Cleerly’s artificial intelligence (AI)-based quantitative coronary CT analysis (AI-QCT) has shown to be superior to the standard of care (SOC) for suspected coronary artery disease (CAD) patients, demonstrating improved diagnostic certainty, which led to more patients receiving lipid-lowering therapy.
The PARAMOUNT study (NCT06713239), which was the first randomised trial comparing this kind of technology to SOC, enrolled 523 symptomatic CAD patients, 300 of whom were women, to receive computed tomography (CT)-based coronary atherosclerotic plaque assessment using its AI-based Labs and ISCHEMIA software or the usual care strategy of stress testing, as outlined in the current American Heart Association and American College of Cardiology (AHA/ACC) guidelines.
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On the prespecified hierarchical composite endpoint at 180 days, the primary results from PARAMOUNT demonstrated that plaque-based care was favoured over SOC with a win ratio of 2.00, meeting the study’s primary endpoint. Meanwhile, in unmatched patient comparisons, plaque-based care patients had a better result 46.7% of the time, compared with 23.4% for usual care, Cleerly stated.
Cleerly shared the results as Late-Breaking Science at the 2026 American Heart Association (AHA) Scientific Sessions in Chicago, which took place between 7-9 October.
The Colorado-based company also highlighted that the biggest contributor towards the trial meeting its primary endpoint was that AI-QCT improved diagnostic certainty about whether a patient’s chest pain was caused by CAD, with a win difference of 16.6 percentage points.
With the full study results expected to be released in early 2027, Udo Hoffman, Cleerly’s chief medical, scientific, and AI officer, said PARAMOUNT’s preliminary results demonstrated for the first time how AI-QCT supports clinicians in diagnosing, staging, and treating CAD and unlocks potential benefits of both “medical management and interventional treatment” for patients with stable chest pain.
The buildup of atherosclerotic plaques, referring to deposits of fats, cholesterol, calcium, and other substances that build up inside the inner lining of the arteries, is a key driver of CAD, which affects around 244 million individuals worldwide, as per the US Centers for Disease Control and Prevention (CDC).
Other noteworthy findings in the study included more patients starting lipid-lowering therapy as a result of receiving AI-QCT and fewer invasive angiograms ending without an intervention. In the AI-QCT arm, lipid-lowering therapy use rose from 31% at baseline to 75% after testing, compared with 32% to 47% in the usual care arm. Among patients who underwent invasive coronary angiography, 38% in the AI-QCT arm did not go on to revascularisation or bypass surgery, versus 60% in the usual care arm.
“For decades, we’ve evaluated patients with chest pain by looking for blockages or reduced blood flow. PARAMOUNT shows that when we measure plaque directly and use it to guide care, physicians gain clearer answers and patients are far more likely to start preventive therapy,” said Todd Villines, co-principal investigator of PARAMOUNT and Donald Barnes Professor of Cardiology in Internal Medicine at the University of Virginia.
“We’re also proud that more than half of our participants were women, a group too often underrepresented in cardiovascular trials,” Villines added.
