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Lessons from the
FAME trials
Prof. Colin Berry
FFR Workshop – AIMRADIAL
Budapest, 21 September 2016
Disclosures
Institutional agreements between the University of
Glasgow (employer) and St Jude Medical,
Novartis, DalCor and AstraZeneca.
No personal contracts or disclosures.
1. Review the evidence from the
FAME and FAME-2 trials
2. Practice guidelines, ESC
3. Conclusions
Objectives
• 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
FAME
Procedure differences between the groups
Tonino et al N Engl J Med 2009
FAME
Primary & Secondary Endpoints at 1 year
Tonino et al N Engl J Med 2009
FAME
Primary outcome, MACE 12 months
Tonino et al N Engl J Med 2009
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
Sels et al JACC Intervention 2011
FAME - NSTEMI
UA / NSTEMI
One third of the trial population
Symptoms > 5 days
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
FAME: 5-Year Follow-Up of FFR-Guided
vs. Angio-Guided PCI in MVD
L.X. Van Nunen et al. Lancet 2015
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
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
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
FAME-2
Total revascularisations
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
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
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
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
Thank you for
your attention

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10 FFR Berry C aimradial2016 - FAME trials

  • 1. Lessons from the FAME trials Prof. Colin Berry FFR Workshop – AIMRADIAL Budapest, 21 September 2016
  • 2. Disclosures Institutional agreements between the University of Glasgow (employer) and St Jude Medical, Novartis, DalCor and AstraZeneca. No personal contracts or disclosures.
  • 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
  • 5. FAME Procedure differences between the groups Tonino et al N Engl J Med 2009
  • 6. FAME Primary & Secondary Endpoints at 1 year Tonino et al N Engl J Med 2009
  • 7. FAME Primary outcome, MACE 12 months 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
  • 20. Thank you for your attention

Editor's Notes

  1. No late penalty
  2. No late penalty