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利伐沙班与依诺肝素相比治疗癌症相关静脉血栓栓塞症的疗效和安全性。

Efficacy and safety of rivaroxaban compared to enoxaparin in treatment of cancer-associated venous thromboembolism.

作者信息

Simmons Benjamin, Wysokinski Waldemar, Saadiq Rayya A, Bott-Kitslaar Dalene, Henkin Stanislav, Casanegra Ana, Lenz Charles, Daniels Paul, Bjarnason Haraldur, Vargas Emily, Hodge David, Holton Sara J, Cerhan James R, Loprinzi Charles, McBane Robert

机构信息

Division of Vascular Diseases, Gonda Vascular Center, Mayo Clinic, Rochester, MN, USA.

Division of General Internal Medicine, Mayo Clinic, Rochester, MN, USA.

出版信息

Eur J Haematol. 2018 Apr 4. doi: 10.1111/ejh.13074.

Abstract

BACKGROUND

Low molecular weight heparin (LMWH) is the guideline-endorsed treatment for cancer-associated venous thromboembolism (cVTE). Study objectives were to compare the efficacy and safety of rivaroxaban and enoxaparin in cVTE.

METHODS

Using a cohort study design, consecutive patients with cVTE (3/1/2013-7/31/2016), enrolled in the Mayo Thrombophilia Clinic Direct Oral Anticoagulants Registry, were compared to contemporary cancer patients receiving enoxaparin. The cumulative incidence of venous thromboembolism (VTE) recurrence, major and clinically relevant non-major bleeding, and survival were assessed at 3 and 12 months.

RESULTS

Ninety-eight patients received rivaroxaban (51% female, mean age 63 ± 12 years) and 168 enoxaparin (34.5% female, mean age 62 ± 15 years). The most common cancers included gastrointestinal/pancreatic, genitourinary and hematologic cancers. More than half of patients had pulmonary emboli at presentation. More than half had metastases, and two-thirds were receiving chemotherapy. At 3 months, there were no differences in VTE recurrence (rivaroxaban 1.0% vs enoxaparin 4.2%; P = .15), major bleeding (rivaroxaban 5.1% vs enoxaparin 3.6%; P = .55), or all-cause mortality (rivaroxaban 4.1% vs enoxaparin 8.9%; P = .14). At 12 months, these outcomes did not differ by treatment strategy.

CONCLUSION

The results of this "real-world" experience with cVTE suggest that rivaroxaban may offer a safe and effective alternative to LMWH.

摘要

背景

低分子量肝素(LMWH)是癌症相关静脉血栓栓塞症(cVTE)指南推荐的治疗药物。本研究的目的是比较利伐沙班和依诺肝素在cVTE治疗中的疗效和安全性。

方法

采用队列研究设计,将梅奥血栓形成倾向门诊直接口服抗凝剂登记处纳入的连续cVTE患者(2013年1月3日至2016年7月31日)与同期接受依诺肝素治疗的癌症患者进行比较。在3个月和12个月时评估静脉血栓栓塞症(VTE)复发、主要及临床相关非主要出血和生存率的累积发生率。

结果

98例患者接受利伐沙班治疗(51%为女性,平均年龄63±12岁),168例接受依诺肝素治疗(34.5%为女性,平均年龄62±15岁)。最常见的癌症包括胃肠道/胰腺癌、泌尿生殖系统癌和血液系统癌。超过一半的患者在就诊时患有肺栓塞。超过一半的患者有转移,三分之二的患者正在接受化疗。在3个月时,VTE复发(利伐沙班1.0% vs依诺肝素4.2%;P = 0.15)、主要出血(利伐沙班5.1% vs依诺肝素3.6%;P = 0.55)或全因死亡率(利伐沙班4.1% vs依诺肝素8.9%;P = 0.14)方面无差异。在12个月时,这些结果在不同治疗策略之间也无差异。

结论

这项关于cVTE的“真实世界”经验结果表明,利伐沙班可能是LMWH的一种安全有效的替代药物。

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