Diagnostic Performance of In-Procedure Angiography-Derived Quantitative Flow Reserve Compared to Pressure-Derived Fractional Flow Reserve: The FAVOR II Europe-Japan Study

J Am Heart Assoc. 2018 Jul 6;7(14):e009603. doi: 10.1161/JAHA.118.009603.

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 with 2D-QCA using FFR as a reference standard. A total of 329 patients were enrolled. Paired assessment of FFR, QFR, and 2D-QCA 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.

Keywords: fractional flow reserve; quantitative coronary angiography.

Publication types

  • Comparative Study
  • Multicenter Study
  • Observational Study
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Aged
  • Angina Pectoris / diagnosis*
  • Angina Pectoris / etiology
  • Angina Pectoris / physiopathology
  • Coronary Angiography / methods*
  • Coronary Stenosis / complications
  • Coronary Stenosis / diagnosis*
  • Coronary Stenosis / physiopathology
  • Coronary Vessels / physiopathology*
  • Europe
  • Feasibility Studies
  • Female
  • Follow-Up Studies
  • Fractional Flow Reserve, Myocardial / physiology*
  • Humans
  • Imaging, Three-Dimensional
  • Japan
  • Male
  • Predictive Value of Tests
  • Prospective Studies
  • Reproducibility of Results
  • Severity of Illness Index

Associated data

  • ClinicalTrials.gov/NCT02959814