European Stroke Organisation Conference
May 16–18, 2018
Aristeidis H. Katsanos, MD, PhD
Dr. Robert Hart presented the first results of the NAVIGATE ESUS trial, a randomized clinical trial (RCT) on the safety and efficacy of Rivaroxaban 15mg once daily compared to acetylsalicylic acid (ASA) 100mg in patients with embolic strokes of undetermined source (ESUS). The trial was stopped prematurely at the second interim analysis, and after randomization of a total of 7213 patients, due to the absence of significant differences between the two groups regarding the primary efficacy outcome of all recurrent stroke or systemic embolism. Moreover, a significant increase in the risk of both hemorrhagic stroke and all major bleeding events was found in the Rivaroxaban group compared to the ASA group. Although no significant differences were found in other pre-specified subgroup analyses, a subgroup analysis of patients with patent foramen ovale randomized within the NAVIGATE ESUS trial presented by Dr. Scott Kasner suggests that Rivaroxaban treatment may reduce the risk of recurrent cerebral ischemic events in this specific patient population compared to ASA.