By Colin Berry, (Glasgow, United Kingdom)
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List of Authors:
Dr Jamie Layland 1,2 PhD, Professor Keith Oldroyd 1 MD (Hons), Professor Nick Curzen 3 BM(Hons) PhD, Dr Arvind Sood 4 MRCP, Dr Kanarath Balachandran 5 MD, Dr Raj Das 6 MD, Dr Shahid Junejo 7 FRCPI, Dr Nadeem Ahmed 1 MBChB, Dr Matthew M.Y. Lee 1 MRCP, Dr Aadil Shaukat 1 MRCP, Ms. Anna O'Donnell 1 BN, Mr Julian Nam 8 MSc, Professor Andrew Briggs 8 DPhil, Dr Robert Henderson 9 DM FRCP, Dr Alex McConnachie 10 PhD, Professor Colin Berry 1,2 FRCP PhD on behalf of the FAMOUS-NSTEMI investigators.
1-West of Scotland Heart and Lung Centre, Golden Jubilee National Hospital, Clydebank, UK;
2-BHF Glasgow Cardiovascular Research Centre, Institute of Cardiovascular and Medical Sciences, University of Glasgow, 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, UK;
9-Trent Cardiac Centre, Nottingham University Hospitals, Nottingham, UK;
10-Robertson Centre for Biostatistics, University of Glasgow, UK.
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 randomised, controlled trial in 350 NSTEMI patients with ≥1 coronary stenosis ≥30% of the lumen diameter assessed visually (threshold for FFR measurement) (NCT01764334) (Figure 1, Table 1). Enrolment took place in 6 UK hospitals from October 2011 – May 2013. FFR was disclosed to the operator in the FFR guided-group (n=176). FFR was measured but not disclosed in the angiography-guided group (n=174). FFR ≤0.80 was an indication for revascularisation 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 9•5% (95% CI 1.4%, 17.7%), p=0.022). FFR disclosure resulted in a change in treatment between medical therapy, PCI or CABG in 38 (21.6%) patients (Figures 2 & 3). At 12 months, revascularisation 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 (Figure 4).
In NSTEMI patients, angiography-guided management was associated with higher rates of coronary revascularisation compared with FFR-guided management. A larger trial is necessary to assess health outcomes and cost effectiveness.
By Bernard De Bruyne, (Aalst, Belgium)
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