FAME 2
Fractional Flow Reserve versus Angiography for Multivessel Evaluation 2
Clinical Question
Population
Patients with stable coronary artery disease with at least one stenosis having an FFR of 0.80 or less at 28 sites in Europe and North America.
FFR-guided PCI with second-generation drug-eluting stents plus optimal medical therapy
Optimal medical therapy alone (with PCI for clinical deterioration)
Primary Endpoint
Composite of death, myocardial infarction, or urgent revascularization at 2 years (originally; modified after early stop)
Key Findings
The trial was stopped early due to a highly significant difference in the primary endpoint: 4.3% with PCI vs 12.7% with medical therapy (HR 0.32; 95% CI, 0.19-0.53; p<0.001).
The benefit was driven primarily by a reduction in urgent revascularization: 1.6% with PCI vs 11.1% with medical therapy.
At 5-year follow-up, PCI continued to show benefit: primary endpoint 13.9% vs 27.0% (HR 0.56; p<0.001).
No significant difference in death or myocardial infarction was observed between groups at any time point.
In the registry of FFR-negative lesions (FFR >0.80), outcomes with medical therapy alone were excellent, validating FFR as a decision-making tool.
Impact on Clinical Practice
Guideline Impact
Limitations
Early termination may have overestimated the treatment effect and prevented adequate assessment of hard endpoints like death and MI.
The primary endpoint was driven by urgent revascularization, a softer endpoint that can be influenced by knowledge of treatment assignment in an unblinded trial.
Open-label design may have led to lower thresholds for urgent catheterization in the medical therapy group.
How Does This Trial Apply to Your Case?
Clinical trials inform guidelines, but every patient is unique. Our Heart Team evaluates how landmark evidence applies to your specific anatomy, risk profile, and preferences.
Get a Second Opinion