Beyer-Westendorf Jan, Mouret Patrick, Turpie Alexander Gg
Thrombosis Research and Angiology, Dresden University Clinic, Dresden, Germany,
Orthopedic Clinic, Klinikum Frankfurt Höchst GmbH, Frankfurt, Germany.
Orthop Res Rev. 2017 Jan 31;9:1-11. doi: 10.2147/ORR.S105227. eCollection 2017.
An established standard of care for the prevention of venous thromboembolism after major orthopedic surgery has been subcutaneous low-molecular-weight heparin. The non-vitamin K antagonist oral anticoagulant rivaroxaban has demonstrated superior efficacy and similar safety to all tested regimens of enoxaparin in large Phase III clinical studies of venous thromboembolism prevention after elective hip and knee arthroplasty. Despite regulatory approval of rivaroxaban for this indication, concerns remain among physicians regarding its optimal and effective use in routine clinical practice. Real-life studies, such as XAMOS and ORTHO-TEP, are providing physicians with more information on the routine use of rivaroxaban for venous thromboembolism prevention after orthopedic surgery, helping to establish its safety and effectiveness in everyday clinical care. Among the most important issues are the risk of bleeding complications, wound healing, timing of first dose, impact of type of anesthesia on thromboprophylaxis effectiveness, patient comorbidities and comedication use, periprocedural management, associated costs, and clinical outcomes in trauma-related fractures. Many of these issues are difficult to study in randomized, double-blind, Phase III trials, and can be assessed more readily using real-life data. In particular, real-life or noninterventional studies lack many of the strict inclusion and exclusion criteria associated with Phase III trials and involve unselected patients who often present with significant comorbidities or comedication use.
预防大型骨科手术后静脉血栓栓塞的既定标准治疗方法是皮下注射低分子肝素。在择期髋关节和膝关节置换术后预防静脉血栓栓塞的大型III期临床研究中，非维生素K拮抗剂口服抗凝药利伐沙班已证明其疗效优于依诺肝素的所有测试方案，且安全性相似。尽管利伐沙班已获监管部门批准用于这一适应症，但医生们仍对其在常规临床实践中的最佳有效使用存在担忧。诸如XAMOS和ORTHO-TEP等真实世界研究，正在为医生提供更多关于利伐沙班在骨科手术后预防静脉血栓栓塞常规使用的信息，有助于确立其在日常临床护理中的安全性和有效性。其中最重要的问题包括出血并发症风险、伤口愈合、首剂给药时间、麻醉类型对血栓预防效果的影响、患者合并症和联合用药情况、围手术期管理、相关费用以及创伤相关骨折的临床结局。这些问题中的许多在随机、双盲III期试验中难以研究，而使用真实世界数据则能更轻松地进行评估。特别是，真实世界或非干预性研究缺乏许多与III期试验相关的严格纳入和排除标准，且纳入的是未经筛选的患者，这些患者往往伴有严重合并症或联合用药情况。
