• OBJECTIVE
    • To analyse the effectiveness and safety of rivaroxaban vs. standard treatment (ST) in the prevention of venous thromboembolism after hip or knee replacement in daily clinical practice in Spain.
  • MATERIAL AND METHOD
    • A sub-analysis of the Spanish data in the XAMOS international observational study that included patients>18 years who received 10mg o.d. rivaroxaban or ST.
  • FOLLOW-UP
    • up to 3 months after surgery.
  • PRIMARY OUTCOMES
    • incidence of symptomatic/asymptomatic thromboembolic events, bleeding, mortality, and other adverse events;
  • SECONDARY OUTCOMES
    • use of health resources and satisfaction after hospital discharge.
  • RESULTS
    • Of the total 801 patients included, 410 received rivaroxaban and 391 ST (64.7% heparin, 24.0% fondaparinux, 11% dabigatran). The incidence of symptomatic thromboembolic events and major bleeding was similar in both groups (0.2% vs. 0.8% wit ST and 0.7% vs. 1.3% with ST [EMA criteria]/0.0% vs. 0.3% with ST [RECORD criteria]). The adverse events incidence associated with the drug was significantly higher rivaroxaban (overall: 4.4% vs. 0.8% with ST, P=.001; serious: 1.5% vs. 0.0% with ST, P=.03). The rivaroxaban used less health resources after discharge, and the majority considered the tolerability as «very good« and the treatment as «very comfortable».
  • DISCUSSION
    • Rivaroxaban is at least as effective as ST in the prevention of venous thromboembolism prevention in daily clinical practice, with a similar incidence of haemorrhages. It provides greater satisfaction/comfort, and less health resources after discharge. These results should be interpreted taking into account the limitations inherent in observational studies.