Author + information
- Received December 8, 2009
- Revision received April 6, 2010
- Accepted April 14, 2010
- Published online July 13, 2010.
- 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
- ↵*Reprint requests and correspondence:
Dr. Nico H. J. Pijls, Catharina Hospital, Department of Cardiology, Michelangelolaan 2, 5623 EJ, Eindhoven, the Netherlands
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)
- fractional flow reserve
- multivessel coronary artery disease
- drug-eluting stents
- percutaneous coronary intervention
- coronary pressure
- pressure wire
Dr. Pijls reports receiving an institutional research grant for the Catharina Hospital Eindhoven from St. Jude Medical. Dr. Oldroyd reports receiving speaker fees from Biosensors and Boston Scientific. Dr. Ver Lee reports receiving lecture fees from and is on the Speakers' Bureau of St. Jude Medical. Dr. De Bruyne reports receiving research grants from The Meijer Lavino Foundationfor Cardiac Research.
- Received December 8, 2009.
- Revision received April 6, 2010.
- Accepted April 14, 2010.
- American College of Cardiology Foundation