What is the FFR cutoff?
An FFR reading <= 0.80 is the most often cut off used in clinical studies (FAME). To expect the outcomes of the major clinical studies (FAME, FAME II, etc.) 0.80 with maximum hyperemia should be used. The AUC Guidelines reflect the FAME cutoff of 0.80.
FFR-Guided Procedures Improved Outcomes vs. Angio Alone
A strong growing body of clinical evidence supports FFR (fractional flow reserve) in increasingly more diverse patient populations and lesion subsets.
FAME I Study shows FFR-guided procedures improved outcomes over angio-guided procedures.¹
- The FAME I Study evaluated angio-guided PCI vs. FFR-guided PCI.
- Lesions identified by angio requiring PCI randomized into two groups - Angio-guided vs. FFR-guided.
- FFR < 0.80 was used as the cutoff.
- The FFR group performed significantly better in MACE-free survival 30-360 days.
- The FFR group was statistically significant in Death/MI and MACE but improved in all metrics vs. the angio-guided group.
FAME II Trial shows deferring ischemic lesions (FFR < 0.80) leads to worse outcomes.2
The goal of the FAME II Study was to assess if MT alone was superior in ischemic lesions. FAME II randomized patients with FFR < 0.80 to PCI + MT or MT compared to patients with FFR > 0.80 who received MT. The trial was stopped early due to the statistically significant poor performance of the MT group.
1. Tonino, et al. New Engl J Med 2009;360:213-24. MACE: death, MI, repeat revascularization. N=1,005 patients
2. De Bruyne, et al. New Engl J Med 2012;367:991-1001