Efficacy and safety of edoxaban and warfarin in patients with atrial fibrillation: a systematic review and meta-analysis
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Introduction
Atrial fibrillation is the most prevalent cardiac arrhythmia, significantly increasing the risk of stroke and heart failure in non-valvular AF, percutaneous coronary intervention and transcatheter aortic valve implantation patients. Warfarin, a vitamin-K antagnoist (VKA) has long been the standard treatment, but with multiple limitations. Edoxaban, factor Xa inhibitor, has shown to affect bleeding outcomes. This study provides a very detailed outlook comparing both drugs in myriad of scenarios.
Methods
This meta-analysis included five studies identified through a thorough review of PubMed, Medline, Embase, Google Scholar and ClinicalTrials.gov from January 2014 to October 2024. The systematic review and meta-analysis was carried out in accordance with the PRISMA guidelines and registered on PROSPERO (CRD420250648890). We included studies that provide specific data on five key outcomes: Stroke and systemic embolism (SSE), major adverse cardiac events (MACE), All-cause mortality (ACM), clinically relevant non-major bleeding (CRNM) and major bleeding (MB). The trial data were pooled using inverse variance method using hazard ratio (HR) and 95% confidence interval (CI) for five outcomes. Risk of bias was assessed using Cochrane RoB v2 tool and the GRADE assessment. Sub-group analysis was utilized to address heterogeneity and Egger’s test to identify small-study effects.
Results
Five clinical trials comprising of 26,832 participants were included in our comprehensive analysis. MACE showed edoxaban to be marginally superior to warfarin (HR 0.90, 95% CI 0.83-0.97, p = 0.01), renal clearance of ≥80 resonated a similar result. VKA performed better in reducing MACE when CHA2DS2VASc score was ≥4.0. Edoxaban had a more significant effect in decreasing the risk of SSE, where previous myocardial infarction (MI) patients showed a poor response to edoxaban (HR 0.58, 95% CI 0.32-1.05). No drug was statistically greater in all-cause mortality. In CRNM, VKA had a far better effect in patients with age of <65 years and those with normal renal clearance had significant group differences. Edoxaban exhibited a greater decrease in risk of MB in a population with <25% heart failure (HF) patients, and those with ≥25% HF patients, VKA was slightly more favorable.
Conclusions
Edoxaban remains to hold a solid ground in multiple key outcomes while essential role of warfarin in significant scenarios such as in patients with higher CHADVAS score, history of previous MI, older age and those with heart failure cannot be ruled out. Further studies are required to confirm our findings.
