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

Abstract

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 2·6 [95% confidence interval (CI) 1·3-5·2] and the treatment-adjusted HR was 2·3 (95% CI 1·1-4·5) for VTE-BLEED high (versus low) risk patients: the corresponding values for major bleeding after day 90 were 3·8 (95% CI 1·6-9·3) and 3·2 (95% CI 1·3-7·7), 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 4·8-23), but not evidently with recurrent VTE (treatment-adjusted HR 1·5; 95% CI 0·85-2·7). 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.

Keywords: anticoagulation therapy; bleeding; prediction; rivaroxaban; venous thromboembolism.

Figure 1

Decision curve analysis. Grey line represents scenario where VTE‐BLEED is used to treat low risk patients but not high risk patients; Horizontal black line represents scenario where all patients are assumed to be of low risk and none are treated with discontinuation of anticoagulants (all receive anticoagulants); dashed grey line represents scenario in which all patients are assumed to be a high risk and all are treated with anticoagulant discontinuation (none receive anticoagulants); vertical long dashed black line represents prevalence of major bleeding in Rivaroxaban‐treated patients in the sensitivity analysis; vertical dotted dashed black line represents prevalence of major bleeding in vitamin K antagonist‐treated patients in the sensitivity analysis. Grey shaded area represents the range of threshold probabilities for which use of VTE‐BLEED is associated with a net clinical benefit over not using the score. Importantly, risks of VTE are not taken into account. VTE, venous thromboembolism.