Quantitative flow ratio versus fractional flow reserve for guiding percutaneous coronary intervention: design and rationale of the randomised FAVOR III Europe Japan trial

DOI: 10.4244/EIJ-D-21-00214

Birgitte Andersen
Birgitte Krogsgaard Andersen1, MD; Martin Sejr-Hansen1, MD; Jelmer Westra1, MD, PhD; Gianluca Campo2, MD, PhD; Ashkan Efterkhari3, MD, PhD; Shengxian Tu4, PhD; Javier Escaned5, MD, PhD; Lukasz Koltowski6, MD, PhD; Barbara E. Stähli7, MD, PhD; Andrejs Erglis8, MD, PhD; Gediminas Jaruševičius9, MD, PhD; Greta Žiubrytė9, MD; Truls Råmunddal10, MD, PhD; Tommy Liu11, MD; William Wijns12, MD, PhD; Ulf Landmesser13, MD, PhD; Luc Maillard14, MD; Hitoshi Matsuo15, MD, PhD; Evald Høj Christiansen1, MD, PhD; Niels Ramsing Holm1, MD
1. Department of Cardiology, Aarhus University Hospital, Skejby, Denmark; 2. Cardiology Unit, Azienda Ospedaliera Universitaria di Ferrara, Ferrara, Italy and Maria Cecilia Hospital, GVM Care & Research, Cotignola (RA), Italy; 3. Department of Cardiology, Aalborg University Hospital, Aalborg, Denmark; 4. School of Biomedical Engineering, Shanghai Jiao Tong University, Shanghai, China; 5. Hospital Clinico San Carlos IdISSC, Complutense University of Madrid, Madrid, Spain; 6. Department of Cardiology, Medical University of Warsaw, Warsaw, Poland; 7. Department of Cardiology, University Heart Center, University Hospital Zürich, Zürich, Switzerland; 8. Department of Cardiology, Riga Stradiņš University, Riga, Latvia; 9. Department of Cardiology, Hospital of Lithuanian University of Health Sciences Kauno Klinikos, Kaunas, Lithuania and Institute of Cardiology, Lithuanian University of Health Sciences, Kaunas, Lithuania; 10. Department of Cardiology, Sahlgrenska University Hospital, Göteborg, Sweden; 11. Department of Cardiology, HagaZiekenhuis, The Hague, the Netherlands; 12. The Lambe Institute for Translational Medicine and Curam, National University of Ireland, Galway, Ireland; 13. Department of Cardiology (CBF), Charite − Universitätsmedizin Berlin, Berlin, Germany; 14. GCS ES Axium Rambot, Clinique Axium, Aix-en-Provence, France; 15. Department of Cardiovascular Medicine, Gifu Heart Center, Gifu, Japan

Quantitative flow ratio (QFR) is a computation of fractional flow reserve (FFR) based on invasive coronary angiographic images. Calculating QFR is less invasive than measuring FFR and may be associated with lower costs. Current evidence supports the call for an adequately powered randomised comparison of QFR and FFR for the evaluation of intermediate coronary stenosis. The aim of the FAVOR III Europe Japan trial is to investigate if a QFR-based diagnostic strategy yields a non-inferior 12-month clinical outcome compared with a standard FFR-guided strategy in the evaluation of patients with intermediary coronary stenosis. FAVOR III Europe Japan is an investigator-initiated, randomised, clinical outcome, non-inferiority trial scheduled to randomise 2,000 patients with either 1) stable angina pectoris and intermediate coronary stenosis, or 2) indications for functional assessment of at least 1 non-culprit lesion after acute myocardial infarction. Up to 40 international centres will randomise patients to either a QFR-based or a standard FFR-based diagnostic strategy. The primary endpoint of major adverse cardiovascular events is a composite of all-cause mortality, any myocardial infarction, and any unplanned coronary revascularisation at 12 months. QFR could emerge as an adenosine- and wire-free alternative to FFR, making the functional evaluation of intermediary coronary stenosis less invasive and more cost-effective.

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clinical researchclinical trialsfractional flow reserveother imaging modalities
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