VTE PROPHYLAXIS USE IN PATIENTS AFTER ORTHOPDAEDIC SURGERY – AN EVOLVING PRACTICE; TRANSFORMING THE FUTURE OF PRIMARY VTE PREVENTION FOLLOWING MAJOR ORTHOPAEDIC SURGERY RIVAROXABAN AND THE RECORD TRIALS

Abstract

Rivaroxaban, an oral, direct FXa inhibitor has shown in large phase III trials to be both superior to enoxaparin a low molecular weight heparin for VTE prophylaxis in patients undergoing MOS, and to also have a good safety profile. RECORD, a pivotal clinical trial program investigating rivaroxaban for the prevention of VTE after THR and TKR surgery, consists of four multinational, randomized, double-blind, double-dummy phase III studies (RECORD1,2,3 and 4) comparing rivaroxaban 10 mg once-daily with enoxaparin 40 mg once-daily or 30 mg twice-daily. The RECORD program has consistently shown superiority of rivaroxaban to enoxaparin at preventing VTE after major orthopaedic surgery. Results from the RECORD 2 study confirmed the benefit of extended thromboprophylaxis after THR. Rivaroxaban was more effective than enoxaparin at reducing the incidence of VTE and all course mortality in patients undergoing THR, with a relative risk reduction (RRR) of 70% in total VTE (RECORD 1). In the TKR populations, rivaroxaban was superior to both once-daily (RECORD 3) and twice-daily (RECORD 4) enoxaparin, with a RRR of 49% and 31.4%, respectively. It also significantly reduced the incidence of symptomatic VTE in TKR patients (RECORD 3). Rivaroxaban groups had low and similar bleeding rates to enoxaparin across the RECORD program. Thus, with its superior efficacy and a good safety profile, oral, once-daily fixed dosing with rivaroxaban could transform the future of VTE prevention after major orthopaedic surgery and improve the quality and reliability of patients care.