Document Detail


Efficacy and safety of rivaroxaban or fondaparinux thromboprophylaxis in major orthopaedic surgery - findings from the ortho-tep registry.
MedLine Citation:
PMID:  22882706     Owner:  NLM     Status:  Publisher    
Abstract/OtherAbstract:
Background:  Thromboprophylaxis with rivaroxaban (R) is superior over enoxaparin in patients undergoing major orthopaedic surgery (MOS). However, rivaroxaban has never been directly compared with fondaparinux (F), which also shows superior efficacy over enoxaparin. The clinical impact of switching from fondaparinux to rivaroxaban thromboprophylaxis is unclear. Objectives:  To evaluate the efficacy and safety of rivaroxaban or fondaparinux thromboprophylaxis in unselected patients undergoing MOS in daily care. Patients/Methods:  Monocentric, retrospective cohort study in 5,061 consecutive patients undergoing MOS at our centre. Comparison of rates of symptomatic VTE, bleeding and surgical complications, length of hospital stay and risk factors for VTE. Results:  Rates of symptomatic VTE were 5.6% (F) and 2.1% (R; p<0.001) with rates for distal DVT being 3.9 vs. 1.1% (p<0.001). Rates of major VTE were numerically higher with fondaparinux (1.8 vs. 1.1%), which was not statistically significant. Rates of severe bleeding (bleeding leading to surgical revision or death, occurring in a critical site, or transfusion of at least 2 units of packed red blood cells) were statistically lower with rivaroxaban compared to fondaparinux (2.9 vs. 4.9%; p=0.010). The mean length of hospital stay was significantly shorter in the rivaroxaban group (8.3 days; 95% CI 8.1- 8.5 vs. 9.3 days; 9.1- 9.5; p< 0.001). Conclusion:  Based on an indirect comparison of two consecutive cohorts, our data suggest that thromboprophylaxis with rivaroxaban is associated with less VTE and bleeding events than fondaparinux in unselected patients undergoing MOS in daily care. Prospective comparisons are warranted to confirm our findings. © 2012 International Society on Thrombosis and Haemostasis.
Authors:
J Beyer-Westendorf; J Lützner; L Donath; O C Radke; E Kuhlisch; A Hartmann; N Weiss; S Werth
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Publication Detail:
Type:  JOURNAL ARTICLE     Date:  2012-8-6
Journal Detail:
Title:  Journal of thrombosis and haemostasis : JTH     Volume:  -     ISSN:  1538-7836     ISO Abbreviation:  J. Thromb. Haemost.     Publication Date:  2012 Aug 
Date Detail:
Created Date:  2012-8-13     Completed Date:  -     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  101170508     Medline TA:  J Thromb Haemost     Country:  -    
Other Details:
Languages:  ENG     Pagination:  -     Citation Subset:  -    
Copyright Information:
© 2012 International Society on Thrombosis and Haemostasis.
Affiliation:
Center for Vascular Medicine and Department of Medicine III, Division of Angiology, University Hospital "Carl Gustav Carus" Dresden, Fetscherstrasse 74; 01307 Dresden, Germany Clinic of Orthopaedic Surgery, University Hospital "Carl Gustav Carus" Dresden, Fetscherstrasse 74; 01307 Dresden, Germany Department of Anesthesiology and Intensive Care Medicine, University Hospital "Carl Gustav Carus" Dresden, Fetscherstrasse 74; 01307 Dresden, Germany Institute for Medical Informatics and Biometry, Technical University Dresden, Germany.
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