Abstract：
UNASSIGNED: The efficacy and safety of dabigatran etexilate for Chinese patients with cerebral venous thrombosis (CVT) has not been well established.
UNASSIGNED: CHOICE-CVT was an exploratory, single-center, randomized, open-label study in the National Center for Neurological Disorders involving Chinese patients with CVT aged 18 to 80 years who were randomly assigned (1:1) to either dabigatran etexilate or warfarin. Oral anticoagulants were initiated after 10-15 days of LMWH. The primary efficacy and safety endpoints included the number of patients with recurrent CVT and/or deep venous thrombosis (DVT) and major clinical bleeding within 180 days. Secondary efficacy endpoints included venous recanalization and change in papilledema at day 180. Secondary safety outcomes comprised death, clinical nonmajor bleeding, and any bleeding. The study was registered with ClinicalTrials.gov under NCT03930940.
UNASSIGNED: Between October 2017 and February 2023, a total of 89 patients were enrolled and randomly assigned to receive either dabigatran etexilate (n = 44) or warfarin (n = 45). At day 180, the dabigatran etexilate group showed a statistically nonsignificant but likely clinically significant number of patients with recurrent CVT and/or DVT (8 (18.2%; 95% CI, 6.3-30.0) vs 3 (6.7%; 95% CI, 0.0-14.2), p = 0.099, with a power (1-β) of 38.401%) compared with the warfarin group. The dabigatran etexilate group showed a comparable number of patients with clinical major bleeding (0 (0) vs 0 (0) p = 1.000), and clinical nonmajor bleeding (1 (2.3%; 95% CI, 0.0-6.9) vs 1 (2.2%; 95% CI, 0.0-6.7)) but demonstrated a lower risk of any bleeding (1 (2.3%; 95% CI, 0.0-6.9) vs 9 (20.0%; 95% CI, 7.8-32.2)) compared with the warfarin group. Most patients in both groups achieved venous recanalization according to the Modified Qureshi scale (27 (75%; 95% CI, 60.1-89.9) in the dabigatran etexilate group vs 34 (82.9%; 95% CI, 70.9-95.0) in the warfarin group) and exhibited improvement in papilledema as per the Frisén classification (35 (97.2%; 95% CI, 91.6-100.0) in the dabigatran etexilate group vs 37 (88.1%, 95% CI, 77.9-98.3) in the warfarin group).
UNASSIGNED: These findings regarding efficacy and safety support the consideration of dabigatran etexilate therapy as a viable treatment option for Chinese patients with CVT.
UNASSIGNED: CHOICE-CVT was an exploratory, single-center, randomized, open-label study in the National Center for Neurological Disorders involving Chinese patients with CVT aged 18 to 80 years who were randomly assigned (1:1) to either dabigatran etexilate or warfarin. Oral anticoagulants were initiated after 10-15 days of LMWH. The primary efficacy and safety endpoints included the number of patients with recurrent CVT and/or deep venous thrombosis (DVT) and major clinical bleeding within 180 days. Secondary efficacy endpoints included venous recanalization and change in papilledema at day 180. Secondary safety outcomes comprised death, clinical nonmajor bleeding, and any bleeding. The study was registered with ClinicalTrials.gov under NCT03930940.
UNASSIGNED: Between October 2017 and February 2023, a total of 89 patients were enrolled and randomly assigned to receive either dabigatran etexilate (n = 44) or warfarin (n = 45). At day 180, the dabigatran etexilate group showed a statistically nonsignificant but likely clinically significant number of patients with recurrent CVT and/or DVT (8 (18.2%; 95% CI, 6.3-30.0) vs 3 (6.7%; 95% CI, 0.0-14.2), p = 0.099, with a power (1-β) of 38.401%) compared with the warfarin group. The dabigatran etexilate group showed a comparable number of patients with clinical major bleeding (0 (0) vs 0 (0) p = 1.000), and clinical nonmajor bleeding (1 (2.3%; 95% CI, 0.0-6.9) vs 1 (2.2%; 95% CI, 0.0-6.7)) but demonstrated a lower risk of any bleeding (1 (2.3%; 95% CI, 0.0-6.9) vs 9 (20.0%; 95% CI, 7.8-32.2)) compared with the warfarin group. Most patients in both groups achieved venous recanalization according to the Modified Qureshi scale (27 (75%; 95% CI, 60.1-89.9) in the dabigatran etexilate group vs 34 (82.9%; 95% CI, 70.9-95.0) in the warfarin group) and exhibited improvement in papilledema as per the Frisén classification (35 (97.2%; 95% CI, 91.6-100.0) in the dabigatran etexilate group vs 37 (88.1%, 95% CI, 77.9-98.3) in the warfarin group).
