机构:[1]Department of Emergency, Xuanwu Hospital, Capital Medical University.内科系统急诊科首都医科大学宣武医院[2]Department of Neurology, Xuanwu Hospital, Capital Medical University.神经科系统神经内科首都医科大学宣武医院[3]Department of Neurology, Beijing Fengtai You'anmen Hospital.[4]Department of Neurosurgery, Xuanwu Hospital Capital Medical University.神经科系统神经外科首都医科大学宣武医院
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 non-major 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 non-significant 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 to 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 non-major 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 to 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 versus 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 dabigatran etexilate group vs. 37 [88.1%, 95%CI, 77.9-98.3] in 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.
基金:
This
work was supported by the Beijing Municipal Science and
Technology Commission (grant number Z161100000516088).
第一作者机构:[1]Department of Emergency, Xuanwu Hospital, Capital Medical University.[2]Department of Neurology, Xuanwu Hospital, Capital Medical University.
共同第一作者:
通讯作者:
通讯机构:[1]Department of Emergency, Xuanwu Hospital, Capital Medical University.[2]Department of Neurology, Xuanwu Hospital, Capital Medical University.
推荐引用方式(GB/T 7714):
Ma Hongrui,Gu Yaqin,Bian Tingting,et al.Dabigatran etexilate versus warfarin in cerebral venous thrombosis in Chinese patients (CHOICE-CVT): an open-label, randomized controlled trial[J].INTERNATIONAL JOURNAL OF STROKE.2024,19(6):635-644.doi:10.1177/17474930241234749.
APA:
Ma Hongrui,Gu Yaqin,Bian Tingting,Song Haiqing,Liu Zhi...&Duan Jiangang.(2024).Dabigatran etexilate versus warfarin in cerebral venous thrombosis in Chinese patients (CHOICE-CVT): an open-label, randomized controlled trial.INTERNATIONAL JOURNAL OF STROKE,19,(6)
MLA:
Ma Hongrui,et al."Dabigatran etexilate versus warfarin in cerebral venous thrombosis in Chinese patients (CHOICE-CVT): an open-label, randomized controlled trial".INTERNATIONAL JOURNAL OF STROKE 19..6(2024):635-644