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

Publikation: Beitrag in FachzeitschriftForschungsartikelBeigetragenBegutachtung

Beitragende

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 (8.3days, 95% CI 8.1-8.5 vs. 9.3days, 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.

Details

OriginalspracheEnglisch
Seiten (von - bis)2045-2052
Seitenumfang8
FachzeitschriftJournal of thrombosis and haemostasis
Jahrgang10
Ausgabenummer10
PublikationsstatusVeröffentlicht - Okt. 2012
Peer-Review-StatusJa

Externe IDs

PubMed 22882706

Schlagworte

ASJC Scopus Sachgebiete

Schlagwörter

  • Deep vein thrombosis, Fondaparinux, Major orthopedic surgery, Rivaroxaban, Venous thromboembolism, Venous thromboembolism prophylaxis