The BHF FAMOUS NSTEMI Trial
For the FAMOUS NSTEMI InvestigatorsESC Hotline for Myocardial Infarction, 1 Sep 2014
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
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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.
Natural history & prognosis after NSTEMI
• Cardiac events Coronary - Spontaneous plaque rupture
- Longer term remodelling
Myocardial - Sudden death & heart failure
• Non-cardiac events - co-morbidity
Decision-makingAnatomy vs. Anatomy + Function
• Ad hoc diagnostic angiography Treatment decisions are based on visual interpretation of the angiogram.
• FFRClass I recommendation in stable CAD
No guideline recommendation in ACS, evidence is lacking. ESC Hotline 1 Sep 2014
Rationale: FFR in NSTEMI
ESC Hotline 1 Sep 2014
• 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.
Berry C et al Am Heart J 2013; NCT01764334
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.
ESC Hotline 1 Sep 2014
FAMOUS-NSTEMIOutcomes
• Primary outcomeThe proportion of patients allocated to medical management only at baseline in each group.
• Secondary outcomes1. 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 lifeESC Hotline 1 Sep 2014
Screened
Consent
Screenedn = 444
Oct. 2011
May 2013
n = 174n = 176
350Randomise
ESC Hotline 1 Sep 2014
Registryn = 503
0
20
40
60
80
100FFR-Guided Angiography-Guided
GRACE Score for Death/MI 6 months= 146
Time from event to angiography3 (2,5) days
Radial access – 90%
%
Baseline characteristics
ESC Hotline 1 Sep 2014
ESC Hotline 1 Sep 2014
FFR vs. Stenosis Severity
Stenosis severity, %
350 patients706 lesions≥ 30% severity
FFR successful100% of patients>99% lesions2 wire dissections
FFR
FFR-disclosureTreatment change
Initial treatment
Change post-FFR
Final decision
FFR treatment change ~ 22% of patients
Primary outcome% medical therapy at baseline
0
5
10
15
20
25
Post-Randomisation 1-year
FFR-guided Angiography-guided
%
p = 0.022 p = 0.054
In-hospital costs were similar
22.7
13.2
ESC Hotline 1 Sep 2014
% medical therapy onlyBaseline & 1 year
0
5
10
15
20
25
Post-Randomisation 1-year
FFR-guided Angiography-guided
%
p = 0.022 p = 0.054
Quality of life was similarESC Hotline 1 Sep 2014
All MACEFFR-guided vs. Angio-guided
Angiography – guidedn = 15 (8.6%)
MACE1 year
FFR – guidedn = 14 (8.0%)
Log Rankp = 0.79
Days
ESC Hotline 1 Sep 2014
Procedure-related MIFFR-guided vs. Angio-guided
Type 4 - Procedure-related MI, 1 year
Angiography - guided
FFR - guided
p = 0.12
Myocardial infarctionFFR-guided vs. Angio-guided
Type 4 MIProcedure-related
Types 1-3 MISpontaneous
Angiography - guided
FFR - guided
FFR - guided
Angiography - guided
p = 0.12 p = 0.56
Summary1. Trial popn represented > 40% of NSTEMI
patients who gave consent.
2. FFR was successful in 100% of patients
and safe (2 dissections in 706 lesions).
3. Randomisation & adherence to protocol were successful.
4. FFR-disclosure commonly changed therapy, PCIs & Type 4 MIs and was cost neutral.
5. Health outcomes were similar.
Conclusions1. FFR is feasible, safe and reduces PCI &
procedure MI in NSTEMI.
2. No difference in health outcomes vs. standard care, but under-powered.
3. 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.