CLINICAL RESEARCH: INTERVENTIONAL CARDIOLOGY
Fractional Flow Reserve Versus Angiography for Guiding Percutaneous Coronary Intervention in Patients With Multivessel Coronary Artery Disease2-Year Follow-Up of the FAME (Fractional Flow Reserve Versus Angiography for Multivessel Evaluation) Study
Nico H.J. Pijls, MD, PhD*,*,
William F. Fearon, MD ,
Pim A.L. Tonino, MD*,
Uwe Siebert, MD, MS, MPH, ScD , ,
Fumiaki Ikeno, MD,
Bernhard Bornschein, MD, MPH,
Marcel van't Veer, MS, PhD*,
Volker Klauss, MD, PhD||,
Ganesh Manoharan, MD¶,
Thomas Engstrøm, MD, PhD#,
Keith G. Oldroyd, MD**,
Peter N. Ver Lee, MD,
Philip A. MacCarthy, MD,
Bernard De Bruyne, MD, PhD FAME Study Investigators
* Catharina Hospital, Eindhoven, the Netherlands
Stanford University Medical Center and Palo Alto VA Health Care Systems, Stanford, California
University for Health Sciences, Medical Informatics and Technology, Hall in Tirol, Austria
Massachusetts General Hospital, Harvard Medical School, Boston, Massachusetts
|| Medizinische Poliklinik, Campus-Innenstadt, University Hospital, Munich, Germany
¶ The Heart Centre, Royal Victoria Hospital, Belfast, United Kingdom
# Rigshopitalet, Copenhagen, Denmark
** Golden Jubilee National Hospital, Glasgow, United Kingdom
Northeast Cardiology Associates and Eastern Maine Medical Center, Bangor, Maine
King's College Hospital, London, United Kingdom
Cardiovascular Center Aalst, Aalst, Belgium
Manuscript received December 8, 2009;
revised manuscript received April 6, 2010,
accepted April 14, 2010.
*
Reprint requests and correspondence: Dr. Nico H. J. Pijls, Catharina Hospital, Department of Cardiology, Michelangelolaan 2, 5623 EJ, Eindhoven, the Netherlands (Email: nico.pijls{at}inter.nl.net).
Objectives: The purpose of this study was to investigate the 2-year outcome of percutaneous coronary intervention (PCI) guided by fractional flow reserve (FFR) in patients with multivessel coronary artery disease (CAD).
Background: In patients with multivessel CAD undergoing PCI, coronary angiography is the standard method for guiding stent placement. The FAME (Fractional Flow Reserve Versus Angiography for Multivessel Evaluation) study showed that routine FFR in addition to angiography improves outcomes of PCI at 1 year. It is unknown if these favorable results are maintained at 2 years of follow-up.
Methods: At 20 U.S. and European medical centers, 1,005 patients with multivessel CAD were randomly assigned to PCI with drug-eluting stents guided by angiography alone or guided by FFR measurements. Before randomization, lesions requiring PCI were identified based on their angiographic appearance. Patients randomized to angiography-guided PCI underwent stenting of all indicated lesions, whereas those randomized to FFR-guided PCI underwent stenting of indicated lesions only if the FFR was  0.80.
Results: The number of indicated lesions was 2.7 ± 0.9 in the angiography-guided group and 2.8 ± 1.0 in the FFR-guided group (p = 0.34). The number of stents used was 2.7 ± 1.2 and 1.9 ± 1.3, respectively (p < 0.001). The 2-year rates of mortality or myocardial infarction were 12.9% in the angiography-guided group and 8.4% in the FFR-guided group (p = 0.02). Rates of PCI or coronary artery bypass surgery were 12.7% and 10.6%, respectively (p = 0.30). Combined rates of death, nonfatal myocardial infarction, and revascularization were 22.4% and 17.9%, respectively (p = 0.08). For lesions deferred on the basis of FFR >0.80, the rate of myocardial infarction was 0.2 % and the rate of revascularization was 3.2 % after 2 years.
Conclusions: Routine measurement of FFR in patients with multivessel CAD undergoing PCI with drug-eluting stents significantly reduces mortality and myocardial infarction at 2 years when compared with standard angiography-guided PCI. (Fractional Flow Reserve Versus Angiography for Multivessel Evaluation [FAME]; NCT00267774)
Key Words: fractional flow reserve • multivessel coronary artery disease • drug-eluting stents • percutaneous coronary intervention • coronary pressure • pressure wire
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Abbreviations and Acronyms
| | CABG = coronary artery bypass grafting | | CAD = coronary artery disease | | CK-MB = creatine kinase-myocardial band | | DES = drug-eluting stent(s) | | FFR = fractional flow reserve | | MACE = major adverse cardiac event(s) | | PCI = percutaneous coronary intervention |
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