title: Fractional flow reserve vs. angiography in guiding management to optimize outcomes in non-ST-segment elevation myocardial infarction: the British Heart Foundation FAMOUS-NSTEMI randomized trial.
abstract: OBJECTIVE
  We assessed the management and outcomes of non-ST segment elevation myocardial infarction (NSTEMI) patients randomly assigned to fractional flow reserve (FFR)-guided management or angiography-guided standard care.
  
  
  RESULTS
  We conducted a prospective, multicentre, parallel group, 1 : 1 randomized, controlled trial in 350 NSTEMI patients with ≥1 coronary stenosis ≥30% of the lumen diameter assessed visually (threshold for FFR measurement) (NCT01764334). Enrolment took place in six UK hospitals from October 2011 to May 2013. Fractional flow reserve was disclosed to the operator in the FFR-guided group (n = 176). Fractional flow reserve was measured but not disclosed in the angiography-guided group (n = 174). Fractional flow reserve ≤0.80 was an indication for revascularization by percutaneous coronary intervention (PCI) or coronary artery bypass surgery (CABG). The median (IQR) time from the index episode of myocardial ischaemia to angiography was 3 (2, 5) days. For the primary outcome, the proportion of patients treated initially by medical therapy was higher in the FFR-guided group than in the angiography-guided group [40 (22.7%) vs. 23 (13.2%), difference 95% (95% CI: 1.4%, 17.7%), P = 0.022]. Fractional flow reserve disclosure resulted in a change in treatment between medical therapy, PCI or CABG in 38 (21.6%) patients. At 12 months, revascularization remained lower in the FFR-guided group [79.0 vs. 86.8%, difference 7.8% (-0.2%, 15.8%), P = 0.054]. There were no statistically significant differences in health outcomes and quality of life between the groups.
  
  
  CONCLUSIONS
  In NSTEMI patients, angiography-guided management was associated with higher rates of coronary revascularization compared with FFR-guided management. A larger trial is necessary to assess health outcomes and cost-effectiveness.
authors.affiliation: West of Scotland Heart and Lung Centre, Golden Jubilee National Hospital, Clydebank, UK BHF Glasgow Cardiovascular Research Centre, Institute of Cardiovascular and Medical Sciences, University of Glasgow, 126 University Place, Glasgow G12 8TA, UK.
authors.forename: Jamie
authors.initials: J
authors.lastname: Layland
authors.affiliation: West of Scotland Heart and Lung Centre, Golden Jubilee National Hospital, Clydebank, UK.
authors.forename: Keith G
authors.initials: KG
authors.lastname: Oldroyd
authors.affiliation: University Hospital Southampton Foundation Trust, Southampton, UK.
authors.forename: Nick
authors.initials: N
authors.lastname: Curzen
authors.affiliation: Hairmyres Hospital, East Kilbride, UK.
authors.forename: Arvind
authors.initials: A
authors.lastname: Sood
authors.affiliation: Royal Blackburn Hospital, Blackburn, UK.
authors.forename: Kanarath
authors.initials: K
authors.lastname: Balachandran
authors.affiliation: Freeman Hospital, Newcastle, UK.
authors.forename: Raj
authors.initials: R
authors.lastname: Das
authors.affiliation: City Hospitals Sunderland Foundation Trust, Sunderland, UK.
authors.forename: Shahid
authors.initials: S
authors.lastname: Junejo
authors.affiliation: West of Scotland Heart and Lung Centre, Golden Jubilee National Hospital, Clydebank, UK.
authors.forename: Nadeem
authors.initials: N
authors.lastname: Ahmed
authors.affiliation: West of Scotland Heart and Lung Centre, Golden Jubilee National Hospital, Clydebank, UK.
authors.forename: Matthew M Y
authors.initials: MM
authors.lastname: Lee
authors.affiliation: West of Scotland Heart and Lung Centre, Golden Jubilee National Hospital, Clydebank, UK.
authors.forename: Aadil
authors.initials: A
authors.lastname: Shaukat
authors.affiliation: West of Scotland Heart and Lung Centre, Golden Jubilee National Hospital, Clydebank, UK.
authors.forename: Anna
authors.initials: A
authors.lastname: O'Donnell
authors.affiliation: Health Economics and Health Technology Assessment Unit, University of Glasgow, Glasgow, UK.
authors.forename: Julian
authors.initials: J
authors.lastname: Nam
authors.affiliation: Health Economics and Health Technology Assessment Unit, University of Glasgow, Glasgow, UK.
authors.forename: Andrew
authors.initials: A
authors.lastname: Briggs
authors.affiliation: Trent Cardiac Centre, Nottingham University Hospitals, Nottingham, UK.
authors.forename: Robert
authors.initials: R
authors.lastname: Henderson
authors.affiliation: Robertson Centre for Biostatistics, University of Glasgow, UK.
authors.forename: Alex
authors.initials: A
authors.lastname: McConnachie
authors.affiliation: West of Scotland Heart and Lung Centre, Golden Jubilee National Hospital, Clydebank, UK BHF Glasgow Cardiovascular Research Centre, Institute of Cardiovascular and Medical Sciences, University of Glasgow, 126 University Place, Glasgow G12 8TA, UK colin.berry@glasgow.ac.uk.
authors.forename: Colin
authors.initials: C
authors.lastname: Berry
mesh_terms: D017023:Coronary Angiography / Q000379:methods; D023921:Coronary Stenosis / Q000000981:diagnostic imaging / Q000503:physiopathology / Q000628:therapy; D003365:Costs and Cost Analysis; D004562:Electrocardiography; D005260:Female; D053805:Fractional Flow Reserve, Myocardial / Q000502:physiology*; D006295:Health Resources / Q000191:economics / Q000706:statistics & numerical data; D006760:Hospitalization / Q000706:statistics & numerical data; D006801:Humans; D008297:Male; D008875:Middle Aged; D009203:Myocardial Infarction / Q000000981:diagnostic imaging / Q000503:physiopathology / Q000628:therapy*; D009204:Myocardial Revascularization / Q000379:methods; D011446:Prospective Studies; D011788:Quality of Life; D015641:Radiography, Interventional / Q000379:methods; D016896:Treatment Outcome
keywords: Acute coronary syndrome; Coronary revascularization; Fractional flow reserve; Medical therapy; Non-ST elevation myocardial infarction