A randomised non-inferiority trial of CCTA guidance versus IVUS guidance for PCI: rationale and design of the P4 clinical trial

Intravascular imaging-guided percutaneous coronary intervention (PCI) improves clinical outcomes compared with angiography-guided PCI. Contemporary coronary computed tomography angiography (CCTA) provides comprehensive assessment of coronary anatomy, plaque characteristics, vessel dimensions, calcification, and lesion-specific physiology, enabling detailed procedural planning before catheterisation. The Precise Procedural and PCI Plan (P4) trial is a prospective, international, multicentre, randomised, open-label trial with blinded endpoint adjudication designed to determine whether a comprehensive CCTA-guided PCI strategy is non-inferior to intravascular ultrasound (IVUS)-guided PCI with respect to clinical outcomes. Approximately 1,100 patients with chronic coronary syndromes or stabilised acute coronary syndrome, at least one coronary stenosis >70%, and fractional flow reserve derived from CCTA <=0.80 are enrolled. Following central core laboratory confirmation of anatomical and physiological eligibility, patients are randomised 1:1 to CCTA-guided or IVUS-guided PCI. Patients assigned to CCTA-guided PCI undergo standardised procedural planning and virtual PCI simulation, with CCTA integrated into the catheterisation laboratory using computed tomography-fluoroscopy synchronisation for intraprocedural guidance. In the IVUS-guided arm, PCI is performed with mandatory pre- and post-PCI IVUS assessment. The primary endpoint is target vessel failure at 12 months, defined as the composite of cardiac death, target vessel myocardial infarction, or ischaemia-driven target vessel revascularisation. P4 will determine whether comprehensive, non-invasive CCTA-guided PCI planning is non-inferior to IVUS-guided PCI regarding 12-month target vessel failure while potentially improving procedural efficiency and standardisation. (ClinicalTrials.gov: NCT05253677)