Key result
Among patients with non-valvular atrial fibrillation at high risk for gastrointestinal bleeding, apixaban was associated with a lower risk of major bleeding compared to rivaroxaban (HR 0.63; 95% CI 0.59-0.66).
Why the study?
The study sought to compare the effectiveness and safety of direct oral anticoagulants (apixaban, rivaroxaban, dabigatran) or vitamin K antagonists in patients with non-valvular atrial fibrillation at high risk for gastrointestinal bleeding.
Do direct oral anticoagulants improve safety and effectiveness compared to vitamin K antagonists and each other in adults with non-valvular atrial fibrillation at high risk for gastrointestinal bleeding?
Cohort (n=314,184)
Yes
Do direct oral anticoagulants improve safety and effectiveness compared to vitamin K antagonists and each other in adults with non-valvular atrial fibrillation at high risk for gastrointestinal bleeding?
Hazard Ratio: 0.63 (95% CI 0.59–0.66)
In patients with non-valvular atrial fibrillation at high risk for gastrointestinal bleeding, DOACs are safer and more effective than VKAs, with apixaban showing the most favorable bleeding profile among the DOACs.
DOACs were associated with lower bleeding and stroke risks vs VKAs in high-GIB-risk NVAF; leaves open whether RCTs should prioritize this population.
BACKGROUND: This observational study compared effectiveness and safety of direct oral anticoagulants (DOACs; apixaban, rivaroxaban, dabigatran) or vitamin K antagonists (VKAs) in patients with non-valvular atrial fibrillation (NVAF) at high risk for gastrointestinal bleeding (GIB). METHODS: Anticoagulant-naïve adults with NVAF with ≥1 GIB risk factor, initiating anticoagulant treatment January 2016-December 2019, and covered by the French national health data system were eligible. Outcomes included major bleeding (MB) and stroke/systemic embolism (SE). Patient characteristics were balanced using propensity score matching. RESULTS: A total of 314,184 patients were identified with 162,150 (51.5%) in the apixaban cohort, 88,427 (28.1%) in the rivaroxaban cohort, 16,465 (5.2%) in the dabigatran cohort, and 47,142 (15.0%) in the VKA cohort (mean age 79.0 years, standard deviation 10.5; 51.0% female). A total of 45,124 apixaban-VKAs, 38,737 rivaroxaban-VKAs, 16,415 dabigatran-VKAs, 88,414 apixaban-rivaroxaban, 16,464 apixaban-dabigatran, and 16,459 rivaroxaban-dabigatran pairs were retained after propensity score matching. Apixaban had lower risk of MB versus dabigatran (hazard ratio [HR], 0.72; 95% confidence interval [CI], 0.63-0.83) and rivaroxaban (HR, 0.63; 95% CI, 0.59-0.66). Apixaban had lower risk of GIB versus dabigatran (HR, 0.46; 95% CI, 0.37-0.56) and rivaroxaban (HR, 0.54; 95% CI, 0.49-0.59). Risk of GIB was similar with dabigatran versus rivaroxaban (HR, 1.05; 95% CI, 0.89-1.24). Apixaban had lower risk of stroke/SE versus rivaroxaban (HR, 0.90; 95% CI, 0.84-0.96), while risk was similar versus dabigatran (HR, 1.1; 95% CI, 0.9-1.3). All DOACs had lower risk of MB and stroke/SE versus VKAs (p<0.001 for all). CONCLUSIONS: DOACs had improved safety and effectiveness from bleeding and stroke/SE, respectively, versus VKAs among patients with NVAF at high risk for GIB. Apixaban was associated with lower MB and GIB risk versus other DOACs. For stroke/SE, apixaban was associated with reduced risk versus rivaroxaban and similar risk versus dabigatran.
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Lip et al. (2024) conducted a cohort in non-valvular atrial fibrillation with high risk of gastrointestinal bleeding (n=314,184). Apixaban vs. Rivaroxaban was evaluated on major bleeding (HR 0.63, 95% CI 0.59-0.66). Among patients with non-valvular atrial fibrillation at high risk for gastrointestinal bleeding, apixaban was associated with a lower risk of major bleeding compared to rivaroxaban (HR 0.63; 95% CI 0.59-0.66).
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