Rivaroxaban versus low-molecular-weight heparin for venous thromboembolism in gastrointestinal and pancreatobiliary cancer

Jang Ho Lee, Jae Seung Lee
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Abstract

Introduction and Objectives: Although low-molecular-weight heparin (LMWH) remains the standard treatment for venous thromboembolism (VTE) in patients with active cancer, a factor Xa inhibitor such as rivaroxaban is increasingly used without clinical evidence. We compared the incidence of bleeding and other treatment outcomes using rivaroxaban and LMWH for the treatment of VTE in patients with gastrointestinal and pancreatobiliary cancer (GI cancer). Methods: This single-center retrospective analysis included patients with VTE associated with GI cancer, who were treated with either rivaroxaban or LMWH. The primary end-point was the incidence of clinically relevant bleeding. Secondary outcomes included the incidence of major bleeding, recurrent VTE, and mortality. Results: Of 281 patients, 78 received rivaroxaban and 203 received LMWH. Clinically relevant bleeding occurred in 20 patients (26%) in the rivaroxaban group and 31 (15%) in the LMWH group (P=0.043). There was no statistically significant difference in the VTE recurrence rate (4% with rivaroxaban vs. 4% with LMWH, P>0.999) or incidence of major bleeding (5% with rivaroxaban vs. 9% with LMWH, P=0.296). Multivariate Cox proportional hazards analysis for cancer type, stage, chemotherapy history, and Eastern Cooperative Oncology Group performance status showed a 1.904-fold higher risk of bleeding with rivaroxaban (1.031 to 3.516, P=0.040). Rivaroxaban use was not associated with a higher hazard ratio than LMWH use for all-cause mortality (HR 1.00, P=0.999). Conclusions: Rivaroxaban use was associated with more bleeding than LMWH use in GI cancer patients.
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利伐沙班与低分子肝素治疗胃肠道和胰胆癌静脉血栓栓塞的比较
虽然低分子肝素(LMWH)仍然是活动性癌症患者静脉血栓栓塞(VTE)的标准治疗方法,但Xa因子抑制剂如利伐沙班的使用越来越多,但没有临床证据。我们比较了利伐沙班和低分子肝素治疗胃肠道和胰胆癌(GI癌)患者静脉血栓栓塞的出血发生率和其他治疗结果。方法:这项单中心回顾性分析纳入了接受利伐沙班或低分子肝素治疗的与胃肠道肿瘤相关的静脉血栓栓塞患者。主要终点是临床相关出血的发生率。次要结局包括大出血发生率、静脉血栓栓塞复发和死亡率。结果:281例患者中78例接受利伐沙班治疗,203例接受低分子肝素治疗。利伐沙班组有20例(26%)出现临床相关出血,低分子肝素组有31例(15%)出现临床相关出血(P=0.043)。两组VTE复发率(利伐沙班组为4%,低分子肝素组为4%,P>0.999)、大出血发生率(利伐沙班组为5%,低分子肝素组为9%,P=0.296)差异均无统计学意义。多因素Cox比例危险度分析显示,利伐沙班组患者的肿瘤类型、分期、化疗史、东部肿瘤合作组表现等因素对出血风险的影响为1.904倍(1.031 ~ 3.516,P=0.040)。使用利伐沙班与使用低分子肝素的全因死亡率风险比无关(HR 1.00, P=0.999)。结论:在胃肠道肿瘤患者中,利伐沙班的使用比低分子肝素的使用与更多的出血相关。
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