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Fractional Flow Reserve-Guided PCI versus Medical Treatment in Stable Coronary Disease: FAME 2 Primary End-Point Data Analysis

ESC Congress 2014 - Hot Line report

Chronic Ischaemic Heart Disease (IHD)



By Bernard De Bruyne, (Aalst, Belgium)
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List of Authors:
Bernard De Bruyne 1, MD, PhD, William F Fearon 2, MD, Nico HJ Pijls 3, MD, PhD, Emanuele Barbato 1, MD, PhD, Pim Tonino 3, MD, PhD, Zsolt Piroth 4, MD, Nikola Jagic 5, MD, Sven Mobius-Winckler 6, MD Gilles Riouffol 7, MD, PhD, Nils Witt 8, MD, PhD, Petr Kala 9, MD, Philip MacCarthy 10, MD, Thomas Engström 11, MD, Keith Oldroyd 12, MD, Kreton Mavromatis 13, MD, Ganesh Manoharan 14, MD, Peter Verlee 15, MD, Ole Frobert 16, MD, Nick Curzen 17, BM, PhD, Jane B Johnson 18, RN, BSN, Andreas Limacher 19, PhD, Eveline Nüesch 19, PhD, Peter Jüni 19, MD for the Fractional Flow Reserve versus Angiography for Multivessel Evaluation 2 (FAME 2) Trial investigators.

1.Cardiovascular Center Aalst, OLV-Clinic Aalst, Belgium
2.Stanford University Medical Center and Palo Alto Veterans Affairs Health Care Systems, Stanford,CA
3.Department of Cardiology, Catharina Hospital, Eindhoven, and Department of Biomedical Enginering, Eindhoven University of Technology, The Netherlands.
4.Hungarian Institute of Cardiology, Budapest, Hungary
5.Clinical Center Kragujevac, Kragujeva, Serbia
6.Heart Center Leipzig, Leipzig, Germany
7.Cardiovascular Hospital, Lyon, France
8.Karolinska Institutet at Södersjukhuset, Stockholm, Sweden
9.University and University Hospital, Brno, Czech Republic
10.King’s College Hospital, London, United Kingdom
11.Rigshospitalet University Hospital, Copenhagen, Denmark
12.Golden Jubilee National Hospital, Glasgow, United Kingdom
13.Atlanta Veterans Affairs Medical Center, Decatur, GA
14.Royal Victoria Hospital, Belfast, United Kingdom
15.Eastern Maine Medical Center, Bangor, ME
16.Örebro University Hospital, Orebro, Sweden
17.Southampton University Hospital NHS Trust, Southampton, United Kingdom
18.St Jude Medical
19.Division of Clinical Epidemiology and Biostatistics,Institute of Social and Preventive


We hypothesized that percutaneous coronary intervention (PCI) is superior to MT in patients with stable coronary artery disease (CAD) and functionally significant stenoses, as determined by fractional flow reserve (FFR).
In 1220 patients with stable CAD, amenable for PCI with drug eluting stents, FFR was assessed in all angiographically visible stenoses. If at least one stenosis had an FFR≤0.80, patients were randomized to FFR-guided PCI plus MT (PCI, n=447) or to MT alone (MT, n=441). If all stenoses had an FFR>0.80, patients received MT and were included in a registry (n=332).
The rate of death, myocardial infarction (MI), or urgent revascularization at 2 years was lower with PCI than MT (8.1% vs 19.5%, HR 0.39, 95%-CI 0.26-0.57, P<0.001), driven by a lower rate of urgent revascularization (4.0% vs 16.3%, HR 0.23, 95%-CI 0.14-0.38, P<0.001). Death or MI were not significantly different. Urgent revascularizations triggered by an MI or ischemic ECG changes were less frequent with PCI (3.4% vs 7.0%, HR 0.47, 95%-CI 0.25-0.86, p=0.013). In a landmark analysis, the rate of death or MI was lower in the PCI group than in the MT group after the landmark at 7 days (4.6% vs 8.0%, HR 0.56, 95%-CI 0.32-0.97, P=0.037). In registry patients, the rate of the primary endpoint remained low (9.0%).
In patients with stable CAD, FFR-guided PCI improves outcome as compared with MT. Patients with CAD but no ischemia have a favorable outcome with MT.


By Udo Sechtem, FESC (Stuttgart, Germany)
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Clinical Trial Update Hot Line: Stable CAD and atrial fibrillation

The content of this article reflects the personal opinion of the author/s and is not necessarily the official position of the European Society of Cardiology.