Bleeding risk on rivaroxaban versus apixaban in older patients with venous thromboembolism: a nationwide observational register-based study.

BACKGROUND

Comparative data on the bleeding risk in cancer-free patients aged ≥65 years treated with rivaroxaban or apixaban for venous thromboembolism is scarce. The aim was to compare major bleeding rates between rivaroxaban and apixaban during primary treatment (0 - 6 months) and secondary treatment (6 months - 5 years). Additionally, all-cause mortality and recurrent pulmonary embolism (PE) were assessed.

METHODS

A register-based cohort study of cancer-free patients in Sweden aged ≥65 years with a first-time PE or deep vein thrombosis and a filled prescription of rivaroxaban or apixaban between January 1, 2014, and July 1, 2023. Cox proportional hazard models were used to compare rates of bleeding, all-cause mortality, and recurrent PE.

FINDINGS: 19,090 patients were included; 7572 on rivaroxaban and 11,518 on apixaban. During primary treatment, rates of major bleeding were 4.4 (95 % confidence interval (CI) 3.7-5.2) per 100 patient-years on rivaroxaban and 3.3 (2.8-3.9) on apixaban, adjusted hazard ratio (aHR) 1.46 (1.15-1.85). During secondary treatment, major bleeding rates were 1.4 (1.2-1.7) per 100 patient-years on rivaroxaban and 1.2 (1.0-1.5) on apixaban, aHR 1.24 (0.94-1.63). No difference was seen in recurrent PE, however, a higher mortality was seen for patients on rivaroxaban.

INTERPRETATION: During primary treatment, apixaban was associated with a lower risk of major bleeding than rivaroxaban without a corresponding increase in recurrent PE risk. During secondary treatment, no difference in bleeding risk was observed.

FUNDING: The Swedish Heart and Lung Foundation. The Swedish State under the agreement between the Swedish Government and the county councils.