お知らせ • Mar 16
Heartflow, Inc. Builds Evidence Base Across The Heart Disease Care Continuum
Heartflow, Inc. 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. 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. 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. 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. 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 (<70 mg/dL). These findings demonstrate that Heartflow's AI-powered insights optimize medical management, pushing beyond conventional diagnostic pathways for more precise and effective treatment outcomes, regardless of traditional risk factors. The primary endpoint data from the landmark DECIDE Registry, the largest prospective registry evaluating the clinical impact of Heartflow Plaque Analysis on medical management decisions, were recently published in JACC Cardiovascular Imaging. This study demonstrated that Plaque Analysis is not only clinically impactful, but also economically sustainable. The analysis revealed that cost-effectiveness and parity with usual care are achieved in under two years with total population savings of $140 million, as incremental testing costs to prevent a single MACE fall significantly below the actual cost of treating a MACE. This research reinforces prevention as a critical value-based care strategy, highlighting how Heartflow's technology delivers substantial long-term savings and improved patient outcomes for both payers and healthcare systems. Heartflow Plaque Analysis is the only FDA-cleared, AI-powered plaque analysis tool with a reported 95% agreement with the gold standard, intravascular ultrasound (IVUS), in a prospective, international trial using blinded core lab adjudication. Heartflow Plaque Staging guides patient risk stratification based on total plaque volume, informing actionable treatment plans, simplifying decision-making and personalizing preventive treatment based on patient risk. Heartflow is expanding the Heartflow One platform with the addition of Heartflow PCI Navigator to support diagnosing, managing and guiding treatment for patients throughout the spectrum of CAD care. PCI Navigator is the only integrated, AI-driven percutaneous coronary interventions (PCI) planning tool that gives interventional cardiologists a patient-specific 3D model detailing anatomy, plaque composition, and lesion-specific physiology, all aligned to optimize potential stent placement. Heartflow introduced PCI Navigator to close the critical information gaps interventional cardiologists face before entering the cardiac catheterization lab. Commercial availability of PCI Navigator is expected in the second quarter of 2026. Heartflow’s technology is redefining precision cardiovascular care through clinically proven AI and the world’s largest coronary imaging dataset. Heartflow has been adopted by more than 1,400 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 ACC/AHA guidelines and supported by more than 600 peer-reviewed publications, Heartflow has redefined how clinicians manage care for over 500,000 patients worldwide. Key benefits include: Proprietary data pipeline: Built from more than 160 million annotated CTA images, Heartflow’s data foundation powers advanced AI models that deliver highly accurate, reproducible 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. 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, SOC 2 Type 2, ISO 13485, and ISO 27001.
