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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.

Authors
  • Klok, Frederikus A1
  • Barco, Stefano1
  • Turpie, Alexander G G2
  • Haas, Sylvia3
  • Kreutz, Reinhold4
  • Mantovani, Lorenzo G5
  • Gebel, Martin6
  • Herpers, Matthias7
  • Bugge, Joerg-Peter8
  • Kostantinides, Stavros V1
  • Ageno, Walter8
  • 1 Centre for Thrombosis and Haemostasis (CTH), University Medical Centre of the Johannes Gutenberg University, Mainz, Germany. , (Germany)
  • 2 Department of Medicine, McMaster University, Hamilton, Canada. , (Canada)
  • 3 Department of Medicine, Formerly Technical University of Munich, Munich, Germany. , (Germany)
  • 4 Institute of Clinical Pharmacology and Toxicology, Charité-Universitätsmedizin, Berlin, Germany. , (Germany)
  • 5 CESP-Centre for Public Health Research, University of Milan Bicocca, Milan, Italy. , (Italy)
  • 6 ClinStat GmbH, Cologne, Germany. , (Germany)
  • 7 Bayer AG, Berlin, Germany. , (Germany)
  • 8 Department of Clinical and Experimental Medicine, University of Insubria, Varese, Italy. , (Italy)
Type
Published Article
Journal
British Journal of Haematology
Publisher
Wiley (Blackwell Publishing)
Publication Date
Nov 01, 2018
Volume
183
Issue
3
Pages
457–465
Identifiers
DOI: 10.1111/bjh.15533
PMID: 30123981
Source
Medline
Keywords
Language
English
License
Unknown

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. © 2018 The Authors. British Journal of Haematology published by John Wiley & Sons Ltd and British Society for Haematology.

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