TCT 2026: CT-guided PCI Matches IVUS Outcomes in Randomized P4 Trial; Heartflow PCI Navigator Changes PCI Plans in Approximately 70% of Patients
CT-guided planning delivered comparable one-year outcomes to IVUS while reducing median procedure time by 17 minutes.
Sentiment and the balance of points
Rhea-AI Sentiment reads the wording of the document, how positive or negative its language is on a 1 to 5 scale. The balance of points shown with the takes weighs what the document actually discloses, so the two can disagree, for example when a trial that missed its main goal is described in upbeat language.
Rhea-AI Summary
Heartflow (HTFL) announced that the randomized P4 trial met its primary endpoint, supporting CT-guided planning for percutaneous coronary intervention (PCI).
The 1,105-patient trial found CT-guided planning non-inferior to intravascular ultrasound (IVUS), imaging performed inside blood vessels. Twelve-month target-vessel failure was 4.1% versus 4.6%. Median procedure time was 46 versus 63 minutes, and median contrast volume was 150 versus 170 mL. P4 used Heartflow FFRCT Analysis and Heartflow Planner, an earlier version of PCI Navigator.
In the separate 203-patient NAVIGATE-PCI registry, physicians modified treatment plans in approximately 70% of patients after reviewing PCI Navigator, compared with angiography alone. Changes included stent length in 41% and lesion preparation technique in 12%. Physicians also reported higher confidence in Navigator-based plans.
How this balance works
Rhea-AI gives every point it takes from this document a weight. Minor counts 1, Moderate 3 and Major 9, so one Major point outweighs several Minor ones. The bar adds up the weights on each side, and when neither side holds more than 65% of the total the balance reads Mixed.
It reads the document as published, with the same rules for every company, and it does not look at what the market expected or at how the stock traded, so a point can be objectively good on a day the stock falls.
Rhea-AI Sentiment measures something else, the tone of the wording.
Positive
- Major pointP4 met its non-inferiority primary endpoint: 12-month target-vessel failure was 4.1% with CT guidance versus 4.6% with IVUS.
- Minor pointMedian procedure time was 17 minutes shorter with CT guidance: 46 versus 63 minutes, a 27% reduction.
- Minor pointMedian contrast volume was approximately 12% lower with CT guidance: 150 mL versus 170 mL.
- Minor pointPCI Navigator prompted treatment-plan changes in approximately 70% of NAVIGATE-PCI patients versus angiography alone.
- Minor pointStent-length changes occurred in 41% of NAVIGATE-PCI patients after PCI Navigator review.
2 minor points
- Minor pointLesion preparation technique changed in 12% of NAVIGATE-PCI patients after PCI Navigator review.
- Minor pointPhysicians rated PCI Navigator plans with higher confidence than angiography-based plans.
Negative
- None.
News Explained
Heartflow says BRAVEHEART registry findings will be presented on
Key Figures
- P4 randomized patients
- 1,105 patients
- P4 trial
- 12-month target-vessel failure
- 4.1% vs. 4.6%
- CT-guided PCI vs. IVUS
- Median procedure time
- 46 vs. 63 minutes; 17 minutes shorter
- CT-guided PCI vs. IVUS
- Median contrast volume
- 150 mL vs. 170 mL; approximately 12% lower
- CT-guided arm vs. IVUS
- Advanced calcium modification
- 9.2% vs. 3.8%
- CT-guided PCI vs. IVUS
- NAVIGATE-PCI treatment plans modified
- Approximately 70%
- 203-patient registry cohort
- Stent length changes
- 41%
- Most frequent NAVIGATE-PCI plan changes
- Lesion preparation technique changes
- 12%
- NAVIGATE-PCI plan changes
Key Terms
ivus medical
ccta medical
ffrct medical
AI-generated analysis. How Rhea-AI works. Not financial advice.
