Clinical Validation of a Virtual Planner for Coronary Interventions Based on Coronary CT Angiography

Low fractional flow reserve (FFR) values after percutaneous coronary intervention (PCI) carry a worse prognosis than high post-PCI FFR values. Therefore, the ability to predict post-PCI FFR might play an important role in procedural planning. Post-PCI FFR values can now be computed from pre-PCI coronary computed tomography angiography (CTA) using the fractional flow reserve derived from coronary computed tomography angiography revascularization planner (FFR_CT Planner).

The aim of this study was to validate the accuracy of the FFR_CT Planner.

In this multicenter, investigator-initiated, prospective study, patients with chronic coronary syndromes and significant lesions based on invasive FFR ≤0.80 were recruited. The FFR_CT Planner was applied to the fractional flow reserve derived from coronary computed tomography angiography (FFR_CT) model, simulating PCI. The primary objective was the agreement between the predicted post-PCI FFR by the FFR_CT Planner and measured post-PCI FFR. Accuracy of the FFR_CT Planner's luminal dimensions was assessed by using post-PCI optical coherence tomography as the reference.

Overall, 259 patients were screened, with 120 patients (123 vessels) included in the final analysis. The mean patient age was 64 ± 9 years, and 24% had diabetes. Measured FFR post-PCI was 0.88 ± 0.06, and the FFR_CT Planner FFR was 0.86 ± 0.06 (mean difference: 0.02 ± 0.07 FFR unit; limits of agreement: -0.12 to 0.15). Optical coherence tomography minimal stent area was 5.60 ± 2.01 mm², and FFR_CT Planner minimal stent area was 5.0 ± 2.2 mm² (mean difference: 0.66 ± 1.21 mm²; limits of agreement: -1.7 to 3.0). The accuracy and precision of the FFR_CT Planner remained high in cases with focal and diffuse disease and with low and high calcium burden.

The FFR_CT-based technology was accurate and precise for predicting FFR after PCI. (Precise Percutaneous Coronary Intervention Plan Study [P3]; NCT03782688).