Data from FAME II Trial Concludes FFR-Guided PCI is Cost Effective and Improves Patient Outcomes

St. Jude Medical

, a global medical device company, today announced that Fractional Flow Reserve (FFR)-guided treatment using PressureWire^™ was cost effective for coronary interventions when compared to the best available medical therapy. Cost utility analysis data from the FAME II trial was presented as a late-breaking clinical trial at the 24^th annual Transcatheter Cardiovascular Therapeutics (TCT) scientific symposium, sponsored by the Cardiovascular Research Foundation. Three-year projected results derived from FAME II trial data revealed that FFR-guided percutaneous coronary intervention (PCI) plus medical therapy had an incremental cost-effectiveness ratio (ICER) of $32,000 per quality-adjusted life year (QALY) compared to medical therapy alone in treating patients with stable coronary artery disease. For comparison, a common threshold of $50,000 per QALY is often cited when evaluating the cost effectiveness of therapies. Interventions with ICERs from $50,000 to $150,000 per QALY are thought to be cost-effective and those below $50,000 per QALY are considered highly cost effective per thresholds established by the World Health Organization. Results reported in FAME II cost-effectiveness data are well below that threshold. While FFR-guided PCI had a higher initial cost than patients treated by medical therapy alone, after one year the cost gap narrowed by more than 50 percent due to a higher number of hospital re-admissions for patients treated only with medical therapy. Clinical results from the FAME II trial previously established that FFR-guided PCI plus medication improves patient outcomes. Cost-effectiveness analysis also found that the use of St. Jude Medical PressureWire^™ FFR measurement technology (which measures blood flow restriction in the coronary arteries) for patients treated with FFR-guided PCI plus medical therapy also significantly improves quality of life indicators, such as freedom from angina and chest pain.