Clinical impact of FFR-guided PCI compared to angio-guided PCI from the France PCI registry

Background: Fractional Flow Reserve (FFR) has become the invasive gold standard to quantify myocardial ischemia generated by a coronary stenosis in patients with chronic coronary syndrome, but in clinical practice it is still underutilised to guide percutaneous coronary intervention (PCI) compared to angiography (angio). Methods: We sought to compare, in a national French registry (France PCI), the clinical impact of FFR-guided PCI compared with angio-guided PCI at one year. We extracted from the France PCI database all chronic coronary syndrome patients treated with PCI for coronary stenosis <90% between 2014 and 2019. Our composite clinical endpoint was the rate of major adverse clinical events (MACE) defined as the composite of the following endpoints: rates of death, myocardial infarction, stent thrombosis, revascularisation, stroke, and bleeding with a BARC score ≥ 3.  Findings: 14384 patients with one-year clinical follow-up were included. Among them, 13125 had angio-guided PCI (91%) and 1259 (9%) had FFR-guided PCI. We observed a significantly higher rate of MACE in the angio-guided group versus the FFR-guided group: 1478 (11·3%) versus 100 (7·9%) (p<0·0001), respectively, with Hazard Ratio (HR) of 1·440, 95% confidence Interval (CI) [1·211-1·713] (p=0·0004). This result was driven by the higher occurrence of death in the angio-guided group versus the FFR-guided-group: 506 (3·9%) versus 17 (1·4%) (p<0·0001), respectively, with HR of 2·845, 95% CI [2·099-3·856] (p<0·0001). After adjustment for potential confounding factors, HRs were 1·287, 95% CI [1·028-1·613] (p=0·028) for MACE and 2·527, 95% CI [1·452-4·399] (p=0·001) for death. No significant differences between angio-guided PCI and FFR-guided PCI were observed for other clinical endpoints. Interpretation: Our study showed that FFR was the most important predictor of death after adjustment for confounding factors. PCI guided with FFR improves outcome at one year compared to angio-guided PCI with a reduction of 64M of death at one year. Funding: None Declaration of Interest: The authors do not have any conflict of interest to report related to this manuscript. Ethical Approval: The French Persons Protection Committee (IR3888) approved the study protocol (no. 15-231). Data file collection and storage were approved by the French National Commission for Data Protection and Liberties (no. 2014-073).