WHY THIS STUDY?

Compared with angiography alone, decision-making based on coronary physiology using FFR (Fractional Flow Reserve) improves patient outcomes.The aim of the study was to compare clinical of FFR and iFR guided coronary revascularization, with the pre-specified hypothesis that MACE is similar with FFR and iFR guided coronary revascularization arms. 1 year results have shown similar MACE rates between iFR (Instantaneous Wave-free Ratio) and FFR. A pre-especified 5 year follow-up was included as part of the trial.

HOW WAS IT EXECUTED?

At 49 sites from 17 countries, 2492 patients, with stable or non-culprit acute coronary syndrome intermediate coronary stenosis, were randomized 1:1 to receive either iFR or FFR guided coronary revascularization.  Pre-specified treatment thresholds of FFR ? 0.80 and iFR<0.90 were used. To reduce bias, measurements outside of the randomization arm were not permitted and patients and follow-up teams were blinded to the randomization arm.  Patient level monitoring of all data including physiological waveforms was completed in each patient. Each clinical event was reviewed by a blinded adjudication committee independent from the study leadership and statistical teams. Pre-specified MACE was defined as all cause death, myocardial infarction and unplanned revascularization.

WHAT WERE THE ESSENTIAL RESULTS?

5-year pre-specified primary outcomes comparing clinical outcomes of FFR and iFR guided coronary revascularization will be presented at  at EuroPCR 2023.

WHY IT IS IMPORTANT?

iFR is widely used for functional assessment of epicardial stenoses. Following demonstration of non-inferiority of clinical decision making based on iFR compared with FFR at 1 year follow-up in the study in terms of MACE (primary endpoint), this presentation will inform on the evolution of the two study arms and the incidence of MACE at 5-year follow-up.

PLEASE LIST THE DEVICE(S)/TECHNOLOGY(IES) INVOLVED IN THIS TRIAL

Coronary Pressure guidewire (Philips / Volcano)