3. 1. Review the evidence from the
FAME and FAME-2 trials
2. Practice guidelines, ESC
3. Conclusions
Objectives
4. • 1005 patients with multivessel CAD in
whom PCI was intended
• Randomised to FFR-guided PCI or
Angiography-guided PCI
• 1st generation DES
• Primary outcome: Death, non-fatal MI
or repeat revascularisation at 1 year
FAME
Tonino et al N Engl J Med 2009
8. Angiographic severity vs. Functional Severity of
Coronary Artery Stenoses
FFR leads to a ‘left shift’ in the severity of disease
Tonino et al N Engl J Med 2009
9. Sels et al JACC Intervention 2011
FAME - NSTEMI
UA / NSTEMI
One third of the trial population
Symptoms > 5 days
10. FAME Health Economic Analysis
Bootstrap simulation of incremental costs and effects
Positive incremental
QALYs indicate higher
effectiveness for FFR-
guided treatment.
Negative incremental
costs indicate lower
costs for FFR-guided
treatment compare with
angiography-guided
strategy
Fearon et al et al Circulation 2010
11. FAME: 5-Year Follow-Up of FFR-Guided
vs. Angio-Guided PCI in MVD
L.X. Van Nunen et al. Lancet 2015
12. L.X. Van Nunen et al. Lancet 2015
Female sex, p=0.027
Otherwise, primary
outcome results
consistent across sub-
groups
FAME: 5-Year Follow-Up of FFR-Guided
vs. Angio-Guided PCI in MVD
13. FAME-2
De Bruyne et al. N Engl J Med 2014
1220 patients, FFR ≤ 0.80
Randomised to PCI or OMT
2 year follow-up
Cardiac death, non-fatal MI or urgent revascularisation
14. FAME-2
Death or myocardial infarction
De Bruyne et al. N Engl J Med 2014
Landmark analysis
0-7days: HR 9.01 (95%CI 1.13-72.0)
8 days-2years: HR 0.56 (95%CI 0.32-0.97)
P for interaction
0.002
PCI+MT vs MT
16. Severe angina (CCS 3) or a PTP>85%)
Proceed directly to invasive angiography
ICA (with FFR when necessary) is
recommended for patients with severe stable
angina (CCS 3) or with a high risk clinical
profile, particularly if the symptoms are
inadequately controlled with medical
treatment - Class I, C
ESC Stable CAD
Montalescot et al, 2013
17. Stable CAD
ICA (with FFR when necessary) should be
considered for risk stratification in patients
with an inconclusive diagnosis on non-
invasive testing, or conflicting results from
different non-invasive modalities.
Class IIa, C
ESC Stable CAD
Montalescot et al, 2013
18. 5.6.1.3 - FFR may be overestimated and the
haemodynamic relevance of a coronary
stenosis underestimated.(320) So far, the
value of FFR-guided PCI in this setting
has not been properly addressed.
While FFR is considered the invasive gold
standard for the functional assessment of
lesion severity in stable CAD, its role in
NSTE-ACS still needs to be defined.
ESC NSTEMI guideline
Roffi, Patrono et al. 2015
19. 1. FFR-guided revascularisation
Long-term clinical outcome data confirm the benefit of
FFR guided decision making about revascularization:
• FFR>0.80: Medical therapy
• FFR≤0.80: Revascularization
2. Consistent results across sub-groups (sex)
3. Guideline recommendations: Class I in stable CAD,
less certain in ACS, and clinical trials are on-going.
Conclusions
Lessons from the FAME trials