Key result
Rivaroxaban linked to ~491% higher gastrointestinal bleeding risk versus apixaban.
Why the study?
Apixaban and rivaroxaban are commonly used for anticoagulation in AF, but their comparative hemorrhagic risk profiles across multiple organ systems warranted evaluation using real-world adverse event data.
Does apixaban reduce the risk of site-specific bleeding events compared to rivaroxaban in patients reported in the FAERS database?
Observational (n=175,516)
Does apixaban reduce the risk of site-specific bleeding events compared to rivaroxaban in patients reported in the FAERS database?
Effect estimate: ROR 5.91 (95% CI 5.61 to 6.22)
Absolute Event Rate: 9440% vs 1743%
p-value: p=< 0.0001
In a large pharmacovigilance database analysis, rivaroxaban was associated with significantly higher reporting odds of multiple bleeding events, including gastrointestinal and cerebral hemorrhage, compared to apixaban.
May support preferring apixaban to limit bleeding in AF; leaves open confirmation by randomized trials.
Apixaban and rivaroxaban are two agents commonly used for anticoagulation to treat and prevent blood clots and strokes in individuals with atrial fibrillation (AF). We extracted data from the FDA Adverse Event Reporting System (FAERS) database to evaluate the reporting frequency of ocular, cerebral, gastrointestinal (GI), rectal, and renal hemorrhage, epistaxis, and hemoptysis related to apixaban and rivaroxaban from January 2012 to March 2024. We calculated relative odds ratios (RORs) with 95% confidence intervals (CIs) to compare the hemorrhagic risk profiles of the two agents. There was no statistical significance in reported cases of ocular hemorrhage in apixaban versus rivaroxaban. Based on RORs, rivaroxaban overall has a significantly higher risk of bleeding in multiple organ systems - especially cerebral, GI, rectal, and renal hemorrhage, as well as epistaxis and hemoptysis. Apixaban may be a safer option for individuals at risk for, or with a history of, these complications.
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Logvinsky et al. (2025) conducted an observational in Anticoagulation-related bleeding (n=175,516). Rivaroxaban vs. Apixaban was evaluated on Gastrointestinal Hemorrhage (ROR 5.91, 95% CI 5.61 to 6.22, p=< 0.0001). Rivaroxaban was associated with significantly higher risks of bleeding across multiple organ systems, including gastrointestinal (ROR 5.91) and cerebral (ROR 1.73) hemorrhage, compared to apixaban.
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