First plaque tool with prospective outcomes data. Faster, sustained LDL-C control: approximately 50% of patients reached goal by 90 days vs. approximately 35% with CCTA alone. 

GAMEFILM data highlight high prevalence of heart disease in retired NFL players, underscoring need for advanced plaque assessment

SAN FRANCISCO, Nov. 02, 2026 (GLOBE NEWSWIRE) — Heartflow, Inc. (Heartflow) (Nasdaq: HTFL), the leader in AI technology for diagnosing and managing coronary artery disease (CAD), today announced prospective clinical outcomes from the DECIDE registry will be presented at the American Heart Association (AHA) Scientific Sessions 2026. In an evaluation of more than 6,000 well-matched patients, Heartflow Plaque Analysis with Plaque Staging demonstrated a 34% reduction in major cardiovascular disease (CVD) events and half the rate of myocardial infarction (MI) at one year compared to coronary computed tomography angiography (CCTA) alone.

The significant reduction in major CVD events stemmed from meaningful shifts in patient care. By quantifying total plaque volume and staging disease severity, the platform equipped clinicians to optimize drug regimens earlier, driving a 41% early increase in patients achieving low-density lipoprotein cholesterol (LDL-C) goal, as compared to CCTA alone.

“The DECIDE registry answers the core questions in preventive cardiology: Does AI-powered coronary plaque analysis guide medical therapy? Does it empower patients to achieve target lipid goals? And ultimately, does it reduce major CVD events?” said Leslee Shaw, Ph.D., Director of the Blavatnik Family Research Institute at the Icahn School of Medicine at Mount Sinai, New York, and co-lead investigator of the DECIDE Registry. “The one-year findings demonstrate that Heartflow Plaque Analysis provides clinicians with the objective data needed to optimize preventive care earlier and with greater precision, while significantly reducing major CVD events and heart attacks compared to CCTA alone. By directly linking this non-invasive approach to targeted lipid lowering, it helps bridge diagnostic imaging with meaningful risk reduction in everyday practice.”

DECIDE Registry: Transforming Plaque Quantification into Preventive Outcomes
Moderated Digital 21, Nov. 9, 11:06 a.m. CT

Key DECIDE findings regarding use of Heartflow Plaque Analysis:

  • 34% fewer major CVD events (cardiovascular death, MI, revascularization or stroke) vs. CCTA alone and half the rate of MI over the first year.
  • Management changed in >50% of patients by 90 days.
  • 50% reached target LDL-C (<70 mg/dL) by 90 days vs. 35% with CCTA alone, sustained through one year.
  • 18.7 mg/dL average LDL-C reduction at 90 days with a management change, sustained at one year.

GAMEFILM: Heartflow AI Uncovers Hidden Heart Disease in 85% of Retired NFL Players
Moderated Digital 22, Nov. 9, 9:15 a.m. CT

Heartflow will also present findings from its groundbreaking GAMEFILM registry evaluating coronary artery disease in former professional athletes. Despite their history of elite physical conditioning, former football players often face long-term cardiac risks that standard visual tests can miss, with studies showing up to one in three former National Football League (NFL) players die from cardiovascular disease.1

The registry evaluated CAD in 200 retired NFL players using CCTA paired with Heartflow Plaque Analysis. Although fewer than 10% reported exertional symptoms (chest pain or dyspnea), quantitative plaque analysis revealed a high prevalence of hidden disease:

  • Detectable coronary plaque was present in 85% of the former NFL players, despite only 13% having a prior CAD diagnosis.
  • On average, nearly 90% of the detected plaque was soft (non-calcified), which is associated with higher disease risk than calcified plaque and cannot be detected by traditional coronary artery calcium scores.
  • 42% of former players had obstructive CAD (>50% stenosis), 33% had severe or extensive plaque burden, and 29% had functionally significant ischemia.
  • Retired linemen exhibited much higher plaque volumes for their age than non-linemen (63.3rd vs. 31.9th percentile).
  • 88% of players not currently on lipid-lowering therapy expressed willingness to initiate treatment following review of their AI plaque analysis results with a physician.

“Many former players are surprised to learn that even after years of elite training and staying active, coronary artery disease can be quietly building in their arteries, and it remains their greatest long-term health threat,” said Yiannis Chatzizisis, M.D., Ph.D., Professor of Cardiology and Chief of the Cardiovascular Division at the University of Miami Miller School of Medicine, and GAMEFILM investigator. “When these former NFL players could see the precise volume and type of plaque in their own arteries with Heartflow Plaque Analysis, nearly 9 in 10 of those not on cholesterol-lowering therapy said they were ready to begin treatment. GAMEFILM is helping us understand the burden of disease in former professional athletes and giving them personalized insights to act on their heart health while there’s still time to make a difference with medication and lifestyle changes.”

Building on its success enrolling retired players from the NFL, National Basketball Association (NBA) and National Hockey League (NHL), the GAMEFILM registry has now expanded to include former players from Major League Baseball (MLB), as well as professional staff from these leagues and U.S. college sports teams. This expansion broadens Heartflow’s initiative to evaluate hidden cardiovascular risk and support proactive, long-term disease management of former professional athletes across major sports.

