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Clinical Implications of NAVIGATE-ESUS Exploratory Analysis: Alexander Merkler, MD, MS

The assistant professor of neurology at Weill Cornell Medicine discussed the results of the NAVIGATE-ESUS trial and whether stroke experts should change how they use anticoagulants.

"We did this exploratory analysis under the hypothesis that patients with left ventricular dysfunction may be at risk for recurrent stroke, and that anticoagulation may be beneficial to that patient group. Essentially, left ventricular dysfunction may be a novel stroke risk factor and perhaps anticoagulation can help them.”

The phase 3 NAVIGATE-ESUS trial (NCT02313909) was a comparator study that evaluated the effect of rivaroxaban (Xarelto; Janssen), an anticoagulant, with that of aspirin on reducing the risk of recurrent stroke or systemic embolism in those with embolic strokes of undetermined source (ESUS). Patients were randomized to either 15 mg of rivaroxaban or 100 mg of aspirin once daily.

Led by Alexander Merkler, MD, MS, a post-hoc analysis specifically looked at those with left ventricular dysfunction. Over a median follow-up of 10.4 months, the primary outcome of recurrent stroke or systemic embolism occurred in 321 participants (4.9% per year). When comparing the 2 treatments, event rates were 2.4% per year (95% CI, 1.1-5.4) in those assigned to rivaroxaban versus 6.5% (95% CI, 4.0-11) in those on aspirin. In comparison, event rates were noticeably similar between treatment arms for those without LV dysfunction.

NeurologyLive sat down with Merkler to discuss the results of the study and the reasons for conducting the investigation in the first place. He also provided his insight on whether these findings change the way clinicians utilize either drug in the hospital setting.

REFERENCE
Merkler AE, Pearce LA, Kasner SE, et al. Left ventricular dysfunction among patients with embolic stroke of undetermined source and the effect of rivaroxaban vs aspirin: a subgroup analysis of the NAVIGATE ESUS randomized clinical trial. JAMA Neurol. Published online October 25, 2021. doi:10.1001/jamaneurol.2021.3828