Intracranial Hemorrhage Among Patients With Atrial Fibrillation Anticoagulated With Warfarin or Rivaroxaban
Why the study?
What are the predictors of intracranial hemorrhage in patients with atrial fibrillation treated with rivaroxaban or warfarin?
Population
14,264 patients with atrial fibrillation from the ROCKET AF trial
Comparison
Rivaroxaban once daily vs Warfarin (Vitamin K Antagonism)
Design
Cohort, Randomized to rivaroxaban or warfarin in the parent trial
Follow-up
1.94 years (median)
Authors
Discussion
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Implication
May inform ICH risk stratification in anticoagulated AF; leaves open whether these predictors should guide therapy.
Key Points
- To determine the incidence, predictors, and outcomes of intracranial hemorrhage in patients with atrial fibrillation undergoing anticoagulation therapy.
- Analyzed baseline characteristics and outcomes in 14,264 patients with atrial fibrillation from the randomized ROCKET AF clinical trial over a median follow-up of 1.94 years.
- Used multivariable Cox proportional hazards modeling to identify independent demographic, clinical, and laboratory predictors associated with intracranial hemorrhage.
- A total of 172 patients (1.2%) experienced 175 intracranial hemorrhage events, reflecting an overall rate of 0.67% per year.
- Randomization to rivaroxaban was associated with a significantly reduced risk of intracranial hemorrhage compared with warfarin (HR, 0.60; 95% CI, 0.44–0.82), as was a history of congestive heart failure (HR, 0.65; 95% CI, 0.47–0.89).
- Independent risk factors for intracranial hemorrhage included Black race (HR, 3.25; 95% CI, 1.43–7.41), Asian race (HR, 2.02; 95% CI, 1.39–2.94), previous stroke or transient ischemic attack (HR, 1.42; 95% CI, 1.02–1.96), older age (HR, 1.35 per 10-year increase; 95% CI, 1.13–1.63), reduced serum albumin, reduced platelet count, and increased diastolic blood pressure (model C-index, 0.69; 95% CI, 0.64–0.73).
Structured PICO
What are the predictors of intracranial hemorrhage in patients with atrial fibrillation treated with rivaroxaban or warfarin?
P
Population
14,264 patients with atrial fibrillation from the ROCKET AF trial
I
Intervention
Rivaroxaban once daily
C
Comparator
Warfarin (Vitamin K Antagonism)
O
Outcome
Intracranial hemorrhage (ICH)safety
In patients with atrial fibrillation on anticoagulation, rivaroxaban was associated with a lower risk of intracranial hemorrhage compared to warfarin, while older age, Asian or black race, prior stroke/TIA, and certain clinical markers increased risk.
Limitations
- External validity requires testing in other atrial fibrillation populations
Cite This Study
Hankey et al. (2014) studied this question.