Rationale and design of the precise percutaneous coronary intervention plan (P3) study: Prospective evaluation of a virtual computed tomography-based percutaneous intervention planner

Introduction: Fractional flow reserve (FFR) measured after percutaneous coronary intervention (PCI) has been identified as a surrogate marker for vessel related adverse events. FFR can be derived from standard coronary computed tomography angiography (CTA). Moreover, the FFR derived from coronary CTA (FFR_CT ) Planner is a tool that simulates PCI providing modeled FFR_CT values after stenosis opening.

Aim: To validate the accuracy of the FFR_CT Planner in predicting FFR after PCI with invasive FFR as a reference standard.

Methods: Prospective, international and multicenter study of patients with chronic coronary syndromes undergoing PCI. Patients will undergo coronary CTA with FFR_CT prior to PCI. Combined morphological and functional evaluations with motorized FFR hyperemic pullbacks, and optical coherence tomography (OCT) will be performed before and after PCI. The FFR_CT Planner will be applied by an independent core laboratory blinded to invasive data, replicating the invasive procedure. The primary objective is to assess the agreement between the predicted FFR_CT post-PCI derived from the Planner and invasive FFR. A total of 127 patients will be included in the study.

Results: Patient enrollment started in February 2019. Until December 2020, 100 patients have been included. Mean age was 64.1 ± 9.03, 76% were males and 24% diabetics. The target vessels for PCI were LAD 83%, LCX 6%, and RCA 11%. The final results are expected in 2021.

Conclusion: This study will determine the accuracy and precision of the FFR_CT Planner to predict post-PCI FFR in patients with chronic coronary syndromes undergoing percutaneous revascularization.