Evaluation of the predictive value of the bleeding prediction score VTE‐BLEED for recurrent venous thromboembolism

Abstract

Introduction VTE‐BLEED is a validated score for identification of patients at increased risk of major bleeding during extended anticoagulation for venous thromboembolism (VTE). It is unknown whether VTE‐BLEED high‐risk patients also have an increased risk for recurrent VTE, which would limit the potential usefulness of the score. Methods This was a post hoc analysis of the randomized, double‐blind, placebo‐controlled PADIS‐PE trial that randomized patients with a first unprovoked pulmonary embolism (PE) initially treated during 6 months to receive an additional 18‐month of warfarin vs. placebo. The primary outcome of this analysis was recurrent VTE during 2‐year follow‐up after anticoagulant discontinuation, that is, after the initial 6‐month treatment in the placebo arm and after 24 months of anticoagulation in the active treatment arm. This rate, adjusted for study treatment allocation, was compared between patients in the high‐ vs. low‐risk VTE‐BLEED group. Results In complete case analysis (n = 308; 82.4% of total population), 89 (28.9%) patients were classified as high risk; 44 VTE events occurred after anticoagulant discontinuation during 668 patient‐years. The cumulative incidence of recurrent VTE was 16.4% (95% confidence interval [CI], 10.0%‐26.1%; 14 events) and 14.6% (95% CI, 10.4%‐20.3%; 30 events) in the high‐risk and low‐risk VTE‐BLEED groups, respectively, for an adjusted hazard ratio of 1.16 (95% CI, 0.62‐2.19). Conclusion In this study, patients with unprovoked PE classified at high risk of major bleeding by VTE‐BLEED did not have a higher incidence of recurrent VTE after cessation of anticoagulant therapy, supporting the potential yield of the score for making management decisions on the optimal 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

“…The present study confirmed the generalizability of the VTE‐BLEED score for real‐world VTE patients on long‐term anticoagulation therapy. Furthermore, consistent with a previous report, in the initial unprovoked VTE patients, we found no significant difference in the risk of recurrent VTEs beyond 30 days between the high‐risk and low‐risk groups regarding the VTE‐BLEED score, suggesting the clinical utility of the score for making management decisions on the optimal duration of anticoagulant therapy in these patients …”

“…Furthermore, consistent with a previous report, in the initial unprovoked VTE patients, we found no significant difference in the risk of recurrent VTEs beyond 30 days between the high-risk and low-risk groups regarding the VTE-BLEED score, suggesting the clinical utility of the score for making management decisions on the optimal duration of anticoagulant therapy in these patients. 18 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%, 4,7,8 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.…”

Prediction of bleeding events using the VTE‑BLEED risk score in patients with venous thromboembolism receiving anticoagulant therapy (Review)

“…The highest differences in the occurrence of major bleeding between high-and low-risk categories were recorded in patients with DVT only (3.6 vs. 0.5%; HR 8.71; 95% CI, 1.12-67.45) and in those with unprovoked VTE (3.6 vs. 0.4%; HR 9.86; 95% CI, 1.28-75.80). Similarly to previous results (23), no significant increase in bleeding events was observed in cancer patients compared to those without cancer (HR 1.93; 95% CI, 0.72-5.17; P= 0.191).…”

“…The advantages of the score quickly became visible. The VTE-BLEED score variables are clearly defined, easy to assess, largely objective and fairly constant over time (23). 'Male with uncontrolled arterial hypertension' is the only potentially inconstant variable.…”

Prediction of Major Bleeding in Anticoagulated Patients for Venous Thromboembolism: Comparison of the RIETE and the VTE-BLEED Scores

“…18 In the long-term, the risk assessment should be considered to decide the duration of anticoagulant therapy. 19 Our study suggests that the usefulness of available bleeding scores may vary depending on the characteristics of the patient population and the time frame evaluated. In this real-world population we confirm that the proportion of patients with VTE classified at high-risk using the VTE-BLEED score is much higher than that initially found in the randomized clinical trials that led to derivation and validation of the score (62% in our series vs. 25-35%).…”