Introduction

Randomized evidence suggests improved outcomes with fractional flow reserve (FFR) guidance of coronary revascularization in well-defined patient cohorts including patients with acute coronary syndrome (ACS).  The impact of FFR-guided revascularization on long-term outcomes of unselected patients with acute coronary syndromes (ACS) is, however, still unknown. The FLORIDA (Fractional FLOw Reserve In cardiovascular DiseAses) study sought to investigate outcomes of FFR-guided versus angiography-guided treatment strategies in a large, real-world cohort including a significant subgroup of ACS-patients.

Methods and Results

Patients enrolled into the anonymized German InGef Research Database and undergoing coronary angiography between January 2014 and December 2015 were included in the FLORIDA-study. Among 64,045 patients undergoing coronary angiography for suspected coronary artery disease (CAD), 1,992 (3.11%) patients had functional lesion assessment with FFR. Using a matched cohort study design within the FLORIDA study cohort (n=3,962) all-cause-mortality as well as major cardiovascular events (MACE: all-cause mortality, myocardial infarction and revascularization procedures) over 3-years of follow-up were analyzed among patients treated by FFR- or angiography-guided treatment respectively. For this analysis, the ACS-subgroup consisting of 629 patients (31.8 %) was investigated.

In ACS patients, all-cause mortality at 3 years was 10.2% in the FFR-assessed group and 14.0% in the angiography-only group (p=0.046), corresponding to a 27% relative risk reduction for the use of FFR.  The incidence of MACE overall, however, was similar (p=0.195) in the FFR-group (47.7%) compared with the angiography-guided treatment group (51.5%), since no significant difference was detectable neither for MI (FFR: 28.6% vs. Angio-only: 27.5%; p=0.71) nor for revascularization by PCI or CABG (FFR: 22.7%, Angio-only: 21.9%; p=0.79) over 3 years of follow-up. Importantly, the mortality benefit was observed independent of the therapeutic strategy guided by FFR (revascularization by PCI/CABG vs. OMT).

Conclusion

In this prespecified subgroup analysis of the large, all-comer FLORIDA-study population, an FFR-based revascularization strategy was associated with an impressive 27% relative risk reduction for all-cause-mortality over 3 years in the cohort of patients with an index ACS presentation. These findings further support the routine use of FFR to guide revascularization strategy in patients presenting with ACS.