Clinical Research
Interventional Cardiology
Fractional Flow Reserve Versus Angiography for Guiding Percutaneous Coronary Intervention in Patients With Multivessel Coronary Artery Disease: 2-Year Follow-Up of the FAME (Fractional Flow Reserve Versus Angiography for Multivessel Evaluation) Study

https://doi.org/10.1016/j.jacc.2010.04.012Get rights and content
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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

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

Cited by (0)

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.