The use of direct oral anticoagulants after pulmonary embolism regarding the bleeding risk in the countries without reimbursement Results from the Regional Pulmonary Embolism Registry

Background: Direct oral anticoagulants (DOACs) have become the standard of care for the treatment of pulmonary embolism (PE), but optimal drug selection requires individualized assessment, particularly in health systems without reimbursement policies. Objectives: To identify the clinical characteristics of patients treated with direct oral anticoagulants (DOACs) for pulmonary embolism and to compare the risk, frequency, and types of bleeding events associated with the use of different DOACs. Methods: This retrospective cohort study analysed 969 patients from the Regional Pulmonary Embolism Registry (REPER) who were discharged with DOAC therapy between January 2015 and January 2023. Patients were stratified into three groups based on the prescribed DOAC: rivaroxaban, apixaban, or dabigatran. Clinical characteristics, bleeding risk scores (VTE-BLEED and HAS-BLED), and the incidence of major bleeding (MB) events within 90 days were compared. Results: Rivaroxaban was the most frequently prescribed DOAC, followed by apixaban and dabigatran. Patient characteristics significantly influenced drug selection, with apixaban being more commonly used in elderly patients, those with renal impairment, malignancy, or prior bleeding history. Patients with VTE-BLEED score 2 or higher were more often treated with apixaban despite the highest price of this drug. Despite difference in risk profiles for bleeding regarding DOAC use, no statistically significant difference was found in the incidence of MB across the groups (p=0.652). The VTE-BLEED score outperformed HAS-BLED in predicting bleeding events (AUC ROC analysis). Conclusions: Apixaban appeared to be the preferred agents for patients at increased risk of bleeding or with complex comorbidities, including renal dysfunction and cancer. The VTE-BLEED score was confirmed as a tool for guiding anticoagulant selection in acute PE. A personalized, risk-adapted approach for anticoagulation therapy after PE is achieved in spite of the total lack of reimbursement for majority of patients in our registry.