Ma Hongrui, Gu Yaqin, Bian Tingting, Song Haiqing, Liu Zhi, Ji Xunming, Duan Jiangang
Department of Emergency, Xuanwu Hospital, Capital Medical University, Beijing, China.
Department of Neurology, Xuanwu Hospital, Capital Medical University, Beijing, China.
Int J Stroke. 2024 Jul;19(6):635-644. doi: 10.1177/17474930241234749. Epub 2024 Feb 26.
The efficacy and safety of dabigatran etexilate for Chinese patients with cerebral venous thrombosis (CVT) has not been well established.
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.
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).
These findings regarding efficacy and safety support the consideration of dabigatran etexilate therapy as a viable treatment option for Chinese patients with CVT.
达比加群酯对中国脑静脉血栓形成（CVT）患者的疗效和安全性尚未得到充分证实。
CHOICE-CVT是一项在国家神经系统疾病中心进行的探索性、单中心、随机、开放标签研究，纳入年龄在18至80岁的中国CVT患者，将其随机（1:1）分为达比加群酯组或华法林组。在低分子肝素治疗10 - 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）患者的数量以及严重临床出血。次要疗效终点包括第180天时的静脉再通和视乳头水肿变化。次要安全性结局包括死亡、临床非严重出血和任何出血。该研究已在ClinicalTrials.gov上注册，注册号为NCT03930940。
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）治疗。在第180天时，达比加群酯组复发性CVT和/或DVT患者数量在统计学上无显著差异，但可能具有临床意义（8例（18.2%；95%CI，6.3 - 30.0） vs 3例（6.7%；95%CI，0.0 - 14.2），p = 0.099，检验效能（1-β）为38.401%），与华法林组相比。达比加群酯组严重临床出血患者数量相当（0例（0） vs 0例（0），p = 1.000），临床非严重出血患者数量也相当（1例（2.3%；95%CI，0.0 - 6.9） vs 1例（2.2%；95%CI，0.0 - 6.7）），但与华法林组相比，任何出血风险较低（1例（2.3%；95%CI，0.0 - 6.9） vs 9例（20.0%；95%CI，7.8 - 32.2））。根据改良的Qureshi量表，两组大多数患者实现了静脉再通（达比加群酯组27例（75%；95%CI，60.1 - 89.9） vs 华法林组34例（82.9%；95%CI，70.9 - 95.0）），并且根据Frisén分类，视乳头水肿均有改善（达比加群酯组35例（97.2%；95%CI，91.6 - 100.0） vs 华法林组37例（88.1%，95%CI，77.9 - 98.3））。
这些关于疗效和安全性的研究结果支持将达比加群酯治疗作为中国CVT患者的一种可行治疗选择。
