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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 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 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 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 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 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 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 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 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 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 15% في خطر حدوث أحداث قلبية. Plaque Staging محدود بالتحقيق فقط؛ Heartflow Plaque Analysis حاصلة على موافقة FDA.
Positive
- Largest validation: nearly 8,000 symptomatic patients
- Highest TPV stage linked to HR 5.10 for major events (p
- DECIDE registry: average LDL −18.7 mg/dL at 90 days; expected 15% risk reduction
Negative
- 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 3.3 years. Associations persisted after adjustment for coronary stenosis, FFRCT and standard cardiovascular risk factors, which supports TPV as an independent prognostic marker rather than a simple proxy for stenosis.
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.
11/09/2025 – 01:30 PM
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 – Heartflow (Nasdaq: HTFL), a leader in the application of AI to coronary artery disease (CAD), unveiled compelling data from its FISH&CHIPS study at the American Heart Association (AHA) Scientific Sessions 2025. The findings reinforce the potential of AI-powered Heartflow Plaque Analysis with Heartflow Plaque Staging to redefine CAD care. Notably, the study highlights the framework as the most clinically validated approach for informed CAD management.
This retrospective analysis, encompassing nearly 8,000 symptomatic patients within the FISH&CHIPS cohort, represents the most extensive validation to date of Heartflow Plaque Staging, a framework predicated on total plaque volume (TPV) measurement.
Key findings include:
- Patients exhibiting the highest TPV stage demonstrated a risk of major cardiovascular events that was five times greater compared to those in the lowest stage (hazard ratio 5.10, p-value
- Higher plaque volume stages exhibited a separate but significant correlation with increased incidence of cardiovascular death and myocardial infarction over an average 3.3-year follow-up period.
- The observed correlations remained significant following adjustments for coronary stenosis, FFRCT values, and pre-existing cardiovascular risk factors.
“This study strongly supports the use of TPV-based staging via Heartflow Plaque Analysis as a predictor of future heart attacks and cardiovascular mortality,” remarked Dr. Timothy Fairbairn, principal investigator of the FISH&CHIPS study, Liverpool Heart and Chest Hospital, and Associate Professor at the University of Liverpool. “The ability to accurately quantify plaque burden will empower cardiologists to more effectively identify individuals at elevated risk, augmenting traditional risk stratification methods and enabling more personalized treatment strategies to mitigate future cardiac events.”
These results build upon previously reported data from the DECIDE Registry, presented at the Society of Cardiovascular Computed Tomography (SCCT) 2025 Annual Scientific Meeting. The DECIDE data showcased that Heartflow Plaque Analysis with Plaque Staging resulted in changes to the medical management strategy in over half of the patient population investigated, yielding an average reduction in LDL cholesterol of 18.7 mg/dL at 90 days. Modeling suggests that medical management adaptations informed by Heartflow Plaque Staging produce a clinically meaningful 15% reduction in the risk of future cardiac events.
“These findings underscore the transformative potential of AI-powered Heartflow Plaque Analysis coupled with Heartflow Plaque Staging to fundamentally reshape our approach to CAD management,” stated Dr. Campbell Rogers, Chief Medical Officer at Heartflow. “By integrating plaque insights directly into the diagnostic process, we can empower physicians with the critical information necessary to make more informed decisions and guide personalized, precision-based treatment strategies 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 leverages AI and the world’s largest coronary imaging dataset to drive precision cardiovascular care. Deployed in over 1,400 global institutions, Heartflow continues to expand its commercial footprint, facilitating broader access to this cutting-edge technology. Supported by ACC/AHA guidelines and underpinned by over 600 peer-reviewed publications, Heartflow’s impact is significant: nearly 500,000 patients worldwide have benefited from redefined clinical management. Key benefits include:
- Proprietary data pipeline: Heartflow leverages a data foundation comprising over 110 million annotated CTA images, powering advanced AI models that yield highly precise and reproducible insights across diverse patient populations.
- Extensive clinical and real-world validation: Clinical evidence from over 100 studies involving over 365,000 patients support Heartflow’s AI-driven solutions. Proven in real-world practice with reproducibility and accuracy, Heartflow’s coronary CTA image acceptance rates exceed 96%.
- Seamless clinical integration via upgraded workflow: Timely delivery of final quality-reviewed analyses enable clinicians to efficiently to move from diagnosis to decision.
- Quality system, global security and patient-data integrity compliance: Heartflow adheres to leading international standards, including HITRUST, SOC 2 Type 2, GDPR, HIPAA, CCPA, ISO 13485, and ISO 27001.
About Heartflow, Inc.
Heartflow is at the forefront of transforming coronary artery disease management, aiming to shift it from the world’s leading cause of death to a condition that can be detected early, diagnosed accurately, and managed effectively throughout a patient’s life. The Heartflow One platform employs sophisticated AI algorithms to generate personalized 3D models of the heart from standard coronary CTA images. This non-invasive process yields clinically relevant insights into plaque location, volume, composition, and its impact on blood flow. Discover more about Heartflow’s role in shaping cardiovascular care at heartflow.com.
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?
Heartflow presented FISH&CHIPS late-breaking data showing TPV-based Heartflow Plaque Analysis predicts long-term cardiovascular risk in nearly 8,000 patients.
How large was the patient cohort in the FISH&CHIPS HTFL analysis and what was follow-up duration?
The retrospective analysis evaluated nearly 8,000 symptomatic patients with a median follow-up of 3.3 years.
What was the risk difference reported for highest versus lowest TPV stage in the HTFL study?
Patients in the highest TPV stage had a 5.10 hazard ratio for major cardiovascular events versus the lowest stage (p
Did Heartflow report any clinical management impact tied to plaque staging (HTFL)?
Yes; DECIDE registry data showed plaque staging led to management changes and an average LDL reduction of 18.7 mg/dL at 90 days.
Does Heartflow Plaque Staging have FDA approval for clinical use (HTFL)?
No; Heartflow Plaque Analysis is FDA-cleared, but Heartflow Plaque Staging is described as investigational-only and not reviewed by the FDA for safety or effectiveness.
How did results hold up after adjusting for other risk measures in the HTFL FISH&CHIPS data?
Associations between higher TPV stages and events remained significant after adjustment for coronary stenosis, FFRCT values, and cardiovascular risk factors.
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