News | January 19, 2012

FAME II FFR Trial Stops Enrollment Following Positive Interim Analysis

January 19, 2011 –– Interim analysis of the FAME II trial found a highly statistically significant reduction in the need for hospital readmission and urgent revascularization when fractional flow reserve (FFR)-guided assessment was used to direct treatment in patients with coronary artery disease. As a result of the positive interim analysis, the FAME II independent data safety monitoring board (DSMB) has recommended investigators stop patient enrollment in this trial, as the DSMB considers it unethical to continue to randomize patients to optimal medical therapy (OMT) 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 and guides the interventional cardiologist in determining which lesions warrant stenting, resulting in improved patient outcomes and reduced healthcare costs.

Standard-of-care for OMT includes the use of aspirin, beta-blockers, anti-anginal medicine and drugs to reduce cholesterol in the blood; these treatments help the heart work more efficiently and receive more oxygen-rich blood. Patients with an FFR measurement indicating ischemia who were randomized into the percutaneous coronary intervention (PCI) and OMT group received PCI along with OMT.

The goal of the St. Jude Medical-sponsored FAME II (Fractional Flow Reserve (FFR)-Guided Percutaneous Coronary Intervention Plus Optimal Medical Treatment vs. Optimal Medical Treatment Alone in Patients with Stable Coronary Artery Disease) trial is to further study the role of FFR in the treatment of stable coronary artery disease by comparing percutaneous coronary intervention (PCI) guided by FFR plus OMT to OMT alone.

The DSMB recommended that St. Jude Medical stop patient enrollment in its FAME II trial due to increased patient risk of major adverse cardiac events (MACE) among patients randomized to OMT alone compared to patients randomized to OMT plus FFR-guided PCI. In particular, patients receiving OMT alone experienced a highly statistically significant increased risk of hospital readmission and urgent revascularization, and the DSMB determined that this difference was highly unlikely to change with inclusion of more patients. The data currently reflect no observed difference in the rates of death or heart attack.

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 Bernard De Bruyne, M.D., Ph.D., of the OLV Clinic in Aalst, Belgium, and coordinating clinical investigator of the FAME II trial. "What we observed to date regarding urgent revascularizations validates the profound role that FFR-guided therapy has in improving patient outcomes. This is further evidence that FFR should be considered the standard-of-care for patients with coronary artery disease."

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 Europe, the United States and Canada.

"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 Frank Callaghan, president of the St. Jude Medical Cardiovascular Division. "Due to the statistically and clinically compelling differences in the number of patients returning to the hospital for an urgent revascularization procedure –– which can be considered a surrogate for a repeat heart attack or death –– we support the recommendation of the DSMB and the trial's Steering Committee. We expect the data will continue to reveal the important role that FFR plays in developing an optimal treatment strategy."

Data will be published as information is analyzed, with initial results expected to be presented in 2012.

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