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

Heartflow, Inc. (Heartflow) (Nasdaq: HTFL), the leader in AI technology for diagnosing and managing coronary artery disease (CAD), 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 70% of cases after incorporating 3D anatomic, plaque, and physiologic insights from Heartflow PCI Navigator compared to standard invasive coronary angiography alone.

“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 FFR_CT 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 FFR_CT 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), with 16% 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, while 93% committed to lifestyle modifications.