Concomitant Use of Single Antiplatelet Therapy With Edoxaban or Warfarin in Patients With Atrial Fibrillation: Analysis From the ENGAGE AF‐TIMI48 Trial
Key result
Concomitant single antiplatelet therapy with an anticoagulant in AF patients increased major bleeding (HR 1.46; 95% CI 1.27-1.67; P<0.001), while edoxaban maintained its relative benefits over warfarin.
Why the study?
Does edoxaban compared to warfarin maintain its efficacy and safety in patients with atrial fibrillation receiving concomitant single antiplatelet therapy?
Population
19,889 patients with atrial fibrillation from the ENGAGE AF-TIMI 48 trial
Comparison
Edoxaban with or without concomitant single… vs Warfarin with or without concomitant single…
Design
Cohort
Authors
Discussion
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Implication
Edoxaban preserves relative efficacy and bleeding reduction versus warfarin with or without SAPT; confirms consistent benefits in AF patients on concomitant antiplatelet therapy.
Key Points
- The aim was to evaluate the impact of single antiplatelet therapy on efficacy and safety of edoxaban in atrial fibrillation patients.
- Randomized trial comparing high-dose and low-dose edoxaban to warfarin.
- 4912 patients received single antiplatelet therapy, primarily aspirin; treatment effects evaluated using Cox proportional hazard regression.
- Follow-up for bleeding and stroke prevention outcomes reported with hazard ratios and confidence intervals.
- Patients receiving antiplatelet therapy had a higher incidence of major bleeding (HRadj=1.46; 95% CI, 1.27-1.67, P<0.001).
- Efficacy of edoxaban versus warfarin for stroke prevention was comparable with SAPT (HRadj for HDER=0.70; 95% CI: 0.50-0.98).
- Edoxaban resulted in lower major bleeding rates compared to warfarin, both with and without SAPT (HRadj=0.82; 95% CI, 0.65-1.03).
Study Design
Type
RCT (n=19,889)
Randomization
randomized
Structured PICO
Does edoxaban compared to warfarin maintain its efficacy and safety in patients with atrial fibrillation receiving concomitant single antiplatelet therapy?
P
Population
19,889 patients with atrial fibrillation from the randomized ENGAGE AF-TIMI 48 trial, evaluated for the efficacy and safety of concomitant single antiplatelet therapy with edoxaban or warfarin.
I
Intervention
Edoxaban (high-dose regimen 60 mg daily or lower-dose regimen 30 mg daily, reduced by half in patients with anticipated increased drug exposure) with or without concomitant single antiplatelet therapy (SAPT)
C
Comparator
Warfarin with or without concomitant single antiplatelet therapy (SAPT)
O
Outcome
Stroke or systemic embolic events (SEEs) and major bleedinghard clinical
Main Result
Hazard Ratio: 1.46 (95% CI 1.27–1.67)
p-value: p=<0.001
Edoxaban maintains its relative efficacy and safety benefits over warfarin in patients with atrial fibrillation regardless of concomitant single antiplatelet therapy use, though SAPT itself increases overall bleeding risk.
Cite This Study
Xu et al. (2016) conducted an RCT in atrial fibrillation (n=19,889). Single antiplatelet therapy (SAPT) with edoxaban or warfarin vs. Edoxaban or warfarin without SAPT was evaluated on major bleeding (HR 1.46, 95% CI 1.27-1.67, p=<0.001). Concomitant single antiplatelet therapy with an anticoagulant in AF patients increased major bleeding (HR 1.46; 95% CI 1.27-1.67; P<0.001), while edoxaban maintained its relative benefits over warfarin.