UNASSIGNED: These findings regarding efficacy and safety support the consideration of dabigatran etexilate therapy as a viable treatment option for Chinese patients with CVT.
摘要：
■达比加群对中国脑静脉血栓形成（CVT）患者的疗效和安全性尚未得到很好的确定。
■选择-CVT是一种探索性的，单中心,随机化，国家神经疾病中心的开放标签研究,涉及年龄18~80岁的中国CVT患者,这些患者被随机分配(1:1)服用达比加群酯或华法林.LMWH10-15天后开始口服抗凝剂。主要疗效和安全性终点包括180天内复发性CVT和/或深静脉血栓形成（DVT）和主要临床出血的患者人数。次要疗效终点包括静脉再通和第180天的乳头水肿变化。次要安全性结果包括死亡，临床非大出血，和任何出血。该研究在ClinicalTrials.gov注册，根据NCT03930940。
■在2017年10月至2023年2月期间，共纳入89例患者，并随机分配接受达比加群酯（n=44）或华法林（n=45）。在第180天，达比加群酯组显示出统计学上不显着但可能具有临床意义的复发性CVT和/或DVT患者数量（8（18.2％；95％CI，6.3-30.0）vs3（6.7％；95％CI，0.0-14.2），p=0.099，与华法林组相比，功率（1-β）为38.401%）。达比加群etexilate组显示出相当数量的临床大出血患者（0（0）vs0（0）p=1.000），和临床非大出血（1（2.3％；95％CI，0.0-6.9）vs1（2.2％；95％CI，0.0-6.7）），但与华法林组相比，出血风险较低（1（2.3％；95％CI，0.0-6.9）vs9（20.0％；95％CI，7.8-32.2））。根据改良Qureshi量表，两组中的大多数患者均实现了静脉再通（达比加群酯组27例（75％；95％CI，60.1-89.9），华法林组34例（82.9％；95％CI，70.9-95.0），并且根据Frisén分类显示出乳头水肿的改善（35（97.2％；80.0％CI，91.6-101.6）华法林组的95%CI，77.9-98.3）。
■这些关于疗效和安全性的发现支持将达比加群作为中国CVT患者可行的治疗选择。
■选择-CVT是一种探索性的，单中心,随机化，国家神经疾病中心的开放标签研究,涉及年龄18~80岁的中国CVT患者,这些患者被随机分配(1:1)服用达比加群酯或华法林.LMWH10-15天后开始口服抗凝剂。主要疗效和安全性终点包括180天内复发性CVT和/或深静脉血栓形成（DVT）和主要临床出血的患者人数。次要疗效终点包括静脉再通和第180天的乳头水肿变化。次要安全性结果包括死亡，临床非大出血，和任何出血。该研究在ClinicalTrials.gov注册，根据NCT03930940。
■在2017年10月至2023年2月期间，共纳入89例患者，并随机分配接受达比加群酯（n=44）或华法林（n=45）。在第180天，达比加群酯组显示出统计学上不显着但可能具有临床意义的复发性CVT和/或DVT患者数量（8（18.2％；95％CI，6.3-30.0）vs3（6.7％；95％CI，0.0-14.2），p=0.099，与华法林组相比，功率（1-β）为38.401%）。达比加群etexilate组显示出相当数量的临床大出血患者（0（0）vs0（0）p=1.000），和临床非大出血（1（2.3％；95％CI，0.0-6.9）vs1（2.2％；95％CI，0.0-6.7）），但与华法林组相比，出血风险较低（1（2.3％；95％CI，0.0-6.9）vs9（20.0％；95％CI，7.8-32.2））。根据改良Qureshi量表，两组中的大多数患者均实现了静脉再通（达比加群酯组27例（75％；95％CI，60.1-89.9），华法林组34例（82.9％；95％CI，70.9-95.0），并且根据Frisén分类显示出乳头水肿的改善（35（97.2％；80.0％CI，91.6-101.6）华法林组的95%CI，77.9-98.3）。
■这些关于疗效和安全性的发现支持将达比加群作为中国CVT患者可行的治疗选择。
