Predictive value of venous thromboembolism (VTE)-BLEED to predict major bleeding and other adverse events in a practice-based cohort of patients with VTE: results of the XALIA study

Venous thromboembolism (VTE)-BLEED, a decision tool for predicting major bleeding during chronic anticoagulation for VTE has not yet been validated in practice-based conditions. We calculated the prognostic indices of VTE-BLEED for major bleeding after day 30 and day 90, as well as for recurrent VTE and all-cause mortality, in 4457 patients enrolled in the international, prospective XALIA study. The median at-risk time was 190 days (interquartile range 106-360). The crude hazard ratio (HR) for major bleeding after day 30 was 2 center dot 6 [95% confidence interval (CI) 1 center dot 3-5 center dot 2] and the treatment-adjusted HR was 2 center dot 3 (95% CI 1 center dot 1-4 center dot 5) for VTE-BLEED high (versus low) risk patients: the corresponding values for major bleeding after day 90 were 3 center dot 8 (95% CI 1 center dot 6-9 center dot 3) and 3 center dot 2 (95% CI 1 center dot 3-7 center dot 7), respectively. The predictive value of VTE-BLEED was similar in selected patients with unprovoked VTE or those treated with rivaroxaban. High VTE-BLEED score was associated with higher incidence of all-cause mortality (treatment-adjusted HR 11, 95% CI 4 center dot 8-23), but not evidently with recurrent VTE (treatment-adjusted HR 1 center dot 5; 95% CI 0 center dot 85-2 center dot 7). These results confirm the predictive value of VTE-BLEED in practice-based data in patients treated with rivaroxaban or conventional anticoagulation, supporting the hypothesis that VTE-BLEED may be useful for making management decisions on the duration of anticoagulant therapy.