Five Year Sustained Benefit of FFR-Guided PCI vs Angiography-Guided Intervention

An analysis of St. Jude’s FAME study 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.


During PCI procedures, FFR is used to provide physicians with a detailed analysis of the blood flow blockage to make decisions on how to best keep the artery expanded to restore blood flow to the heart and to determine whether coronary intervention – such as stenting, is necessary.

Fractional flow reserve is a physiological index used to determine the hemodynamic severity of narrowings (or lesions) in the coronary arteries, and is measured using St. Jude Medical PressureWire™ Aeris™ and PressureWire™ Certus™ FFR measurement system. FFR specifically identifies which coronary narrowings are responsible for obstructing the flow of blood to a patient’s heart muscle (called ischemia), and helps guide the interventional cardiologist in determining which lesions warrant stenting, resulting in improved patient outcomes and reduced healthcare costs.

St. Jude Medical, Inc. is pointing to five year results from the landmark FAME trial (Fractional Flow Reserve vs. Angiography in Multivessel Evaluation) which, it says, confirm the long term benefits of fractional flow reserve (FFR) in guiding percutaneous coronary intervention (PCI) over angiography alone.

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, in patients with multi-vessel coronary artery disease, FFR-guided PCI resulted in a 27 percent relative reduction of cardiac mortality versus angiography alone.

Adverse events among patients who received FFR-guided PCI consistently decreased compared to patients who received angiography-guided PCI.

The five year data further supports the positive economic impact and reduction of health care resource utilization shown by the original results of the study.

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.

Investigator comments

“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.

Company comments

“The five year data from the FAME study build upon our understanding of applying FFR to guide the care of patients battling coronary artery disease, and this study has continued to demonstrate that St. Jude Medical’s PressureWire technology can improve patient outcomes and the clinical benefits of PCI, while reducing costs for the health care system,” said Mark Carlson, M.D., chief medical officer at St. Jude Medical. “FFR technology provides physicians with the insight they need to make improved clinical decisions for their patients.”

Source: Business Wire


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