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Major bleeding rates after prophylaxis against venous thromboembolism: Systematic review, meta-analysis, and cost implications

Published online by Cambridge University Press:  01 November 2004

James Muntz
Affiliation:
Baylor College of Medicine
David A Scott
Affiliation:
Fourth Hurdle Consulting Ltd, London, UK
Adam Lloyd
Affiliation:
Fourth Hurdle Consulting Ltd, London, UK
Matthias Egger
Affiliation:
Universities of Bristol, Bristol, UK, and Bern, Switzerland

Abstract

Objectives: The frequency and consequences of major bleeding associated with anticoagulant prophylaxis for prevention of venous thromboembolism is examined.

Methods: We conducted a systematic review and meta-analysis of controlled trials that reported rates of major bleeding after pharmaceutical thromboprophylaxis in patients undergoing major orthopedic surgery. Thromboprophylactic agents were divided into four groups:warfarin/other coumarin derivatives (WARF), unfractionated heparin (UFH), low molecular weight heparin (LMWH), and pentasaccharide (PS). Meta-analysis was conducted comparing LMWH with each of WARF, UFH, and PS. The frequency of re-operation due to major bleeding was reviewed and combined with published costs to estimate the mean cost of managing major bleeding events in these patients.

Results: Twenty-one studies including 20,523 patients met inclusion criteria for the meta-analysis. No evidence of significant between-trial heterogeneity in risk ratios was found. Combined (fixed effects) relative risks (RR) of major bleeding compared with LMWH were WARF – RR 0.59 (95 percent confidence interval [CI], 0.44–0.80); UFH – RR 1.52 (95 percent CI, 1.04–2.23); PS – RR 1.52 (95 percent CI, 1.11–2.09). Seventy-one studies including 32,433 patients were included in the review of consequences of major bleeding. We estimated that the average cost of major bleeding is $113 per patient receiving thromboprophylaxis.

Conclusions: LMWH results in fewer major bleeding episodes than UFH and PS but more than WARF. These events are costly and clinically important.

Type
GENERAL ESSAYS
Copyright
© 2004 Cambridge University Press

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