Department of Clinical Pharmacy, University of California, San Francisco, 505 Parnassus Ave, San Francisco, CA 94143, United States of America.
Department of Pharmacy Services, University of California, Davis Health, 2315 Stockton Blvd, Sacramento, CA 95817, United States of America.
Thromb Res. 2021 Dec;208:148-155. doi: 10.1016/j.thromres.2021.10.023. Epub 2021 Oct 29.
Patients with central nervous system malignancies have limited representation in studies evaluating DOACs for VTE treatment. This study evaluated the safety and efficacy of DOACs in comparison with LMWH for cancer-associated VTE in patients with primary brain tumors or secondary brain metastases.
MATERIALS & METHODS: In this multicenter, retrospective cohort study, adult patients with a diagnosis of primary brain tumor or secondary brain metastases who received either a DOAC or LMWH for treatment of cancer-associated VTE were evaluated. The primary outcome was the cumulative incidence of any intracranial hemorrhage within a 6-month period following the initiation of anticoagulation. Secondary outcomes included the cumulative incidence of any bleeding event, and recurrent VTE events.
Between January 1, 2012 and October 9, 2019, one-hundred eleven patients met inclusion criteria. The 6-month cumulative incidence of intracranial hemorrhage was 4.3% (95% CI, 0.74-13.2%) in the DOAC group, compared to 5.9% (95% CI, 1.5-14.9%) in the LMWH group (p = 0.61). The 6-month cumulative incidence of bleeding events was 14.3% (95% CI, 6.2-25.8%) in the DOAC group, compared to 27.8% (95% CI, 15.5-41.6%) in the LMWH group (p = 0.10). The 6-month cumulative incidence of recurrent VTE events was 5.6% in the DOAC group (95% CI, 1.5-14.2%), compared to 6.6% in the LMWH group (95% CI, 1.7-16.5%) (p = 0.96). No differences were found with respect to other secondary outcomes.
There were no significant differences in bleeding or recurrent VTE events between DOACs and LMWH. These findings suggest DOACs may be safe and effective for VTE treatment in this patient population.
患有中枢神经系统恶性肿瘤的患者在评估 DOAC 治疗 VTE 的研究中代表性有限。本研究评估了 DOAC 与 LMWH 在原发性脑肿瘤或继发性脑转移患者中治疗癌症相关 VTE 的安全性和有效性。
在这项多中心、回顾性队列研究中,评估了接受 DOAC 或 LMWH 治疗癌症相关 VTE 的诊断为原发性脑肿瘤或继发性脑转移的成年患者。主要结局是抗凝治疗开始后 6 个月内任何颅内出血的累积发生率。次要结局包括任何出血事件和复发性 VTE 事件的累积发生率。
2012 年 1 月 1 日至 2019 年 10 月 9 日,111 名患者符合纳入标准。DOAC 组 6 个月颅内出血的累积发生率为 4.3%(95%CI,0.74-13.2%),LMWH 组为 5.9%(95%CI,1.5-14.9%)(p=0.61)。DOAC 组 6 个月出血事件的累积发生率为 14.3%(95%CI,6.2-25.8%),LMWH 组为 27.8%(95%CI,15.5-41.6%)(p=0.10)。DOAC 组 6 个月复发性 VTE 事件的累积发生率为 5.6%(95%CI,1.5-14.2%),LMWH 组为 6.6%(95%CI,1.7-16.5%)(p=0.96)。其他次要结局无差异。
DOAC 与 LMWH 之间在出血或复发性 VTE 事件方面没有显著差异。这些发现表明 DOAC 可能对该患者群体的 VTE 治疗安全有效。