The clinical trial, known as HPTN 052, was slated to end in 2015 but the findings are being released early as the result of a scheduled interim review of the study data by an independent dataandsafetymonitoringboard(DSMB).
Following a positive interim analysis showing that fractional flow-reserve-guided PCI was superior to optimal medical treatment, an independent DataandSafetyMonitoringBoard(DSMB) has recommended that patient enrollment in the ongoing FAME II trial be stopped.
This study had neither a steering committee, as a group of experts who regularly convened to discuss the trial and its data, nor a datasafetymonitoringboard(DSMB), which carefully watches study information to make sure patients are not harmed.