Though the benefit of FFR (fractional flow reserve) over angiography is statistically important only over the first 2 years, this pattern is maintained at long term according to FAME 5 year follow up, presented at the ECS and simultaneously published in The Lancet.
Between the second and fifth year, the number of patients at risk is so low that the difference between strategies loses statistical significance; however, risk evolves at the same rate in both groups and, therefore, the original difference in favor of FFR is no less significant.
The FAME trial randomized 1.005 patients receiving DES to treat multivessel disease (>50% stenosis in at least 2 of 3 major coronary arteries) in 20 centers in Europe and US. Patients were randomized to angiography guided PCI (n = 496) vs. FFR guided PCI (n = 509). In the angiography guided group, all ≥50% lesions were treated with DES while in the FFR guided group, only ≤0.80 lesions were treated.
At 5 years, the completed follow up data became available for 86% of patients of the FAME cohort. MACE rates (major adverse cardiac events) (primary end point, death, MI and repeat revascularization) and all cause death/MI and cardiac death/ MI were similar between both arms of the study (angiography 31% vs FFR 28%; p=0.31).
Kaplan-Meier survival curves reveal the difference between FFR and angiography remains stable during the 5 year follow up.
The multivariable analysis showed a correlation between men and strategy (p for intervention = 0.027), FFR being associated to a lower risk of MACE at 5 years in men.
Nico H.J. Pijls