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|Independent Data Safety Monitoring Board Recommends St. Jude Medical’s FAME II Clinical Trial Stop Enrollment Following Positive Interim Analysis|
Follow-up trial to landmark FAME trial examines benefits of using FFR-guided assessment for stent procedures with optimal medical treatment compared to optimal medical treatment alone
FFR is a physiological index used to determine the hemodynamic severity of narrowings in the coronary arteries, and is measured using St. Jude Medical’s PressureWire™ Aeris and PressureWire™ Certus. FFR specifically identifies which coronary narrowings are responsible for obstructing the flow of blood to a patient's heart muscle (called ischemia), and guides the interventional cardiologist in determining which lesions warrant stenting, resulting in improved patient outcomes and reduced healthcare costs.
The goal of the
The DSMB recommended that
The FAME II trial may provide new insights about the benefits of coronary intervention and answer questions raised by the COURAGE (Clinical Outcomes Utilizing Revascularization and Aggressive Drug Evaluation) trial, which demonstrated no difference in the outcomes between PCI plus OMT compared to OMT alone. However, the COURAGE study did not require use of PressureWire™ FFR measurement technology.
“The FAME II trial is unprecedented in its ability to provide further
answers and evidence regarding the optimal way to treat patients with
coronary artery disease and myocardial ischemia,” said
The FAME II trial will continue following patients currently enrolled
according to the trial protocol and will not enroll any new patients.
The trial randomized 1,219 patients with stable coronary artery disease
in 28 centers in
“The original FAME trial demonstrated that FFR guidance improves
outcomes in patients with stable coronary artery disease and two or
three vessel disease. Today, FAME II confirms that PCI is beneficial for
patients with one, two and three vessel disease whose ischemia has been
documented by FFR,” said
Data will be published as information is analyzed, with initial results expected to be presented in 2012.
About the Original FAME Trial
The original FAME (Fractional Flow Reserve (FFR) vs. Angiography in
Multivessel Evaluation) trial was a randomized, prospective,
multi-center trial which enrolled 1,005 patients with multivessel
coronary artery disease. The FAME study compared outcomes for patients
whose treatment was guided by FFR to those whose treatment was guided
only by angiography using St. Jude Medical’s PressureWire Certus
technology. The 12-month results, published in the
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