Major bleeding during secondary prevention of venous thromboembolism in patients who have completed anticoagulation: a systematic review and meta-analysis

Authors

  • L. A. Castellucci,

    1. Department of Medicine, The Ottawa Hospital Research Institute at the University of Ottawa, Ottawa, ON, Canada
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  • G. Le Gal,

    1. Department of Medicine, The Ottawa Hospital Research Institute at the University of Ottawa, Ottawa, ON, Canada
    2. EA3878, Université de Brest, Brest, France
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  • M. A. Rodger,

    1. Department of Medicine, The Ottawa Hospital Research Institute at the University of Ottawa, Ottawa, ON, Canada
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  • M. Carrier

    Corresponding author
    1. Department of Medicine, The Ottawa Hospital Research Institute at the University of Ottawa, Ottawa, ON, Canada
    2. Institut de Recherche de l'hôpital Montfort, University of Ottawa, Ottawa, ON, Canada
    • Correspondence: Marc Carrier, Ottawa Hospital Research Institute, University of Ottawa, Ottawa Hospital – General Campus, 501 Smyth Road Box 201a, Ottawa, Ontario, Canada K1H 8L6.

      Tel.:+1 613 737 8899 ext. 73034; fax: +1 613 739 6266.

      E-mail: mcarrier@toh.on.ca

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  • Manuscript handled by: M. Levi
  • Final decision: F. R. Rosendaal, 3 January 2014

Summary

Background

The risk of major bleeding in patients who have completed anticoagulation therapy for unprovoked venous thromboembolism (VTE) is unknown.

Objective

To report the major bleeding and fatal bleeding rates in patients randomized to placebo or observation (i.e. no anticoagulation therapy) for the secondary prevention of recurrent VTE.

Patients and methods

We performed a systematic review and meta-analysis of the literature to summarize the rates of major bleeding and fatal bleeding in patients randomized to placebo or observation during the secondary prevention of VTE. Unrestricted searches of MEDLINE (January 1, 1950 to August 31, 2013), Embase (January 1, 1980 to August 31, 2013), and the Cochrane Register of Controlled Trials using the OVID interface were conducted. Publications from potentially relevant journals were also searched by hand. We used a random-effects model to pool study results and I2 testing to assess for heterogeneity.

Results

The analysis included 11 studies and 3965 patients who were followed for a median of 24 months. The overall pooled major bleeding rate was 0.45 per 100 patient-years (95% CI 0.29–0.64, I2 = 0%), and the overall pooled fatal bleeding rate was 0.14 per 100 patient-years (95% CI 0.057–0.26, I2 = 0%).

Conclusions

Patients not receiving anticoagulant therapy for the secondary prevention of VTE experience major bleeding events, and this may have an impact on recommendations for extended treatment in this patient population.

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