FAME II - Fractional Flow Reserve (FFR) Guided Percutaneous Coronary Intervention (PCI) Plus Optimal Medical Treatment (OMT) Verses OMT

Fractional Flow Reserve-Guided Percutaneous Coronary Intervention Plus Optimal Medical Treatment Versus Optimal Medical Treatment Alone in Patients With Stable Coronary Artery Disease

The overall purpose of the FAME II trial is to compare the clinical outcomes, safety and cost-effectiveness of FFR-guided PCI plus optimal medical treatment (OMT) versus OMT alone in patients with stable coronary artery disease.

Prospective, multi-center, multi-national, multi-continental, randomized clinical trial.

Inclusion Criteria:

1. Patients with

   • stable angina or,
   • stabilized angina pectoris or,
   • atypical chest pain or no chest pain but with documented silent ischemia

2. at least one stenosis is present of at least 50% in one major native epicardial coronary artery and supplying viable myocardium

3. Eligible for PCI

4. Signed written informed consent

Exclusion Criteria:

1. Patients in whom the preferred treatment is CABG
2. Patients with left main coronary artery disease requiring revascularization
3. Patients with a recent STEMI or Non-STEMI
4. Prior CABG
5. Contra-indication to dual antiplatelet therapy
6. LVEF < 30%
7. Severe LV hypertrophy
8. Planned need for concomitant cardiac surgery
9. Extremely tortuous or calcified coronary arteries precluding FFR measurements
10. A life expectancy of less than 2 years
11. Age under 21