Myocardial Ischemic Events in Patients With Atrial Fibrillation Treated With Dabigatran or Warfarin in the RE-LY (Randomized Evaluation of Long-Term Anticoagulation Therapy) Trial
Key result
Dabigatran showed a nonsignificant increase in MI compared with warfarin (0.81% vs 0.64% per year for 150 mg BID; HR 1.27, 95% CI 0.94-1.71, P=0.12), but other ischemic events were not increased.
Why the study?
Does dabigatran increase the risk of myocardial ischemic events compared to warfarin in patients with atrial fibrillation?
Population
Patients with atrial fibrillation from the RE-LY study
Comparison
Dabigatran 110 mg or 150 mg twice daily (BID) vs Warfarin
Design
RCT
Authors
Discussion
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Implication
Reassures no excess ischemic risk with dabigatran versus warfarin in AF; confirms cardiovascular safety in this population.
Study Design
Type
RCT
Structured PICO
Does dabigatran increase the risk of myocardial ischemic events compared to warfarin in patients with atrial fibrillation?
P
Population
Patients with atrial fibrillation from the RE-LY (Randomized Evaluation of Long-Term Anticoagulation Therapy) study
I
Intervention
Dabigatran 110 mg or 150 mg twice daily (BID)
C
Comparator
Warfarin
O
Outcome
Myocardial infarction (MI)composite
Main Result
Effect estimate: HR 1.27 (95% CI 0.94-1.71)
Absolute Event Rate: 0.81% vs 0.64%
p-value: p=0.12
Dabigatran does not significantly increase the overall risk of myocardial ischemic events compared to warfarin in patients with atrial fibrillation, despite a slight, non-significant numerical increase in MI.
Cite This Study
Hohnloser et al. (2012) conducted an RCT in Atrial fibrillation. Dabigatran vs. Warfarin was evaluated on Myocardial infarction (HR 1.27, 95% CI 0.94-1.71, p=0.12). Dabigatran showed a nonsignificant increase in MI compared with warfarin (0.81% vs 0.64% per year for 150 mg BID; HR 1.27, 95% CI 0.94-1.71, P=0.12), but other ischemic events were not increased.