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Thromb Haemost 2013; 109(01): 154-163
DOI: 10.1160/TH12-07-0510
New Technologies, Diagnostic Tools and Drugs
Schattauer GmbH

Efficacy and safety of thromboprophylaxis with low-molecular-weight heparin or rivaroxaban in hip and knee replacement surgery

Findings from the ORTHO-TEP registry
Jan Beyer-Westendorf
1   Center for Vascular Medicine and Department of Medicine III, Division of Angiology, University Hospital “Carl Gustav Carus” Dresden, Dresden, Germany
,
Jörg Lützner
2   Clinic of Orthopaedic Surgery, University Hospital “Carl Gustav Carus” Dresden, Dresden, Germany
,
Lars Donath
1   Center for Vascular Medicine and Department of Medicine III, Division of Angiology, University Hospital “Carl Gustav Carus” Dresden, Dresden, Germany
,
Luise Tittl
1   Center for Vascular Medicine and Department of Medicine III, Division of Angiology, University Hospital “Carl Gustav Carus” Dresden, Dresden, Germany
,
Holger Knoth
3   Pharmacy Department, University Hospital “Carl Gustav Carus” Dresden, Dresden, Germany
,
Oliver C. Radke
3   Pharmacy Department, University Hospital “Carl Gustav Carus” Dresden, Dresden, Germany
,
Eberhard Kuhlisch
5   Institute for Medical Informatics and Biometry, Technical University Dresden, Germany
,
Thoralf Stange
5   Institute for Medical Informatics and Biometry, Technical University Dresden, Germany
,
Albrecht Hartmann
2   Clinic of Orthopaedic Surgery, University Hospital “Carl Gustav Carus” Dresden, Dresden, Germany
,
Klaus-Peter Günther
2   Clinic of Orthopaedic Surgery, University Hospital “Carl Gustav Carus” Dresden, Dresden, Germany
,
Norbert Weiss
1   Center for Vascular Medicine and Department of Medicine III, Division of Angiology, University Hospital “Carl Gustav Carus” Dresden, Dresden, Germany
,
Sebastian Werth
1   Center for Vascular Medicine and Department of Medicine III, Division of Angiology, University Hospital “Carl Gustav Carus” Dresden, Dresden, Germany
› Author Affiliations Financial support: The Ortho-TEP registry was partially supported by a grant of Bayer Healthcare, providing funding for a documentation assistant. The authors declare that the sponsor had no influence on the conduct of the study, data collection, statistical analysis or written presentation of study findings.
Further Information

Publication History

Received: 24 July 2012

Accepted after major revision: 01 October 2012

Publication Date:
25 November 2017 (online)

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Summary

Prospective trials have shown that rivaroxaban thromboprophylaxis is superior over low-molecular-weight heparin (LMWH) in patients undergoing hip and knee replacement surgery. However, patients treated under trial conditions are different from unselected routine patients, which may affect efficacy and safety of thromboprophylaxis. The objective was to evaluate the efficacy and safety of rivaroxaban or LMWH thromboprophylaxis in unselected patients undergoing hip and knee replacement surgery in daily care. In a monocentric, retrospective cohort study in 5,061 consecutive patients undergoing hip and knee replacement surgery a comparison of LMWH (hospital standard in 2006–2007) and rivaroxaban (since 2009) was made with regard to rates of symptomatic VTE, bleeding and surgical complications and length of hospital stay. Rates of symptomatic VTE were 4.1 % (LMWH) and 2.1 % (rivaroxaban; p=0.005) with rates for distal DVT 2.5 vs. 1.1 % (p<0.001). Rates of major VTE were numerically higher with LMWH (1.7 vs. 1.1%, not statistically significant). Rates of major bleeding (overt bleeding leading to surgical revision or death, occurring in a critical site, or transfusion of at least two units of packed red blood cells) were statistically lower with rivaroxaban (2.9 vs. 7.0%; p<0.001). Rivaroxaban patients had fewer surgical complications (1.1 vs. 3.7%; p<0.001) and a shorter length of hospitalisation (8.3 days; 95% CI 8.1– 8.5 vs. 11.1 days; 10.7– 11.5; p< 0.001). We conclude that rivaroxaban thromboprophylaxis is more effective than LMWH in unselected patients undergoing hip and knee replacement surgery in daily care and that switching from LMWH to rivaroxaban could be beneficial. Prospective comparisons are warranted to confirm our findings.

Keywords

Low-molecular-weight heparin - major orthopaedic surgery - rivaroxaban - venous thromboembolism - VTE prophylaxis
 

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