Clinical outcomes and management associated with major bleeding in patients with atrial fibrillation treated with apixaban or warfarin: insights from the ARISTOTLE trial
Why the study?
What are the clinical consequences of major bleeding, and does treatment with apixaban versus warfarin modify the risk of death, stroke, or MI following a major bleed in patients with atrial fibrillation?
Population
Patients with atrial fibrillation who experienced a major bleeding event (n=848) in the ARISTOTLE trial
Comparison
Apixaban vs Warfarin
Design
Cohort
Follow-up
30 days (post-bleeding event window evaluated)
Authors
Discussion
Loading...
Member takes
Implication
Post-ICH mortality remains extremely high in AF regardless of anticoagulant; extends evidence that apixaban and warfarin confer similar post-bleed risks.
Key Points
- To evaluate the clinical outcomes, management strategies, and mortality risks associated with major bleeding events in patients with atrial fibrillation treated with apixaban versus warfarin.
- Ancillary analysis of the randomized ARISTOTLE trial (NCT00412984) assessing major bleeding defined by International Society on Thrombosis and Haemostasis criteria.
- Evaluated 30-day time to death, ischaemic stroke, or myocardial infarction using Cox regression models with time-dependent indicators for intracranial (ICH) and non-ICH bleeding.
- Major bleeding occurred in 848 individuals (4.7%), with a 30-day mortality rate of 14.9% (126 deaths); 30-day mortality was 43.2% (76 of 176) after an ICH versus 9.2% (64 of 695) after non-ICH bleeding.
- Following an ICH, the risk of death increased markedly (HR 121.5, 95% CI 91.3–161.8) alongside elevated risk of stroke or MI (HR 21.95, 95% CI 9.88–48.81), while non-ICH bleeds increased 30-day death, stroke, or MI roughly 12-fold.
- Treatment with reversal agents or clotting factors occurred in 20.8% of major bleeds and blood transfusion in 37%, with no differential interaction between apixaban and warfarin on subsequent risk of death, stroke, or MI.
Structured PICO
What are the clinical consequences of major bleeding, and does treatment with apixaban versus warfarin modify the risk of death, stroke, or MI following a major bleed in patients with atrial fibrillation?
P
Population
Patients with atrial fibrillation who experienced a major bleeding event (n=848) in the ARISTOTLE trial
I
Intervention
Apixaban
C
Comparator
Warfarin
O
Outcome
Time to event (death, ischaemic stroke, or myocardial infarction) following major bleedinghard clinical
Major bleeding in anticoagulated patients with atrial fibrillation is associated with a substantially increased risk of death, stroke, or MI, and this risk is similarly elevated regardless of whether the patient was treated with apixaban or warfarin.
Cite This Study
Held et al. (2014) studied this question.