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Eur Heart J. 2015 Jan 7;36(2):100-11. doi: 10.1093/eurheartj/ehu338. Epub 2014 Sep 1.

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.

Author information

1
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.
2
West of Scotland Heart and Lung Centre, Golden Jubilee National Hospital, Clydebank, UK.
3
University Hospital Southampton Foundation Trust, Southampton, UK.
4
Hairmyres Hospital, East Kilbride, UK.
5
Royal Blackburn Hospital, Blackburn, UK.
6
Freeman Hospital, Newcastle, UK.
7
City Hospitals Sunderland Foundation Trust, Sunderland, UK.
8
Health Economics and Health Technology Assessment Unit, University of Glasgow, Glasgow, UK.
9
Trent Cardiac Centre, Nottingham University Hospitals, Nottingham, UK.
10
Robertson Centre for Biostatistics, University of Glasgow, UK.
11
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.

Abstract

AIM:

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.

METHODS AND 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.

CONCLUSION:

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.

KEYWORDS:

Acute coronary syndrome; Coronary revascularization; Fractional flow reserve; Medical therapy; Non-ST elevation myocardial infarction

PMID:
25179764
PMCID:
PMC4291317
DOI:
10.1093/eurheartj/ehu338
[Indexed for MEDLINE]
Free PMC Article
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