CardioExchange Archive

Following a positive interim analysis showing that fractional flow reserve-guided PCI was superior to optimal medical treatment, an independent data and safety monitoring board (DSMB) has recommended that patient enrollment in the ongoing FAME II trial be stopped. The news was announced by the trial sponsor, St. Jude Medical.

FAME II (Fractional Flow Reserve-Guided Percutaneous Coronary Intervention Plus Optimal Medical Treatment Versus Optimal Medical Treatment Alone in Patients with Stable Coronary Artery Disease) investigators had planned to randomize 1832 patients with stable coronary artery disease to either PCI guided by FFR plus optimal medical treatment (OMT) or OMT alone. At the time of the announcement, 1219 patients had been randomized.

According to the company, the DSMB recommendation was based on an increase in the risk of major adverse cardiac events in patients randomized to OMT alone. “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 company stated. There were no significant differences between the groups in the rates of death or MI.

It should be noted that all patients in FAME II underwent FFR prior to randomization, according to the original announcement of the trial. Patients who had hemodynamically significant lesions as assessed by FFR were then randomized to PCI or OMT. The trial was designed to address the limitations of COURAGE, in which CAD patients as documented by angiography were randomized to PCI or OMT. However, the follow-up to COURAGE, the ISCHEMIA trial, will randomize ischemic patients to PCI or OMT without prior angiography. FAME II does not appear to address the question of which patients should undergo angiography in the first place.