First Patients Enrolled in FAME II FFR Clinical Trial

May 25, 2010 – A clinical trial will examine benefits of fractional flow reserve (FFR)-guided stenting with optimal medical treatment compared to medical treatment alone. The FAME II clinical trial, the follow-up to the landmark FAME trial, recently started enrolling patients.

St. Jude Medical announced the new trial today at EuroPCR in Paris. FAME II will study the role of FFR in the treatment of stable coronary artery disease. It will compare the clinical outcomes, safety and cost effectiveness of percutaneous coronary intervention (PCI) guided by FFR plus optimal medical treatment (OMT) to OMT alone.

Angiography and FFR aid physicians in making the best treatment decisions. FFR 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.

Trial Design
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 two- or three-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. He is the 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.”

About 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 study’s coordinating investigators are Bernard De Bruyne, Professor Nico Pijls, M.D., Ph.D., of Catharina Hospital in Eindhoven, the Netherlands and William F. Fearon, M.D., of Stanford University Medical Center in California.
About Fractional Flow Reserve

FFR is a physiological index used to determine the hemodynamic severity of narrowings in the coronary arteries, and can be measured using the PressureWire Aeris and PressureWire Certus. FFR specifically identifies which coronary narrowings are responsible for obstructing the flow of blood to a patient’s heart muscle (called ischemia), and guides the interventional cardiologist in assessing which lesions warrant coronary interventions, resulting in improved treatment outcomes.

About the FAME Trial

The FAME study was a randomized, prospective, multicenter trial that enrolled 1,005 patients with multivessel coronary artery disease. It compared outcomes for patients whose treatment was guided by FFR to those whose treatment was guided only by angiography. The 12-month results, published in the Jan. 15, 2009 issue of the New England Journal of Medicine, demonstrated that instances of major adverse cardiovascular events (MACE), including death, myocardial infarction or repeat revascularization, were reduced by 28 percent for patients whose treatment was guided by FFR rather than by standard angiography alone.

Two-year results presented as a late-breaking trial during the 2009 Transcatheter Cardiovascular Therapeutics (TCT) Conference demonstrated that patients who received FFR-guided treatment continued to experience improved outcomes over time, including a 34 percent risk reduction in death or heart attack.

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