Safety and Efficacy of Rivaroxaban Versus Warfarin in Cerebral Venous Thrombosis: A Comprehensive Meta-Analysis

Background: Long-term management of cerebral venous thrombosis (CVT) with rivaroxaban is still under evaluation. The primary objective was to compare the contemporary evidence of the safety and efficacy of rivaroxaban versus warfarin in the long-term (≥ 6 months) treatment of CVT. Methods: We searched electronic databases up to 30 April 2025 for randomised control trials (RCTs) and observational studies in CVT management. We utilised the Mantel–Haenszel (M-H) method with a fixed-effects model to calculate risk differences (RDs) between rivaroxaban and warfarin arms. The ROB 2.0 and ROBINS-I tools were used to observe the risk of bias among included studies. Results: A total of 12 studies were identified (4 RCTs and 8 observational cohorts), evaluating 1174 patients treated with rivaroxaban (n = 262) or warfarin (n = 912). The rate of recurrence of venous thrombosis was 4% lower among rivaroxaban- compared to warfarin-treated patients (1.5% vs. 4.0%; RD = −0.04; p = 0.04). However, non-recanalisation events were identical among rivaroxaban and warfarin arms (16.4% vs. 16.5%; RD = −0.01, p = 0.68). Additionally, long-term all-cause mortality (p = 0.39), clinically relevant bleeding events (p = 0.18), new intracranial haemorrhage (p = 0.79), and good clinical outcome (p = 0.92) events were similar between rivaroxaban and warfarin arms. While RCTs and observational cohorts have methodological concerns and potential bias, we validated our results by excluding studies with serious or critical risks of bias to ensure the robustness of our findings. Conclusions: Compared to warfarin, rivaroxaban offers lower recurrence rates with similar efficacy and safety profiles along with improved clinical convenience.

• Publication year

  2025

• Venue

  Neurology International

• Publication date

  2025-11-01

• Fields of study

  Medicine

• Identifiers
  DOI 10.3390/neurolint17110183PMID 41295442PMCID 12655077
• External record

  Open on Semantic Scholar

• Source metadata

  Semantic Scholar, PubMed

• No claims are published for this paper.

• No concepts are published for this paper.

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• Coma in adult cerebral venous thrombosis: The BEAST study

  2024influential reference
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  2024influential reference
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• Age of onset of cerebral venous thrombosis: the BEAST study

  2023influential reference
• Fixed-effect Versus Random-effects Models for Meta-analyses: Fixed-effect Models.

  2023cited by this paper
• Study of Rivaroxaban for Cerebral Venous Thrombosis: A Randomized Controlled Feasibility Trial Comparing Anticoagulation With Rivaroxaban to Standard-of-Care in Symptomatic Cerebral Venous Thrombosis

  2023influential reference
• Pathophysiology, diagnosis and management of cerebral venous thrombosis: A comprehensive review

  2023cited by this paper
• Fixed-Effect vs Random-Effects Models for Meta-Analysis: 3 Points to Consider

  2022cited by this paper
• Strengthening systematic reviews in public health: guidance in the Cochrane Handbook for Systematic Reviews of Interventions, 2nd edition

  2022cited by this paper
• OUP accepted manuscript

  2022cited by this paper
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• Contemporary Incidence and Burden of Cerebral Venous Sinus Thrombosis in Children of the United States

  2022influential reference
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• Predictors of Recurrent Venous Thrombosis After Cerebral Venous Thrombosis: Analysis of the ACTION-CVT Study.

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• Thromboembolic events, bleeding, and mortality in patients with cerebral venous thrombosis: a nationwide cohort study

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• Rivaroxaban for the treatment of cerebral venous thrombosis

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• Rivaroxaban for the treatment of cerebral venous thrombosis: a single-center experience

  2021cited by this paper
• Direct oral anticoagulants in treatment of cerebral venous thrombosis: a systematic review

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• Comparing the efficacy and safety of direct oral anticoagulants with vitamin K antagonist in cerebral venous thrombosis

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• Incidence and Mortality of Cerebral Venous Thrombosis in a Norwegian Population

  2020influential reference
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  2020cited by this paper
• Use of oral rivaroxaban in cerebral venous thrombosis

  2020influential reference
• Safety and efficacy of rivaroxaban in pediatric cerebral venous thrombosis (EINSTEIN-Jr CVT).

  2020cited by this paper
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  2019cited by this paper
• RoB 2: a revised tool for assessing risk of bias in randomised trials

  2019influential reference
• Diagnosis and Treatment of Cerebral Venous Thrombosis: A Review

  2018cited by this paper
• Misdiagnosis of Cerebral Vein Thrombosis in the Emergency Department

  2018cited by this paper
• Comparative risk of major bleeding with rivaroxaban and warfarin: Population‐based cohort study of unprovoked venous thromboembolism

  2018cited by this paper
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  2018cited by this paper
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• European Stroke Organization guideline for the diagnosis and treatment of cerebral venous thrombosis – endorsed by the European Academy of Neurology

  2017influential reference
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• ROBINS-I: a tool for assessing risk of bias in non-randomised studies of interventions

  2016influential reference
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  2016cited by this paper
• New oral anticoagulants: their advantages and disadvantages compared with vitamin K antagonists in the prevention and treatment of patients with thromboembolic events

  2015cited by this paper
• Should lifelong anticoagulation for unprovoked venous thromboembolism be revisited?

  2015cited by this paper
• Predicting anticoagulant-related bleeding in patients with venous thromboembolism: a clinically oriented review

  2014influential reference
• Guidelines for the prevention of stroke in patients with stroke and transient ischemic attack: a guideline for healthcare professionals from the American Heart Association/American Stroke Association.

  2014influential reference
• Rivaroxaban: Practical Considerations for Ensuring Safety and Efficacy

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• Oral rivaroxaban for symptomatic venous thromboembolism.

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• Balancing risks and benefits of extended anticoagulant therapy for idiopathic venous thrombosis

  2009influential reference
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• Warfarin-induced bleeding complications - clinical presentation and therapeutic options.

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  2007cited by this paper
• Warfarin drug interactions.

  2004influential reference
• Effects of oral anticoagulation with various INR levels in deep vein thrombosis cases

  2004cited by this paper
• Cerebral Venous Thrombosis in Children: A Multifactorial Origin

  2003cited by this paper
• Publication bias in meta-analysis: its causes and consequences.

  2000cited by this paper
• Interobserver agreement for the assessment of handicap in stroke patients.

  1989cited by this paper
• Interobserver agreement for the assessment of handicap in stroke patients.

  1988cited by this paper
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  year unknowncited by this paper
• Vascular Health and Risk Management Dovepress Assessing the Risk of Recurrent Venous Thromboembolism – a Practical Approach

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