Alexander G. G. Turpie, MD, Department of Medicine, Hamilton Health Sciences, General Division, 237 Barton Street East, Hamilton, Ontario, Canada, Tel.: +1 905 929 4385, Fax: +1 905 628 9505, E-mail:
Thromb Haemost. 2014 Jan;111(1):94-102. doi: 10.1160/TH13-08-0666. Epub 2013 Oct 24.
Rivaroxaban demonstrated superior efficacy and a similar safety profile to enoxaparin for the prevention of venous thromboembolism in the phase III RECORD programme in patients undergoing elective hip or knee replacement surgery. The XAMOS study investigated adverse events, including bleeding and thromboembolic events, in patients receiving rivaroxaban for thromboprophylaxis in routine clinical practice. XAMOS was a non-interventional, open-label cohort study in patients undergoing major orthopaedic surgery of the hip or knee (predominantly elective arthroplasty), in which rivaroxaban was compared with other pharmacological thromboprophylaxis. All adverse events were documented, including symptomatic thromboembolic and bleeding events. Crude and adjusted incidences based on propensity score subclasses were calculated and compared between the rivaroxaban and standard-of-care groups. A total of 17,701 patients were enrolled from 252 centres in 37 countries. Crude incidences of symptomatic thromboembolic events three months after surgery in the safety population were 0.89% in the rivaroxaban group (n=8,778) and 1.35% in the standard-of-care group (n=8,635; odds ratio [OR] 0.65; 95% confidence interval [CI] 0.49-0.87), and 0.91% and 1.31% (weighted) in the propensity score-adjusted analysis (OR 0.69; 95% CI 0.56-0.85), respectively. Treatment-emergent major bleeding events (as defined in the RECORD studies) occurred in 0.40% and 0.34% of patients in the rivaroxaban and standard-of-care groups in the safety population (OR 1.19; 95% CI 0.73-1.95), and in 0.44% versus 0.33% (weighted) in the propensity score-adjusted analysis (OR 1.35; 95% CI 0.94-1.93), respectively.This study in unselected patients confirmed the favourable benefit-risk profile of rivaroxaban seen in the RECORD programme.
利伐沙班在 III 期 RECORD 研究中显示出优于依诺肝素的疗效，用于预防择期髋关节或膝关节置换术患者的静脉血栓栓塞。XAMOS 研究调查了接受利伐沙班进行常规临床实践中的血栓预防的患者的不良事件，包括出血和血栓栓塞事件。XAMOS 是一项非干预性、开放性队列研究，纳入了接受髋关节或膝关节（主要为择期关节置换术）大骨科手术的患者，其中利伐沙班与其他药物性血栓预防方法进行了比较。所有不良事件均有记录，包括有症状的血栓栓塞和出血事件。根据倾向评分亚类计算了粗发生率和调整发生率，并在利伐沙班组和标准治疗组之间进行了比较。来自 37 个国家的 252 个中心共纳入了 17701 例患者。在安全性人群中，手术后 3 个月时有症状的血栓栓塞事件的粗发生率在利伐沙班组为 0.89%（n=8778），在标准治疗组为 1.35%（n=8635；比值比[OR] 0.65；95%置信区间[CI] 0.49-0.87），在倾向评分调整分析中为 0.91%和 1.31%（加权）（OR 0.69；95% CI 0.56-0.85）。在安全性人群中，治疗期间发生的大出血事件（RECORD 研究中定义）在利伐沙班组和标准治疗组中的发生率分别为 0.40%和 0.34%（OR 1.19；95% CI 0.73-1.95），在倾向评分调整分析中为 0.44%和 0.33%（加权）（OR 1.35；95% CI 0.94-1.93）。这项在未选择的患者中的研究证实了利伐沙班在 RECORD 研究中观察到的有利风险获益特征。
