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

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 (FFRCT) Planner is a tool that simulates PCI providing modeled FFRCT values after stenosis opening. Aim To validate the accuracy of the FFRCT 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 FFRCT 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 FFRCT 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 FFRCT 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 FFRCT Planner to predict post‐PCI FFR in patients with chronic coronary syndromes undergoing percutaneous revascularization.

Trans-lesional fractional flow reserve gradient as derived from coronary CT improves patient management: ADVANCE registry

“… 31 Our results highlight that ΔFFR CT can provide clinically relevant insight into the physiological pattern of disease requiring revascularization. With the emerging use of CCTA and FFR CT to guide PCI, 32 ΔFFR CT may provide further non-invasive guidance for optimizing revascularization strategies and outcomes.…”

Procedural Outcomes After Percutaneous Coronary Interventions in Focal and Diffuse Coronary Artery Disease

“…This substudy is a predefined analysis of the P3 (Precise PCI Plan), which study design and main results have been reported elsewhere. 10 , 11 Briefly, the P3 study was a prospective, investigator‐initiated, multicenter study of patients with stable CAD referred for PCI. Patients with a significant epicardial lesion based on an FFR ≤0.80 were considered for inclusion.…”

Artificial Intelligence as a Diagnostic Tool in Non-Invasive Imaging in the Assessment of Coronary Artery Disease

“…The authors reported that culprit lesions had worse haemodynamic parameters, and that detailed assessment with anatomical severity, adverse plaque characteristics, and axial plaque stress demonstrated discriminatory ability in identifying culprit lesions for subsequent ACS, compared with traditional anatomy-based models. In another study, Dey et al [ 39 ] investigated whether lesion-specific ischemia by invasive FFR could be predicted by an ML-based ischemia risk score derived from plaque measurement from CCTA, using a boosted ensemble algorithm. The authors found that the new ML-powered integrated ischemia risk score showed higher prediction of ischemia, when compared to traditional individual CCTA metrics such as plaque volume or pre-test likelihood of CAD [ 39 ].…”

“…In another study, Dey et al [ 39 ] investigated whether lesion-specific ischemia by invasive FFR could be predicted by an ML-based ischemia risk score derived from plaque measurement from CCTA, using a boosted ensemble algorithm. The authors found that the new ML-powered integrated ischemia risk score showed higher prediction of ischemia, when compared to traditional individual CCTA metrics such as plaque volume or pre-test likelihood of CAD [ 39 ]. Finally, there is a growing interest in the use of CCTA and AI to guide clinical response following treatment such as PCI for significant lesions.…”