N/A
Completed N=1,170
FAME II - Fractional Flow Reserve (FFR) Guided Percutaneous Coronary Intervention (PCI) Plus Optimal Medical Treatment (OMT) Verses OMT
Source: ClinicalTrials.gov NCT01132495 ↗Enrolled (actual)
1,170
Serious AEs
46.5%
Results posted
Dec 2016
Primary outcomePrimary: Major Adverse Cardiac Event Rate (MACE) — 6.7; 32.7; 9.4; 12.2 percentage of subjects with SAEs
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Major Adverse Cardiac Event Rate (MACE) |
6.7; 32.7; 9.4; 12.2; 6.7; 9.3 | — |
| SECONDARY Overall MACE |
10.1; 22; 12.7; 2.7; 3.6; 3.0 | — |
Eligibility Criteria
Inclusion Criteria
- Patients with
- stable angina or,
- stabilized angina pectoris or,
- atypical chest pain or no chest pain but with documented silent ischemia
- at least one stenosis is present of at least 50% in one major native epicardial coronary artery and supplying viable myocardium
- Eligible for PCI
- Signed written informed consent
Exclusion Criteria
- Patients in whom the preferred treatment is CABG
- Patients with left main coronary artery disease requiring revascularization
- Patients with a recent STEMI or Non-STEMI
- Prior CABG
- Contra-indication to dual antiplatelet therapy
- LVEF < 30%
- Severe LV hypertrophy
- Planned need for concomitant cardiac surgery
- Extremely tortuous or calcified coronary arteries precluding FFR measurements
- A life expectancy of less than 2 years
- Age under 21
Data sourced from ClinicalTrials.gov (NCT01132495). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.