St. Jude Medical Begins FAME II Enrollment

May 25, 2010—St. Jude Medical, Inc. (St. Paul, MN) announced that the first patient was enrolled in the FAME II (Fractional Flow Reserve [FFR]-Guided Percutaneous Coronary Intervention Plus Optimal Medical Treatment Versus Optimal Medical Treatment [OMT] Alone in Patients With Stable Coronary Artery Disease] trial. The goal of the FAME II trial is to study the role of FFR in treating stable stable coronary artery disease by comparing the clinical outcomes, safety, and cost effectiveness of percutaneous coronary intervention (PCI) guided by FFR plus OMT to OMT alone. Bernard De Bruyne, MD; Professor Nico Pijls, MD; and William F. Fearon, MD, are the coordinating clinical investigators for the FAME II trial.

According to St. Jude Medical, all patients will have an FFR measurement of affected arteries using the company's PressureWire Certus or PressureWire Aeris before randomization. Patients found to have one or more ischemic lesions (FFR measurement < 0.8) will be randomized 1:1 to PCI plus OMT or OMT alone. Patients with an FFR measurement indicating ischemia who are randomized into the PCI plus OMT group will receive PCI with a stent along with OMT.

The FAME II trial is a follow-up to the FAME (FFR Versus Angiography in Multivessel Evaluation) trial, which compared FFR-guided stenting using St. Jude's PressureWire to angiographic-guided stenting in patients with multivessel coronary artery disease. Results demonstrated superior clinical outcomes in patients whose treatment was guided by FFR before coronary stenting; after 2 years, the combined risk of death or myocardial infarction was 34% lower for patients whose treatment was guided by PressureWire technology. In addition to superior clinical outcomes, the FAME trial also demonstrated that after 1 year, the FFR-guided intervention strategy reduced health care costs per patient by about $2,000 or 14%, St. Jude stated.

The company noted that the FAME II trial seeks to answer questions regarding the benefits of coronary intervention that were raised by the recent COURAGE (Clinical Outcomes Utilizing Revascularization and Aggressive Drug Evaluation) trial, which demonstrated no difference in the outcomes between PCI plus OMT compared to OMT alone. COURAGE did not include the use of PressureWire technology to indicate the presence of ischemia. FAME II will explore whether FFR-guided interventions provide an added benefit to the treatment of patients with stable coronary artery disease.

FAME II will enroll approximately 1,600 patients who have at least one hemodynamically significant lesion and are amenable to PCI with drug-eluting stents (unless contraindicated). Enrollment will be conducted at 30 centers in Europe and the United States. The prospective, multicenter, multinational, randomized trial's primary endpoint will be the 24-month major adverse cardiac event rate, defined as all-cause death, documented myocardial infarction, and unplanned hospitalization leading to urgent revascularization. Other endpoints include cost effectiveness and functional status.

In other company news, on May 19, St. Jude Medical and LightLab Imaging, Inc. (Westford, MA) announced a definitive agreement under which St. Jude will acquire LightLab, which recently received Food and Drug Administration clearance for the C7-XR imaging system and companion C7 Dragonfly imaging catheter, reported in the Regulatory Update section of the News in this issue.