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

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DOI

  • Jelmer Westra
  • Birgitte Krogsgaard Andersen
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  • Gianluca Campo, Maria Cecilia Hospital, GVM Care and Research, Cotignola (RA), Italy.
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  • Hitoshi Matsuo, Department of Cardiovascular Medicine, Gifu Heart Center, Gifu City, Japan.
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  • Lukasz Koltowski, Department of Cardiology, Medical University of Warsaw, Warszawa, Poland.
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  • Ashkan Eftekhari
  • Tommy Liu, Department of Cardiology, Hagaziekenhuis, The Hague, The Netherlands.
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  • Luigi Di Serafino, Division of Cardiology, Department of Advanced Biomedical Sciences, University of Naples Federico II, Naples, Italy.
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  • Domenico Di Girolamo, Azienda Ospedaliera Sant'Anna e San Sebastiano, Caserta, Italy.
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  • Javier Escaned, Hospital Clinico San Carlos IDISSC, Complutense University, Madrid, Spain.
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  • Holger Nef, Department of Cardiology and Angiology, University of Giessen, Giessen, Germany.
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  • Christoph Naber, Klinik für Kardiologie und Angiologie, Essen, Germany.
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  • Marco Barbierato, Emodinamica Aziendale AULSS 3 Serenissima, Ospedale Dell'Angelo, Mestre, Italy.
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  • Shengxian Tu, Biomedical Instrument Institute, School of Biomedical Engineering, Shanghai Jiao Tong University, Shanghai, China; Shanghai Med-X Engineering Research Center, Shanghai Jiao Tong University, Shanghai, China.
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  • Omeed Neghabat
  • Morten Madsen
  • Matteo Tebaldi, Cardiovascular Institute, Azienda Ospedaliero-Universitaria di Ferrara, Cona, Italy.
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  • Toru Tanigaki, Department of Cardiovascular Medicine, Gifu Heart Center, Gifu City, Japan.
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  • Janusz Kochman, Department of Cardiology, Medical University of Warsaw, Warszawa, Poland.
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  • Samer Somi, Department of Cardiology, Hagaziekenhuis, The Hague, The Netherlands.
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  • Giovanni Esposito, Division of Cardiology, Department of Advanced Biomedical Sciences, University of Naples Federico II, Naples, Italy.
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  • Giuseppe Mercone, Azienda Ospedaliera Sant'Anna e San Sebastiano, Caserta, Italy.
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  • Hernan Mejia-Renteria, Hospital Clinico San Carlos IDISSC, Complutense University, Madrid, Spain.
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  • Federico Ronco, Emodinamica Aziendale AULSS 3 Serenissima, Ospedale Dell'Angelo, Mestre, Italy.
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  • Hans Erik Bøtker
  • William Wijns, Cardiovascular Research Centre, OLV Hospital, Aalst, Belgium; The Lambe Institute for Translational Medicine and Curam, National University of Ireland, Galway, and Saolta University Healthcare Group, Galway, Ireland.
  • ,
  • Evald Høj Christiansen
  • Niels Ramsing Holm

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.

Original languageEnglish
JournalJournal of the American Heart Association
Volume7
Issue14
ISSN2047-9980
DOIs
Publication statusPublished - 6 Jul 2018

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