AHA 2025: Late-Breaking Data Reinforce the Prognostic Power of AI-Driven Heartflow Plaque Analysis as the Most Clinically Validated Framework for Coronary Risk Stratification
Heartflow (Nasdaq: HTFL) reported late-breaking FISH&CHIPS results at AHA 2025 showing AI-driven Heartflow Plaque Analysis total plaque volume (TPV) staging predicts long-term coronary risk.
Key data: a retrospective cohort of nearly 8,000 symptomatic patients; highest TPV stage had a hazard ratio 5.10 (p < 0.0001) for major cardiovascular events over a median 3.3 years. Associations remained after adjustment for stenosis, FFRCT and risk factors. Related DECIDE registry data showed medical-management changes with an average LDL reduction of 18.7 mg/dL at 90 days and an expected 15% decrease in cardiac event risk. Plaque Staging is investigational-only; Heartflow Plaque Analysis is FDA-cleared.
Heartflow (Nasdaq: HTFL) ha riportato agli ultimi aggiornamenti all'AHA 2025 risultati FISH&CHIPS che mostrano che, basata sull'IA, Heartflow Plaque Analysis la valutazione TPV (volumetria totale della placca) permette di classificare il rischio coronarico a lungo termine.
Dati chiave: una coorte retrospectiva di quasi 8.000 pazienti sintomatici; lo stadio TPV più alto aveva un hazard ratio 5,10 (p < 0,0001) per eventi cardiovascolari maggiori nel corso di una mediana di 3,3 anni. Le associazioni sono rimaste dopo aggiustamento per stenosi, FFRCT e fattori di rischio. Dati correlati del registro DECIDE hanno mostrato cambiamenti nella gestione medica con una riduzione media del LDL di 18,7 mg/dL a 90 giorni e una prevista riduzione del 15% del rischio di eventi cardiaci. Plaque Staging è investigazionale; Heartflow Plaque Analysis è approvato dalla FDA.
Heartflow (Nasdaq: HTFL) informó resultados de FISH&CHIPS publicados tarde en AHA 2025 que muestran que la Heartflow Plaque Analysis impulsada por IA, la clasificación de PLaque por TPV, predice el riesgo coronario a largo plazo.
Datos clave: una cohorte retrospectiva de casi 8,000 pacientes sintomáticos; el estadio de TPV más alto tenía una hazard ratio 5,10 (p < 0,0001) para eventos cardiovasculares mayores en una mediana de 3,3 años. Las asociaciones se mantuvieron tras ajustar por estenosis, FFRCT y factores de riesgo. Datos relacionados del registro DECIDE mostraron cambios en el manejo médico con una reducción media de LDL de 18,7 mg/dL a los 90 días y una prevista reducción del 15% en el riesgo de eventos cardíacos. Plaque Staging es solo de investigación; Heartflow Plaque Analysis está aprobado por la FDA.
Heartflow (Nasdaq: HTFL)는 AHA 2025에서 FISH&CHIPS의 최신 발표 결과를 발표했고, AI 기반의 Heartflow Plaque Analysis가 총 플라크 부피(TPV) 분류를 통해 장기 관상동맥 위험을 예측한다고 제시했습니다.
핵심 데이터: 거의 8,000명의 증상 환자에 대한 회고적 코호트; 가장 높은 TPV 단계에서 주요 심혈관 사건의 위험비가 5.10( p < 0.0001)였고 중앙값 3.3년 동안 관찰되었습니다. 협착, FFRCT 및 위험 요인으로 교정한 후에도 연관성은 남았습니다. 관련 DECIDE 레지스트리 데이터는 의학적 관리 변화와 90일 시 LDL 감소 18.7 mg/dL의 평균 감소 및 심장 사건 위험의 15% 감소를 보여주었습니다. Plaque Staging은 연구용이며, Heartflow Plaque Analysis는 FDA 승인을 받았습니다.
Heartflow (Nasdaq: HTFL) a annoncé lors de l'AHA 2025 des résultats FISH&CHIPS de dernière heure montrant que l'IA Heartflow Plaque Analysis, évaluation TPV (volume total de plaque), permet de prédire le risque coronaire à long terme.
