Five-Year FAME Data Show Sustained Benefit of St. Jude Medical's PressureWire for FFR-Guided PCI

September 3, 2015—St. Jude Medical, Inc. announced that 5-year results from the landmark FAME (Fractional Flow Reserve [FFR] vs Angiography in Multivessel Evaluation) trial have confirmed the long-term benefits of FFR with the company’s PressureWire technology versus angiography alone in guiding percutaneous coronary intervention (PCI). An analysis of the study’s 5-year follow-up data confirms that in patients with multivessel coronary artery disease, FFR-guided PCI can contribute to reductions in all-cause mortality, cardiac mortality, and overall use of health care resources. The 5-year data were presented at the European Society of Cardiology’s ESC Congress 2015, held August 29 to September 2 in London, United Kingdom.

According to the company, the FAME investigators found that PressureWire FFR guidance can lead to better treatment and clinical decision making, which can result in fewer adverse events in the first 2 years and a sustained benefit up to 5 years.

The 5-year follow-up FAME data showed that FFR-guided PCI in patients with multivessel coronary artery disease resulted in a 27% relative reduction in cardiac mortality and a consistent decrease in adverse events versus angiography alone. Additionally, the 5-year data support the positive economic impact and reduction of health care resource utilization shown by the original results of the study.

In the company’s press release, FAME’s Principal Investigator Nico H.J. Pijls, MD, commented, “Original 12-month results from the FAME trial and the study’s 2-year follow-up data demonstrated clearly that PCI guided by FFR results in a significant reduction in major adverse cardiac events for patients undergoing PCI. Now, the study’s 5-year follow-up data have given us a critical look at the impact of FFR guidance over time. We’ve proven that the benefits are sustained and can dramatically impact the long-term well being and clinical outcomes of patients as compared to only using angiography to guide intervention.” Dr. Pijls is with Catharina Hospital in Eindhoven, The Netherlands.

St. Jude Medical stated that the 5-year data build upon previously published results from the company-sponsored FAME trial at 12-months and 2-year follow-up, which demonstrated improved clinical outcomes in patients with stable coronary artery disease and two- or three-vessel disease. At 12-months, instances of major adverse cardiac events were reduced by 28% for patients whose treatment was guided by FFR rather than by standard angiography alone. The 2-year results demonstrated that patients who underwent FFR-guided treatment continued to experience improved outcomes over time, including a 34% risk reduction in death or heart attack.