Measuring Fractional Flow Reserve During PCI Improves 1-Year Outcomes

January 26, 2009 By Michael W Tempelhof, MD [mailto:tempe004@mc.duke.edu]

Percutaneous coronary intervention (PCI) for treatment of NSTEMI and/or STEMI from ischemia has been associated with improvements in short-term and long-term clinical outcomes. However, in ischemic patients with multiple vessel disease, determination of which lesion is the culprit stenotic lesion requiring intervention is often difficult.

Fractional Flow Reserve (FFR): is the ratio of maximal blood flow in a stenotic vessel to normal maximal flow.

STUDY OBJECTIVE: To investigate whether FFR-guided PCI would be associated with better outcomes (rates of major adverse cardiac events (MACE) at 1 year, death, MI, or repeat revascularization at 1 year) vs. routine angiography-guided PCI in ischemic patients with multivessel disease.

STUDY DESIGN and METHODS: 1005 Patients with stenoses of >50% in at least two of the three major coronary arteries where randomized to either routine PCI, or FFR-guided PCI, where FFR was measured in all significant stenoses, with stenting in lesions with an FFR ≤0.8.

RESULTS: Rates of MACE at 1 year was significantly lower in the FFR arm compared with the routine-PCI arm (13.2% vs. 18.3%, p = 0.02). The incidence of death (1.8% vs. 3.0%, p = 0.19), myocardial infarction (MI) (5.7% vs. 8.7%, p = 0.07), and coronary artery bypass grafting or revascularization at year (6.5% vs. 9.5%, p = 0.08) was similar between both arms.

Mean procedure time was similar between the two study arms 70 minutes. Quantity of contrast dye utilized was significantly lower in the FFR arm, 272ml vs. 302 ml for standard PCI arm. The number of patients who were angina free at 1 year was also similar between the two arms (81% vs. 78%, p = 0.2). As measured by the EuroQOL-5D, the quality of life scores were similar between the two arms(p = 0.65).

CONCLUSIONS: The FAME trial results indicate that FFR-guided PCI is associated with a significantly lower incidence of MACE at year compared with routine angiography-guided PCI in ischemic patients with multivessel disease. FFR-guided PCI had a favorable cost-benefit ratio, similar procedural times to standard PCI and exposed patients to less contrast dye.

Tonino PA, De Bruyne B, Pijls NH, et al., on behalf of the FAME Investigators. Fractional flow reserve versus angiography for guiding percutaneous coronary intervention.

Source
N Engl J Med. 2009 Jan 15;360(3):213-24.