Results of FAME II Reveal Better Patient Outcomes With FFR-Guided Cardiac Stenting

August 28, 2012—St. Jude Medical, Inc. (St. Paul, MN) announced results of the FAME II trial, which demonstrated that patients who underwent fractional flow reserve (FFR)-guided stenting plus optimal medical therapy had superior outcomes compared to those who received medical therapy alone. The results were presented as part of a Hot Line session at the 2012 European Society of Cardiology congress in Munich, Germany, as well as being published online ahead of print in the New England Journal of Medicine.

St. Jude Medical describes FAME II as a randomized, all-comers trial conducted at 28 sites in Europe and North America, with approval by the institutional review board at each participating center. The results showed that the use of PressureWire FFR measurement technology (St. Jude Medical) resulted in an 86% reduction in the relative risk for unplanned readmission to the hospital with urgent revascularization in patients with stable coronary artery disease.

With regard to the primary endpoint of a composite of death, heart attack, or urgent revascularization during the first 2 years, FAME II demonstrated a significantly lower event rate in patients undergoing percutaneous coronary intervention (PCI) plus optimal medical therapy when compared to patients undergoing medical therapy alone (4.3% vs 12.7%). The rate of hospital readmission leading to urgent revascularization was reduced by 86% for patients in the FFR-guided PCI arm of the trial, and there was no evidence of a significant difference in mortality or heart attack between patients who received PCI plus optimal medical therapy and those who received medical therapy alone.

“The FAME II trial provides new evidence-based guidance demonstrating the profound role that FFR and second-generation drug-eluting stents can have in improving patient care,” said Bernard De Bruyne, MD, PhD, of the OLV Clinic in Aalst, Belgium, and Coordinating Clinical Investigator of the FAME II trial in a press release issued by St. Jude Medical. “Though there have been questions in the past about whether a patient should have a stent or is better off with medical treatment, we now know that if a lesion is significant, as determined by FFR guidance, the stenting procedure will provide a better outcome. With this new knowledge, I believe that FFR should become the standard of care for treating patients with stable coronary artery disease and significant coronary narrowings.”