Late-Breaking P4 study, simultaneously published in NEJM, shows CT guidance delivers matched one-year clinical outcomes with shorter procedures, demonstrating pre-procedural CCTA can guide key PCI planning decisions
NAVIGATE-PCI shows Heartflow PCI Navigator drove modifications to stent length and lesion prep compared to angiography alone
SAN FRANCISCO, Nov. 01, 2026 (GLOBE NEWSWIRE) -- Heartflow, Inc. (Heartflow) (Nasdaq: HTFL), the leader in AI technology for diagnosing and managing coronary artery disease (CAD), today announced new landmark randomized clinical data presented at Transcatheter Cardiovascular Therapeutics (TCT), the annual scientific symposium of the Cardiovascular Research Foundation, demonstrating computed tomography (CT)-guided percutaneous coronary intervention (PCI) matches gold-standard imaging outcomes with greater efficiency. These data are supported by registry insights on the procedural impact of Heartflow PCI Navigator.
In a late-breaking presentation simultaneously published in the New England Journal of Medicine (NEJM), the 1,105-patient P4 randomized clinical trial met its primary endpoint, demonstrating that CT-guided PCI planning was non-inferior to gold-standard intravascular ultrasound (IVUS) for one-year clinical outcomes. In the largest randomized trial of its kind, CT guidance achieved these matched results compared to IVUS while significantly improving procedural efficiency, delivering faster procedure times and utilizing lower contrast volume. Data from the NAVIGATE-PCI registry showed that interventional cardiologists altered their procedural strategy in approximately
“CT has already become routine for planning structural procedures like TAVR. The data presented at TCT show coronary intervention is ready to follow the same path with advanced pre-procedural imaging and Heartflow’s AI-powered analysis to deliver precision and efficiency,” said Campbell Rogers, M.D., F.A.C.C., Chief Medical Officer at Heartflow. “What we learned planning P4 cases across six separate tools shaped Heartflow PCI Navigator, which brings anatomy, plaque and physiology together in the first and only PCI planning tool backed by prospectively validated accuracy and randomized clinical trial data. Together, P4 and NAVIGATE-PCI support a paradigm shift in coronary intervention, bringing non-invasive CT-guided PCI planning into routine cath lab practice.”
P4 Trial: Validating CT-guided PCI Against IVUS with Greater Efficiency
Main Arena 4, November 1
The Heartflow-supported, investigator-initiated P4 trial directly evaluated the clinical efficacy of non-invasive CT-guided PCI planning against invasive IVUS guidance.
Enrolling 1,105 patients across 23 centers in the U.S., Europe, and Japan, P4 randomized stable CAD patients to either CT-guided PCI planning, including Heartflow FFRCT Analysis and Heartflow Planner (an earlier version of Heartflow PCI Navigator), or intra-procedural IVUS guidance.
Key P4 trial one-year findings showed CT-guided PCI matched IVUS on outcomes while enabling a faster procedure and lower contrast use, including:
- CT-guided PCI matched IVUS for the primary endpoint of 12-month target-vessel failure (
4.1% vs.4.6% ). - CT-guided PCI had a 17-minute shorter median procedure time than IVUS (46 minutes vs. 63 minutes, a
27% reduction). - Contrast volume was reduced by approximately
12% in the CT-guided arm (median 150 mL vs. 170 mL). - CT-guided PCI more than doubled the use of advanced calcium modification (
9.2% vs.3.8% ).
“Intravascular ultrasound is an established benchmark, but performing assessments inside the cath lab adds procedural time and requires expertise,” said Carlos Collet, M.D., Ph.D., principal investigator of the P4 trial and Director of Cardiovascular Imaging, Physiology and Translational Therapeutics at the Cardiovascular Research Foundation in New York. “P4 shows that non-invasive CT-guided PCI planning achieves comparable clinical outcomes with shorter procedure times and less contrast, enabling interventionalists to anticipate challenges, tailor their strategy, and enter the cath lab better prepared.”
