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Aims: The 6-variable VTE-BLEED (Table 1) was recently shown to accurately predict overall major bleeding in patients with venous thromboembolism (VTE) during long-term treatment with vitamin-k antagonists, direct thrombin inhibitors as well as direct Xa inhibitors (Eur Respir J 2016; 48:1369–1376; Thromb Haemost 2017; 117:1164–1170). The prognostic factor of VTE-BLEED for intracranial intracranial hemorrhage (ICH) and/or fatal bleeding is unknown.

Methods: We performed a post hoc analysis of the pooled RE-COVER studies (5107 VTE patients) and the HOKUSAI study (8240 VTE patients), both high quality randomized controlled trials with blinded endpoint adjudication. VTE-BLEED was calculated for all patients. Patients with <2 points were categorized as “low risk”. We calculated the Odds Ratio (OR) for ICH, fatal bleeding and the combined endpoint for patients in the high risk group (versus low risk) for both individual studies. We also pooled the data from both cohorts for an overall estimation.

Results: In line with was previously shown for the prediction of major bleeding, the OR for all three outcomes ranged between 3.8 and 6.7 for the two individual studies. The pooled Odds Ratio for ICH was 4.0 (95% CI 1.7–9.3), for fatal bleeding 5.6 (95% CI 1.7–19) and for ICH or fatal bleeding 4.7 (95% 2.2–10) respectively. We found no relevant heterogeneity between the two studies (I2=0% for all 3 meta-analyses), and the effect was consistent for all three anticoagulant drug classes.

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Table 1. VTE-BLEED score items

ItemScore
Active cancera2
Male with uncontrolled arterial hypertensionb1
Anemiac1.5
History of bleedingd1.5
Age ≥60 years old1.5
Renal dysfunctione1.5
Classification of patients with VTE-BLEED
  Low bleeding riskTotal score <2
  High bleeding riskTotal score ≥2
ItemScore
Active cancera2
Male with uncontrolled arterial hypertensionb1
Anemiac1.5
History of bleedingd1.5
Age ≥60 years old1.5
Renal dysfunctione1.5
Classification of patients with VTE-BLEED
  Low bleeding riskTotal score <2
  High bleeding riskTotal score ≥2
Open in new tab

Table 1. VTE-BLEED score items

ItemScore
Active cancera2
Male with uncontrolled arterial hypertensionb1
Anemiac1.5
History of bleedingd1.5
Age ≥60 years old1.5
Renal dysfunctione1.5
Classification of patients with VTE-BLEED
  Low bleeding riskTotal score <2
  High bleeding riskTotal score ≥2
ItemScore
Active cancera2
Male with uncontrolled arterial hypertensionb1
Anemiac1.5
History of bleedingd1.5
Age ≥60 years old1.5
Renal dysfunctione1.5
Classification of patients with VTE-BLEED
  Low bleeding riskTotal score <2
  High bleeding riskTotal score ≥2

Conclusions: These data support the usefulness of VTE-BLEED for making management decisions on the duration of anticoagulant therapy in VTE patients.

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Abstracts > Saturday 25 August 2018
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