title: Fractional flow reserve (FFR) versus angiography in guiding management to optimise outcomes in non-ST segment elevation myocardial infarction (FAMOUS-NSTEMI) developmental trial: cost-effectiveness using a mixed trial- and model-based methods.
abstract: BACKGROUND
  In the Fractional flow reserve (FFR) versus angiography in guiding management to optimise outcomes in non-ST elevation myocardial infarction (FAMOUS) clinical trial, FFR was shown to significantly reduce coronary revascularisation, compared to visual interpretation of standard coronary angiography without FFR. We estimated the cost-effectiveness from a UK National Health Service perspective, based on the results of FAMOUS.
  
  
  METHODS
  A mixed trial- and model-based approach using decision and statistical modelling was used. Within-trial (1-year) costs and QALYs were assembled at the individual level and then modelled on subsequent management strategy [coronary artery bypass graft (CABG), percutaneous coronary intervention (PCI) or medical therapy (MT)] and major adverse coronary events (death, MI, stroke and revascularisation). One-year resource uses included: material, hospitalisation, medical, health professional service use and events. Utilities were derived from individual EQ5D responses. Unit costs were derived from the literature. Outcomes were extended to a lifetime on the basis of MACE during the 1st year. Costs and QALYs were modelled using generalized linear models whilst MACE was modelled using logistic regression. The analysis adopted a payer perspective. Costs and outcomes were discounted at 3.5 %.
  
  
  RESULTS
  Costs were related to the subsequent management strategy and MACE whilst QALYs were not. FFR led to a modest cost increase, albeit an imprecise increase, over both the trial [£112 (-£129 to £357)] and lifetime horizons [£133 (-£199 to £499)]. FFR led to a small, albeit imprecise, increase in QALYs over both the trial [0.02 (-0.03 to 0.06)] and lifetime horizons [0.03 (-0.21 to 0.28)]. The mean ICER was £7516/QALY and £4290/QALY over the trial and lifetime horizons, respectively. Decision remained high; FFR had 64 and 59 % probability of cost-effectiveness over trial and lifetime horizons, respectively.
  
  
  CONCLUSIONS
  FFR was cost-effective at the mean, albeit with considerable decision uncertainty. Uncertainty can be reduced with more information on long-term health events.
authors.affiliation: Health Economics and Health Technology Assessment, University of Glasgow, Glasgow, UK.
authors.forename: Julian
authors.initials: J
authors.lastname: Nam
authors.affiliation: Health Economics and Health Technology Assessment, University of Glasgow, Glasgow, UK.
authors.forename: Andrew
authors.initials: A
authors.lastname: Briggs
authors.affiliation: Institute of Cardiovascular and Medical Sciences, BHF Glasgow Cardiovascular Research Centre, University of Glasgow, Glasgow, UK.
authors.forename: Jamie
authors.initials: J
authors.lastname: Layland
authors.affiliation: Department of Cardiology, Golden Jubilee National Hospital, Agamemnon Street, Clydebank, G81 4DY UK.
authors.forename: Keith G
authors.initials: KG
authors.lastname: Oldroyd
authors.affiliation: Department of Cardiology, University Hospital Southampton Foundation Trust, Southampton, UK.
authors.forename: Nick
authors.initials: N
authors.lastname: Curzen
authors.affiliation: Department of Cardiology, Hairmyres Hospital, East Kilbride, UK.
authors.forename: Arvind
authors.initials: A
authors.lastname: Sood
authors.affiliation: Department of Cardiology, Royal Blackburn Hospital, Blackburn, UK.
authors.forename: Kanarath
authors.initials: K
authors.lastname: Balachandran
authors.affiliation: Department of Cardiology, Freeman Hospital, Newcastle, UK.
authors.forename: Raj
authors.initials: R
authors.lastname: Das
authors.affiliation: Department of Cardiology, City Hospitals Sunderland Foundation Trust, Sunderland, UK.
authors.forename: Shahid
authors.initials: S
authors.lastname: Junejo
authors.affiliation: Department of Cardiology, Golden Jubilee National Hospital, Agamemnon Street, Clydebank, G81 4DY UK.
authors.forename: Hany
authors.initials: H
authors.lastname: Eteiba
authors.affiliation: Department of Cardiology, Golden Jubilee National Hospital, Agamemnon Street, Clydebank, G81 4DY UK.
authors.forename: Mark C
authors.initials: MC
authors.lastname: Petrie
authors.affiliation: Department of Cardiology, Golden Jubilee National Hospital, Agamemnon Street, Clydebank, G81 4DY UK.
authors.forename: Mitchell
authors.initials: M
authors.lastname: Lindsay
authors.affiliation: Department of Cardiology, Golden Jubilee National Hospital, Agamemnon Street, Clydebank, G81 4DY UK.
authors.forename: Stuart
authors.initials: S
authors.lastname: Watkins
authors.affiliation: Department of Cardiology, University Hospital Southampton Foundation Trust, Southampton, UK.
authors.forename: Simon
authors.initials: S
authors.lastname: Corbett
authors.affiliation: Department of Cardiology, Hairmyres Hospital, East Kilbride, UK.
authors.forename: Brian
authors.initials: B
authors.lastname: O'Rourke
authors.affiliation: Department of Cardiology, Golden Jubilee National Hospital, Agamemnon Street, Clydebank, G81 4DY UK.
authors.forename: Anna
authors.initials: A
authors.lastname: O'Donnell
authors.affiliation: Department of Cardiology, Aberdeen Royal Infirmary, Aberdeen, UK.
authors.forename: Andrew
authors.initials: A
authors.lastname: Stewart
authors.affiliation: Department of Cardiology, Aberdeen Royal Infirmary, Aberdeen, UK.
authors.forename: Andrew
authors.initials: A
authors.lastname: Hannah
authors.affiliation: Robertson Centre for Biostatistics, University of Glasgow, Glasgow, UK.
authors.forename: Alex
authors.initials: A
authors.lastname: McConnachie
authors.affiliation: Department of Cardiology, Nottingham University Hospitals NHS Trust, Nottingham, UK.
authors.forename: Robert
authors.initials: R
authors.lastname: Henderson
authors.affiliation: Institute of Cardiovascular and Medical Sciences, BHF Glasgow Cardiovascular Research Centre, University of Glasgow, Glasgow, UK ; Department of Cardiology, Golden Jubilee National Hospital, Agamemnon Street, Clydebank, G81 4DY UK.
authors.forename: Colin
authors.initials: C
authors.lastname: Berry