Vessel fractional flow reserve (vFFR) for the assessment of stenosis severity: the FAST II study.

Abstract

Fractional flow reserve (FFR)-guided percutaneous coronary intervention (PCI) is superior to angiography-guided PCI. The clinical uptake of FFR has been limited, however, by the need to advance a wire in the coronary artery, the additional time required and the need for hyperaemic agents which can cause patient discomfort. FFR derived from routine coronary angiography eliminates these issues. The aim of this study was to assess the diagnostic performance and accuracy of three-dimensional quantitative coronary angiography (3D-QCA)-based vessel FFR (vFFR) compared to pressure wire-based FFR (≤0.80). The FAST II (Fast Assessment of STenosis severity) study was a prospective observational multicentre study designed to evaluate the diagnostic accuracy of vFFR compared to the reference standard (pressure wire-based FFR ≤0.80). A total of 334 patients from six centres were enrolled. Both site-determined and blinded independent core lab vFFR measurements were compared to FFR. The core lab vFFR was 0.83±0.09 and pressure wire-based FFR 0.83±0.08. A good correlation was found between core lab vFFR and pressure wire-based FFR (R=0.74; p<0.001; mean bias 0.0029±0.0642). vFFR had an excellent diagnostic accuracy in identifying lesions with an invasive wire-based FFR ≤0.80 (area under the curve [AUC] 0.93; 95% confidence interval [CI]: 0.90-0.96; p<0.001). Positive predictive value, negative predictive value, diagnostic accuracy, sensitivity and specificity of vFFR were 90%, 90%, 90%, 81% and 95%, respectively. 3D-QCA-based vFFR has excellent diagnostic performance to detect FFR ≤0.80. The study was registered on clinicaltrials.gov under identifier NCT03791320.