Department of Pulmonary and Critical Care Medicine, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea.
Center for Pulmonary Hypertension and Venous Thrombosis, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea.
J Korean Med Sci. 2019 Jun 2;34(21):e160. doi: 10.3346/jkms.2019.34.e160.
Low-molecular-weight heparin (LMWH) is the standard treatment for venous thromboembolism (VTE) in patients with active cancer. However, use of factor Xa inhibitors, such as rivaroxaban, is increasing on the basis of limited clinical evidence. The present single-center study compared the incidence of bleeding and other treatment outcomes in gastrointestinal and pancreatobiliary cancer (GI tract cancer) patients administered rivaroxaban or LMWH for the treatment of VTE.
Retrospective data from 281 GI tract cancer patients who were treated for VTE with rivaroxaban (n = 78) or LMWH (n = 203) between 1 January 2012 and 31 December 2016, were analyzed. Primary end-point was the incidence of major and clinically relevant bleeding. Secondary outcomes included the incidence of recurrent VTE and mortality.
Clinically relevant bleeding occurred in 19 patients (24.4%) in the rivaroxaban group and 31 (15.3%) in the LMWH group ( = 0.074). No inter-group difference was observed for rate of VTE recurrence (3.8% with rivaroxaban vs. 3.9% with LMWH; > 0.999) or incidence of major bleeding (5.1% with rivaroxaban vs. 8.9% with LMWH; = 0.296). Multivariate Cox proportional hazards analysis for age, cancer type, metastasis, history of chemotherapy or recent surgery, and Eastern Cooperative Oncology Group performance status revealed a 1.904-fold higher risk of bleeding with rivaroxaban than LMWH (1.031-3.516; = 0.040). No significant inter-group difference was found in terms of hazard ratio for all-cause mortality.
Compared to LMWH, rivaroxaban was associated with a higher incidence of clinically relevant bleeding in GI tract cancer patients presenting with VTE.
低分子肝素（LMWH）是活动性癌症患者静脉血栓栓塞症（VTE）的标准治疗方法。然而，在有限的临床证据基础上，越来越多的人开始使用因子 Xa 抑制剂，如利伐沙班。本单中心研究比较了胃肠道和胰腺胆道癌（GI 道癌）患者使用利伐沙班或 LMWH 治疗 VTE 的出血发生率和其他治疗结果。
回顾性分析了 2012 年 1 月 1 日至 2016 年 12 月 31 日期间 281 例接受利伐沙班（n=78）或 LMWH（n=203）治疗 VTE 的 GI 道癌患者的数据。主要终点是主要和临床相关出血的发生率。次要结局包括 VTE 复发和死亡率。
利伐沙班组有 19 例（24.4%）患者发生临床相关出血，LMWH 组有 31 例（15.3%）（ = 0.074）。两组 VTE 复发率（利伐沙班组 3.8%，LMWH 组 3.9%； > 0.999）或大出血发生率（利伐沙班组 5.1%，LMWH 组 8.9%； = 0.296）均无差异。多变量 Cox 比例风险分析显示，年龄、癌症类型、转移、化疗或近期手术史以及东部合作肿瘤组表现状态与利伐沙班相比，出血风险增加 1.904 倍（1.031-3.516； = 0.040）。两组全因死亡率的危险比无显著差异。
与 LMWH 相比，利伐沙班在出现 VTE 的 GI 道癌患者中与更高的临床相关出血发生率相关。
