Real-world data confirm clinical trial outcomes for rivaroxaban in orthopaedic patients.

Venous thromboembolism (VTE) is a potential cause of morbidity and mortality in patients after major orthopaedic surgery. Based on the results of the international phase III RECORD (Regulation of Coagulation in Orthopaedic Surgery to Prevent Deep Vein Thrombosis and Pulmonary Embolism) program, the oral, direct Factor Xa inhibitor rivaroxaban has been approved in many countries for the prevention of VTE after elective hip arthroplasty or knee arthroplasty. However, study results of randomized controlled trials may have limited generalizability to routine clinical practice in unselected patients. The phase IV XAMOS (Xarelto® in the Prophylaxis of Postsurgical Venous Throboembolism after Elective Major Orthopaedic Surgery of the Hip or Knee) study and the ORTHO-TEP (large single-center registry) collected real-world data to assess the effectiveness and safety of rivaroxaban compared with standard of care in large cohorts of patients undergoing major orthopaedic surgery. This review evaluates real-world data from XAMOS and ORTHO-TEP, confirming the favorable benefit-risk profile of rivaroxaban for the prevention of VTE in patients after major orthopaedic surgery that was demonstrated by the phase III RECORD studies in patients after elective hip or knee arthroplasty.