St Jude Medical announced on 23 September 2009 that the two-year results from the landmark FAME (Fractional flow reserve vs. angiography in multivessel evaluation) trial demonstrated the durability of the improved outcomes noted at one-year for patients with multivessel coronary artery disease whose treatment was guided by FFR rather than by standard angiography alone.
Two-year results demonstrated that the risk of death or myocardial infarction was 34% lower for patients whose treatment was guided by St Jude Medical’s PressureWire technology prior to coronary stenting.
The two-year results demonstrated that patients who received FFR-guided treatment had increasingly superior outcomes over time; the two patient groups had a difference in patient death and myocardial infarction of 3.8% after 12 months and 4.3% after two years.
Study results also showed that at two years:
- The risk of a patient dying or having a heart attack was reduced by approximately 34% when FFR measurement was performed prior to stenting. (12.7% for the angiography-guided group compared to 8.4% for the FFR-guided group.)
- The risk of a patient having a heart attack was 6.1% for the FFR-guided group, compared to 9.7% in the control group, a reduction of 37%
- Only one out of 513, or 0.2%, of deferred lesions resulted in a late myocardial infarction
- Use of FFR technology did not increase average procedural times
After one year, FFR-guided treatment was also demonstrated to be cost-saving, with a difference of about US$2,000, or 14%, between total healthcare costs for the FFR-guided cohort and the group treated by angiography alone. These lower healthcare costs were a result of reduced procedural costs, reduced follow-up costs for major adverse cardiac events and shorter hospital stays.
“The two-year data from the FAME study continue to show improved outcomes when multivessel coronary stenting is guided by measurement of FFR,” said co-principal investigator of the FAME study William F Fearon, associate director of interventional cardiology at Stanford University Medical Center, Palo Alto, US. “Use of FFR technology represents a rare opportunity in medicine in which an innovative product not only improves clinical outcomes but also saves money.”
The FAME study was a randomised, prospective, multicentre trial which enrolled 1,005 patients with multivessel coronary artery disease. It compared outcomes for patients whose treatment was guided by FFR to those whose treatment was guided only by angiography 12 months after receiving a stent. The two-year results from the study, which exclusively used St Jude Medical’s PressureWire Certus technology to measure FFR, were presented at a late-breaking clinical trial at TCT 2009, the annual scientific symposium of the Cardiovascular Research Foundation. The 12-month results from the FAME study were published in the 15 January 2009 issue of the New England Journal of Medicine.