Fractional flow reserve versus angiography in guiding management to optimize outcomes in non–ST-elevation myocardial infarction (FAMOUS-NSTEMI): rationale and design of a randomized controlled clinical trial

Berry, C. et al. (2013) Fractional flow reserve versus angiography in guiding management to optimize outcomes in non–ST-elevation myocardial infarction (FAMOUS-NSTEMI): rationale and design of a randomized controlled clinical trial. American Heart Journal, 166(4), 662-668.e3. (doi:10.1016/j.ahj.2013.07.011)

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Publisher's URL: http://dx.doi.org/10.1016/j.ahj.2013.07.011

Abstract

<p>Background: In patients with acute non–ST-elevation myocardial infarction (NSTEMI), coronary arteriography is usually recommended; but visual interpretation of the angiogram is subjective. We hypothesized that functional assessment of coronary stenosis severity with a pressure-sensitive guide wire (fractional flow reserve [FFR]) would have additive diagnostic, clinical, and health economic utility as compared with angiography-guided standard care.</p> <p>Methods and design: A prospective multicenter parallel-group 1:1 randomized controlled superiority trial in 350 NSTEMI patients with ≥1 coronary stenosis ≥30% severity (threshold for FFR measurement) will be conducted. Patients will be randomized immediately after coronary angiography to the FFR-guided group or angiography-guided group. All patients will then undergo FFR measurement in all vessels with a coronary stenosis ≥30% severity including culprit and nonculprit lesions. Fractional flow reserve will be disclosed to guide treatment in the FFR-guided group but not disclosed in the “angiography-guided” group. In the FFR-guided group, an FFR ≤0.80 will be an indication for revascularization by percutaneous coronary intervention or coronary artery bypass surgery, as appropriate. The primary outcome is the between-group difference in the proportion of patients allocated to medical management only compared with revascularization. Secondary outcomes include the occurrence of cardiac death or hospitalization for myocardial infarction or heart failure, quality of life, and health care costs. The minimum and average follow-up periods for the primary analysis are 6 and 18 months, respectively.</p> <p>Conclusions: Our developmental clinical trial will address the feasibility of FFR measurement in NSTEMI and the influence of FFR disclosure on treatment decisions and health and economic outcomes.</p>

Item Type:Articles
Status:Published
Refereed:Yes
Glasgow Author(s) Enlighten ID:Berry, Professor Colin and Briggs, Professor Andrew and Oldroyd, Dr Keith and Layland, Dr Jamie and Ford, Professor Ian
Authors: Berry, C., Layland, J., Sood, A., Curzen, N. P., Balachandran, K. P., Das, R., Junejo, S., Henderson, R. A., Briggs, A. H., Ford, I., and Oldroyd, K. G.
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:American Heart Journal
Publisher:Elsevier
ISSN:0002-8703
ISSN (Online):1097-6744
Copyright Holders:Copyright © 2013 The Authors
First Published:First published in the American Heart Journal 166(4):662-668.e3
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