Real-world comparison of bleeding risks among non-valvular atrial fibrillation patients prescribed apixaban, dabigatran, or rivaroxaban

Abstract

Limited real-world data are available regarding the comparative safety of non-vitamin K antagonist oral anticoagulants (NOACs). The objective of this retrospective claims observational cohort study was to compare the risk of bleeding among non-valvular atrial fibrillation (NVAF) patients prescribed apixaban, dabigatran, or rivaroxaban. NVAF patients aged ≥18 years with a 1-year baseline period were included if they were new initiators of NOACs or switched from warfarin to a NOAC. Cox proportional hazards modelling was used to estimate the adjusted hazard ratios of any bleeding, clinically relevant non-major (CRNM) bleeding, and major inpatient bleeding within 6 months of treatment initiation for rivaroxaban and dabigatran compared to apixaban. Among 60,227 eligible patients, 8,785 were prescribed apixaban, 20,963 dabigatran, and 30,529 rivaroxaban. Compared to dabigatran or rivaroxaban patients, apixaban patients were more likely to have greater proportions of baseline comorbidities and higher CHA2DS2-VASc and HAS-BLED scores. After adjusting for baseline clinical and demographic characteristics, patients prescribed rivaroxaban were more likely to experience any bleeding (HR: 1.35, 95% confidence interval [CI]: 1.26–1.45), CRNM bleeding (HR: 1.38, 95% CI: 1.27–1.49), and major inpatient bleeding (HR: 1.43, 95% CI: 1.17–1.74), compared to patients prescribed apixaban. Dabigatran patients had similar bleeding risks as apixaban patients. In conclusion, NVAF patients treated with rivaroxaban appeared to have an increased risk of any bleeding, CRNM bleeding, and major inpatient bleeding, compared to apixaban patients. There was no significant difference in any bleeding, CRNM bleeding, or inpatient major bleeding risks between patients treated with dabigatran and apixaban.

Comparing risk of major bleeding between users of different oral anticoagulants in patients with nonvalvular atrial fibrillation

“…in a US claims database also found that rivaroxaban had a worse safety profile than dabigatran and apixaban 23 . Similar observations have been made in other studies as well 27,29–31 . The difference found for rivaroxaban might be explained by selective prescribing of this drug to patients with higher stroke and bleeding risk.…”

“…23 Similar observations have been made in other studies as well. 27,[29][30][31] The difference found for rivaroxaban might be explained by selective prescribing of this drug to patients with higher stroke and bleeding risk. Although the analysis was corrected for confounding, unobserved confounding could still be present.…”

Patient characteristics and stroke and bleeding events in nonvalvular atrial fibrillation patients treated with apixaban and vitamin K antagonists: a Spanish real-world study

“…Intracranial bleeding is considered the most prominent and potentially fatal complication in patients on oral anticoagulants [1,10]. As apixaban may have greater clinical benefits than acenocoumarol, this may have been accepted by physicians when selecting anticoagulant treatment [13][14][15]. Likewise, 77.5% of patients initiated apixaban at a dose of 10 mg/day, consistent with other studies [11,12].…”

“…In patients with NVAF, novel oral anticoagulants (NOACs) have demonstrated a better risk-benefit profile than VKA in clinical trials [10]. Available NOACs include dabigatran, rivaroxaban, apixaban and edoxaban [11][12][13][14][15]. No head-to-head clinical trials have compared NOACs, although observational studies suggest differences in the risk-benefit profile between them [11].…”

Use of New Oral Anticoagulants/ Direct Oral Anticoagulants in Malignant Patients

“…AF in cancer patients may be a comorbid state due to their older age, disbalance of electrolytes, hypoxia, and age-related metabolic disorders, thus the link between AF and cancer may be due to the above-determined factors [19]. The comorbidity profiles were quite similar to apixaban, dabigatran, and rivaroxaban for bleedings and strokes [20].…”