Thromboprophylaxis for hip and knee surgery: critical appraisal of rivaroxaban

Erica Romualdi, Francesco Dentali, Alessandro Squizzato, Walter Ageno

Department of Clinical Medicine, University of Insubria, Varese, Italy

Abstract: Major orthopedic surgery, including total knee replacement surgery (TKR) and total hip replacement (THR) surgery, is associated with a high risk of venous thromboembolism (VTE). In the absence of prophylactic strategies, the overall incidence of VTE can range between 40% and 60%. Over the last years, the use of anticoagulant drugs such as unfractionated heparin, warfarin, low molecular weight heparin, and fondaparinux has greatly reduced the incidence of this potentially severe complication. Unfortunately, all these anticoagulant drugs present some drawbacks, such as the need for subcutaneous administration or the necessity of frequent laboratory monitoring. More recently, a number of alternative anticoagulant agents have been developed for the prevention of VTE in patients undergoing major orthopedic surgery as well as in other high risk groups. Rivaroxaban, an oral factor Xa inhibitor, has been extensively studied in the setting of major orthopedic surgery. In the RECORD trials program, two studies, RECORD 1 and RECORD 2 were carried out in patients undergoing total hip replacement, and two studies, RECORD 3 and RECORD 4 were carried out in patients undergoing total knee replacement. In all these studies, rivaroxaban, at the fixed, daily dose of 10 mg, was shown to be more effective than the comparator enoxaparin for the prevention of VTE, with a similar safety profile. Rivaroxaban, which is now approved in many countries for the prevention of VTE in patients undergoing TKR and THR, has the potential to change current clinical practice by simplifying anticoagulant prophylaxis strategies, in particular, in this setting, where extended administration of thromboprophylaxis for as much as five weeks after the surgical procedure is required.

Keywords: rivaroxaban; thromboprophylaxis; orthopedic surgery; arthroplasty