Background: Predicting the bleeding risk during anticoagulation therapy is a key clinical challenge in patients with venous thromboembolism (VTE). However, there is no established prediction score for major bleeding (MB) in patients with VTE treated with direct oral anticoagulants (DOACs).
Methods and results: Using the COMMAND VTE Registry-2, which enrolled 5,197 patients with acute symptomatic VTE between 2015 and 2020 among 31 centers in Japan, we investigated the risk factors for MB beyond 7 days and within 180 days in patients who received DOACs. A prediction score was developed in the derivation cohort (n=1,618), and prediction performance was evaluated in the validation cohort (n=809). Multivariate logistic regression analysis in the derivation cohort identified factors associated with MB. Based on β coefficients for each factor, the prediction score assigned 2 points to active cancer, history of MB, and thrombocytopenia, and 1 point to creatinine >1.2 mg/dL and anemia, summing them. The C statistic of the prediction score was 0.74 (95% confidence interval [CI] 0.68-0.80) in the derivation cohort and 0.74 (95% CI 0.67-0.81) in the validation cohort (P=0.98). When a cut-off value of 3 was used for the risk score, the sensitivity and specificity were 56.1% and 79.2%, respectively.
Conclusions: The prediction score developed for MB during DOAC therapy (COMMAND-BLEED score) could be clinically useful for decision-making regarding anticoagulation strategies with DOACs.
Keywords: Direct oral anticoagulants; Major bleeding; Prediction score; Venous thromboembolism.