Prediction of major bleeding in patients receiving DOACs for venous thromboembolism: A prospective cohort study.

BACKGROUND

In the direct oral anticoagulants (DOACs) era, extended anticoagulation is an attractive strategy after venous thromboembolism (VTE). The role of currently available bleeding risk scores for VTE patients treated with DOACs in clinical practice is undefined.

METHODS

Consecutive patients with VTE were included in a prospective multicenter cohort at the initiation of treatment with DOACs. The role of ATRIA, HAS-BLED, Kuijer, ORBIT, RIETE and VTE-BLEED scores in predicting major bleeding (ISTH definition) while on DOAC treatment was assessed.

RESULTS

Overall, 1034 patients were included and followed for one year or until the end of treatment or the occurrence of major bleeding. During study period, 26 major bleedings occurred in 25 patients (2.8% patient-year). Anemia, bleeding history and creatinine clearance <60 ml/min were significant predictors of major bleedings. The predictive value of bleeding risk scores was modest. In the 12-month study period, ORBIT (HR intermediate-high vs. low risk patients 3.62, 95% CI 1.65-7.94 and c-statistics 0.645, 95% CI 0.523-0.767) and VTE-BLEED (HR high vs. low 16.11, 95% CI 2.18-119.09 and c-statistics 0.674, 95% CI 0.593-0.755) score significantly predicted major bleeding. The lowest incidence of major bleeding (0.3%) was observed in the low-risk category of VTE-BLEED, while the highest (7.1%) in the high-risk category of ORBIT.

CONCLUSIONS

In a real-life cohort of patients with VTE treated with DOACs, the predictive value of currently available bleeding risk scores was modest and not statistically different. Whether these scores can be used for decision making on anticoagulation should be assessed in management studies.