New sub-analysis data demonstrating that edoxaban (Lixiana) provides comparable efficacy and greater safety compared to warfarin, across non-valvular atrial fibrillation (NVAF) patients with different stroke risk scores was presented at the European Society of Cardiology Congress in Barcelona, Spain.

The findings are based on a sub-analysis of the Effective aNticoaGulation with factor XA next GEneration in Atrial Fibrillation (ENGAGE AF-TIMI 48) clinical study, and provide more specific insights into the use of oral, once-daily direct factor Xa-inhibitor edoxaban compared to warfarin in NVAF patients grouped by stroke risk (as measured by CHA2DS2-VASc score). 

The ENGAGE AF-TIMI 48 study has previously shown that once-daily edoxaban is as effective as warfarin for the prevention of stroke or systemic embolic events (SEEs), while significantly reducing the risk of bleeding. This new sub-analysis has established that the benefit of edoxaban over warfarin is maintained, with no significant effect modification by CHA2DS2-VASc score, which assesses stroke risk more accurately than the previously used CHADS2 score.

It also shows that edoxaban provides an incremental absolute reduction in safety events (including major bleeding, intracranial haemorrhage and cardiovascular hospitalisations) for NVAF patients, over those receiving warfarin, as the risk of stroke increases. 

While overall results from ENGAGE AF-TIMI 48 demonstrate that edoxaban provides superior safety for NVAF patients in terms of major bleeding risk compared to warfarin, this data further shows that the safety benefit remains in place in patients with higher CHA2DS2-VASc scores (p-int=0.99 for major bleeding). Major bleeding is a key consideration in assessing appropriate treatment in NVAF, and as such, this data highlights the value of edoxaban for patients at varying levels of stroke risk.

Joris De Groot, MD, PhD, Cardiologist, University of Amsterdam and lead author of the study, commented: “These findings can greatly benefit physicians in clinical practice. Reducing stroke risk is paramount to effective NVAF management. The availability of data regarding the use of edoxaban in NVAF patients of varying levels of stroke risk will help better inform treatment decisions and support treatment assurance for physicians and patients.”