Groundbreaking Announcement from Cleerly

In a groundbreaking announcement, Cleerly has unveiled interim results from the CONFIRM2 trial, asserting to be the largest cardiovascular phenotype outcomes study ever conducted. This pivotal study indicates that women diagnosed with chronic coronary artery disease (CAD) are at a significantly higher risk of major adverse coronary events (MACE) compared to their male counterparts.

Details of the CONFIRM2 Trial

The CONFIRM2 trial, which examined a comprehensive pool of 3,551 patients, combined both retrospective and prospective data while employing advanced Artificial Intelligence-based Quantitative Computed Tomography (AI-QCT) technology to predict mortality and occurrences of MACE. The gender breakdown of the trial population was nearly equal, with women making up 49.5%.

Key Findings and Implications

Key findings revealed that, although men generally bear a heavier overall CAD burden, the risk of developing MACE is notably elevated in women. This increased risk is attributed to higher levels of plaque volume—both calcified and non-calcified—as well as greater percentages of atheroma volumes detected through the cutting-edge AI-QCT technology.

Insights from Dr. Gudrun Feuchtner

Dr. Gudrun Feuchtner, the lead researcher for the Cleerly study, expressed her insights during a conversation with Clinical Trials Arena shortly after the results were shared at the 2025 American College of Cardiology’s Annual Scientific Expo. She emphasized the importance of adopting AI-QCT instead of traditional imaging methods to enhance clinical outcomes for women, who are often under-diagnosed regarding cardiovascular issues.

Dr. Feuchtner stated, 'Our main analysis focused on the disparities between genders in heart disease, as conditions are often recognized too late in women, leading to poorer outcomes. Current cardiology practices rely on tools that measure risk factors; however, those measurements often fall short. AI technology allows us to accurately stratify the various layers of atherosclerosis, providing granular insights not just into calcium volume, but also into the presence of more dangerous components like lipid-rich necrotic cores, which increase an individual’s risk even further. Our findings suggest that these metrics significantly improve risk prediction for women compared to men.'

Complementing Previous Research

The Cleerly study, aptly titled 'AI-Quantitative CT Coronary Plaque Features Associate with a Higher Relative Risk in Women: CONFIRM2-Registry,' complements previous research such as the CREDENCE and PACIFIC-1 studies conducted in 2024, which confirmed that Cleerly’s AI Ischemia QCT system can effectively predict MACE in CAD patients.

Urgent Call to Rethink Diagnostic Approaches

With these alarming findings, the medical community is urged to rethink their diagnostic approaches for women. As more research surfaces, it becomes increasingly evident that AI technology could lead to safer and more effective heart disease management, particularly for women who experience a complicated and under-recognized path in cardiovascular health.