Données clés : une cohorte rétrospective d nearly 8 000 patients symptomatiques ; le stade TPV le plus élevé avait un hazard ratio 5,10 (p < 0,0001) pour les événements cardiovasculaires majeurs sur une médiane de 3,3 ans. Les associations sont restées après ajustement pour la sténose, le FFRCT et les facteurs de risque. Des données associées du registre DECIDE ont montré des modifications de la prise en charge médicale avec une réduction moyenne du LDL de 18,7 mg/dL à 90 jours et une diminution attendue de 15% du risque d'événements cardiaques. Plaque Staging est purement investigatif; Heartflow Plaque Analysis est approuvé par la FDA.
Heartflow (Nasdaq: HTFL) meldete auf der AHA 2025 späte Ergebnisse von FISH&CHIPS, die zeigen, dass die AI-gesteuerte Heartflow Plaque Analysis die Gesamtplakkovolumen-Staging (TPV) verwendet, um das langfristige koronare Risiko vorherzusagen.
Wesentliche Daten: eine retrospektive Kohorte von nahezu 8.000 symptomatischen Patienten; der höchste TPV-Stadium hatte ein Hazard Ratio 5,10 (p < 0,0001) für schwere kardiovaskuläre Ereignisse über eine mittlere Beobachtungsdauer von 3,3 Jahren. Die Zusammenhänge blieben nach Anpassung an Stenose, FFRCT und Risikofaktoren bestehen. Verwandte DECIDE-Registrierungsdaten zeigten Änderungen in der medizinischen Behandlung mit einer durchschnittlichen LDL-Senkung von 18,7 mg/dL nach 90 Tagen und einer erwarteten 15%-igen Verringerung des Risikos kardialer Ereignisse. Plaque Staging ist rein investigativ; Heartflow Plaque Analysis ist von der FDA freigegeben.
Heartflow (ناسداك: HTFL) أبلغت عن نتائج متقدمة من FISH&CHIPS في AHA 2025 تُظهر أن Heartflow Plaque Analysis المعتمدة على الذكاء الاصطناعي، وتقييم TPV (الحجم الإجمالي لللوحات)، يتنبأ بالمخاطر التاجية على المدى الطويل.
البيانات الرئيسية: مجموعة استعادية من ما يقرب من 8,000 مريض مصحوبين بأعراض؛ كان أعلى مرحلة TPV لها نسبة مخاطر 5.10 (p < 0.0001) للأحداث القلبية الوعائية الكبرى على مدى وسطي قدره 3.3 سنوات. بقيت العلاقات بعد التadjust لمتلازمة التضيق، وFFRCT وعوامل الخطر. أظهرت بيانات سجل DECIDE المرتبط تغيرات في الإدارة الطبية مع انخفاض LDL بمقدار 18.7 ملغم/دdl على مدى 90 يوماً وتوقع انخفاضاً قدره 15% في خطر حدوث أحداث قلبية. Plaque Staging محدود بالتحقيق فقط؛ Heartflow Plaque Analysis حاصلة على موافقة FDA.
- Largest validation: nearly 8,000 symptomatic patients
- Highest TPV stage linked to HR 5.10 for major events (p<0.0001)
- DECIDE registry: average LDL −18.7 mg/dL at 90 days; expected 15% risk reduction
- Retrospective study design limits causal inference
- Heartflow Plaque Staging is investigational-only and not reviewed for safety/effectiveness by FDA
Insights
Large multicenter outcomes data link Heartflow total plaque volume staging to substantially higher long‑term cardiovascular risk.
The analysis of nearly 8,000 symptomatic patients shows that higher total plaque volume (TPV) measured by Heartflow Plaque Analysis stratifies event risk: the highest TPV stage had a hazard ratio of 5.10 (p-value <0.0001) for major cardiovascular events versus the lowest stage, over a median follow-up of
Risks and dependencies include that Heartflow Plaque Staging is described as investigational-only and not FDA‑reviewed for that framework, which limits immediate regulatory or guideline adoption. The retrospective nature of the analysis also constrains causal inference about management changes driving outcomes. Concrete items to watch include further prospective validation, regulatory status for the staging framework, and follow-up event data; near-term signals to monitor are replication in prospective cohorts and any formal FDA review or label expansion within the next 12–24 months.
