Five-year FAME Data Confirms Long-term Benefit of FFR-Guided PCI

September 9, 2015 — St. Jude Medical Inc. announced that five-year results from the FAME trial have confirmed the long-term benefits of fractional flow reserve (FFR) in guiding percutaneous coronary intervention (PCI) over angiography alone. An analysis of the study’s five-year follow-up data confirms that in patients with multi-vessel coronary artery disease, FFR-guided PCI can contribute to reductions in all-cause mortality, cardiac mortality and an overall use of healthcare resources.

The data, which were presented at the European Society of Cardiology (ESC) Congress 2015, build upon previously published results from the St. Jude Medical-sponsored FAME (Fractional Flow Reserve vs. Angiography in Multivessel Evaluation) trial at 12-months and two-year follow-up intervals.

“Original 12 month results from the FAME trial and the study’s two-year follow-up data demonstrated clearly that PCI guided by fractional flow reserve results in a significant reduction in major adverse cardiac events for patients undergoing PCI,” said the FAME study’s principal investigator, Nico H.J.Pijls, M.D., Ph.D., of Catharina Hospital in Eindhoven, The Netherlands. “Now, the study’s five-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 wellbeing and clinical outcomes of patients as compared to only using angiography to guide intervention.

After five years of patient follow-up, FAME researchers have found that FFR guidance using St. Jude Medical PressureWire technology can lead to a more favorable treatment and clinical decision making, which can result in fewer events in the first two years and a sustained benefit up to five years. In addition, five year follow up data from the FAME trial demonstrate:

• Improved patient outcomes. In patients with multi-vessel coronary artery disease, FFR-guided PCI resulted in a 27 percent relative reduction of cardiac mortality versus angiography alone;
• An overall decline in adverse events. Adverse events among patients who received FFR-guided PCI consistently decreased compared to patients who received angiography-guided PCI; and
• FFR’s positive economic impact on healthcare cost. Five-year data from the FAME trial further supports the positive economic impact and reduction of healthcare resource utilization shown by the original results of the study.

For more information: www.sjm.com