WASHINGTON (dpa-AFX) - St. Jude Medical Inc. (STJ) announced that an interim analysis of the FAME II trial has found a highly statistically significant reduction in the need for hospital readmission and urgent revascularization when Fractional Flow Reserve or 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 or 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 or OMT alone, St. Jude Medical said. 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. 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.
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