Fractional flow reserve versus angiography for guidance of PCI in patients with multivessel coronary artery disease (FAME): 5-year follow-up of a randomised controlled trial.
BACKGROUND
In the Fractional Flow Reserve Versus Angiography for Multivessel Evaluation (FAME) study, fractional flow reserve (FFR)-guided percutaneous coronary intervention (PCI) improved outcome compared with angiography-guided PCI for up to 2 years of follow-up. The aim in this study was to investigate whether the favourable clinical outcome with the FFR-guided PCI in the FAME study persisted over a 5-year follow-up.


METHODS
The FAME study was a multicentre trial done in Belgium, Denmark, Germany, the Netherlands, Sweden, the UK, and the USA. Patients (aged ≥ 18 years) with multivessel coronary artery disease were randomly assigned to undergo angiography-guided PCI or FFR-guided PCI. Before randomisation, stenoses requiring PCI were identified on the angiogram. Patients allocated to angiography-guided PCI had revascularisation of all identified stenoses. Patients allocated to FFR-guided PCI had FFR measurements of all stenotic arteries and PCI was done only if FFR was 0·80 or less. No one was masked to treatment assignment. The primary endpoint was major adverse cardiac events at 1 year, and the data for the 5-year follow-up are reported here. Analysis was by intention to treat. This trial is registered with ClinicalTrials.gov, number NCT00267774.


RESULTS
After 5 years, major adverse cardiac events occurred in 31% of patients (154 of 496) in the angiography-guided group versus 28% (143 of 509 patients) in the FFR-guided group (relative risk 0·91, 95% CI 0·75-1·10; p=0·31). The number of stents placed per patient was significantly higher in the angiography-guided group than in the FFR-guided group (mean 2·7 [SD 1·2] vs 1·9 [1·3], p<0·0001).


CONCLUSIONS
The results confirm the long-term safety of FFR-guided PCI in patients with multivessel disease. A strategy of FFR-guided PCI resulted in a significant decrease of major adverse cardiac events for up to 2 years after the index procedure. From 2 years to 5 years, the risks for both groups developed similarly. This clinical outcome in the FFR-guided group was achieved with a lower number of stented arteries and less resource use. These results indicate that FFR guidance of multivessel PCI should be the standard of care in most patients.


BACKGROUND
St Jude Medical, Friends of the Heart Foundation, and Medtronic.
Department of Cardiology, Catharina Hospital Eindhoven, Eindhoven, Netherlands; Department of Biomedical Engineering, Eindhoven University of Technology, Eindhoven, Netherlands.
Lokien X
LX
van Nunen
Department of Cardiology, Catharina Hospital Eindhoven, Eindhoven, Netherlands; Department of Biomedical Engineering, Eindhoven University of Technology, Eindhoven, Netherlands.
Frederik M
FM
Zimmermann
Department of Cardiology, Catharina Hospital Eindhoven, Eindhoven, Netherlands; Department of Biomedical Engineering, Eindhoven University of Technology, Eindhoven, Netherlands.
Pim A L
PA
Tonino
Cardiovascular Center Aalst, Onze Lieve Vrouw Ziekenhuis, Aalst, Belgium; Division of Cardiology, Department of Advanced Biomedical Sciences, Federico II University of Naples, Naples, Italy.
Emanuele
E
Barbato
Bristol Heart Institute, University Hospitals Bristol NHS Foundation Trust, Bristol, UK.
Andreas
A
Baumbach
Heart Centre, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark.
Thomas
T
Engstrøm
Medizinische Poliklinik, Campus-Innenstadt, University Hospital, Munich, Germany.
Volker
V
Klauss
King's College Hospital, London, UK.
Philip A
PA
MacCarthy
Heart Centre, Royal Victoria Hospital, Belfast, UK.
Ganesh
G
Manoharan
Golden Jubilee National Hospital, Glasgow, UK.
Keith G
KG
Oldroyd
Northeast Cardiology Associates and Eastern Maine Medical Center, Bangor, ME, USA.
Peter N
PN
Ver Lee
Department of Cardiology, Catharina Hospital Eindhoven, Eindhoven, Netherlands; Department of Biomedical Engineering, Eindhoven University of Technology, Eindhoven, Netherlands.
Marcel
M
Van't Veer
Stanford University Medical Center and Palo Alto VA Health Care Systems, Stanford, CA, USA.
William F
WF
Fearon
Cardiovascular Center Aalst, Onze Lieve Vrouw Ziekenhuis, Aalst, Belgium.
Bernard
B
De Bruyne
Department of Cardiology, Catharina Hospital Eindhoven, Eindhoven, Netherlands; Department of Biomedical Engineering, Eindhoven University of Technology, Eindhoven, Netherlands. Electronic address: nico.pijls@inter.nl.net.
Nico H J
NH
Pijls
D017023:Coronary Angiography; D003324:Coronary Artery Disease / Q000175:diagnosis* / Q000000981:diagnostic imaging / Q000401:mortality / Q000601:surgery; D005260:Female; D053805:Fractional Flow Reserve, Myocardial; D006801:Humans; D008297:Male; D008875:Middle Aged; D062645:Percutaneous Coronary Intervention / Q000379:methods*; D012737:Sex Factors