St. Jude Medical initiates enrollment in FAME II trial for coronary artery disease

St. Jude Medical, Inc. (NYSE:STJ), a global medical device company, announced today at EuroPCR that the first patient was enrolled in the FAME II (Fractional Flow Reserve (FFR)-Guided Percutaneous Coronary Intervention Plus Optimal Medical Treatment vs. Optimal Medical Treatment Alone in Patients with Stable Coronary Artery Disease) trial. The goal of the FAME II trial is to study the role of Fractional Flow Reserve (FFR) in the treatment of stable coronary artery disease by comparing the clinical outcomes, safety and cost effectiveness of percutaneous coronary intervention (PCI) guided by FFR plus optimal medical treatment (OMT) to OMT alone.

“I am optimistic that this large-scale, international trial examining the use of FFR will address the questions raised by the COURAGE trial about the clinical benefits of PCI by comparing FFR-guided treatment with optimal medical treatment.”

There are many different tools that aid physicians in the treatment of coronary artery disease. One tool is a coronary angiogram, which is an X-ray examination of the blood vessels or chambers of the heart. Another technology that aids physicians in making the best treatment decisions for their patients is the measurement of FFR, which provides a more detailed, physiological analysis of blood flow blockages in the heart. An FFR measurement of above .80 indicates stenting that particular lesion may not be beneficial, even though the narrowing may look severe on the X-ray.

Prior to randomization, all patients will have an FFR measurement of affected arteries using the St. Jude Medical PressureWire™ Certus or PressureWire™ Aeris. Patients found to have one or more ischemic lesion (FFR measurement below .80) will be randomized 1:1 to PCI and OMT or OMT only. Standard of care for OMT includes the use of aspirin, beta blockers, anti-anginal medicine, and drugs to reduce cholesterol in the blood; these treatments help the heart work more efficiently and receive more oxygen-rich blood. Patients with an FFR measurement indicating ischemia who are randomized into the PCI and OMT group will receive PCI with a stent, a small metal mesh tube that is inserted into an artery to reduce its narrowing and help restore normal blood flow, along with OMT.

The FAME II trial is a follow-up to the landmark FAME (Fractional Flow Reserve (FFR) vs. Angiography in Multivessel Evaluation) trial, which compared FFR-guided stenting using the St Jude Medical PressureWire™ to angiographic-guided stenting in patients with 2- or 3-vessel (multivessel) coronary artery disease. Results demonstrated superior clinical outcomes in patients whose treatment was guided by FFR prior to coronary stenting; after two years, the combined risk of death or myocardial infarction (heart attack) was 34 percent lower for patients whose treatment was guided by PressureWire technology. In addition to superior clinical outcomes, the FAME trial also demonstrated that after one year, the FFR-guided intervention strategy reduced health care costs per patient by about $2,000, or 14 percent.

The FAME II trial seeks to answer questions as to the benefits of coronary intervention raised by the recent COURAGE (Clinical Outcomes Utilizing Revascularisation and Aggressive Drug Evaluation) trial, which demonstrated no difference in the outcomes between PCI and OMT compared to OMT alone. However, the study did not include 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.

"We expect the FAME II trial to provide further answers and evidence regarding the optimal way to treat patients with coronary artery disease," said Bernard De Bruyne, M.D., Ph.D., of the OLV Clinic in Aalst, Belgium, and coordinating clinical investigator of the FAME II trial. "I am optimistic that this large-scale, international trial examining the use of FFR will address the questions raised by the COURAGE trial about the clinical benefits of PCI by comparing FFR-guided treatment with optimal medical treatment."

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

"The FAME trial demonstrated unequivocally that FFR-guided PCI interventions can improve patient outcomes by reducing the rate of mortality and heart attack in patients with multivessel coronary artery disease," said Frank Callaghan, president of the St. Jude Medical Cardiovascular Division. "St. Jude Medical is pleased to also sponsor the FAME II trial, which is an important next step to discovering the benefits of using FFR measurements in a new patient population."