Document Type : Original Article
Authors
1 Isfahan Neuroscience Research Center, Isfahan University of Medical Sciences, Isfahan, Iran
2 Department of Neurology, School of Medicine, Isfahan University of Medical Sciences, Isfahan, Iran
Abstract
Background: Anticoagulation therapy following cerebral vein thrombosis (CVT) can improve mortality and morbidity. Vitamin K antagonists are currently the routine oral anticoagulant used for CVT; while by introduction of rivaroxaban, a direct factor Xa inhibitor, the attentions have been deviated toward novel agents, but the evidence is not strong. The current study is aimed to compare the efficacy and safety of rivaroxaban versus warfarin for anticoagulation therapy of CVT.
Methods: The current randomized clinical trial has been conducted on 50 patients with CVT among which, 25 ones were randomly allocated to rivaroxaban treatment (20 mg per day for three months) and remained 25 ones to warfarin treatment [adjusted based on international normalized ratio (INR) of 2-3]. The Modified Rankin Scale (mRS) and clinical investigations, including the incidence of seizure, papilledema, intra/extra-cranial bleeding, blurred vision, headache, nausea and vomiting, and death were evaluated at discharge time and within 3 and 6 months following CVT incidence; eventually, two groups were compared.
Results: Comparison of mRS scores between the groups revealed significant differences in none of the interval assessments, at the time of admission (P = 0.510), within three months (P = 0.630), and within six months (P = 0.990), while both of the approaches led to significant decrease in mRS scores following both of the treatments (P < 0.001). The comparison of drug-related adverse effects showed insignificant difference between warfarin versus rivaroxaban (P > 0.050).
Conclusion: Based on this study, rivaroxaban is an efficacious agent for the treatment of CVT without remarkable adverse effects.
Keywords
- Patel MR, Mahaffey KW, Garg J, Pan G, Singer DE, Hacke W, et al. Rivaroxaban versus warfarin in nonvalvular atrial fibrillation. N Engl J Med 2011; 365(10): 883-91.
- Stam J. Thrombosis of the cerebral veins and sinuses. N Engl J Med 2005; 352(17): 1791-8.
- Ferro JM, Canhao P, Stam J, Bousser MG, Barinagarrementeria F. Prognosis of cerebral vein and dural sinus thrombosis: Results of the international study on cerebral vein and dural sinus thrombosis (ISCVT). Stroke 2004; 35(3): 664-70.
- Saadatnia M, Fatehi F, Basiri K, Mousavi SA, Mehr GK. Cerebral venous sinus thrombosis risk factors. Int J Stroke 2009; 4(2): 111-23.
- Saadatnia M, Pirhaji Z. Factors influencing the incidence of papilledema in patients with cerebral venous thrombosis. Adv Biomed Res 2017; 6: 165.
- Janghorbani M, Zare M, Saadatnia M, Mousavi SA, Mojarrad M, Asgari E. Cerebral vein and dural sinus thrombosis in adults in Isfahan, Iran: Frequency and seasonal variation. Acta Neurol Scand 2008; 117(2): 117-21.
- Luo Y, Tian X, Wang X. Diagnosis and treatment of cerebral venous thrombosis: A review. Front Aging Neurosci 2018; 10: 2.
- Miranda B, Ferro JM, Canhao P, Stam J, Bousser MG, Barinagarrementeria F, et al. Venous thromboembolic events after cerebral vein thrombosis. Stroke 2010; 41(9): 1901-6.
- Martinelli I, Bucciarelli P, Passamonti SM, Battaglioli T, Previtali E, Mannucci PM. Long-term evaluation of the risk of recurrence after cerebral sinus-venous thrombosis. Circulation 2010; 121(25): 2740-6.
- Geisbusch C, Richter D, Herweh C, Ringleb PA, Nagel S. Novel factor xa inhibitor for the treatment of cerebral venous and sinus thrombosis: First experience in 7 patients. Stroke 2014; 45(8): 2469-71.
- Saposnik G, Barinagarrementeria F, Brown RD Jr, Bushnell CD, Cucchiara B, Cushman M, et al. Diagnosis and management of cerebral venous thrombosis: A statement for healthcare professionals from the American Heart Association/American Stroke Association. Stroke 2011; 42(4): 1158-92.
- Saadatnia M, Naghavi N, Fatehi F, Zare M, Tajmirriahi M. Oral contraceptive misuse as a risk factor for cerebral venous and sinus thrombosis. J Res Med Sci 2012; 17(4): 344-7.
- Bauersachs R, Berkowitz SD, Brenner B, Buller HR, Decousus H, Gallus AS, et al. Oral rivaroxaban for symptomatic venous thromboembolism. N Engl J Med 2010; 363(26): 2499-510.
- Banks JL, Marotta CA. Outcomes validity and reliability of the modified Rankin scale: implications for stroke clinical trials: A literature review and synthesis. Stroke 2007; 38(3): 1091-6.
- Wasay M, Khan M, Rajput HM, Farooq S, Memon MI, AlRukn SA, et al. New oral anticoagulants versus warfarin for cerebral venous thrombosis: A multi-center, observational study. J Stroke 2019; 21(2): 220-3.
- Linkins LA, Choi PT, Douketis JD. Clinical impact of bleeding in patients taking oral anticoagulant therapy for venous thromboembolism: A meta-analysis. Ann Intern Med 2003; 139(11): 893-900.
- Fang MC, Go AS, Chang Y, Hylek EM, Henault LE, Jensvold NG, et al. Death and disability from warfarin-associated intracranial and extracranial hemorrhages. Am J Med 2007; 120(8): 700-5.
- Covut F, Kewan T, Perez O, Flores M, Haddad A, Daw H. Apixaban and rivaroxaban in patients with cerebral venous thrombosis. Thromb Res 2019; 173: 77-8.
- Anticoli S, Pezzella FR, Scifoni G, Ferrari C, Pozzessere C. Treatment of cerebral venous thrombosis with rivaroxaban. J Biomedical Sci 2016; 5: 3.
- Misra UK, Kalita J, Chandra S, Kumar B, Bansal V. Low molecular weight heparin versus unfractionated heparin in cerebral venous sinus thrombosis: A randomized controlled trial. Eur J Neurol 2012; 19(7): 1030-6.
- Mutgi SA, Grose NA, Behrouz R. Rivaroxaban for the treatment of cerebral venous thrombosis. Int J Stroke 2015; 10(Suppl A100): 167-8.
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