NAVIGATE-PCI Registry: Optimizing Strategy Before Entering the Cath Lab
TCT AI Lab 3, November 1
NAVIGATE-PCI is a prospective, multi-center registry evaluating the real-world utility of Heartflow PCI Navigator, the first and only integrated, AI-driven PCI planning tool that gives interventional cardiologists a patient-specific 3D model detailing anatomy, plaque composition, and lesion-specific physiology, all aligned to streamline procedures with increased efficiency and clinical confidence. In the 203-patient cohort presented at TCT, investigators evaluated how access to integrated pre-procedural insights altered treatment strategies established immediately after invasive angiography.
Key NAVIGATE-PCI findings include:
- Treatment plans were modified in approximately
70% of patients after physicians reviewed Heartflow PCI Navigator prior to intervention, compared to angiography alone. The most frequent changes included stent length (41% ) and lesion preparation technique (12% ). - Physicians rated their PCI Navigator plans with higher confidence than their angiography-based plans.
“Angiography only shows a two-dimensional silhouette, leaving critical blind spots around plaque burden, calcium and true vessel size,” said Ziad A. Ali, M.D., D.Phil., principal investigator of the NAVIGATE-PCI registry and Director of the DeMatteis Cardiovascular Institute at St. Francis Heart Center in New York. “Heartflow PCI Navigator fundamentally changes our approach, providing the comprehensive 3D and physiologic clarity needed to tailor treatment plans with greater confidence before entering the cath lab.”
The BRAVEHEART Registry: Revealing High CAD Burden in Firefighters to Accelerate Prevention
TCT 1488, November 3
Highlighting the impact of Heartflow’s technology across the entire continuum of care, investigators will also present data from the prospective BRAVEHEART registry. The study evaluated the use of AI-powered Heartflow Plaque Analysis and Heartflow FFRCT Analysis to identify hidden coronary risk and encourage earlier preventive therapy in 96 asymptomatic firefighters with at least 10 years of occupational smoke exposure.
Key BRAVEHEART findings include:
- Subclinical coronary plaque was identified in
72% of asymptomatic firefighters (mean age 48.1 years), with16% presenting with severe total plaque volume (>250 mm³). - Willingness to initiate lipid-lowering medical therapy was reported by
68% of participants following review of their CCTA and Heartflow Analysis insights, while93% committed to lifestyle modifications.
Experience Heartflow PCI Navigator at TCT 2026
TCT 2026 attendees are invited to visit Heartflow at exhibit booth #3819 for live demonstrations of Heartflow PCI Navigator. See the full schedule of other Heartflow programs, including a lunch symposium, hands-on training workshops, and more at event.heartflow.com/tct2026.
About Heartflow PCI Navigator
Heartflow expanded 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 intervention (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.
About Heartflow Plaque Analysis with Plaque Staging
Heartflow Plaque Analysis is the only FDA-cleared, AI-powered plaque analysis tool with
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.4 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.3,5,6,7 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
_____________________________
1 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.
2 Rinehart, et al. JACC Imaging. 2025.
3 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)h
4 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.
5 Narula, et al. EHJ CVI 2024.
6 Danad, et al. JAMA Cardiol 2017.
7 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).
FAQ
AI-generated questions and answers. How Rhea-AI works. Not financial advice.
What did Heartflow’s P4 trial show about CT-guided PCI outcomes?
P4 met its primary endpoint, showing CT-guided PCI planning was non-inferior to IVUS guidance for one-year clinical outcomes. Twelve-month target-vessel failure was 4.1% with CT guidance versus 4.6% with IVUS. Median procedure time was 46 versus 63 minutes.
Which patients and Heartflow tools were included in the P4 trial?
P4 randomized 1,105 patients with stable coronary artery disease across 23 centers in the U.S., Europe, and Japan. The CT-guided planning arm included Heartflow FFRCT Analysis and Heartflow Planner, an earlier version of PCI Navigator; the comparison arm used IVUS guidance during the procedure.
How did advanced calcium modification differ between groups in Heartflow’s P4 trial?
Advanced calcium modification was used in 9.2% of CT-guided PCI cases versus 3.8% of IVUS-guided cases, more than doubling its use.