Five year data for FAME study of PressureWire FFR-guided stenting in PCI-St Jude Medical

St. Jude Medical has announced that five year results from the landmark 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 health care resources.

The data, which were presented at the ESC Congress 2015, 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 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 demonstrates 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.

There was also 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. Finally, five year data from the FAME trial further supports the positive economic impact and reduction of health care resource utilization shown by the original results of the study.