Key result
Apixaban was associated with a significantly lower risk of major bleeding (HR 0.53) compared to vitamin K antagonists in patients aged 75 years or older with non-valvular atrial fibrillation.
Why the study?
Risk factors and comorbidities can complicate the management of non-valvular atrial fibrillation, requiring real-world evaluation of DOACs versus VKAs in patients at high risk for gastrointestinal bleeding.
Do direct oral anticoagulants reduce major bleeding and stroke/systemic embolism compared to vitamin K antagonists in patients with non-valvular atrial fibrillation at high risk of gastrointestinal bleeding?
Cohort (n=314,184)
Do direct oral anticoagulants reduce major bleeding and stroke/systemic embolism compared to vitamin K antagonists in patients with non-valvular atrial fibrillation at high risk of gastrointestinal bleeding?
Hazard Ratio: 0.53 (95% CI 0.5–0.58)
p-value: p=<0.0001
In patients with non-valvular atrial fibrillation at high risk for gastrointestinal bleeding, DOACs (especially apixaban) are associated with improved safety and effectiveness compared to VKAs.
DOACs were associated with lower major bleeding than VKAs in high GI-bleed risk AF subgroups; supports hypothesis generation but should not yet change practice.
BACKGROUND: Risk factors and comorbidities can complicate management of non-valvular atrial fibrillation. We describe and compare real-world safety and effectiveness of direct oral anticoagulants (DOACs; apixaban, rivaroxaban, dabigatran) and vitamin K antagonists (VKAs) in subgroups of patients with non-valvular atrial fibrillation at high risk for gastrointestinal (GI) bleeding, utilizing data from a national quasi-exhaustive French database. METHODS: Anticoagulant-naïve adults with non-valvular atrial fibrillation with ≥1 gastrointestinal bleeding risk factor, initiating anticoagulant treatment January 2016-December 2019, and covered by the French national health data system were eligible. The following subgroups were evaluated: patients age ≥75 years, receiving concomitant medications, HAS-BLED score ≥3, and chronic kidney disease stage 3-4. Outcomes included major bleeding and stroke/systemic embolism. Patient characteristics were balanced using propensity score matching. RESULTS: A total of 314,184 patients were identified; characteristics were similar for propensity score-matched subgroups in VKA/DOAC and DOAC/DOAC comparisons. DOACs showed lower risk of major bleeding versus VKAs in all subgroups evaluated (p<0.0001 for all). Apixaban showed lower risk of major bleeding and gastrointestinal bleeding versus rivaroxaban in all subgroups (p≤0.05 for all) and versus dabigatran in elderly patients, patients with HAS-BLED score ≥3, and those receiving concomitant medications (p<0.05 for all). Stroke/systemic embolism risk was lower with apixaban versus rivaroxaban in elderly patients, those with HAS-BLED ≥3, and those receiving concomitant medications; risks were similar for other comparisons. CONCLUSIONS: DOACs were associated with improved safety and effectiveness when compared to VKAs among subgroups of non-valvular atrial fibrillation patients at high risk of gastrointestinal bleeding. Apixaban was associated with lower risks of major bleeding, gastrointestinal bleeding, and stroke/systemic embolism versus rivaroxaban as well as lower risk of major bleeding, gastrointestinal bleeding bleed and similar risk of stroke/systemic embolism versus dabigatran among several of these patient subgroups.
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Lip et al. (2025) conducted a cohort in Non-valvular atrial fibrillation at high risk of gastrointestinal bleeding (n=314,184). Apixaban vs. Vitamin K antagonists (VKAs) was evaluated on Major bleeding leading to hospitalization (in patients age ≥75 years) (HR 0.53, 95% CI 0.50-0.58, p=<0.0001). Apixaban was associated with a significantly lower risk of major bleeding (HR 0.53) compared to vitamin K antagonists in patients aged 75 years or older with non-valvular atrial fibrillation.
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