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Direct oral anticoagulants versus vitamin K antagonists for cerebral venous thrombosis (DOAC-CVT): an international, prospective, observational cohort study

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机构: [1]Department of Neurology, Amsterdam UMC, University of Amsterdam, Amsterdam, Netherlands. [2]Department of Neurology, Sahlgrenska University Hospital, Gothenburg, Sweden [3]Department of Clinical Neuroscience, Institute of Neuroscience and Physiology, Sahlgrenska Academy at University of Gothenburg, Gothenburg, Sweden. [3]Department of Neurology, Christian Medical College Hospital, Vellore, India. [4]Department of Neurology, Spitalul Universitar de Urgenta Bucuresti, Bucharest, Romania. [5]Department of Neurology, Instituto Nacional de Neurologia y Neurocirugia Manuel Velasco Suarez, Mexico City, Mexico. [6]Neurosciences Department, Hospital Dr Rafael A Calderon Guardia, San Jose, Costa Rica. [7]Department of Neurology, Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao Paulo, Sao Paulo, Brazil. [8]Stroke Unit, Hospital Clinico de la Universidad de Chile, Santiago, Chile. [9]Department of Neurology, Inselspital, University Hospital and University of Bern, Bern, Switzerland. [10]Department of Neurology, Hospital Germans Trias i Pujol, Badalona, Spain. [11]Department of Neurology, Helsinki University Hospital and University of Helsinki, Helsinki, Finland. [12]Department of Neurology, Xuanwu Hospital, Capital Medical University, Beijing, China. [13]Duke University Hospital, Durham, NC, USA, UNC Health Rex Comprehensive Stroke Center, Raleigh, NC, USA. [14]Department of Neurology, Royal Adelaide Hospital, Adelaide, SA, Australia. [15]Department of Neurology, Akershus University Hospital, Nordbyhagen, Norway. [16]Department of Neurology, Hadassah-Hebrew University Medical Center, Jerusalem, Israel. [17]Department of Neurosciences, Research Group Experimental Neurology, KU Leuven, Leuven, Belgium, Department of Neurology, University Hospitals Leuven, Leuven, Belgium. [18]Department of Neurology, Tubingen University Hospital, Tubingen, Germany. [19]Department of Neurology, Aga Khan University, Karachi, Pakistan. [20]Department of Neurology, Christchurch Hospital, Christchurch, New Zealand. [21]Department of Neurology, Istanbul Tip Fakultesi, Istanbul, Turkiye. [22]Department of Neurosurgery, Xuanwu Hospital, Capital Medical University, Beijing, China. [23]ASST Vallecamonica, Esine, Italy. [24]Department of Neurology, Medical Faculty, Pamukkale University, Kinikli, Denizli, Turkiye. [25]Stroke Centre, Hospital Dr Nelio Mendonca, Funchal, Portugal. [26]Stroke Unit, Centro Hospitalar Tondela Viseu, Viseu, Portugal. [27]Isala ziekenhuis, Zwolle, Netherlands. [28]CARE Institute of Neurological Sciences, CARE Hospital, Banjara Hills, Hyderabad, India. [29]Department of Neurology, Haaglanden Medical Center, The Hague, Netherlands. [30]Department of Neurology, University of Health Sciences, Bakirkoy Prof Dr Mazhar Osman Mental Health and Neurological Diseases Training and Research Hospital, Istanbul, Turkiye. [31]Department of Epidemiology and Data Science, Amsterdam UMC, Vrije Universiteit, Amsterdam, Netherlands. [32]Department of Neuroradiology, Centro Hospitalar Universitario Lisboa Norte, Lisbon, Portugal. [33]Department of Internal Medicine, Radboud University Medical Center, Nijmegen, Netherlands. [34]Department of Neurosciences, Stroke Center, Centro Hospitalar Universitario de Lisboa Central-ULS Sao Jose, CEEM and Institute of Anatomy, Faculdade de Medicina da Universidade de Lisboa, Gulbenkian Institute of Molecular Medicine, Lisbon, Portugal. [35]Hospital da Luz, University of Lisbon, Lisbon, Portugal. [36]Department of Neurology, Amsterdam UMC, University of Amsterdam, Amsterdam, Netherlands.
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There is an unmet need for high-quality data from prospective studies on the safety and effectiveness of direct oral anticoagulants (DOACs) for the treatment of cerebral venous thrombosis (CVT). We aimed to compare the safety and effectiveness of DOACs versus vitamin K antagonists (VKAs) for the treatment of CVT in a setting that reflects daily clinical practice.DOAC-CVT was an international, prospective, observational cohort study done in 65 hospitals in 23 countries across five continents. Eligible patients were adults (aged ≥18 years) with radiologically confirmed CVT starting oral anticoagulant treatment with either DOACs or VKAs, as per local practice, within 30 days after diagnosis. Exclusion criteria were previous use of anticoagulants at the time of CVT diagnosis or an absolute contraindication to DOACs (eg, pregnancy and lactation, or severe renal or liver disease). Data were collected during routine clinical visits or telephone consultations at CVT diagnosis (baseline) and at 3 months, 6 months, and 12 months after CVT diagnosis. The primary endpoint was a composite of symptomatic venous thromboembolism and major bleeding events (International Society on Thrombosis and Haemostasis criteria) at 6 months. Main outcomes were adjusted for the confounders age, renal function, active cancer, CNS infections, concomitant antiplatelet use, country of inclusion's income status, Glasgow Coma Scale score, intracranial haemorrhage, antiphospholipid antibodies, previous major bleeding, and previous venous thromboembolism using inverse probability-of-treatment weighting. This study is registered at ClinicalTrials.gov (NCT04660747) and is ongoing.Between Jan 27, 2021, and Jan 15, 2024, 619 patients were included; 401 (65%) patients started DOAC treatment, and 218 (35%) patients started VKA treatment. 390 (63%) of 619 patients were female and 229 (37%) of 619 patients were male. Patients' median age was 41 years (IQR 28-51). 6-month follow-up data were available for 617 (>99%) of 619 patients. 12 (3%) of 401 patients in the DOAC group and seven (3%) of 218 patients in the VKA group had a primary outcome event (weighted odds ratio [OR] 0·99 [95% CI 0·37-3·38]). Three (1%) of 401 patients in the DOAC group died versus three (1%) of 218 patients in the VKA group (weighted OR 0·55 [95% CI 0·11-2·80]).The rate of recurrent thrombosis and major bleeding did not differ between patients with CVT treated with DOACs versus VKAs. This study adds to the increasing evidence that DOACs are a reasonable treatment option for CVT alongside VKAs.Netherlands Thrombosis Foundation.Copyright © 2025 Elsevier Ltd. All rights reserved, including those for text and data mining, AI training, and similar technologies.

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大类 | 1 区 医学
小类 | 1 区 临床神经病学
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第一作者机构: [1]Department of Neurology, Amsterdam UMC, University of Amsterdam, Amsterdam, Netherlands.
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