Does routine measurement of fractional flow reserve reduce the risk of death or heart attack by 35 percent after stent placement in patients with multivessel disease? Do 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? Can FFR be performed quickly in the cath lab and does it make it possible to treat culprit lesions only, while avoiding time, damage, and expense from placing stents?
IIP > read on here > http://www.radi.se…
…St. Jude Medical, Inc. (NYSE:STJ) today announced the publication of results from the landmark FAME (Fractional flow reserve (FFR) vs. Angiography in Multivessel Evaluation) study that demonstrate a statistically significant 30 percent difference in Major Adverse Cardiac Events (MACE) such as death, myocardial infarction and repeat revascularization. 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 guidewire, 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 approximately 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, P=0.04). The 12-month overall MACE rate was 18.4 percent, compared to 13.2 percent for the FFR-guided group (p=0.02). 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…
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 patients.
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<0.001). It took an average of 71 minutes to complete PCI in the FFR-guided group compared to 70 minutes in the angiography-guided group…