St. Jude Medical reported that an 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, the FAME II's Data Safety Monitoring Board (DSMB) 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.
The endpoint of the FAME II (FFR-Guided PCI Plus OMT vs. OMT 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 PCI guided by FFR plus OMT to OMT alone.
The DSMB recommended that St. Jude cease patient enrollment of the FAME II trial due to the 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 only OMT experienced a "highly statistically significant increased risk of hospital readmission and urgent revascularization," according to St. Paul, Minn.-based St. Jude, "and the DSMB determined that this difference was highly unlikely to change with inclusion of more patients. These data currently reflect no observed difference in the rates of death or heart attack."
St. Jude suggested that the FAME II trial may provide "insights about the benefits of coronary intervention and answer questions raised by the COURAGE trial," which demonstrated no difference in the outcomes between PCI plus OMT compared with OMT alone. However, COURAGE did not require the use of FFR measurement technology.
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 U.S. and Canada.
“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,” said Frank Callaghan, president of St. Jude's cardiovascular division.
Data will be published as information is analyzed, St. Jude reported. The company said initial results are expected in 2012.