The BHF FAMOUS NSTEMI Trial

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The BHF FAMOUS NSTEMI Trial
J. Layland, K.G. Oldroyd, N. Curzen, A. Sood, K.
Balachandran, R. Das, S. Junejo, N. Ahmed, M.
Lee, A. Shaukat, A. O'Donnell, J. Nam, A. Briggs,
R. Henderson, A. McConnachie, C. Berry
For the FAMOUS NSTEMI Investigators ESC Hotline
for Myocardial Infarction, 1 Sep 2014
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Disclosures

• British Heart Foundation Project Grant.
• St Jude Medical provided the pressure wires to
  the 6 hospitals that participated in this study.
• Investigators CB, NC, KGO are Consultants /
  Speakers to St Jude Medical and/or Volcano Corp.
• Institutional research agreement between St Jude
  Medical and University of Glasgow / CB.
• Travel support from Pfizer.

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Natural history prognosis after NSTEMI

• Cardiac events
• Coronary - Spontaneous plaque rupture
• - Longer term remodelling
• Myocardial - Sudden death heart failure
• Non-cardiac events - co-morbidity

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Standard care Anatomy vs. Anatomy Function

• Urgent diagnostic angiography
• Treatment decisions for OMT, PCI CABG are
  based on visual interpretation of the angiogram.
• FFR
• Class I recommendation in stable CAD
• No guideline recommendation in ACS, evidence is
  lacking.

ESC Hotline 1 Sep 2014
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Rationale FFR in NSTEMI

• Ischaemia hypothesis
• Lesion-level ischaemia predicts coronary risk.
• FFR ischaemic threshold 0.80 specifies CABG vs.
  PCI vs. medical therapy (OMT)
• FFR in angina Optimises the PCI strategy, and
  reduces procedure-related MIs MACE.
• FFR in NSTEMI - Validity of FFR in culprit
  non-culprit arteries is uncertain.

ESC Hotline 1 Sep 2014
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FAMOUS-NSTEMI trial

• Hypothesis
• Routine FFR is feasible in NSTEMI patients and
  adds diagnostic, clinical and economic benefits,
  compared to standard angiography-guided
  management.
• Objective
• Developmental trial for evidence-synthesis to
  inform a definitive health outcome trial.

Berry C et al Am Heart J 2013 NCT01764334
ESC Hotline 1 Sep 2014
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FAMOUS-NSTEMI Outcomes

• Primary outcome
• The proportion of patients allocated to medical
  management only at baseline in each group.
• Secondary outcomes
• 1. Feasibility safety of routine FFR.
• 2. Relationship of FFR vs. stenosis severity.
• 3. MACE cardiac death, non-fatal MI, heart
  failure.
• 4. Resource use
• 5. Quality of life

ESC Hotline 1 Sep 2014
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Golden Jubilee, Glasgow
Hairmyres
Freeman
Sunderland
Royal Blackburn
Southampton
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Oct. 2011 May 2013
Screened n 444
Screened
Consent
Registry n 503
n 174
n 176
Randomise
350
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Baseline characteristics 350 randomised trial
participants
GRACE Score for Death/MI 6 months 146 Time
from event to angiography 3 (2,5) days Radial
access 90

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FFR vs. Stenosis Severity
350 patients 706 lesions 30 severity FFR
successful 100 of patients gt99 lesions 2
(0.03) wire dissections
FFR
Stenosis severity,
ESC Hotline 1 Sep 2014
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FFR-disclosure - Impact on treatment plan
Change post-FFR
Final decision
Initial treatment
FFR treatment change 22 of patients
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Primary outcome medical therapy only
22.7

13.2
p 0.054
p 0.022
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medical therapy only Post-randomisation 1 year

p 0.054
p 0.022
Costs and quality of life were similar
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All MACE FFR-guided vs. Angio-guided
Angiography guided n 15 (8.6)
Log Rank p 0.79
MACE 1 year
FFR guided n 14 (8.0)
Days
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Procedure-related MI FFR-guided vs. Angio-guided
Type 4 MI Procedure-related
p 0.12
Angiography - guided
FFR - guided
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Myocardial infarction type FFR-guided vs.
Angio-guided
Type 4 MI Procedure-related
Types 1-3 MI Spontaneous
p 0.12
p 0.56
Angiography - guided
FFR - guided
FFR - guided
Angiography - guided
ESC Hotline 1 Sep 2014
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Summary

• Trial popn represented gt 40 of NSTEMI patients
  who gave informed consent.
• FFR was successful in 100 of patients
• and safe (0.03 guidewire dissections).
• 3. Randomisation adherence to protocol were
  successful.
• FFR-disclosure commonly changed therapy, and
  reduced revascularisation Type 4 MIs.
• Health outcomes were similar.

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Conclusions

• FFR is feasible safe initially, and optimises
  PCI in NSTEMI.
• The trial was designed but not powered to assess
  health outcomes (no differences).
• FFR-guided group outcomes
• Most MACE ? Not related to FFR disclosure.
• Late MACE ? Natural history of CAD progression.
• 4. A large trial is needed to assess health
  outcomes cost-effectiveness.

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FAMOUS-NSTEMI
Thank you. Patients, staff, funders.
Clinical Event Committee Dr Andrew Hannah, Dr
Andrew Stewart Data Safety Monitoring
Committee Prof John Norrie, Prof Andrew Clark, Dr
Saqib Chowdhary
European Heart Journal 1 Sept. 2014 on-line