The randomized P4 trial, presented at TCT 2026 and simultaneously published in the New England Journal of Medicine, enrolled 1,105 patients to compare coronary CT angiography (CCTA)-guided percutaneous coronary intervention with intravascular ultrasound (IVUS)-guided intervention. The primary endpoint of 12-month target-vessel failure occurred in 4.1% of CCTA-guided patients versus 4.6% of IVUS-guided patients, meeting the prespecified noninferiority criterion. Median procedural time was 46 versus 63 minutes, while contrast volume was 150 versus 170 mL. Separately, Heartflow reported that its 203-patient NAVIGATE-PCI registry showed changes in procedural planning in approximately 70% of cases; that observational result does not establish improved clinical outcomes.
American College of Cardiology+1
Sources: American College of Cardiology, November 1 · Heartflow clinical announcement
Why it matters strategically
The trial potentially changes how hospitals allocate resources between preprocedural imaging and imaging performed inside the catheterization laboratory.
If CT-guided planning provides comparable outcomes with shorter procedures, hospitals could reconsider their use of IVUS, imaging software, and catheterization laboratory capacity.
However, noninferiority is not superiority. The study does not establish that CT guidance should replace IVUS in every patient population.
