Kwong Louis, Turpie Alexander G G
Department of Orthopaedic Surgery, Harbor-UCLA Medical Center, Torrance, CA, USA.
Department of Medicine, Hamilton General Hospital, HHS-McMaster Clinic, Hamilton, Ontario, Canada.
Curr Orthop Pract. 2015 May;26(3):299-305. doi: 10.1097/BCO.0000000000000232.
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.
静脉血栓栓塞症（VTE）是大型骨科手术后患者发病和死亡的潜在原因。基于国际III期RECORD（骨科手术中预防深静脉血栓形成和肺栓塞的凝血调节）项目的结果，口服直接Xa因子抑制剂利伐沙班已在许多国家被批准用于预防择期髋关节置换术或膝关节置换术后的VTE。然而，随机对照试验的研究结果对于未经过挑选的患者的常规临床实践而言，其普遍适用性可能有限。IV期XAMOS（利伐沙班用于预防髋部或膝部择期大型骨科手术后的术后静脉血栓栓塞症）研究和ORTHO-TEP（大型单中心注册研究）收集了真实世界数据，以评估在接受大型骨科手术的大量患者队列中，与标准治疗相比，利伐沙班的有效性和安全性。本综述评估了来自XAMOS和ORTHO-TEP的真实世界数据，证实了利伐沙班在预防大型骨科手术后患者VTE方面具有良好的效益风险比，这一点在III期RECORD研究中针对择期髋关节或膝关节置换术后患者已得到证实。
