PARIS, May 22, 2018 /PRNewswire/ -- Abbott (NYSE: ABT) today announced five-year results from the FAME 2 study, which showed that patients had fewer major adverse cardiac events (MACE) when they received a heart stent guided by Abbott's fractional flow reserve (FFR) diagnostic tool in combination with medical therapy compared to patients who received only medical therapy. MACE is defined as heart attack, death and urgent need to reestablish blood flow. Abbott's PressureWireTM uses the diagnostic metric FFR to measure the pressure of blood as it flows through a patient's blocked artery. This provides an objective measure to help cardiologists determine which vessels would benefit from receiving a stent.
The five-year data from the FAME 2 study were presented in a late-breaking session at EuroPCR, the annual meeting of the European Association of Percutaneous Cardiovascular Interventions (EAPCI) and simultaneously published in The New England Journal of Medicine.
"For the first time, a study has shown that patients with stable coronary artery disease who received a stent guided by an FFR diagnostic had a benefit over medical therapy alone, including fewer heart attacks and needs for urgent revascularization," said principal investigator Bernard De Bruyne, M.D., Ph.D., of the Cardiovascular Center Aalst, Onze Lieve Vrouw Ziekenhuis, Aalst, Belgium. "Data from this study confirm the importance of FFR-guided stenting decisions combined with medical therapy over medical therapy alone."
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Coronary artery disease is the most common type of heart disease, which is the leading cause of death worldwide. It occurs when arteries that supply blood to the heart become blocked or narrowed. Physicians can use an FFR diagnostic tool to measure how a narrowed artery affects blood flow to the heart, and can then determine the appropriate treatment. If a narrowed artery has a positive FFR test, placing a stent via a percutaneous coronary intervention (PCI) is one recommended treatment.
Five-year follow up from the FAME 2 study included 733 patients with stable coronary artery disease who had significant blockages or narrowing of the arteries as determined by FFR. Analysis showed that 13.9 percent of patients (62) in the FFR-guided PCI group experienced a MACE, while almost twice as many patients in the medical therapy group experienced MACE (27 percent (119); p=<0.001). The lower rate of MACE in the PCI group was largely driven by reduced urgent revascularization – the need to reestablish blood flow to the heart – a component of MACE (6.3 percent vs. 21.1 percent, p<0.001).