Heartflow data from 20,000-patient registry reveals game-changing insights for coronary care 

What if a routine heart scan could do more than detect disease… What if it could actually help change the course? That’s the question Heartflow seems to be answering with its latest data from the DECIDE Registry, a landmark real-world study involving nearly 20,000 patients across the United States. 

The company’s AI-powered Plaque Analysis tool, which goes beyond traditional heart scans, led to changes in treatment plans for over half the patients studied. And it did so regardless of standard risk factors or conventional imaging findings. 

Presented at the 2025 Society of Cardiovascular Computed Tomography (SCCT) Annual Scientific Meeting, the results are prompting physicians to rethink how they assess and act on coronary artery disease (CAD). As Dr. Sarah Rinehart, medical director of cardiovascular imaging in Charleston, WV and co-lead principal investigator of the registry, put it, in a statement: 

“These data confirm what we’re seeing in clinical practice — Heartflow Plaque Analysis provides individualized insights that go beyond what a traditional analysis of a patient’s risk factors or CCTA alone can show. By quantifying plaque burden and characterizing higher-risk non-calcified plaque types, Heartflow’s technology empowers physicians to personalize care and intervene earlier, which can change the trajectory of a patient’s coronary health.” 

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Beyond what the eye can see 

Traditional tools like coronary computed tomography angiography (CCTA) and population-level risk scoring (age, hypertension, smoking, etc.) are useful but limited. They often miss the nuances of individual patient risk, especially when it comes to non-calcified or low-attenuation plaques, which can be just as dangerous as the more obvious calcium build-up. 

Heartflow’s Plaque Analysis uses AI to quantify all types of plaque, not just what shows up clearly on scans. That deeper insight led to an average reduction of 18.7mg/dL in LDL cholesterol among patients who had their treatment plans altered — translating to an estimated 15% drop in the risk of a cardiac event. Even patients with no calcified plaque at all saw change: 30% had their medical management adjusted based on the AI findings.

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Stratifying risk with AI 

To simplify these detailed insights into something actionable, Heartflow introduced a new Plaque Staging framework as part of the registry. Though still investigational, it groups patients into four categories, mild, moderate, severe, or extensive, based on AI-detected plaque volume and composition. 

The framework was developed using clinical outcomes from the FISH&CHIPS Study, which showed that patients in the higher plaque stages had up to five times the rate of cardiovascular events over 3.3 years. These findings were previously presented at the British Society of Cardiovascular Imaging in April 2025. 

“The results from the DECIDE Registry clearly show how Heartflow Plaque Analysis can meaningfully change CAD care, with more than half of patients seeing their treatment plans altered after Heartflow Plaque Analysis,” said Dr. Campbell Rogers, Chief Medical Officer at Heartflow. “We expect that tools like Plaque Staging will enhance the impact Heartflow Plaque Analysis is already making by providing a clearer framework for personalized patient care.” 

The bigger picture 

With around 20,000 patients enrolled at over 30 U.S. sites, the DECIDE Registry is not just about validating a tool; it’s about documenting a shift in clinical behavior. The primary endpoint looks at whether treatment decisions change after Plaque Analysis. But secondary outcomes include biomarker shifts, cardiovascular event rates, and even hospitalizations. 

The study’s early momentum has already earned recognition: Dr. Cian McCarthy, another lead investigator, received the top Clinical Trials and Registries Award at SCCT 2025. 

For a condition as common and potentially deadly as coronary artery disease, this kind of individualized insight, rooted in AI and real-world data, might just be what clinicians have been waiting for. 

Heartflow Plaque Analysis is FDA-cleared. Heartflow Plaque Staging is investigational only and not yet reviewed by the FDA. 

Join us at MedTech Malta 2025 

Want to hear more from experts and explore the frontiers of cardiovascular innovation? Join us at MedTech Malta 2025, happening from 12 to 14 November at the Mediterranean Conference Centre in Valletta. For more information or to get involved, reach out to us at [email protected].