St Jude Medical has announced that the five-year results from the landmark FAME trial (Fractional flow reserve vs. angiography in multivessel evaluation) 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 multivessel 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 ESC Congress yesterday, build upon previously-published results from the St Jude Medical sponsored FAME trial at 12-months and two-year follow up intervals. After five years of patient follow up, FAME researchers have found that FFR guidance using St Jude Medical’s PressureWire technology can lead to a more favourable 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: in patients with multivessel coronary artery disease, FFR-guided PCI resulted in a 27% relative reduction of cardiac mortality versus angiography alone; adverse events among patients who received FFR-guided PCI consistently decreased compared with patients who received angiography-guided PCI; and five-year data from the FAME trial further supports the positive economic impact and reduction of healthcare resource use shown by the original results of the study.
FAME study’s principal investigator, Nico HJ Pijls (Catharina Hospital, Eindhoven, The Netherlands), says: “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. 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.”