| Three presentations at ACC reinforce Heartflow’s AI-powered technology predicts MACE, drives superior lipid outcomes and results in cost-effective care |
| First patient enrolled in pioneering NAVIGATE-PCI Registry assessing impact of Heartflow PCI Navigator on clinical strategy, efficiency and physician confidence across 5,000 patients |
MOUNTAIN VIEW, Calif., March 16, 2026 (GLOBE NEWSWIRE) -- Heartflow, Inc. (Heartflow) (Nasdaq: HTFL), the leader in AI technology for coronary artery disease (CAD), today announced new clinical evidence and a landmark registry launch that together advance the company's vision of transforming CAD management across every stage of the patient journey. At the American College of Cardiology (ACC) Annual Scientific Session, Heartflow is presenting new clinical evidence that further establishes AI-powered Heartflow Plaque Analysis as the leading tool for identifying high-risk patients earlier and guiding more effective medical management.
Simultaneously, Heartflow has enrolled the first patient in the NAVIGATE-PCI Registry, the first large-scale effort to evaluate the real-world impact of CT-guided percutaneous coronary intervention (PCI) planning on clinical strategy, procedural efficiency and physician confidence. The registry is evaluating how often treatment plans change when physicians use the AI-driven insights provided by Heartflow PCI Navigator compared to angiography alone.
“These milestones reflect tremendous progress toward Heartflow's goal of 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,” said Campbell Rogers, M.D., F.A.C.C., Chief Medical Officer at Heartflow. “The Heartflow Plaque Analysis data presented at ACC and the launch of the NAVIGATE-PCI Registry represent important steps in building the rigorous real-world evidence needed to support AI-driven decision-making across the full continuum of cardiovascular care. From identifying high-risk patients earlier and improving how they are managed to generating the evidence needed to guide more precise interventions when required, Heartflow is giving physicians deeper insights and greater confidence so they can deliver better outcomes for patients.”
Heartflow Plaque Analysis: New Clinical Evidence for Earlier Risk Stratification and Management
Heartflow Plaque Analysis will be featured in three ACC 2026 presentations, covering long-term validation of risk stratification, real-world comparative effectiveness in lipid management, and economic sustainability. Collectively, these data reinforce Plaque Analysis as a personalized, clinically actionable and cost-effective solution for CAD management.
AI-Based Coronary Plaque Analysis and Adverse Cardiovascular Events: The Mass General Brigham CCTA Registry (Poster 1082-09, March 29, 10:06 a.m. CDT)This cohort, based on a large-scale registry tracking over 15,000 patients, with up to 16 years of follow-up, demonstrated that Plaque Analysis is a powerful predictor of major adverse cardiovascular events (MACE), even after accounting for traditional risk factors and the severity of coronary stenosis. The findings reveal that patients with extensive plaque volume face a fourfold higher risk of such events. This robust, real-world data solidifies Heartflow Plaque Staging as the most powerful CTA-based independent predictor for personalized risk stratification, enabling clinicians to identify high-risk individuals beyond conventional metrics.
“Stenosis has long been our primary lens for evaluating coronary risk, but it tells an incomplete story, as this registry demonstrates. With over 15,000 patients and 16 years of follow-up, we now have compelling real-world evidence that total plaque volume independently drives adverse events, regardless of risk factors or the presence of anatomical stenosis,” said Ron Blankstein, M.D., Director of Cardiac Computed Tomography at Brigham and Women's Hospital, and Professor of Medicine and Radiology at Harvard Medical School. “These findings catalyze a meaningful shift in how we approach risk stratification by more accurately identifying patients who might otherwise have been characterized as having lower risk based on conventional assessment and optimizing management based on their actual disease burden.”
Comparative Effectiveness of Coronary Computed Tomographic Angiography With or Without AI-Plaque Analysis and Stress Testing on Lipid Lowering After One Year: A Primary Analysis of the DECIDE Registry (Poster 1469-058, March 29, 12:30 p.m. CDT)This analysis, involving nearly 3,800 patients, compared patient management guided by CCTA with Plaque Analysis versus traditional stress-test-guided care over a one-year follow-up. A significantly higher portion of patients whose care was informed by Plaque Analysis initiated lipid-lowering therapy and achieved guideline-recommended LDL goals (