Background: We evaluate the prognostic value of measuring fractional flow reserve
(FFR) after percutaneous coronary intervention (post-PCI FFR) and intravascular imaging
in patients undergoing PCI for three-vessel coronary artery disease (CAD) in the FAME
3 trial. Methods: The FAME 3 trial is a multicenter, international, randomized study
comparing FFR-guided PCI with coronary artery bypass grafting (CABG) in patients with
multivessel CAD. PCI was not non-inferior with respect to the primary endpoint of
death, myocardial infarction (MI), stroke or repeat revascularization at 1 year. Post-PCI
FFR data were acquired on a patient and vessel-related basis. Intravascular imaging
guidance was tracked. The primary end point is a comparison of target vessel failure
(TVF) defined as a composite of cardiac death, target vessel MI and target vessel
revascularization at one year based on post-PCI FFR values. Cox regression with robust
standard errors was used for analysis. Results: Of the 757 patients randomized to
PCI, 461 (61%) had post-PCI FFR measurement and 11.1% had intravascular imaging performed.
The median post-PCI FFR was 0.89 [IQR 0.85-0.94]. On a vessel-level, post-PCI FFR
was found to be a significant predictor of TVF univariately (HR=0.67 [95% CI:0.48-0.93]
for 0.1 unit increase, p=0.0165). On a patient-level, the single lowest post-PCI FFR
value was also found to be a significant predictor of TVF univariately (HR=0.65 [95%
CI:0.48-0.89] for 0.1 unit increase, p=0.0074). Post-PCI FFR was an independent predictor
of TVF in multivariable analysis adjusted for key clinical parameters. Outcomes were
similar between patients who had intravascular imaging guidance and those who did
not. Conclusions: Post-PCI FFR measurement was a significant predictor of TVF on a
vessel and patient level and an independent predictor of outcomes in a population
with complex three-vessel CAD eligible for CABG. The limited use of intravascular
imaging did not affect outcomes.
