The results from an international 1005 patient strong FAME (Fractional flow reserve (FFR) vs. Angiography in Multivessel Evaluation) study were published in last week’s issue of the New England Journal of Medicine. The goal of the trial was to assess whether intracoronary pressure measurement during coronary cath, i.e. FFR that looks at the pressure drop across the stenotic coronary artery, improves long term outcomes. The investigators from six countries randomized patients with multivessel coronary artery disease to undergo percutaneous coronary intervention (PCI) with implantation of drug-eluting stents guided by angiography alone or guided by FFR measurements in addition to angiography. The study used St. Jude Medical PressureWire® Certus guidewire. The investigators found that the risk of a patient dying or having an MI was reduced by approximately 35 percent when FFR measurement was done.
We are not surprised with these results. Until now, coronary angiography has been an imaging modality lacking the functional (physiologic) component. With this study, PCI is posed to become a functional modality, based on solid measurements, and not just on appearances of dye flows across stenotic lesions.
From the study abstract:
Methods In 20 medical centers in the United States and Europe, we randomly assigned 1005 patients with multivessel coronary artery disease to undergo PCI with implantation of drug-eluting stents guided by angiography alone or guided by FFR measurements in addition to angiography. Before randomization, lesions requiring PCI were identified on the basis of their angiographic appearance. Patients assigned to angiography-guided PCI underwent stenting of all indicated lesions, whereas those assigned to FFR-guided PCI underwent stenting of indicated lesions only if the FFR was 0.80 or less. The primary end point was the rate of death, nonfatal myocardial infarction, and repeat revascularization at 1 year.
Results The mean (±SD) number of indicated lesions per patient was 2.7±0.9 in the angiography group and 2.8±1.0 in the FFR group (P=0.34). The number of stents used per patient was 2.7±1.2 and 1.9±1.3, respectively (P<0.001). The 1-year event rate was 18.3% (91 patients) in the angiography group and 13.2% (67 patients) in the FFR group (P=0.02). Seventy-eight percent of the patients in the angiography group were free from angina at 1 year, as compared with 81% of patients in the FFR group (P=0.20).
Conclusions Routine measurement of FFR in patients with multivessel coronary artery disease who are undergoing PCI with drug-eluting stents significantly reduces the rate of the composite end point of death, nonfatal myocardial infarction, and repeat revascularization at 1 year.
Abstract in New England Journal of Medicine…
Statement from St. Jude: FAME Study Published in New England Journal of Medicine
Product page: PressureWire® Certus…
PressureWire® Certus product brochure (.pdf)…
