St. Jude Medical Initiates a Study to Evaluate the Economic Impact of FFR in Asia and Australia
Country-specific analysis will evaluate the cost effectiveness of an FFR-guided intervention strategy for patients with multivessel coronary artery disease in Japan, China, India, Korea, and Australia
February 16, 2012 — St. Jude Medical, Inc. announced it will evaluate the incremental cost-effectiveness of fractional flow reserve (FFR)-guided treatment for patients with multivessel coronary artery disease in Japan, China, India, Korea, and Australia. The analysis will also determine the potential health and budget impact that FFR-guided treatment provides for each of the countries.
The detailed analysis will be based on the results of the landmark FAME (Fractional Flow Reserve (FFR) vs. Angiography in Multivessel Evaluation) study, statistics from country-specific percutaneous coronary intervention (PCI) registries and from published literature.
The research will reveal for each country the:
• Cost savings from using an FFR-guided approach to PCI
• Cumulative savings for the health care system annually
• Impact on health for the population undergoing PCI
St. Jude Medical provided an educational grant for similar research in Europe, with results revealing that the impact of FFR-guided treatment using the PressureWire technology can improve patient health while also significantly saving money. The analysis indicated that within the health care systems of Germany, the U.K., France, Italy, and Belgium, that the FFR-guided approach has the potential to reduce deaths and heart attacks as well as save between 500€ and 950€ per patient, depending on the country. Additionally, previous economic analysis determined that an FFR-guided intervention strategy reduced health care costs per patient by about $2,000, or 14 percent, in the context of the U.S. health care system.
The detailed analysis will be funded by an educational research grant from St. Jude Medical and led by professor Uwe Siebert, MD, MSc, MPH, ScD and a FAME study co-author. Each country will also have local clinical advisors to help validate the data modeling.
About the FAME Trial. The FAME (Fractional Flow Reserve (FFR) vs. Angiography in Multivessel Evaluation) trial is a randomized, prospective, multi-center trial that enrolled 1,005 patients with multivessel coronary artery disease. The FAME study compared outcomes for patients whose treatment was guided by FFR to those whose treatment was guided only by angiography using St. Jude Medical’s PressureWire Certus technology. The 12-month results, published in the Jan. 15, 2009 issue of the New England Journal of Medicine, demonstrated that instances MACE were reduced by 28 percent for patients whose treatment was guided by FFR rather than by standard angiography alone. Two-year results demonstrated that patients who received FFR-guided treatment continued to experience improved outcomes over time, including a 34 percent reduction in risk of death or heart attack.
