St Jude Medical initiates a study to evaluate the economic impact of FFR in Asia and Australia


St Jude Medical has announced that 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.

FFR measurements can be taken using St Jude’s 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, and guides the physician in determining which lesions warrant stenting.

The detailed analysis will be based on the results of the FAME (Fractional flow reserve (FFR) vs. angiography in multivessel evaluation) study, statistics from country-specific percutaneous coronary intervention registries and from published literature.

The research will reveal for each country the: 

  • Cost savings from using an FFR-guided approach to percutaneous coronary intervention
  • Cumulative savings for the health care system annually
  • Impact on health for the population undergoing percutaneous coronary intervention

“All of the research that has been conducted in the USA 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, 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 €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 US$2,000, or 14%, in the context of the US health care system.

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

“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.”

About the FAME trial

The FAME trial is a randomised, prospective, multicentre 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. The 12-month results, published in the 15 January 2009 issue of the New England Journal of Medicine, demonstrated that instances MACE were reduced by 28% 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% reduction in risk of death or heart attack.