Rivaroxaban for thromboprophylaxis after fracture-related orthopedic surgery in routine clinical practice

Background: The risk of venous thromboembolism is high in patients undergoing fracture-related major orthopedic surgery, but data on pharmacological thromboprophylaxis are limited. This analysis evaluated the effectiveness and safety of rivaroxaban after fracture-related orthopedic surgery in routine care compared with other pharmacological thromboprophylaxis (standard of care [SOC]). Methods: The study population comprised a subset of patients with lower-limb fracture from XArelto in the prophylaxis of post-surgical venous thromboembolism after elective Major Orthopaedic Surgery of hip or knee (XAMOS; a phase IV noninterventional study) and a XAMOS extension study (XAMOS-Extra). The study participants included patients who underwent surgery for hip/femur or lower-leg fractures (below-knee lower-leg fractures, eg, the tibia or foot). All adverse events were recorded, including symptomatic thromboembolic events and bleeding events. Results: Data from 790 patients were available for analysis (n = 350 for rivaroxaban and n = 440 for SOC). The incidence of symptomatic thromboembolic events 3 months postsurgery was 0.57% (2 of the 350) in the rivaroxaban group and 1.14% (5 of the 440) in the SOC group (odds ratio [OR]: 0.50; 95% confidence interval [CI]: 0.10-2.59). Treatment-emergent major bleeding events occurred in 0.29% (1 of the 350) of patients receiving rivaroxaban and 0.45% (2 of the 440) of patients receiving SOC (OR: 0.63; 95% CI: 0.06-6.95). There were no cases of fatal or critical bleeding in either treatment group. The incidences of wound complications and any other adverse events were numerically lower with rivaroxaban compared with SOC. Conclusions: These data from routine practice demonstrate that rivaroxaban can provide effective thromboprophylaxis after fracture-related orthopedic surgery of the lower limb with a favorable safety profile.