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

SummaryVenous 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.

Validation of the VTE‐BLEED score’s long‐term performance for major bleeding in patients with venous thromboembolisms: From the COMMAND VTE registry

“…In the previous studies validating the VTE‐BLEED score, the proportion of high‐risk patients with a VTE‐BLEED score of ≥2 ranged from 25% to 37%, while in the present study, it was much higher (68%). This was mainly because the prevalence of patients with active cancer (20%), anemia (52%), and renal dysfunction (39%) was higher in the present study population, suggesting the presence of more patients with these comorbidities in the real world.…”

“…This was mainly because the prevalence of patients with active cancer (20%), anemia (52%), and renal dysfunction (39%) was higher in the present study population, suggesting the presence of more patients with these comorbidities in the real world. Furthermore, the incidence of major bleeding in patients with a VTE‐BLEED score of ≥2 was 4.3% at 1 year in the present study, which was relatively high compared to the previous studies from 2.1% to 2.4% in warfarin users . This is partly because the present study population included a higher proportion of patients with other known risk factors for bleeding such as a low body weight and thrombocytopenia, which are not included in the VTE‐BLEED score.…”

“…The strength of the present study was that the VTE‐BLEED score was well applied in the non‐selective cohort, which enrolled consecutive patients with acute symptomatic VTEs. Another strength was that the present study evaluated major bleeding events during a longer period (a median at‐risk time of 672 days) compared with the XALIA study (a median at‐risk time of 190 days) and the Hokusai‐VTE study (a maximum of 365 days) . The present study confirmed the generalizability of the VTE‐BLEED score for real‐world VTE patients on long‐term anticoagulation therapy.…”

“…4 The VTE-BLEED score was also externally validated in patients in the previous two studies, who were edoxaban/warfarin-treated patients in the RCT; the HOKUSAI-VTE trial; 7,13 and rivaroxaban/warfarin-treated patients in the post-authorization safety study, the XALIA study. 8,16 Therefore, the VTE-BLEED score was externally well validated in the previous studies. However, it still needs further application in non-selective cohorts of patients with VTEs before it can be widely used in daily clinical TA B L E 2 The cumulative 5-year incidence of major bleeding in each subgroup of the VTE-BLEED score components practice.…”

“…4 The VTE-BLEED score was derived from patients in randomized clinical trials (RCTs), 5,6 and externally validated in another RCT and an observational study of selected patients. 7,8 However, the VTE-BLEED score has not yet been applied in non-selected patients in the real world. The generalizability of the VTE-BLEED score in nonselective patients is clinically important when considering its use in daily clinical practice.…”