Key result
Edoxaban 60 mg was associated with similar risks of thromboembolic events (HR 1.00; 95% CI 0.59-1.71) and bleeding compared to warfarin, but lower all-cause mortality.
Why the study?
The comparative effectiveness and safety of edoxaban 60 mg and 30 mg versus warfarin for stroke prevention in AF had not been well described in a nationwide cohort of Caucasian patients in standard clinical practice.
Does edoxaban 60 mg reduce thromboembolic events, mortality, and bleeding compared to warfarin in patients with atrial fibrillation?
Cohort
Yes
Does edoxaban 60 mg reduce thromboembolic events, mortality, and bleeding compared to warfarin in patients with atrial fibrillation?
Hazard Ratio: 1 (95% CI 0.59–1.71)
Absolute Event Rate: 0.95% vs 1%
In a real-world Danish nationwide cohort of patients with atrial fibrillation, edoxaban 60 mg demonstrated comparable thromboembolic and bleeding risks to warfarin, but was associated with significantly lower all-cause mortality.
Edoxaban 60 mg was associated with similar thromboembolic/bleeding risks but lower mortality versus warfarin in AF; extends real-world data but leaves randomized confirmation open.
BACKGROUND AND PURPOSE: The effectiveness and safety of edoxaban 60 mg and 30 mg for stroke prevention compared with warfarin in patients with atrial fibrillation have not been well-described in a nationwide cohort of Caucasian patients treated in standard clinical practice. METHODS: We used Danish nationwide registries to identify patients with atrial fibrillation during June 2016 and November 2018 who were treated with edoxaban or warfarin and computed rates per 100 person-years of thromboembolic, all-cause mortality, and bleeding events using an inverse probability of treatment weighting approach to account for baseline confounding. We used weighted pooled logistic regression to compute hazard ratios with 95% confidence intervals comparing events between edoxaban 60 mg and warfarin users; edoxaban 30 mg was not included in formal comparisons. RESULTS: -VASc score was similar between warfarin and edoxaban 60 mg with a score of 3 (interquartile range (IQR) 2-4). In the inverse probability of treatment-weighted pseudo-population, the thromboembolic event rate for edoxaban 60 mg was 0.95 and 1.0 for warfarin, corresponding weighted hazard ratio of 1.00 (95% confidence intervals (CI) 0.59, 1.71). Edoxaban 60 mg users were associated with lower rates of all-cause mortality (3.93) compared to warfarin (6.04), with a hazard ratio of 0.64 (95% CI 0.47 to 0.88). The event rates for bleeding were 3.36 and 3.14, respectively; hazard ratio 1.09 (95% CI 0.77, 1.57). CONCLUSION: Edoxaban 60 mg is a safe and effective treatment compared with warfarin for stroke prevention in routine clinical care for Danish (mainly Caucasian) patients with AF, with non-significantly different risks for stroke and clinically relevant bleeding, but lower all-cause mortality.
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Nielsen et al. (2021) conducted a cohort in atrial fibrillation. Edoxaban vs. Warfarin was evaluated on thromboembolic events (HR 1.00, 95% CI 0.59-1.71). Edoxaban 60 mg was associated with similar risks of thromboembolic events (HR 1.00; 95% CI 0.59-1.71) and bleeding compared to warfarin, but lower all-cause mortality.
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