Diagnostic performance of in-procedure angiography-derived quantitative flow reserve compared to pressure-derived fractional flow reserve: The FAVOR II Europe-Japan study

Abstract

Background—Quantitative flow ratio (QFR) is a novel modality for physiological lesion assessment based on 3-dimensional vessel reconstructions and contrast flow velocity estimates. We evaluated the value of online QFR during routine invasive coronary angiography for procedural feasibility, diagnostic performance, and agreement with pressure-wire–derived fractional flow reserve (FFR) as a gold standard in an international multicenter study. Methods and Results—FAVOR II E-J (Functional Assessment by Various Flow Reconstructions II Europe-Japan) was a prospective, observational, investigator-initiated study. Patients with stable angina pectoris were enrolled in 11 international centers. FFR and online QFR computation were performed in all eligible lesions. An independent core lab performed 2-dimensional quantitative coronary angiography (2D-QCA) analysis of all lesions assessed with QFR and FFR. The primary comparison was sensitivity and specificity of QFR compared with2D-QCAusing FFR as a reference standard.A total of 329patients were enrolled. Paired assessment of FFR, QFR, and2DQCA was available for 317 lesions. Mean FFR, QFR, and percent diameter stenosis were 0.83±0.09, 0.82±10, and 45±10%, respectively. FFR was ≤0.80 in 104 (33%) lesions. Sensitivity and specificity by QFR was significantly higher than by 2D-QCA (sensitivity, 86.5% (78.4–92.4) versus 44.2% (34.5–54.3); P<0.001; specificity, 86.9% (81.6–91.1) versus 76.5% (70.3–82.0); P=0.002). Area under the receiver curve was significantly higher for QFR compared with 2D-QCA (area under the receiver curve, 0.92 [0.89–0.96] versus 0.64 [0.57–0.70]; P<0.001). Median time to QFR was significantly lower than median time to FFR (time to QFR, 5.0 minutes [interquartile range, –6.1] versus time to FFR, 7.0 minutes [interquartile range, 5.0–10.0]; P<0.001). Conclusions—Online computation of QFR in the catheterization laboratory is clinically feasible and is superior to angiographic assessment for evaluation of intermediary coronary artery stenosis using FFR as a reference standard. Clinical Trial Registration—URL: https://www.clinicaltrials.gov. Unique identifier: NCT02959814.