Background:The efficacy and bleeding complications of direct oral anticoagulant (DOAC) therapy for cancer-associated venous thromboembolism (VTE) in routine clinical practice remain unclear. Moreover, data on long-term outcomes in patients with cancer-associated VTE who received DOAC therapy are limited.

Methods and Results:This retrospective study enrolled 1,096 consecutive patients with acute VTE who received warfarin or DOAC therapy between April 2014 and May 2017. The mean follow-up period was 665±490 days. The number of cancer-associated VTE patients who received DOAC therapy was 334. Patients who could not be followed up and those prescribed off-label under-dose DOAC were excluded. Finally, 303 patients with cancer-associated VTE were evaluated. The number of cases of major bleeding and VTE recurrence was 54 (17.8%) and 26 (8.6%), respectively. In the multivariate analysis, the factors correlated with major bleeding were high cancer stage, high performance status, liver dysfunction, diabetes mellitus, and stomach cancer; those correlated with recurrent VTE were initial diagnosis of pulmonary embolism, uterine cancer, and previous cerebral infarction. Major bleeding was an independent risk factor of all-cause death. In the Kaplan-Meier analysis, those who received prolonged DOAC therapy had lower composite major bleeding and recurrent VTE risks than those who did not.

Conclusions:In DOAC therapy for cancer-associated VTE, major bleeding prevention is important because it is an independent risk factor of death.

背景：在常规临床实践中，直接口服抗凝剂（DOAC）治疗与癌症相关的静脉血栓栓塞（VTE）的疗效和出血并发症尚不清楚。此外，接受DOAC治疗的癌症相关VTE患者的长期结局数据有限。

方法和结果：这项回顾性研究招募了1,096名在2014年4月至2017年5月之间接受华法林或DOAC治疗的急性VTE患者。平均随访时间为665±490天。接受DOAC治疗的与癌症相关的VTE患者为334名。排除了无法随访的患者和处方外剂量不足的DOAC患者。最后，对303例与癌症相关的VTE患者进行了评估。大出血和VTE复发病例分别为54（17.8％）和26（8.6％）。在多变量分析中，与大出血相关的因素包括癌症的高发期，高性能状态，肝功能障碍，糖尿病和胃癌。与复发性VTE相关的是肺栓塞，子宫癌和先前的脑梗死的初步诊断。大出血是全因死亡的独立危险因素。在Kaplan-Meier分析中，接受DOAC长期治疗的患者与未接受DOAC治疗的患者相比，具有更低的复合性大出血和复发性VTE风险。

结论：在DOAC治疗癌症相关性VTE中，重要的出血预防非常重要，因为它是独立的死亡危险因素。