Economic Evaluation of FAME Confirms Cost Benefit of FFR-Guided PCI

December 16, 2010—St. Jude Medical, Inc. (St. Paul, MN) announced that 1-year results from an economic evaluation of the landmark FAME (Fractional Flow Reserve [FFR] Versus Angiography in Multivessel Evaluation) trial were published in Circulation (2010;122:2545–2550). The data confirm that percutaneous coronary intervention (PCI) guided by the company's FFR measurement system in patients with multivessel coronary artery disease improves patient outcomes and offers cost-saving benefits, the company stated.

The St. Jude Medical FFR measurement systems are the PressureWire Certus, which was the only FFR guidewire used in the FAME trial, and the wireless PressureWire Aeris.

According to the company, the evaluation showed that mean overall costs associated with the FFR-guided group were significantly lower than the group guided by angiography alone. Mean overall cost for FFR-guided treatment was $14,300 compared with $16,700 for angiography-guided treatment. The cost savings occurred during both the initial procedure, primarily due to a decrease in unnecessary drug-eluting stent use, and during follow-up as a result of a decrease in rehospitalization and fewer major adverse cardiac events (MACE). Results further indicated that MACE, such as death, myocardial infarction, and repeat revascularization, occurred in 13.2% of patients who received FFR-guided treatment compared to 18.3% of patients who received angiography-guided treatment.

“Economic evaluation of the FAME study reveals that FFR-guided PCI in patients with multivessel coronary disease is one of those rare situations in which a new technology not only improves outcomes but also conserves resources,” commented coprincipal investigator William F. Fearon, MD. “This study also reflects the benefits this technology has on patient care and the advantages it offers to the health care system as a whole.”

Based on its large size, multicenter nature, and randomized prospective design, the economic evaluation of the FAME trial further strengthens the evidence supporting the health economic advantage to performing FFR-guided PCI, stated St. Jude Medical.

In January 2009, the 12-month results were published in the New England Journal of Medicine (2009;360:213–224). The study showed that instances of MACE were reduced by 28% for patients whose treatment was guided by FFR rather than by standard angiography alone. Click here for Cardiac Interventions Today's coverage. In September 2009, the 2-year FAME results were presented at the 2009 Transcatheter Cardiovascular Therapeutics conference. The findings demonstrated that patients who received FFR-guided treatment continued to experience improved outcomes over time, including a 34% risk reduction of death or heart attack. Click here for Cardiac Interventions Today's coverage. In May 2010, St. Jude Medical announced the commencement of the FAME II trial, which was covered in Cardiac Interventions Today.