Direct oral anticoagulants versus vitamin K antagonists for cerebral venous thrombosis (DOAC-CVT): an international, prospective, observational cohort study.
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van de Munckhof Anita, van Kammen Mayte Sánchez, Tatlisumak Turgut, Krzywicka Katarzyna, Aaron Sanjith, Antochi Florina, Arauz Antonio, Barboza Miguel A, Conforto Adriana B, Contreras Daniel Galdames, Heldner Mirjam R, Hernández-Pérez Maria, Hiltunen Sini, Ji Xunming, Kam Wayneho, Kleinig Timothy J, Kristoffersen Espen S, Leker Ronen R, Lemmens Robin, Poli Sven, Wasay Mohammad, Wu Teddy, Yeşilot Nilüfer, Chen Jian, Cotelli Maria Sofia, Demeestere Jelle, Duan Jiangang, Ergin Nesrin, Freitas Tiago Esteves, Gomes Ana, den Hertog Heleen M, Lindgren Erik, Martinez-Majander Nicolas, Metanis Issa, Miraclin Angel, Rani Lucia Jansi, Reddy Y Muralidhar, Saleem Shafaq, Scutelnic Adrian, Shanmugasundaram Sathish, van den Wijngaard Ido R, Gençdal Işıl Yazıcı, van Eekelen Rik, Vellema Jelle, Arnold Marcel, Neto Lia, Middeldorp Saskia, de Sousa Diana Aguiar, Jood Katarina, Putaala Jukka, Ferro José M, Coutinho Jonathan M, DOAC-CVT investigators
Аннотация
METHODS: 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.
FINDINGS: 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]).
INTERPRETATION: 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.
FUNDING: Netherlands Thrombosis Foundation.