TCT 2026: CT-guided PCI Matches IVUS Outcomes in Randomized P4 Trial; Heartflow PCI Navigator Changes PCI Plans in Approximately 70% of Patients

(NASDAQ:HTFL) Heartflow, Inc. announced new randomized clinical data at the Transcatheter Cardiovascular Therapeutics (TCT) symposium, demonstrating that CT-guided percutaneous coronary intervention (PCI) matches gold-standard intravascular ultrasound (IVUS) outcomes with greater procedural efficiency. The P4 randomized clinical trial enrolled 1,105 patients across 23 centers in the U.S., Europe, and Japan, and met its primary endpoint by showing CT-guided PCI planning was non-inferior to IVUS for one-year clinical outcomes. 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%). The NAVIGATE-PCI registry, involving 203 patients, showed that treatment plans were modified in approximately 70% of cases after physicians reviewed Heartflow PCI Navigator, 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 angiography-based plans. The BRAVEHEART registry evaluated 96 asymptomatic firefighters with at least 10 years of occupational smoke exposure, finding subclinical coronary plaque in 72% and severe total plaque volume (>250 mm³) in 16%. Following review of their CCTA and Heartflow Analysis, 68% of participants were willing to initiate lipid-lowering therapy and 93% committed to lifestyle modifications. Heartflow Plaque Analysis is the only FDA-cleared, AI-powered plaque analysis tool with 95% agreement against IVUS in a prospective, international trial. The Heartflow Plaque Staging framework is validated in 23,000 patients with up to 16 years of follow-up. Heartflow’s technology is supported by more than 625 peer-reviewed publications and has been adopted by over 1,800 institutions globally, managing care for over 750,000 patients worldwide. Heartflow’s AI models are powered by a database of more than 200 million annotated CTA images. Clinical validation includes over 200 studies assessing over 365,000 patients. Heartflow’s coronary CTA image acceptance rates exceed 97%. The company meets or exceeds international standards including HITRUST r2, SOC 2 Type 2, MDSAP, ISO 13485, and ISO 27001.