St. Jude Medical, Inc., a global medical device company headquartered in Saint Paul, Minnesota, is undertaking study to evaluate the incremental cost-effectiveness of Fractional Flow Reserve (FFR)-guided treatment for patients with multivessel coronary artery disease in India, Japan, China, Korea, and Australia. The analysis, which will also determine the potential health and budget impact that FFR-guided treatment provides for each of the countries, demonstrates the company’s commitment to improving the health, welfare, and quality of life for the billions of people residing in these countries.

The detailed analysis will be funded by an educational research grant from St. Jude Medical and led by Professor Uwe Siebert, M.D., MSc, M.P.H., ScD and a FAME study co-author. Each country will also have local clinical advisors to help validate the data modeling.

FFR measurements can be taken using the PressureWire Aeris or PressureWire Certus, and indicate the severity of blood flow blockages in the coronary arteries. This physiological measurement identifies which coronary narrowings are responsible for obstructing the flow of blood to a patient's heart muscle (called ischemia), and guides the physician in determining which lesions warrant stenting.

The detailed analysis will be based on the results of the landmark FAME (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 and impact on health for the population undergoing PCI.

“All of the research that has been conducted in the US and Europe regarding the benefits of using our PressureWire FFR measurement technology indicates that it improves clinical outcomes and saves money; we hope to discover similar outcomes in the Asian and Australian markets,” said Frank J. Callaghan, president of St. Jude Medical Cardiovascular Division. “FFR represents a unique opportunity in medicine that aligns with the needs of government - to help make healthcare more affordable, and physicians - to improve care.”

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 UK, France, Italy and Belgium that the FFR-guided approach has the potential to reduce deaths and heart attacks as well as save between Euro 500 and  Eutro 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 per cent, in the context of the US health care system.

“We believe that conducting this research will enable a better understanding of the broader economic and health impact that FFR-guided therapy may provide,” Siebert said. “Having this knowledge on hand will help provide physicians, hospitals and governments with the information they need to decide on treatment options for ideal patient care.”
 
The FAME (Fractional Flow Reserve (FFR) vs. Angiography in Multivessel Evaluation) trial is a randomized, prospective, multi-center trial which 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.