Functional Assessment by Virtual Online Reconstruction. The FAVOR III Europe Japan Study

  • STATUS
    Recruiting
  • End date
    Dec 1, 2023
  • participants needed
    2000
  • sponsor
    Aarhus University Hospital Skejby
Updated on 7 May 2021
Investigator
Niels R Holm, MD
Primary Contact
Aarhus University Hospital (0.0 mi away) Contact
+58 other location
angiography
stenosis
chest pain
angina pectoris
coronary artery stenosis
stable angina
adenosine

Summary

Quantitative Flow Ratio (QFR) is a novel method for evaluating the functional significance of coronary stenosis. QFR is estimated based on two angiographic projections. Studies have shown a good correlation with the present wire-based standard approach Fractional Flow Reserve (FFR) for assessment of intermediate coronary stenosis. The purpose of the FAVOR III Europe Japan study is to investigate if a QFR-based diagnostic strategy will results in non-inferior clinical outcome after 12 months compared to a standard pressure-wire guided strategy in evaluation of patients with chest pain (stable angina pectoris) and intermediate coronary stenosis.

Description

Patients at high risk of having one or more coronary stenosis are evaluated routinely by invasive coronary angiography (CAG). Lesions are often quantified by visual assessment of the angiogram, but physiological assessment of the functional significance by fractional flow reserve has been shown to improve clinical outcome, to reduce number of stents implanted, and has obtained the highest recommendation in European guidelines. FFR is assessed during CAG by advancing a wire with a pressure transducer towards the stenosis and measure the ratio in pressure between the two sides of the stenosis during medical induced maximum blood flow (hyperaemia).

The solid evidence for FFR evaluation of coronary stenosis and the relative simplicity in performing the measurements have supported adoption of an FFR based strategy but the need for interrogating the stenosis by a pressure wire, the small risks associated hereto, the cost of the wire, and the drug inducing hyperaemia has limited more widespread adoption.

Quantitative Flow Ratio is a novel method for evaluating the functional significance of coronary stenosis by calculation of the pressure drop in the vessel based on computation of two angiographic projections.

Two multi-center studies, the FAVOR II Europe-Japan and China studies evaluated the feasibility and diagnostic performance of in-procedure QFR, showing very good agreement between QFR and FFR.

The purpose of the FAVOR III Europe Japan study is to investigate if a QFR-based diagnostic strategy yields non-inferior 12-month clinical outcome compared to a standard pressure-wire guided strategy in evaluation of patients with stable angina pectoris and intermediate coronary stenosis.

Primary hypothesis: A QFR based diagnostic strategy results in non-inferior clinical outcome, assessed by a composite endpoint of all cause death, non-fatal myocardial infarction (MI) and unplanned revascularization after one year, compared to a strategy of pressure wire-based FFR for assessment of physiological significance of intermediate coronary artery stenosis.

Methods: Investigator initiated, 1:1 randomized, prospective, clinical outcome, non-inferiority, multi-center trial performed at up to 40 international sites with inclusion of 2000 patients.

Patients with stable angina pectoris or need for evaluation of non-culprit lesions after acute MI are enrolled. At least two angiographic projections are acquired during resting conditions. If the angiographic criteria are met, the patient is randomized to either a QFRor an FFR-based diagnostic strategy.

Revascularization is performed according to best standard by percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG).

Patient follow-up is continued until 24 months.

Details
Condition Coronary Artery Disease, Coronary heart disease, Cardiac Ischemia, Myocardial Ischemia
Treatment QFR-based diagnostic strategy, FFR-based diagnostic strategy
Clinical Study IdentifierNCT03729739
SponsorAarhus University Hospital Skejby
Last Modified on7 May 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Age of 18 years and above
Both genders
Indication for invasive coronary angiography
Patients with stable angina pectoris, or assessment of secondary lesions in stabilized non-STEMI patients or assessment of secondary lesions in patients with prior STEMI and staged evaluation of secondary lesions
Able to provide written informed consent
Angiographic inclusion criteria
Diameter stenosis of 40-90% diameter stenosis
Vessel diameter of at least 2.5 mm and supplying viable myocardium
Patients with restenosis in a native coronary artery can be included

Exclusion Criteria

Severely impaired renal function: Glomerular filtration rate (GFR) < 20 mL/min/1.73m
Life expectancy less than one year
Cardiogenic shock or unstable haemodynamic state (Killip class III and IV)
ST-elevation myocardial infarction (STEMI) within 72 hours
Bypass graft to any target vessel
Atrial fibrillation at the time of the procedure
Chronic total occlusions of any vessel with possible or established indication for treatment
Pregnancy or intention to become pregnant during the course of the trial
Breast feeding
Planned need for concomitant valvular or aortic surgery
Left ventricular ejection fraction (LVEF) < 30%
Previous inclusion in the FAVOR III trial
Enrolled in another clinical study, and for this reason not treated according to present European Society of Cardiology guidelines, or the protocol treatment conflicts with the protocol treatment of FAVOR III
Inability to tolerate contrast media
Inability to tolerate Adenosine
Angiographic exclusion criteria
Ostial right coronary artery > 50% diameter stenosis
Left main coronary artery > 50% diameter stenosis
Lesions properties indicative of myocardial bridging
Bifurcation lesions with major (>1 mm) step down in reference size across the bifurcation
Severe tortuosity of any target vessel
Severe overlap in the stenosed segment
Poor image quality precluding identification of vessel contours
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