Why the study?
Does rivaroxaban reduce recurrent stroke or systemic embolism in patients with recent embolic stroke of undetermined source compared to aspirin?
Population
7213 patients with recent ischemic stroke presumed to be from cerebral embolism but without arterial…
Comparison
Rivaroxaban 15 mg daily vs Aspirin 100 mg daily
Design
RCT, randomly assigned
Follow-up
median 11 months
Key result
Rivaroxaban was not superior to aspirin for preventing recurrent stroke after an embolic stroke of undetermined source (HR 1.07; 95% CI 0.87-1.33; P=0.52) and caused more major bleeding.
Authors
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Rivaroxaban should not replace aspirin after ESUS due to lack of efficacy and excess bleeding; challenges anticoagulation assumptions and reinforces aspirin as standard.
RCT (n=7,213)
Yes
Does rivaroxaban reduce recurrent stroke or systemic embolism in patients with recent embolic stroke of undetermined source compared to aspirin?
Hazard Ratio: 1.07 (95% CI 0.87–1.33)
Absolute Event Rate: 5.1% vs 4.8%
p-value: p=0.52
In patients with embolic stroke of undetermined source, rivaroxaban was not superior to aspirin for preventing recurrent stroke and was associated with a higher risk of major bleeding.
Hart et al. (2018) conducted an RCT in Embolic stroke of undetermined source (n=7,213). Rivaroxaban vs. Aspirin (100 mg daily) was evaluated on First recurrence of ischemic or hemorrhagic stroke or systemic embolism (HR 1.07, 95% CI 0.87 to 1.33, p=0.52). Rivaroxaban was not superior to aspirin for preventing recurrent stroke after an embolic stroke of undetermined source (HR 1.07; 95% CI 0.87-1.33; P=0.52) and caused more major bleeding.