Department of Thrombosis and Hemostasis, LUMC, Leiden, The Netherlands.
J Thromb Haemost. 2014 Jul;12(7):1116-20. doi: 10.1111/jth.12605. Epub 2014 Jun 19.
Treatment of acute venous thromboembolism (VTE) in cancer patients is challenging, owing to a high risk of recurrent VTE and bleeding complications. The anticoagulants of choice are low molecular weight heparins (LMWHs), because of a proven higher efficacy than vitamin K antagonists (VKAs) and a similar bleeding profile. The recently introduced new oral anticoagulants (NOACs) have the potential to be alternative options for these patients, as these drugs share practical advantages with LMWH, are administered orally, and had similar efficacy to VKAs but a lower bleeding risk in phase 3 studies in the general VTE population.
A systematic literature search was performed to identify phase 3 trials investigating NOACs for the treatment of VTE. The efficacy outcome was recurrent VTE, and the safety outcome was major and clinically relevant non-major bleeding. Pooled incidence rates and risk ratios (RRs) were calculated for cancer patients and non-cancer patients separately.
Five studies were included, with 19 060 patients, of whom 973 (5.1%) had active cancer. The pooled incidence rates of recurrent VTE were 4.1% (95% confidence interval [CI] 2.6-6.0) in cancer patients treated with NOACs, and 6.1% (95% CI 4.1-8.5) in patients treated with VKAs (RR 0.66, 95% CI 0.38-1.2). The pooled incidence rates of major or non-major clinically relevant bleeding were 15% (95% CI 12-18) in cancer patients treated with NOACs, and 16% (95% CI 9.9-22) in patients treated with VKAs (RR 0.94, 95% CI 0.70-1.3). These results form a solid basis for the initiation of a head-to-head comparison of NOACs with LMWH in cancer patients.
由于癌症患者存在较高的静脉血栓栓塞症（VTE）复发风险和出血并发症风险，因此癌症患者的急性 VTE 治疗极具挑战性。在选择抗凝药物时，低分子肝素（LMWH）优于维生素 K 拮抗剂（VKA），因为 LMWH 的疗效已得到证实，且出血风险与 VKA 相似。最近新出现的新型口服抗凝药物（NOAC）有可能成为这些患者的替代选择，因为这些药物与 LMWH 具有相同的实际优势，且经口服给药，在一般 VTE 人群的 III 期研究中，其疗效与 VKA 相当，出血风险更低。
进行了系统的文献检索，以确定用于治疗 VTE 的 III 期 NOAC 试验。疗效结局为 VTE 复发，安全性结局为大出血和临床相关非大出血。分别对癌症患者和非癌症患者计算了累积发生率和风险比（RR）。
共纳入 5 项研究，纳入 19060 例患者，其中 973 例（5.1%）患有活动性癌症。NOAC 治疗的癌症患者 VTE 复发的累积发生率为 4.1%（95%CI 2.6-6.0），VKA 治疗的癌症患者 VTE 复发的累积发生率为 6.1%（95%CI 4.1-8.5）（RR 0.66，95%CI 0.38-1.2）。NOAC 治疗的癌症患者大出血或临床相关非大出血的累积发生率为 15%（95%CI 12-18），VKA 治疗的癌症患者大出血或临床相关非大出血的累积发生率为 16%（95%CI 9.9-22）（RR 0.94，95%CI 0.70-1.3）。这些结果为在癌症患者中开展 NOAC 与 LMWH 的头对头比较奠定了坚实的基础。
