FAME-2 TRIAL
Problem Stable Coronary Disease
Format Multicenter randomized “all comersâ€ù trial
Treatment Fractional Flow Reserve-Guided PCI
Control Best medical therapy
Population 1220 patients
Inclusion criteria 1. Stable angina pectoris (Canadian Cardiovascular Society Class [CCS] 1, 2, 3); or
angina pectoris CCS class 4 subsequently stabilized medically (minimum 7 days); or
atypical or no chest pain but documented ischemia on noninvasive testing;
2. At least one stenosis of at least 50% diameter reduction in at least one major native
epicardial coronary artery with a diameter of at least 2.5 mm and supplying viable
myocardium
3. Eligible for PCI
4. Signed written informed consent obtained
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 (less than 1 week) STEMI or Non-STEMI
4. Prior CABG
5. Contra-indication to dual antiplatelet therapy
6. LVEF < 30%
7. Severe LV hypertrophy (defined as a septal wall thickness at echocardiography of
more than 13 mm)
8. Planned need for concomitant valvular or aortic surgery
9. Extremely tortuous or calcified coronary arteries precluding FFR measurements
10. A life expectancy of less than 2 years
11. Age under 21 4
12. Pregnancy or intention to become pregnant during the course of the trial
13. Refusal or inability to sign an informed consent. Mental condition (psychiatric or
organ cerebral disease) rendering the subject unable to understand the nature,
scope, and possible consequences of the trial or mental retardation or language
barrier such that the patient is unable to give informed consent
14. Potential for non-compliance towards the requirements in the trial protocol (especially
the medical treatment) or follow-up visits
15. Participation or planned participation in another cardiovascular clinical trial before two
year follow-up is completed
Follow-up 24 months
Primary endpoint Composite of death from any cause, nonfatal myocardial infarction, or unplanned hospitalization leading to urgent revascularization during the first 2 years
Secondary endpoint(s) Secondary end points included individual components of the primary end point, cardiac death, nonurgent revascularization, and angina class
Details Note: second generation DES were used
Brief summary: FFR-guided PCI w/ 2nd gen DES significantly reduced revasc, trend for MI/death
PAPER: Fractional Flow Reserve-Guided PCI versus Medical Therapy in Stable Coronary Disease.
Date 27 Aug 2012
Journal N Engl J Med. 2012 Aug 27. [Epub ahead of print]
Information PCI vs. best medical therapy in patients >=1 functionally significant stenosis (FFR<0.8)
-Reduced composite of death/MI/urgent revasc. (HR 0.32; P<0.001)
-Group with FFR<0.8 receiving PCI had similar outcomes to a cohort with FFR>0.8
-Trend towards but no significant difference in death/MI
-Significant reduction in urgent revasc.
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