title: Efficacy and safety of rivaroxaban or fondaparinux thromboprophylaxis in major orthopedic surgery: findings from the ORTHO-TEP registry.
abstract: BACKGROUND
  Thromboprophylaxis with rivaroxaban (R) is superior to enoxaparin in patients undergoing major orthopedic 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.
  
  
  OBJECTIVE
  To evaluate the efficacy and safety of rivaroxaban or fondaparinux thromboprophylaxis in unselected patients undergoing MOS.
  
  
  METHODS
  This is a monocentric, retrospective cohort study in 5061 consecutive patients undergoing MOS at our centre, comparing 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%), but not statistically significant. Rates of severe bleeding (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 compared with 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).
  
  
  CONCLUSIONS
  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. Prospective comparisons are warranted to confirm our findings.
authors.affiliation: Division of Angiology, Department of Medicine III, Center for Vascular Medicine, University Hospital 'Carl Gustav Carus' Dresden Dresden, Germany. jan.beyer@uniklinikum-dresden.de
authors.forename: J
authors.initials: J
authors.lastname: Beyer-Westendorf
authors.forename: J
authors.initials: J
authors.lastname: Lützner
authors.forename: L
authors.initials: L
authors.lastname: Donath
authors.forename: O C
authors.initials: OC
authors.lastname: Radke
authors.forename: E
authors.initials: E
authors.lastname: Kuhlisch
authors.forename: A
authors.initials: A
authors.lastname: Hartmann
authors.forename: N
authors.initials: N
authors.lastname: Weiss
authors.forename: S
authors.initials: S
authors.lastname: Werth
mesh_terms: D000284:Administration, Oral; D000368:Aged; D000369:Aged, 80 and over; D000925:Anticoagulants / Q000008:administration & dosage* / Q000009:adverse effects; D001780:Blood Coagulation Tests; D004334:Drug Administration Schedule; D005260:Female; D000077425:Fondaparinux; D005858:Germany; D006801:Humans; D053208:Kaplan-Meier Estimate; D016015:Logistic Models; D008136:Longevity; D008297:Male; D008875:Middle Aged; D009025:Morpholines / Q000008:administration & dosage* / Q000009:adverse effects; D019637:Orthopedic Procedures / Q000009:adverse effects* / Q000401:mortality; D011134:Polysaccharides / Q000008:administration & dosage* / Q000009:adverse effects; D019106:Postoperative Hemorrhage / Q000139:chemically induced / Q000401:mortality / Q000628:therapy; D016016:Proportional Hazards Models; D012042:Registries; D012189:Retrospective Studies; D018570:Risk Assessment; D012307:Risk Factors; D000069552:Rivaroxaban; D013876:Thiophenes / Q000008:administration & dosage* / Q000009:adverse effects; D013997:Time Factors; D016896:Treatment Outcome; D054556:Venous Thromboembolism / Q000097:blood / Q000209:etiology / Q000401:mortality / Q000517:prevention & control*
chemical_list: D000925:Anticoagulants; D009025:Morpholines; D011134:Polysaccharides; D013876:Thiophenes; D000069552:Rivaroxaban; D000077425:Fondaparinux