Key result
Compared with warfarin, apixaban 5 mg twice-daily and 2.5 mg twice-daily were associated with a lower risk of stroke or systemic embolism (HR 0.70 and HR 0.63, respectively) in patients with nonvalvular atrial fibrillation.
Why the study?
Does apixaban (5 mg BID or 2.5 mg BID) reduce stroke/systemic embolism and major bleeding compared to warfarin in patients with nonvalvular atrial fibrillation?
Cohort (n=76,854)
Yes
Does apixaban (5 mg BID or 2.5 mg BID) reduce stroke/systemic embolism and major bleeding compared to warfarin in patients with nonvalvular atrial fibrillation?
Hazard Ratio: 0.7 (95% CI 0.6–0.81)
Absolute Event Rate: 2.15% vs 3.04%
In a real-world US cohort, both 5 mg and 2.5 mg twice-daily doses of apixaban were associated with lower risks of stroke/systemic embolism and major bleeding compared to warfarin in patients with nonvalvular atrial fibrillation.
Observational data link apixaban to lower stroke/SE risk versus warfarin in AF; leaves open need for randomized confirmation of dose effects.
Prior real-world studies have shown that apixaban is associated with a reduced risk of stroke/systemic embolism (stroke/SE) and major bleeding versus warfarin. However, few studies evaluated the effectiveness and safety of apixaban according to its dosage, and most studies contained limited numbers of patients prescribed 2.5 mg twice-daily (BID) apixaban. Using pooled data from 4 American claims database sources, baseline characteristics and outcomes for patients prescribed 5 mg BID and 2.5 mg BID apixaban versus warfarin were compared. After 1:1 propensity-score matching, 31,827 5 mg BID apixaban-matched warfarin patients and 6600 2.5 mg BID apixaban-matched warfarin patients were identified. Patients prescribed 2.5 mg BID apixaban were older, had clinically more severe comorbidities, and were more likely to have a history of stroke and bleeding compared with 5 mg BID apixaban patients. Compared with warfarin, 5 mg BID apixaban was associated with a lower risk of stroke/SE (hazard ratio [HR]: 0.70, 95% confidence interval [CI]: 0.60-0.81) and major bleeding (HR: 0.59, 95% CI: 0.53-0.66). Compared with warfarin, 2.5 mg BID apixaban was also associated with a lower risk of stroke/SE (HR: 0.63, 95% CI: 0.49-0.81) and major bleeding (HR: 0.59, 95% CI: 0.49-0.71). In this real-world study, both apixaban doses were assessed in 2 patient groups differing in age and clinical characteristics. Each apixaban dose was associated with a lower risk of stroke/SE and major bleeding compared with warfarin in the distinct population for which it is being prescribed in United States clinical practice. TRIAL REGISTRATION: Clinicaltrials.Gov Identifier: NCT03087487.
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Li et al. (2018) conducted a cohort in Nonvalvular atrial fibrillation (n=76,854). Apixaban vs. Warfarin was evaluated on Stroke/systemic embolism (stroke/SE) (HR 0.70, 95% CI 0.60-0.81). Compared with warfarin, apixaban 5 mg twice-daily and 2.5 mg twice-daily were associated with a lower risk of stroke or systemic embolism (HR 0.70 and HR 0.63, respectively) in patients with nonvalvular atrial fibrillation.
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