达比加群酯与华法林治疗中国患者脑静脉血栓形成(CHOICE-CVT):一项开放标签随机对照试验。

IF 6.3 2区 医学 Q1 CLINICAL NEUROLOGY International Journal of Stroke Pub Date : 2024-07-01 Epub Date: 2024-02-26 DOI:10.1177/17474930241234749
Hongrui Ma, Yaqin Gu, Tingting Bian, Haiqing Song, Zhi Liu, Xunming Ji, Jiangang Duan
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引用次数: 0

摘要

背景达比加群酯治疗中国脑静脉血栓(CVT)患者的疗效和安全性尚未得到充分证实:CHOICE-CVT是在国家神经疾病中心进行的一项探索性、单中心、随机、开放标签研究,涉及18至80岁的中国脑静脉血栓患者,他们被随机分配(1:1)至达比加群酯或华法林。口服抗凝药在服用 LMWH 10-15 天后开始使用。主要疗效和安全性终点包括 180 天内复发 CVT 和/或深静脉血栓形成 (DVT) 以及临床大出血的患者人数。次要疗效终点包括静脉再通和第180天乳头水肿的变化。次要安全性结果包括死亡、临床非大出血和任何出血。该研究已在 ClinicalTrials.gov 登记,编号为 NCT03930940:2017年10月至2023年2月期间,共有89名患者入组并随机分配接受达比加群酯(44人)或华法林(45人)治疗。在第180天,达比加群酯组与华法林组相比,复发性CVT和/或DVT患者的数量在统计学上无显著性,但在临床上可能有显著性(8 [18.2%;95%CI,6.3-30.0] vs 3 [6.7%;95%CI,0.0-14.2],P=0.099,功率[1-β]为38.401%)。达比加群酯组出现临床大出血(0 [0] vs 0 [0],P=1.000)和临床非大出血(1 [2.3%; 95%CI, 0.0-6.9] vs 1 [2.2%; 95%CI, 0.0-6.7]),但与华法林组相比,发生任何出血的风险较低(1 [2.3%; 95%CI, 0.0-6.9] vs 9 [20.0%; 95%CI, 7.8-32.2])。根据改良库雷希量表,两组中的大多数患者都实现了静脉再通畅(达比加群依替酯组为 27 [75%;95%CI,60.1-89.9] ;华法林组为 34 [82.9%;95%CI,70.9-95.0])。0]),根据弗里森分类法,乳头水肿有所改善(达比加群酯组35[97.2%;95%CI,91.6-100.0]对华法林组37[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 患者的可行治疗方案。
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Dabigatran etexilate versus warfarin in cerebral venous thrombosis in Chinese patients (CHOICE-CVT): An open-label, randomized controlled trial.

Background: The efficacy and safety of dabigatran etexilate for Chinese patients with cerebral venous thrombosis (CVT) has not been well established.

Methods: 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.

Results: 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).

Conclusions: These findings regarding efficacy and safety support the consideration of dabigatran etexilate therapy as a viable treatment option for Chinese patients with CVT.

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来源期刊
International Journal of Stroke
International Journal of Stroke 医学-外周血管病
CiteScore
13.90
自引率
6.00%
发文量
132
审稿时长
6-12 weeks
期刊介绍: The International Journal of Stroke is a welcome addition to the international stroke journal landscape in that it concentrates on the clinical aspects of stroke with basic science contributions in areas of clinical interest. Reviews of current topics are broadly based to encompass not only recent advances of global interest but also those which may be more important in certain regions and the journal regularly features items of news interest from all parts of the world. To facilitate the international nature of the journal, our Associate Editors from Europe, Asia, North America and South America coordinate segments of the journal.
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