Cleerly has announced interim results from a trial, described as the largest-ever cardiovascular phenotype outcomes study, finding that women living with chronic coronary artery disease (CAD) are at higher risk of major adverse coronary events (MACE) than men.
The Cleerly CONFIRM2 trial was a retrospective and prospective, open-label trial that examined 3,551 patients to determine if AI-based Quantitative Computed Tomography (AI-QCT) could be used to predict mortality and MACE. By design, 49.5% of the trial population comprised of women.
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Results found that while the overall burden for CAD in the population studied fell mostly on men, women were at higher risk of developing MACE than men due to higher rates of plaque volume, calcified plaque, non-calcified plaque, and percentage atheroma volumes detected through AI-QCT.
Lead researcher for the Cleerly study, Gudrun Feuchtner, spoke with Clinical Trials Arena shortly after unveiling the results at the 2025 American College of Cardiology’s Annual Scientific Expo, arguing that the adoption of AI-QCT over traditional QCT could improve clinical outcomes for women.
Feuchtner said: “We had one main analysis, and we focused on the differences between men and women because heart disease is under-diagnosed in women and outcomes for women are worse.
“Currently in cardiology, we [have tools to measure] risk factors, but the performance of these [measurements] is very poor. AI analysis can more precisely stratify the different layers of atherosclerosis, so not only can we quantify calcium, but we can also quantify other components like calcified plaque, non-calcified plaque or lipid necrotic-rich core plaque, which puts an individual at even higher risk. In the trial, we found that these features enhance risk prediction in women more than men.”
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By GlobalDataThe Cleerly study, titled: “AI-Quantitative CT Coronary Plaque Features Associate with a Higher Relative Risk in Women: CONFIRM2-Registry” joins research published in 2024, namely the CREDENCE (NCT02173275) and PACIFIC-1 (NCT01521468) studies, both of which also found Cleerly’s AI Ischemia QCT system able to predict MACE in CAD patients.
Elsewhere in the field of cardiac devices, Johnson & Johnson MedTech’s Shockwave Medical has launched its Javelin Peripheral IVL Catheter in the US for peripheral artery disease (PAD).
