Rationale and design of the precise percutaneous coronary intervention plan (<scp>P3</scp>) study: Prospective evaluation of a virtual computed tomography‐based percutaneous intervention planner
Sakura Nagumo, Carlos Collet, Bjarne Linde Nørgaard, Hiromasa Otake, Brian Ko, Bon‐Kwon Koo, Jonathon Leipsic, Daniele Andreini, Ward Heggermont, Jesper Møller Jensen, Yu Takahashi, Abdul Rahman Ihdayhid, Zinlong Zhang, Emanuele Barbato, Michael Mæng, Takuya Mizukami, Jozef Bartúnek, Adam Updegrove, Martin Pěnička, Campbell Rogers, Charles A. Taylor, Bernard De Bruyne, Jeroen Sonck
Abstract
Abstract 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.