Heartflow's CT planning matches IVUS in a 1,105-patient PCI trial

MedDevice Startups Staff · 4 days ago · 2 min read · Via Heartflow release

Heartflow says planning a coronary intervention from CT angiography works as well as guiding it with intravascular ultrasound. Target-vessel failure at 12 months was 4.1 percent with CT planning and 4.6 percent with IVUS. The P4 trial met its primary endpoint of non-inferiority. Results ran in the New England Journal of Medicine on November 1 and were presented the same day at TCT 2026 in San Diego.

P4 randomized 1,105 patients with stable coronary disease at 23 centers in the United States, Europe and Japan. Carlos Collet of the Cardiovascular Research Foundation was principal investigator. Median procedure time fell to 46 minutes from 63, a 27 percent cut. Median contrast volume dropped to 150 mL from 170. Operators reached for advanced calcium modification in 9.2 percent of CT-planned cases against 3.8 percent in the IVUS arm.

Heartflow also reported the NAVIGATE-PCI registry, a 203-patient cohort led by Ziad Ali of St. Francis Heart Center. Reviewing its PCI Navigator output changed the treatment plan in about 70 percent of patients compared with angiography alone. Stent length changed in 41 percent of cases and lesion preparation technique in 12 percent. The company identifies Heartflow Plaque Analysis as its FDA-cleared product and did not state a clearance status for PCI Navigator.

The number worth sitting with is the 17 minutes. A trial that moves imaging out of the cath lab and into the planning step changes workflow economics well before it changes outcomes, and economics is what the secondary endpoints actually speak to.

Questions & Answers

What did the Heartflow P4 trial show about CT-guided PCI?

The Heartflow P4 trial found CT-guided PCI planning non-inferior to intravascular ultrasound guidance. Target-vessel failure at 12 months was 4.1 percent with CT planning versus 4.6 percent with IVUS.

How many patients were in the Heartflow P4 trial and where was it run?

P4 randomized 1,105 patients with stable coronary artery disease at 23 centers in the United States, Europe and Japan. Carlos Collet of the Cardiovascular Research Foundation served as principal investigator. The results were published in the New England Journal of Medicine on November 1, 2026.

Is Heartflow PCI Navigator FDA cleared?

Heartflow's November 1, 2026 release identified Heartflow Plaque Analysis as FDA cleared but did not state a clearance status for Heartflow PCI Navigator. In the 203-patient NAVIGATE-PCI registry, PCI Navigator changed treatment plans in about 70 percent of cases.

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