A Global Registry of Fractional Flow Reserve (FFR)-Guided Management During Routine Clinical Procedures

Background
The use and clinical outcomes of Fractional Flow Reserve (FFR)-guided revascularization in patients presenting with either stable Coronary Artery Disease (CAD) or an Acute Coronary Syndrome (ACS) in real-world clinical practice is uncertain. Our objective was to prospectively characterize the frequency of the change in treatment plan when FFR is performed compared to the initial decision based on angiography alone and its associated outcomes.

Methods
We undertook a prospective, multicenter, multinational, open-label, observational study of coronary physiologic measurements during clinically-indicated coronary angiography. Treatment plan, either medical therapy, PCI or CABG, was prospectively recorded prior to performing FFR. Standard pre-defined adverse events were prospectively identified and recorded per local investigators. Database was locked on 19 June 2018. (PRESSUREwire; ClinicalTrails.gov identifier: NCT02935088)

Results
2217 subjects were enrolled in 70 hospitals across 15 countries between October 2016 - April 2017. The mean FFR (all measurements) was 0.84. The treatment plan based on angiography-alone changed in 763/2196 subjects (34.7%) and 895/2931 lesions (30.5%) post-FFR. In the per-patient analysis, the initial treatment plan based on angiography vs. the final treatment plan post-FFR were: medical management 1350 (61.5%) vs. 1470 (66.9%) (p=0.0017); PCI 717 (32.7%) vs. 604 (27.5%) (p=0.0004); CABG 119 (5.4%) vs. 121 (5.5%) (p=0.8951). For the subjects initially assigned to medical management, 19.1% (258/1350) had changed to PCI and for the subjects initially assigned to PCI, 51.6% (370/717) had changed to medical therapy. The frequency of intended revascularization changed from 38.1% to 33.0% per patient (p=0.0005) and from 35.5 % to 29.6% per lesion (p<0.0001) following FFR. There were no (0%) serious adverse events related to FFR measurement.

Conclusions
On an individual patient basis, use of FFR in real-world clinical practice changes the treatment plan compared to angiography in more than one third of all-comers selected for physiology guided managements. FFR measurement is safe, providing incremental information to guide revascularization decisions.