Abstract
Background and purposeCerebral venous thrombosis causes disability from venous infarct and hemorrhage and potential mortality. Anticoagulation improves survival and disability outcomes, yet direct oral anticoagulants are currently not indicated in cerebral venous thrombosis due to lack of evidence, despite being on the market for nearly a decade. This systematic review will collate evidence of reported safety and efficacy of direct oral anticoagulant therapy in cerebral venous thrombosis.MethodsA search strategy was developed with a research librarian and registered on a protocol database (PROSPERO CRD42017078398). All published studies from MEDLINE and EMBASE up to February 2019 containing patients diagnosed with cerebral venous thrombosis who were treated with a direct oral anticoagulant (dabigatran, rivaroxaban, apixaban, or edoxaban) will be included. A risk of bias analysis will be performed to evaluate quality of studies overall.DiscussionCurrent guidelines in the treatment of cerebral vein thrombosis dating back to 2011 from the American Heart Association/American Stroke Association endorse the utility of anticoagulation for the treatment of cerebral vein thrombosis; however, they did not support the use of direct oral anticoagulants. Updated guidelines from the European Stroke Organization, endorsed by the European Academy of Neurology in 2017, also refute utilization of direct oral anticoagulants due to a lack of evidence. There have been nearly 10 years of experience with direct oral anticoagulants in the treatment of venous thrombosis and prevention of stroke in patients with atrial fibrillation, with purported efficacy and safety in comparison with heparins and vitamin K antagonists. Our goal is to undertake a systematic review to assess the effectiveness and safety of direct oral anticoagulants in patients with cerebral vein thrombosis to help guide clinical decision-making for patients unable to take heparins or vitamin K antagonists and to direct future studies to contribute further to an area of certain evidence-based needs.Systematic review registrationPROSPERO CRD42017078398
Highlights
Background and purposeCerebral venous thrombosis causes disability from venous infarct and hemorrhage and potential mortality
The benefits of direct oral anticoagulants (DOAC) in comparison with vitamin K antagonist (VKA) include more predictable pharmacokinetics resulting in no necessity of blood work checking of international normalized ratio (INR) and fewer interactions with other medications or foods, as well as reduced risk of intracranial hemorrhage [7]
The population suffering from Cerebral vein thrombosis (CVT) has a reported morbidity from intracranial hemorrhage or venous infarct as high as 20–30%, and the mean age is 39 years, investigation and utilization of potentially advantageous medications are certainly needed [1]
Summary
Eligibility criteria The eligible population includes patients of any age with a diagnosis of cerebral vein thrombosis (by cerebral angiogram, magnetic resonance venography (MRV), or computed tomographic venography (CTV)) who were treated with a direct oral anticoagulant (apixaban, rivaroxaban, dabigatran, or edoxaban) at any point of treatment, the acute or long-term phase. All studies with or without a comparison group are eligible for this review, including prospective trials or retrospective cohorts, case reports, or case series. Study records Data management and collection Two authors (GB, JG) will independently extract data capturing pertinent demographics, treatment dosage and duration, and follow-up and outcomes. Data synthesis The purpose of this systematic review is to explore the evidence of DOAC use in CVT to assess for safety and efficacy, as well as guide protocol design for future prospective studies. The current guidelines state that DOAC use is not indicated in CVT because no high-level studies have been done as of yet; multiple case reports and case series have been published in the literature which have not been systematically reviewed, as well as possibly small trials. Our goal for data synthesis will be to qualitatively and descriptively present the data, and if possible, inferential statistics and meta-analysis will be performed
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