Quantitative Non-Calcified Plaque Volume Predicts Heart Attack and Death Risk
Cleerly, a leader in AI-based cardiovascular imaging, has presented groundbreaking findings from the international CONFIRM2 Registry at the Transcatheter Cardiovascular Therapeutics (TCT) 2025 Conference in San Francisco. The study, titled "AI-Guided Quantitative Plaque Evaluation from CT to Identify Patients with Future Myocardial Infarction or Death," analyzed data from 6,550 symptomatic patients (48% male, mean age 59) across multiple global sites who underwent coronary computed tomography angiography (CCTA) with AI-based quantitative coronary CT analysis (AI-QCT). Over a median follow-up of 4.4 years, the research demonstrated that AI-driven plaque characterization provides significant prognostic value beyond traditional stenosis severity assessments. A key finding was that a substantial number of major adverse cardiovascular events—including myocardial infarction and death—occurred in patients who did not have obstructive coronary artery disease (CAD) as defined by standard stenosis thresholds. This underscores a critical limitation of current clinical practice, which often focuses solely on vessel narrowing to determine risk. The study revealed that high-risk plaque features, especially large non-calcified plaques, are strong predictors of future cardiac events, even in patients with non-obstructive disease. Alexander Van Rosendael, MD, PhD, the study’s first author, emphasized the paradigm-shifting nature of the results. “These results challenge our traditional approach to cardiac risk assessment,” he said. “By identifying high-risk plaque features, we can now detect vulnerable patients who would have been missed by conventional stenosis-focused evaluations.” The ability to detect these hidden risks using AI-QCT could lead to earlier interventions, more personalized treatment plans, and ultimately, a reduction in heart attacks. Cleerly’s AI-QCT technology, which is FDA-cleared, uses advanced algorithms to analyze millions of CT images from over 40,000 patients to provide detailed phenotyping of coronary artery disease. Unlike traditional methods that rely on visual interpretation or simple stenosis measurements, AI-QCT quantifies plaque burden, composition, and morphology with high precision. This allows clinicians to move beyond binary classifications of “blocked” or “not blocked” and instead assess the true biological risk of a patient’s coronary disease. The findings reinforce the potential of AI to transform cardiovascular risk stratification. By identifying patients with vulnerable plaque before symptoms escalate, clinicians can initiate preventive therapies—such as intensified lipid-lowering treatment or lifestyle interventions—earlier and more effectively. The study suggests that high-risk plaque features may become important therapeutic targets, paving the way for more proactive and precision-based management of heart disease. Cleerly’s mission is to eliminate heart attacks by establishing a new standard of care through AI-driven, noninvasive imaging. The company’s platform enhances clinical decision-making, improves patient outcomes, and increases health literacy across the care continuum. With a world-class team and a foundation in real-world data, Cleerly continues to advance the science of cardiovascular imaging. The CONFIRM2 results represent a major step forward in using artificial intelligence to uncover hidden cardiovascular risks. As AI becomes increasingly integrated into clinical practice, these findings could reshape how heart disease is detected, monitored, and treated—moving from reactive to predictive and preventive care. The study not only validates the power of AI in medical imaging but also highlights the urgent need to look beyond stenosis when assessing heart attack risk.
