FAME II Data Show Cost Effectiveness and Improved Outcomes With FFR-Guided PCI

October 24, 2012—St. Jude Medical, Inc. (St. Paul, MN) announced that cost-utility analysis data from the FAME II trial demonstrated that fractional flow reserve (FFR)-guided treatment using the company's PressureWire system was cost effective for coronary interventions when compared to the best available medical therapy. William F. Fearon, MD, presented the data at the TCT 2012: Transcatheter Cardiovascular Therapeutics conference in Miami, Florida.

According to St. Jude Medical, 3-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 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 incremental cost-effectiveness ratios from $50,000 to $150,000 per QALY are thought to be cost effective, and those < $50,000 per QALY are considered highly cost effective per thresholds established by the World Health Organization. The results from the FAME II cost-effectiveness data are well below that threshold, noted St. Jude Medical.

Although FFR-guided PCI had a higher initial cost than treatment with medical therapy alone, at 1 year, the cost gap narrowed by more than 50% because of a higher number of hospital readmissions 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 the PressureWire FFR measurement technology for patients treated with FFR-guided PCI plus medical therapy 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,” commented Dr. Fearon, who is Associate Professor at Stanford University Medical Center. “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.”

As summarized in St. Jude Medical's press release, 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. Data for this analysis of the FAME II trial was collected and analyzed until trial enrollment was stopped earlier in the year, when the FAME II independent Data Safety Monitoring Board recommended investigators stop patient enrollment due to a highly statistically significant reduction in the need for hospital readmission and urgent revascularization. Because the trial was stopped early, the incremental cost-effectiveness ratio was estimated based on in-trial results and extrapolated to estimate 3 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% reduction in death or heart attack), the FFR-guided intervention strategy reduced health care costs per patient by more than $2,000 (14%) in the United States, stated the company.