The FAVOR III Europe Japan trial is designed to randomize 2,000 patients to determine if a QFR-based diagnostic strategy is non-inferior to an FFR-guided strategy for 12-month clinical outcomes.
RCT (n=2,000)
randomised
Yes
Does a QFR-based diagnostic strategy yield non-inferior clinical outcomes compared to a standard FFR-guided strategy in patients with intermediate coronary stenosis?
This paper describes the design of the FAVOR III Europe Japan trial, which will evaluate whether a less invasive QFR-based strategy is non-inferior to standard FFR for guiding PCI in intermediate coronary lesions.
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.
Andersen et al. (Sat,) conducted a rct in Intermediate coronary stenosis (n=2,000). QFR-based diagnostic strategy vs. Standard FFR-based diagnostic strategy was evaluated on Composite of all-cause mortality, any myocardial infarction, and any unplanned coronary revascularisation at 12 months. The FAVOR III Europe Japan trial is designed to randomize 2,000 patients to determine if a QFR-based diagnostic strategy is non-inferior to an FFR-guided strategy for 12-month clinical outcomes.