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