New data from St. Jude Medical Inc.’s FAME II trial evaluating the benefits of fractional flow reserve (FFR) as a guide to cardiac stenting show that the strategy is cost effective when compared to medical therapy alone, according to results presented last week at the annual Transcatheter Cardiovascular Therapeutics (TCT) symposium in Miami. Researchers found that at 12 months, the cost of FFR-guided up-front percutaneous coronary intervention (PCI) using St. Jude’s PressureWire Aeris or Certus FFR devices was $2,508 more expensive than medical therapy. But the FFR-guided strategy, in which patients found to have ischemia on the scan were randomized to stenting or medical therapy, was deemed cost effective due to the quality-of-life improvements observed with PCI. The overall cost-effectiveness of up-front PCI was $53,000 per quality-adjusted life year. The three-year projected cost for the FFR-guided PCI approach was $32,000 per quality-adjusted life year. “The cost gap narrows more than 50% by one year,” said lead investigator William Fearon, associate professor of medicine at Stanford University School of Medicine. “Since angina and quality of life are significantly improved by PCI, results of this study indicate that FFR-guided PCI appears to be economically attractive in an analysis of cost-effectiveness.”
FAME II’s full clinical results were first presented in August at the European Society of Cardiology Congress in Munich, showing that the rate of urgent revascularization was 86% lower for...
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