St. Jude Medical Commences Enrollment in FAME II Trial

May 25, 2010—At the EuroPCR 2010 conference in Paris, 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 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 prior to 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 approximately $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.

“We expect the FAME II trial to provide further answers and evidence regarding the optimal way to treat patients with coronary artery disease,” commented Dr. De Bruyne, MD. “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 OMT.”

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.

Also at the EuroPCR 2010 meeting, St. Jude Medical announced that it will evaluate the incremental cost effectiveness of FFR-guided treatment for patients with multivessel coronary artery disease in the United Kingdom, Germany, France, Italy, Switzerland, Belgium, and Canada. FAME study investigator Professor Uwe Siebert, MD, will conduct the analysis, and each country will have local clinical advisors to help validate the data modeling, the company stated.

St. Jude Medical stated that the analysis will also determine FFR's potential health and budget impact for each of the seven countries. The detailed analysis will be based on the results of the FAME study, statistics from country-specific PCI registries, and from published literature. The research will reveal for each country whether there is cost savings from using an FFR-guided approach to PCI, whether there is a cumulative savings for the health care system annually, and whether there is an impact on health for the population undergoing PCI.