The BHF FAMOUS NSTEMI Trial - PowerPoint PPT Presentation

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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 ... – PowerPoint PPT presentation

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Title: The BHF FAMOUS NSTEMI Trial


1
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
2
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.

3
Natural history prognosis after NSTEMI
  • Cardiac events
  • Coronary - Spontaneous plaque rupture
  • - Longer term remodelling
  • Myocardial - Sudden death heart failure
  • Non-cardiac events - co-morbidity

4
Decision-making Anatomy vs. Anatomy Function
  • Ad hoc diagnostic angiography
  • Treatment decisions 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
5
Rationale FFR in NSTEMI
  • Ischaemia hypothesis
  • Lesion-level ischaemia predicts coronary risk.
  • FFR ischaemic threshold 0.80 specifies OMT vs.
    PCI vs. CABG
  • FFR - Unnecessary PCIs and procedure-related MI
    will be reduced.
  • The validity of FFR in culprit and non-culprit
    arteries is uncertain.

ESC Hotline 1 Sep 2014
6
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
7
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
8
Golden Jubilee, Glasgow
Hairmyres
Freeman
Sunderland
Royal Blackburn
Southampton
9
Oct. 2011 May 2013
Screened n 444
Screened
Consent
Registry n 503
n 174
n 176
Randomise
350
ESC Hotline 1 Sep 2014
10
Baseline characteristics
GRACE Score for Death/MI 6 months 146 Time
from event to angiography 3 (2,5) days Radial
access 90

ESC Hotline 1 Sep 2014
11
FFR vs. Stenosis Severity
350 patients 706 lesions 30 severity FFR
successful 100 of patients gt99 lesions 2 wire
dissections
FFR
Stenosis severity,
ESC Hotline 1 Sep 2014
12
FFR-disclosure Treatment change
Change post-FFR
Final decision
Initial treatment
FFR treatment change 22 of patients
13
Primary outcome medical therapy at baseline
22.7

In-hospital costs were similar
13.2
p 0.054
p 0.022
ESC Hotline 1 Sep 2014
14
medical therapy only Baseline 1 year

p 0.054
p 0.022
Quality of life was similar
ESC Hotline 1 Sep 2014
15
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
ESC Hotline 1 Sep 2014
16
Procedure-related MI FFR-guided vs. Angio-guided
Type 4 - Procedure-related MI, 1 year
p 0.12
Angiography - guided
FFR - guided
17
Myocardial infarction 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
18
Summary
  • Trial popn represented gt 40 of NSTEMI patients
    who gave consent.
  • FFR was successful in 100 of patients
  • and safe (2 dissections in 706 lesions).
  • 3. Randomisation adherence to protocol were
    successful.
  • FFR-disclosure commonly changed therapy, ? PCIs
    Type 4 MIs and was cost neutral.
  • 5. Health outcomes were similar.

19
Conclusions
  • FFR is feasible, safe and reduces PCI procedure
    MI in NSTEMI.
  • No difference in health outcomes vs. standard
    care, but under-powered.
  • 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.

20
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
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