title: Efficacy and safety of thromboprophylaxis with low-molecular-weight heparin or rivaroxaban in hip and knee replacement surgery: findings from the ORTHO-TEP registry.
abstract: 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.
authors.affiliation: Center for Vascular Medicine, University Hospital Carl Gustav Carus, Technical University Dresden, Fetscherstrasse 74, 01307 Dresden, Germany. jan.beyer@uniklinikum-dresden.de
authors.forename: Jan
authors.initials: J
authors.lastname: Beyer-Westendorf
authors.forename: Jörg
authors.initials: J
authors.lastname: Lützner
authors.forename: Lars
authors.initials: L
authors.lastname: Donath
authors.forename: Luise
authors.initials: L
authors.lastname: Tittl
authors.forename: Holger
authors.initials: H
authors.lastname: Knoth
authors.forename: Oliver C
authors.initials: OC
authors.lastname: Radke
authors.forename: Eberhard
authors.initials: E
authors.lastname: Kuhlisch
authors.forename: Thoralf
authors.initials: T
authors.lastname: Stange
authors.forename: Albrecht
authors.initials: A
authors.lastname: Hartmann
authors.forename: Klaus-Peter
authors.initials: KP
authors.lastname: Günther
authors.forename: Norbert
authors.initials: N
authors.lastname: Weiss
authors.forename: Sebastian
authors.initials: S
authors.lastname: Werth
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D000925:Anticoagulants / Q000008:administration & dosage* / Q000009:adverse effects; D019644:Arthroplasty, Replacement, Hip / Q000009:adverse effects* / Q000401:mortality; D019645:Arthroplasty, Replacement, Knee / Q000009:adverse effects* / Q000401:mortality; D001803:Blood Transfusion; D005260:Female; D005343:Fibrinolytic Agents / Q000008:administration & dosage* / Q000009:adverse effects; D005858:Germany; D006470:Hemorrhage / Q000139:chemically induced / Q000628:therapy; D006495:Heparin, Low-Molecular-Weight / Q000008:administration & dosage* / Q000009:adverse effects; D006801:Humans; D053208:Kaplan-Meier Estimate; D007902:Length of Stay; D016015:Logistic Models; D008297:Male; D008875:Middle Aged; D009025:Morpholines / Q000008:administration & dosage* / Q000009:adverse effects; D015999:Multivariate Analysis; D016017:Odds Ratio; D016016:Proportional Hazards Models; D012042:Registries; D012189:Retrospective Studies; D012307:Risk Factors; D000069552:Rivaroxaban; D013876:Thiophenes / Q000008:administration & dosage* / Q000009:adverse effects; D013923:Thromboembolism / Q000097:blood / Q000209:etiology / Q000401:mortality / Q000517:prevention & control*; D013997:Time Factors; D016896:Treatment Outcome; D020246:Venous Thrombosis / Q000097:blood / Q000209:etiology / Q000401:mortality / Q000517:prevention & control*
chemical_list: D000925:Anticoagulants; D005343:Fibrinolytic Agents; D006495:Heparin, Low-Molecular-Weight; D009025:Morpholines; D013876:Thiophenes; D000069552:Rivaroxaban