News | January 15, 2009

FAME Study: Routine FFR Use Reduces Risks After Stenting Patients with Multivessel Disease

January 16, 2009 - St. Jude Medical Inc. today said results from the landmark FAME (Fractional flow reserve (FFR) vs. Angiography in Multivessel Evaluation) study, which demonstrate a statistically significant 30 percent difference in major adverse cardiac events (MACE) such as death, myocardial infarction and repeat revascularization, was published in the New England Journal and Medicine.

The randomized, prospective, multi-center trial looked at 1,005 patients with multivessel coronary artery disease 12 months after receiving a stent and compared outcomes for patients whose treatment was guided by FFR to those whose treatment was guided only by angiography.

Published in the Jan. 15 issue of the New England Journal of Medicine, the FAME study results show superior clinical and cost-effectiveness outcomes for the FFR-guided patient group for which investigators used a pressure sensor mounted on a guide wire, PressureWire Certus, developed and marketed by Radi Medical Systems, which was acquired in December 2008 by St. Jude Medical.

In the study, the risk of a patient dying or having a heart attack was reduced by about 35 percent when FFR measurement was performed (11.1 percent for the angiography-guided group compared to 7.3 percent for the FFR-guided group). The 12-month overall MACE rate was 18.4 percent, compared to 13.2 percent for the FFR-guided group. This means that the likelihood of a patient having to return for further treatment (repeat stent placement or coronary artery bypass graft surgery) was significantly lower for the FFR-guided group.

In addition to the significant difference in MACE, the quality of life (freedom from angina and chest pain) for patients whose treatment was guided by FFR was equal to, and in some cases better than, that of patients whose treatment was based solely on angiography.

"Treatment decisions today should not be just about which stent you pick, they should be about where you put a stent," said the FAME study’s co-principal investigator, Professor Nico Pijls, M.D., Ph.D., of Catharina Hospital in Eindhoven, the Netherlands. "We know that stenting ischemia-producing stenoses improves symptoms and outcomes, and that stenting non-ischemic stenoses has no benefit compared to medical treatment only. FFR is a simple measurement that can be performed quickly in the cath lab and makes it possible to treat culprit lesions only, while avoiding time, damage, and expense from placing stents which do not benefit the patient.”

The FAME study is the first large-scale, randomized, prospective, multi-center clinical trial that compares stenting guided by FFR to stenting guided by angiography alone in patients with two or more diseased coronary arteries. The goal of the FAME study is to explore whether routine use of FFR can guide physicians to place stents optimally when assessing patients with multivessel disease. The FAME study was conducted in 20 centers in Europe and the United States and included 1,005

The FAME study also shows that FFR measurement is cost-saving and does not add time to the procedure. The average procedural costs were $5,332 for the FFR-guided group compared to $6,007 for the angiography-guided group (P

William F. Fearon, M.D., associate director of interventional cardiology at Stanford University Medical Center, Palo Alto, CA, and co-principal investigator of the FAME study, added, “FAME confirms what previous smaller studies have suggested: that FFR-guided PCI improves outcomes and is cost-effective. Routine measurement of FFR in these complex patients significantly decreased the rate of death, myocardial infarction and the need for repeat revascularization compared to standard angiography-guided PCI. These results demonstrate the importance of revascularizing ischemia-producing lesions and medically treating hemodynamically insignificant ones.”

PressureWire Certus has regulatory approval in the U.S., Europe and Japan.

Fractional Flow Reserve (FFR) is an index for functional severity of coronary stenoses as measured by PressureWire. The FFR threshold of 0.75 is 100 percent specific in identifying which lesion or lesions are responsible for a patient’s ischemia (Ref. NEJM 1996), enabling the interventional cardiologist's direction of coronary interventions and results assessment for improved treatment outcomes.

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