Efficacy and safety of rivaroxaban or fondaparinux thromboprophylaxis in major orthopedic surgery: findings from the ORTHO-TEP registry

J Beyer-Westendorf, J Lützner, L Donath, O C Radke, E Kuhlisch, A Hartmann, N Weiss, S Werth

Publication: Contribution to journalJournal articlesResearchpeer-review

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.

OBJECTIVES: To evaluate the efficacy and safety of rivaroxaban or fondaparinux thromboprophylaxis in unselected patients undergoing MOS.

PATIENTS/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).

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. Prospective comparisons are warranted to confirm our findings.

Original languageEnglish
JournalThrombosis and haemostasis
Volume10
Issue number10
Pages (from-to)2045-2052
Number of pages8
ISSN0340-6245
DOIs
Publication statusPublished - 10.2012

Research areas and keywords

  • Administration, Oral
  • Aged
  • Aged, 80 and over
  • Anticoagulants
  • Blood Coagulation Tests
  • Drug Administration Schedule
  • Female
  • Germany
  • Humans
  • Kaplan-Meier Estimate
  • Logistic Models
  • Longevity
  • Male
  • Middle Aged
  • Morpholines
  • Orthopedic Procedures
  • Polysaccharides
  • Postoperative Hemorrhage
  • Proportional Hazards Models
  • Registries
  • Retrospective Studies
  • Risk Assessment
  • Risk Factors
  • Rivaroxaban
  • Thiophenes
  • Time Factors
  • Treatment Outcome
  • Venous Thromboembolism
  • Comparative Study
  • Journal Article
  • Research Support, Non-U.S. Gov't

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