FAME II Trial Concludes FFR-Guided PCI is Cost Effective, Improves Patient Outcomes
October 30, 2012 — Fractional flow reserve (FFR)-guided treatment was shown to be cost effective for guiding coronary interventions when compared to the medical therapy. Cost utility analysis data from the FAME II trial was presented as a late-breaking clinical trial at the 24th 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.
“The FAME II cost-effectiveness analysis offers evidence that FFR-guided treatment is an economically attractive option that provides improved patient outcomes,” said William F. Fearon, associate professor, Stanford University Medical Center, who presented the data. “The results are quite different from what was seen in the COURAGE trial, and I believe further demonstrate that FFR is a critical contributing factor to successful PCIs.”
To determine costs, the analysis measured both direct medical costs of the procedure as well as those for follow-up events. Quality of life was assessed using the EQ-5D (a standardized instrument for measuring health outcomes). Data for this analysis of the FAME II trial was collected and analyzed up until trial enrollment was stopped earlier in the year when the FAME II independent Data Safety Monitoring Board (DSMB) recommended investigators stop patient enrollment due to a highly statistically significant reduction in the need for hospital readmission and urgent revascularization. Since the trial was stopped early, the incremental cost-effectiveness ratio was estimated based on in-trial results and extrapolated to estimate three years of patient follow-up.
These results add to the economic analysis of PressureWire-guided PCI using data from the original FAME trial, which compared coronary stenting guided by FFR to standard angiography in more than 1,000 patients with multivessel coronary artery disease. The analysis found that in addition to superior clinical outcomes (which include a 34 percent reduction in death or heart attack), the FFR-guided intervention strategy reduced health care costs per patient by more than $2,000, or 14 percent in the United States.
FFR is a physiological index used to determine the hemodynamic severity of narrowings (or lesions) in the coronary arteries, and is measured using St. Jude Medical PressureWire Aeris and PressureWire Certus. FFR specifically identifies which coronary narrowings are responsible for obstructing the flow of blood to a patient’s heart muscle (called ischemia), and helps guide the interventional cardiologist in determining which lesions warrant stenting, resulting in improved patient outcomes and reduced healthcare costs.
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