Precise Procedural and PCI Plan (P4) randomized clinical trial

doi:10.1056/NEJMoa2610771

P4

Patient / Population Intervention / Exposure Comparison Outcome

In patients needing PCI with a CCTA-derived fractional flow reserve of 0.80 or less, CCTA-guided PCI was non-inferior for target-vessel failure at 12 months compared with IVUS-guided PCI.

N

1,105patients

Design

Investigator-initiated, multicentre, open-label randomised trial (23 sites in Europe, the US and Japan; sponsor CoreAalst). PCI planned and guided by coronary CT angiography, integrated into the catheterisation laboratory, versus IVUS-guided PCI

Endpoint

Major adverse cardiac events at 12 months

ResultTarget-vessel failure at 12 months with CCTA-guided PCI 23 patients (4.1%) vs 25 patients (4.6%) with IVUS-guided PCI (risk difference -0.42 percentage points; 95% CI -2.82 to 1.99; P<0.001 for non-inferiority; P = 0.73 for superiority). Clinical procedural complications occurred in 6 patients vs 9 patients.

Collet C, Mizukami T, et al. N Engl J Med. 2026; published online 1 November. 10.1056/NEJMoa2610771

Discussion & critique

In patients selected by a CCTA-derived fractional flow reserve of 0.80 or less, a CCTA-guided strategy met non-inferiority to IVUS guidance for target-vessel failure at 12 months, but did not show superiority. Event rates were low in both arms and the 4.5 percentage point margin is wide relative to them, so the trial cannot exclude a meaningful relative excess. Follow-up is only 12 months, the trial was open label with blinded adjudication, and the comparator was another imaging strategy, not angiography alone. The abstract does not report the components of the composite, procedural efficiency measures or lesion complexity, and the trial was funded by GE HealthCare and Heartflow.