BACKGROUND:Standard therapy for cancer-associated venous thromboembolism (VTE) is low-molecular-weight heparin. The use of direct oral anticoagulants for cancer-associated VTE has increased; however, their efficacy and safety in lung cancer patients remain unclear. OBJECTIVES:We examined the efficacy and safety of rivaroxaban compared with dalteparin for cancer-associated VTE in patients with primary lung cancer. METHODS:A single-center retrospective study of 204 patients with primary lung cancer who were prescribed rivaroxaban (n = 131) or dalteparin (n = 73) for VTE was performed. The primary endpoint was a composite event including recurrence and major or clinically relevant nonmajor bleeding. Secondary endpoints included the incidence of recurrence, major and clinically relevant nonmajor bleeding, all-cause mortality, and bleeding or pulmonary embolism-related mortality. RESULTS:The composite event occurred in 38 (29.0) and 12 (16.4%) patients in the rivaroxaban and dalteparin (p = 0.045) groups, respectively. The multivariate Cox proportional hazards model for age, Eastern Cooperative Oncology Group performance score, and bleeding risk factors revealed the rivaroxaban group showed a 1.176-fold composite event risk without statistical significance (0.595-2.324, p = 0.641). There was no statistically significant intergroup difference for the incidence of VTE recurrence (5.3% in the rivaroxaban group versus 2.7% in the dalteparin group, p = 0.495) and major or clinically relevant nonmajor bleeding (23.7% in the rivaroxaban group versus 13.7% in the dalteparin group, p = 0.089). There was no significant difference in the all-cause mortality rate (hazard ratio 0.864, 95% CI 0.624-1.196, p = 0.337). CONCLUSIONS:There was no difference in the safety and efficacy profile of rivaroxaban compared with dalteparin. Therefore, rivaroxaban may be a valuable treatment option for lung cancer-associated VTE.

译文

背景:癌症相关的静脉血栓栓塞症(VTE)的标准疗法是低分子量肝素。直接口服抗凝剂用于与癌症相关的VTE的使用有所增加;然而,它们在肺癌患者中的疗效和安全性尚不清楚。
目的:我们研究了利伐沙班与达肝素相比对原发性肺癌患者与癌症相关的VTE的有效性和安全性。
方法:对204例原发性肺癌患者进行单中心回顾性研究,他们接受利伐沙班(n = 131)或达肝素(n = 73)的VTE处方。主要终点为复合事件,包括复发和重大或临床相关的非重大出血。次要终点包括复发率,重大和临床相关的非重大出血,全因死亡率以及与出血或肺栓塞相关的死亡率。
结果:利伐沙班和达肝素(p = 0.045)组分别发生38例(29.0)和12例(16.4%)患者的复合事件。年龄,东部合作肿瘤小组表现评分和出血危险因素的多变量Cox比例风险模型显示,利伐沙班组的复合事件风险为1.176倍,无统计学意义(0.595-2.324,p = 0.641)。 VTE复发的发生率在两组间均无统计学差异(利伐沙班组为5.3%,达肝素组为2.7%,p = 0.495)以及重大或临床相关的非重大出血(利伐沙班组为23.7%,而利伐沙班组为13.7%)。达肝素组,p = 0.089)。全因死亡率没有显着差异(危险比0.864,95%CI 0.624-1.196,p = 0.337)。
结论:利伐沙班与达肝素相比,安全性和疗效无差异。因此,利伐沙班可能是与肺癌相关的VTE的一种有价值的治疗选择。

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