Rivaroxaban versus standard of care in venous thromboembolism prevention following hip or knee arthroplasty in daily clinical practice (Spanish data from the international study XAMOS)
Granero J(1), Díaz de Rada P(2), Lozano LM(3), Martínez J(4), Herrera A(5); en nombre de los investigadores del grupo XAMOS España.
(1) Departamento de Cirugía Ortopédica y Traumatología, Hospital Germans Trias i Pujol, Badalona, Barcelona, España.
(2) Departamento de Cirugía Ortopédica y Traumatología, Clínica Universitaria de Navarra, Pamplona, España.
(3) Departamento de Cirugía Ortopédica y Traumatología, Hospital Clínic i Provincial, Barcelona, España.
(4) Departamento de Cirugía Ortopédica y Traumatología, Hospital de Alcorcón, Alcorcón, Madrid, España.
(5) Departamento de Cirugía Ortopédica y Traumatología. Hospital Miguel Servet, Zaragoza, España.
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.
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.
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».
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.
CITATION Rev Esp Cir Ortop Traumatol. 2015 Jul 17. pii: S1888-4415(15)00076-4. doi: 10.1016/j.recot.2015.05.009.