Multicenter outcomes FISH&CHIPS study of nearly 8,000 patients confirms total plaque volume as a powerful independent predictor of long-term cardiovascular events
NEW ORLEANS, Nov. 09, 2025 (GLOBE NEWSWIRE) -- Heartflow, Inc. (Heartflow) (Nasdaq: HTFL), the leader in AI technology for coronary artery disease (CAD), today announced late-breaking data from the FISH&CHIPS Study presented at the American Heart Association (AHA) Scientific Sessions 2025. The new data add to the robust and growing body of evidence supporting AI-powered Heartflow Plaque Analysis with Heartflow Plaque Staging* — the most clinically validated framework for actionable CAD care.
The retrospective analysis, which evaluated nearly 8,000 symptomatic patients from a cohort of the FISH&CHIPS Study, represents the largest validation to date of the Heartflow Plaque Staging framework based on total plaque volume (TPV) measurement.1
Key findings include:
- Patients in the highest TPV stage experienced more than a 5x greater risk of major cardiovascular events compared with patients in the lowest stage (hazard ratio 5.10, p-value < 0.0001).
- Higher plaque volume stages were independently associated with significantly increased rates of cardiovascular death and myocardial infarction over a median 3.3 years of follow-up.
- Associations remained significant after adjustment for coronary stenosis, FFRCT values and cardiovascular risk factors.
“This study provides strong validation of TPV-based staging measured with Heartflow Plaque Analysis as a predictor of future heart attacks or cardiovascular death,” said Timothy Fairbairn, Ph.D., principal investigator for the FISH&CHIPS study, Liverpool Heart and Chest Hospital, and Associate Professor at the University of Liverpool, UK. “The ability to accurately measure plaque will enable cardiologists to better predict which patients are most at risk above the traditional risk factors, and thus personalize treatment, in order to prevent heart attacks or death in the future.”
The findings build on results from the DECIDE Registry presented at the Society of Cardiovascular Computed Tomography (SCCT) 2025 Annual Scientific Meeting in July. DECIDE data showed that Heartflow Plaque Analysis with Plaque Staging led to changes in medical management for more than half of patients, resulting in an average reduction in LDL cholesterol of 18.7 mg/dL at 90 days. These results indicate management changes guided by Heartflow Plaque Staging result in an expected
“We are demonstrating how AI-powered Heartflow Plaque Analysis with Heartflow Plaque Staging can fundamentally change the way we manage CAD,” said Campbell Rogers, M.D., F.A.C.C., Chief Medical Officer at Heartflow. “These latest findings show that by embedding plaque insights directly into the diagnostic pathway, we can help physicians make more confident decisions to guide personalized and precise treatment for their patients.”
*Heartflow Plaque Analysis is an FDA-cleared device. Heartflow Plaque Staging is an investigational-only framework, and its safety and effectiveness have not been reviewed by the FDA.
About Heartflow’s Technology and Research
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 nearly 500,000 patients worldwide. Key benefits include:
- Proprietary data pipeline: Built from more than 110 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 100 studies assessing over 365,000 patients. Proven in real-world practice with reproducibility and accuracy, Heartflow’s coronary CTA image acceptance rates exceed
96% . - 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, GDPR, HIPAA, CCPA, 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 Fairbairn et al. AHA 2025.
2 Rinehart SJ, et al. DECIDE Primary Outcomes. J Cardiovasc Comput Tomogr. 2025; 19(4):S78-79. doi.org/10.1016/j.jcct.2025.05.185
3 Collins et al. Lancet 2016. DOI: 10.1016/S0140-6736(16)31357-5
4 Fairbairn et al. HEART. 2025. doi:10.1136/heartjnl-2025-BSCI.5
FAQ
What did Heartflow (HTFL) announce at AHA 2025 on November 9, 2025?
How large was the patient cohort in the FISH&CHIPS HTFL analysis and what was follow-up duration?
What was the risk difference reported for highest versus lowest TPV stage in the HTFL study?
Did Heartflow report any clinical management impact tied to plaque staging (HTFL)?
Does Heartflow Plaque Staging have FDA approval for clinical use (HTFL)?
How did results hold up after adjusting for other risk measures in the HTFL FISH&CHIPS data?
