Bach Miriam, Bauersachs Rupert
Rupert Bauersachs, Klinikum Darmstadt GmbH, Department of Vascular Medicine, Grafenstraße 9, 64283 Darmstadt, Germany, Tel.: +49 6151 / 107 4401, E-mail:
Thromb Haemost. 2016 Sep 28;116(Suppl. 2):S24-S32. doi: 10.1160/TH16-06-0486. Epub 2016 Sep 14.
Venous thromboembolism (VTE) is associated with numerous complications and high mortality rates. Patients with cancer are at high risk of developing cancer-associated thrombosis (CAT), and VTE recurrence is common. Evidence supporting use of non-vitamin K antagonist (VKA) oral anticoagulants (NOACs) in patients with cancer is lacking - direct comparisons between NOACs and low-molecular-weight heparin (LMWH) are needed, along with patient-reported outcomes. Cancer Associated thrombosis - expLoring soLutions for patients through Treatment and Prevention with RivarOxaban (CALLISTO) is an international research programme exploring the potential of the direct, oral factor Xa inhibitor rivaroxaban for the prevention and treatment of CAT, supplementing existing data from EINSTEIN DVT and EINSTEIN PE. Here, we focus on four CALLISTO studies: A Study to Evaluate the Efficacy and Safety of Rivaroxaban Venous Thromboembolism Prophylaxis in Ambulatory Cancer Participants receiving Chemotherapy (CASSINI), Anticoagulation Therapy in SELECTeD Cancer Patients at Risk of Recurrence of Venous Thromboembolism (SELECT-D), Rivaroxaban in the Treatment of Venous Thromboembolism in Cancer Patients - a Randomized Phase III Study (CONKO-011) and a database analysis. Optimal anticoagulation duration for VTE treatment has always been unclear. Following favourable results for rivaroxaban 20 mg once-daily (Q. D.) for secondary VTE prevention (EINSTEIN EXT), EINSTEIN CHOICE is assessing rivaroxaban safety and (20 mg Q. D. or 10 mg Q. D.) vs acetylsalicylic acid (ASA), and will investigate whether an alternative rivaroxaban dose (10 mg Q. D.) could offer long-term VTE protection. It is anticipated that results from these studies will provide important answers and expand upon current evidence for rivaroxaban in VTE management.
静脉血栓栓塞症（VTE）与多种并发症及高死亡率相关。癌症患者发生癌症相关血栓形成（CAT）的风险很高，且VTE复发很常见。缺乏支持在癌症患者中使用非维生素K拮抗剂（VKA）口服抗凝剂（NOACs）的证据——需要对NOACs与低分子肝素（LMWH）进行直接比较，并纳入患者报告的结局。癌症相关血栓形成——通过利伐沙班治疗和预防探索患者解决方案（CALLISTO）是一项国际研究项目，旨在探索直接口服Xa因子抑制剂利伐沙班在预防和治疗CAT方面的潜力，补充来自EINSTEIN DVT和EINSTEIN PE的现有数据。在此，我们重点介绍CALLISTO的四项研究：一项评估利伐沙班对接受化疗的门诊癌症参与者进行静脉血栓栓塞预防的疗效和安全性的研究（CASSINI）、对选定的有静脉血栓栓塞复发风险的癌症患者进行抗凝治疗（SELECT-D）、利伐沙班治疗癌症患者静脉血栓栓塞的随机III期研究（CONKO-011）以及一项数据库分析。VTE治疗的最佳抗凝持续时间一直不明确。在利伐沙班20 mg每日一次（QD）用于继发性VTE预防取得良好结果（EINSTEIN EXT）之后，EINSTEIN CHOICE正在评估利伐沙班的安全性以及（20 mg QD或10 mg QD）与阿司匹林（ASA）相比的情况，并将研究利伐沙班的另一种剂量（10 mg QD）是否能提供长期VTE保护。预计这些研究的结果将提供重要答案，并扩展目前利伐沙班在VTE管理方面的证据。
