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

Journal: Thrombosis and Haemostasis
ISSN: 0340-6245
DOI: http://dx.doi.org/10.1160/TH12-07-0510
Issue: 2013: 109/1 (Jan) pp. 1–173
Pages: 154-163

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

Findings from the ORTHO-TEP registry

J. Beyer-Westendorf (1), J. Lützner (2), L. Donath (1), L. Tittl (1), H. Knoth (3), O. C. Radke (4), E. Kuhlisch (5), T. Stange (5), A. Hartmann (2), K.-P. Günther (2), N. Weiss (1), S. Werth (1)

(1) Center for Vascular Medicine and Department of Medicine III, Division of Angiology, University Hospital “Carl Gustav Carus” Dresden, Dresden, Germany; (2) Clinic of Orthopaedic Surgery, University Hospital “Carl Gustav Carus” Dresden, Dresden, Germany; (3) Pharmacy Department, University Hospital “Carl Gustav Carus” Dresden, Dresden, Germany; (4) Department of Anesthesiology and Intensive Care Medicine, University Hospital “Carl Gustav Carus” Dresden, Dresden, Germany; (5) Institute for Medical Informatics and Biometry, Technical University Dresden, Germany

Keywords

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

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.

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