical variables like CAD-RADS 2.0, coronary artery calcium (CAC) score, and the DUKE CAD index. Ibrahim Danad, MD, PhD, of Radboud University Medical Center and principal investigator, emphasized the impact of the findings: “This research shows we can now identify patients at risk for MACE with greater precision than ever before.” Alexander van Rosendael, MD, PhD, of Leiden University Medical Center and lead presenter at the congress, added, “Plaque burden quantification by AI-QCT delivers critical insights that standard visual interpretation often misses—especially in patients with mild to moderate disease, who make up a large portion of the clinical population.” Key findings from the late-breaking presentation include: AI-QCT significantly enhanced risk discrimination, offering incremental predictive power over conventional methods. Quantitative plaque metrics were strongly associated with future cardiovascular events, even in patients with low-to-moderate stenosis. The AI model demonstrated consistent performance across diverse patient populations, including those with varying levels of risk and disease severity. In addition to the late-breaking study, Cleerly presented five other research abstracts highlighting progress in stenosis quantification, diagnostic accuracy across different demographics, and sex-based differences in plaque characteristics. These studies further validate the role of AI in enabling more personalized, data-driven cardiovascular care. Cleerly’s technology is FDA-cleared and based on analysis of over 40,000 patient scans, leveraging artificial intelligence to deliver comprehensive phenotyping of coronary artery disease from noninvasive CT imaging. The company is committed to transforming heart disease care by improving early detection and risk stratification. For more information on Cleerly’s research and innovations, visit www.cleerlyhealth.com. About Cleerly Cleerly is on a mission to eliminate heart attacks by establishing a new standard of care for cardiovascular disease. Through AI-powered analysis of coronary CT scans, Cleerly provides clinicians with deeper, more accurate insights into heart health. Its platform supports improved decision-making across the care continuum and enhances health literacy for patients and providers alike. Led by a team of leading clinical and technical experts, Cleerly is advancing the science of noninvasive heart disease detection. Learn more at cleerlyhealth.com. References: Van Rosendael AR, Crabtree T, Bax JJ, Nakanishi R, Mushtaq S, Pontone G, Andreini D, Buechel RR, Gräni C, Feuchtner G, Patel TR, Choi AD, Al-Mallah M, Nabi F, Karlsberg RP, Rochitte CE, Alasnag M, Hamdan A, Cademartiri F, Marques H, Kalra D, German DM, Gupta H, Hadamitzky M, Deaño RC, Khalique O, Knaapen P, Hoffmann U, Earls J, Min JK, Danad I; CONFIRM 2 investigators. Rationale and design of the CONFIRM2 (Quantitative COroNary CT Angiography Evaluation For Evaluation of Clinical Outcomes: An InteRnational, Multicenter Registry) study. J Cardiovasc Comput Tomogr. 2024 Jan-Feb;18(1):11-17. doi: 10.1016/j.jcct.2023.10.004. Epub 2023 Nov 10. PMID: 37951725; PMCID: PMC10923095.