St Jude Medical announced on 26 May 2010 at EuroPCR it will evaluate the incremental cost-effectiveness of Fractional Flow Reserve (FFR)-guided treatment for patients with multivessel coronary artery disease in the UK, Germany, France, Italy, Switzerland, Belgium and Canada. The analysis will also determine FFR’s potential health and budget impact for each of the seven countries.
FFR measurements indicate the severity of blood flow blockages in the coronary arteries. Using the PressureWire Aeris or PressureWire Certus, this physiological measurement helps physicians to better identify which specific lesion or lesions are responsible for a patient’s ischaemia.
The detailed analysis will be based on the results of the FAME (Fractional Flow Reserve 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:
- 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
- Whether there is an impact on health for the population undergoing PCI
The landmark FAME study, also sponsored by St Jude Medical, compared treatment guided by FFR to standard angiography in more than 1,000 patients with multivessel coronary artery disease and found that in addition to superior clinical outcomes (which include a 34% reduction in death or heart attack), the FFR-guided intervention strategy reduced health care costs per patient by about $2,000, or 14% in the USA.
The detailed analysis will be conducted by Uwe Siebert, a FAME study investigator. Each country will also have local clinical advisors to help validate the data modeling.
The FAME Trial
The FAME study 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 exclusively for FFR measurement. The 12-month results, published in the 15 January 2009 issue of the New England Journal of Medicine, demonstrated that instances of major adverse cardiovascular events (MACE), including death, myocardial infarction or repeat revascularisation, were reduced by 28% 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 Conference demonstrated that patients who received FFR-guided treatment continued to experience improved outcomes over time, including a 34% risk reduction in death or myocardial infarction. FFR-guided treatment was also demonstrated to be cost-saving, with a difference per patient of about US$2,000, or 14%, between total healthcare costs for the FFR-guided group and the group treated by angiography alone after a year. The reduced healthcare costs were a result of reduced procedural costs, reduced follow-up costs for major adverse cardiac events and shorter hospital stays.