FAME 2
Trial question
What is the role of FFR-guided PCI in patients with stable coronary artery disease?
Study design
Multi-center
Open label
RCT
Population
Characteristics of study participants
22.0% female
78.0% male
N = 888
888 patients (194 female, 694 male)
Inclusion criteria: patients with stable coronary artery disease for whom PCI was being considered and in whom at least one stenosis was functionally significant, FFR ≤0.80
Key exclusion criteria: left main coronary artery disease requiring revascularization, recent < 1 week STEMI or non-STEMI, prior CABG, contraindication to dual antiplatelet therapy, LVEF < 30%, severe LV hypertrophy, age < 21 years, or pregnancy
Interventions
N=447 PCI (FFR-guided PCR plus best available medical therapy)
N=441 medical therapy (best available medical therapy alone)
Primary outcome
Death, myocardial infarction, or urgent revascularization
4.3
12.7
12.7 %
9.5 %
6.3 %
3.2 %
0.0 %
Percutaneous coronary
intervention
Medical
therapy
Significant
decrease ▼
NNT = 11
Significant decrease in death, myocardial infarction, or urgent revascularization (4.3% vs. 12.7%; HR 0.32, 95% CI 0.19 to 0.53)
Secondary outcomes
Significant decrease in urgent revascularization (1.6% vs. 11.1%; HR 0.13, 95% CI 0.06 to 0.3)
Significant decrease in urgent revascularization triggered by myocardial infarction or evidence of ischemia on electrocardiography (0.9% vs. 5.2%; HR 0.13, 95% CI 0.04 to 0.43)
Conclusion
In patients with stable coronary artery disease for whom PCI was being considered and in whom at least one stenosis was functionally significant, FFR ≤0.80, PCI was superior to medical therapy with respect to death, myocardial infarction, or urgent revascularization.
Reference
De Bruyne B, Pijls NH, Kalesan B et al. Fractional flow reserve-guided PCI versus medical therapy in stable coronary disease. N Engl J Med. 2012 Sep 13;367(11):991-1001.
Open reference URL