“Achieving faster, durable lipid control is a vital goal, and seeing that translate into a 34% reduction in one-year major CVD events in the DECIDE data is extraordinary,” said Campbell Rogers, M.D., F.A.C.C., Chief Medical Officer at Heartflow. “From the more than 6,000-patient DECIDE registry to our GAMEFILM registry, the data being presented at AHA prove that Heartflow Plaque Analysis goes beyond detecting disease to altering patient trajectories and connecting non-invasive precision to proactive, life-saving prevention.”

Experience Heartflow Plaque Analysis with Plaque Staging at AHA 2026

AHA 2026 attendees are invited to visit Heartflow at exhibit booth #711 for live demonstrations of Heartflow Plaque Analysis and Heartflow FFRCT Analysis. See the full schedule of other Heartflow programs, including an expert theater, simulation zone, and more at event.heartflow.com/aha2026.

About Heartflow Plaque Analysis with Plaque Staging

Heartflow Plaque Analysis is the only FDA-cleared, AI-powered plaque analysis tool with 95% agreement against the gold standard, intravascular ultrasound (IVUS), in a prospective, international trial.2 Heartflow Plaque Staging builds on this foundation, categorizing plaque burden into clinical risk stages to guide actionable risk stratification.3,4 The framework is validated in 23,000 patients with up to 16 years of follow-up, offering the reproducibility clinicians need for serial monitoring and individualized preventive care.

About Heartflow’s Technology and Research

Heartflow’s technology is redefining precision diagnostic testing and management for coronary artery disease (CAD) through clinically proven AI and the world’s largest coronary imaging dataset. Heartflow has been adopted by more than 1,800 institutions globally and continues to strengthen its commercial presence to make this cutting-edge solution more widely available to an increasingly diverse patient population. Backed by American College of Cardiology and American Heart Association (ACC/AHA) guidelines and supported by more than 625 peer-reviewed publications, Heartflow has redefined how clinicians manage care for over 750,000 patients worldwide.5 Key benefits include:

  • Unmatched proprietary data pipeline: Built from the world’s largest database of more than 200 million annotated CTA images, Heartflow’s data foundation powers advanced AI models that deliver highly accurate, reproducible diagnostic insights across diverse patient populations.
  • Extensive clinical and real-world validation: Heartflow’s AI-driven solutions have been validated through clinical evidence in over 200 studies assessing over 365,000 patients. Heartflow is the only AI platform prospectively validated against invasive gold standards and demonstrated through real-world evidence to improve patient outcomes.3,6,7,8 Proven in real-world practice with reproducibility and accuracy, Heartflow’s coronary CTA image acceptance rates exceed 97%.
  • Seamless clinical integration via upgraded workflow: Heartflow delivers final quality-reviewed analyses instantly upon order, enabling clinicians to move from diagnosis to decision without delay.
  • Quality system, global security and patient-data integrity compliance: Heartflow meets or exceeds leading international standards, including HITRUST r2, SOC 2 Type 2, MDSAP, ISO 13485, and ISO 27001.

About Heartflow, Inc.

Heartflow is transforming coronary artery disease from the world’s leading cause of death into a condition that can be detected early, diagnosed accurately, and managed for life. The Heartflow One platform uses AI to turn coronary CTA images into personalized 3D models of the heart, providing clinically meaningful, actionable insights into plaque location, volume, and composition and its effect on blood flow — all without invasive procedures. Discover how we’re shaping the future of cardiovascular care at heartflow.com.

Media Contact
Elliot Levy
elevy@heartflow.com

Investor Contact
Nick Laudico
nlaudico@heartflow.com

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1 Venkataramani AS, Gandhavadi M, Jena AB. Association between playing American football… JAMA. 2018;319:800–806. https://doi.org/10.1001/jama.2018.0140
2 Ihdayhid A, et al. Radiol Cardiothorac Imaging. 2024. doi: 10.1148/ryct.230312 and internal bridging study with ICC correlation between first generation and second generation Plaque Analysis algorithm.
3 Rinehart, et al. JACC Imaging. 2025.
4 Fairbairn et al. Coronary CT Angiography Plaque as a Predictor of Death, Cardiovascular Death and Myocardial Infarction. Presented at AHA 2025. (Real-world study with n=7,899 patients, higher TPV results in increased cardiovascular death and MI)
5 Gulati M, et al. 2021 AHA/ACC/ASE/CHEST/SAEM/SCCT/SCAI Guideline for the Evaluation and Diagnosis of Chest Pain. Circulation 2021; 144:e368–e454.
6 Narula, et al. EHJ CVI 2024.
7 Danad, et al. JAMA Cardiol 2017.
8 Madsen KT, et al. ADVANCE-DK 7-year. Presented at TCT Scientific Sessions 2024. (n=900 patients determined a 2.5x increase in cardiovascular events or deaths at 7 years).


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Heartflow, Inc.