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

Layland, J. et al. (2015) 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. European Heart Journal, 36(2), pp. 100-111. (doi:10.1093/eurheartj/ehu338) (PMID:25179764) (PMCID:PMC4291317)

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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 ≥ 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.

Item Type:Articles
Status:Published
Refereed:Yes
Glasgow Author(s) Enlighten ID:McConnachie, Dr Alex and Lee, Matthew and Briggs, Professor Andrew and Layland, Dr Jamie and Ford, Professor Ian
Authors: Layland, J., Oldroyd, K. G., Curzen, N., Sood, A., Balachandran, K., Das, R., Junejo, S., Ahmed, N., Lee, M.M.Y., Shaukat, A., O'Donnell, A., Nam, J., Briggs, A., Henderson, R., McConnachie, A., Berry, C., Hannah, A., Stewart, A., Metcalfe, M., Norrie, J., Chowdhary, S., Clark, A., Henderson, R., Balachandran, K., Berry, C., Baird, G., O'Donnell, A., Sood, A., Curzen, N., Das, R., Ford, I., Layland, J., Junejo, S., and Oldroyd, K.
College/School:College of Medical Veterinary and Life Sciences > Institute of Cardiovascular and Medical Sciences
College of Medical Veterinary and Life Sciences > Institute of Health and Wellbeing > Health Economics and Health Technology Assessment
College of Medical Veterinary and Life Sciences > Institute of Health and Wellbeing > Robertson Centre
Journal Name:European Heart Journal
Publisher:Oxford University Press
ISSN:0195-668X
ISSN (Online):1522-9645
Copyright Holders:Copyright © 2014 The Authors
First Published:First publshed in European Heart Journal 36(2):100-111
Publisher Policy:Reproduced under a Creative Commons License

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Project CodeAward NoProject NamePrincipal InvestigatorFunder's NameFunder RefLead Dept
575371Fractional Flow Reserve versus Angiographically Guided Management to Optimise Outcomes in Unstable Coronary Syndromes: a Developmental Clinical StudyColin BerryBritish Heart Foundation (BHF)PG/11/55/28999RI CARDIOVASCULAR & MEDICAL SCIENCES