Safety and Efficacy of Dabigatran Etexilate vs Dose-Adjusted Warfarin in Patients With Cerebral Venous Thrombosis

Background: Cerebral venous thrombosis (CVT) is an uncommon cause of stroke that mainly affects young adults and children. Initial treatment with heparin followed by wafarin is the mainstay of treatment. Only insufficient experience is available for direct oral anticoagulants (DOACs). Aims: The study aims to demonstrate the efficacy and safety of DOACs such as (Rivaroxaban and Dabigatran) in patients with objectively confirmed CVT. Methods: Data of 46 cases of CVT collected using a standardized case report form. Inclusion criteria were patients diagnosed with CVT, confirmed by CT or MRI imaging. Results: The total number of patients was 46 (9 males and 37 females). The mean age of the patients was 35.2± 5 years. The most common clinical manifestations among our patients were headache followed by seizure. 52% of cases were unprovoked, while 48% were provoked by pregnancy and oral contraceptive pills. Superior sagittal sinus (55%) and transverse sinus (44.9%) were the most common sites. Involvement of more than three venous sinuses was 34.8%. Thrombophilic abnormality was detected in 21.7% of patients. Initiation of anticoagulation (AC) was mostly low molecular weight heparin (LMWH) (80%), followed by unfractionated heparin (UFH) (17.7%) and fondaparinex (2%). Maintenance AC with Rivaroxaban after heparin (LMWH/UFH) was in 63% of our patients, the rest were switched from Warfarin to Rivaroxaban (34.8%), and one was treated by Dabigatran (2%). CVT recurrence was observed in one patient. Major bleeding (according to ISTH criteria) was not reported in our case series. Conclusions: DOACs demonstrated good safety and efficacy profile and can potentially replace warfarin in CVT patients. Disclosures No relevant conflicts of interest to declare.

Download Full-text

Safety and efficacy of Direct Oral Anticoagulants in cerebral venous thrombosis: A meta‐analysis

Acta Neurologica Scandinavica ◽

10.1111/ane.13506 ◽

2021 ◽

Author(s):

Gaurav Nepal ◽

Sanjeev Kharel ◽

Riwaj Bhagat ◽

Yow Ka Shing ◽

Megan Ariel Coghlan ◽

...

Keyword(s):

Venous Thrombosis ◽

Cerebral Venous Thrombosis ◽

Meta Analysis ◽

Oral Anticoagulants ◽

Direct Oral Anticoagulants ◽

Safety And Efficacy

Download Full-text

Dural Arteriovenous Fistulae After Cerebral Venous Thrombosis

Stroke ◽

10.1161/strokeaha.120.031235 ◽

2020 ◽

Vol 51 (11) ◽

pp. 3344-3347

Author(s):

José M. Ferro ◽

Jonathan M. Coutinho ◽

Olav Jansen ◽

Martin Bendszus ◽

Francesco Dentali ◽

...

Keyword(s):

Venous Thrombosis ◽

Cerebral Venous Thrombosis ◽

Mr Angiography ◽

Sinus Thrombosis ◽

Controlled Trial ◽

Dabigatran Etexilate ◽

Dural Sinus ◽

Arteriovenous Fistulae ◽

3 Dimensional

Background and Purpose: This analysis examined the frequency of dural arteriovenous fistulae (dAVF) after cerebral venous thrombosis (CVT) in patients included in a randomized controlled trial comparing dabigatran etexilate with dose-adjusted warfarin (RE-SPECT CVT [A Clinical Trial Comparing Efficacy and Safety of Dabigatran Etexilate With Warfarin in Patients With Cerebral Venous and Dural Sinus Thrombosis]), who had systematic follow-up magnetic resonance (MR) imaging. Methods: RE-SPECT CVT was a Phase 3, prospective, randomized, parallel-group, open-label, multicenter, exploratory trial with blinded end point adjudication. We allocated patients with acute CVT to dabigatran 150 mg twice daily or dose-adjusted warfarin, for 24 weeks and obtained a standardized MR protocol including time-of-flight MR angiography, 3-dimensional phase-contrast venography, and 3-dimensional contrast-enhanced MR venography at the end of the treatment period. A blinded adjudication committee assessed the presence of dAVF in a predefined substudy of the trial. Results: We analyzed development of dAVF in 112 of 120 randomized patients; 57 allocated to dabigatran and 55 to warfarin. For 3 (2.7%) of these 112 patients, quality of follow-up imaging was insufficient to evaluate dAVF. A dAVF (Borden I) was found in 1 patient (0.9%) allocated to warfarin; however, this dAVF was already present at baseline. The patient did not present with hemorrhage at baseline or during the trial and was asymptomatic at follow-up. Conclusions: Despite systematic imaging, we found no new dAVF 6 months after CVT. Routine follow-up cerebral MR angiography aiming to detect new dAVF 6 months after CVT has a very low yield. Registration: URL: https://www.clinicaltrials.gov . Unique identifier: NCT02913326.

Download Full-text

Safety and efficacy of rivaroxaban in pediatric cerebral venous thrombosis (EINSTEIN-Jr CVT)

Blood Advances ◽

10.1182/bloodadvances.2020003244 ◽

2020 ◽

Vol 4 (24) ◽

pp. 6250-6258

Author(s):

Philip Connor ◽

Mayte Sánchez van Kammen ◽

Anthonie W. A. Lensing ◽

Elizabeth Chalmers ◽

Krisztián Kállay ◽

...

Keyword(s):

Venous Thrombosis ◽

Cerebral Venous Thrombosis ◽

Absolute Difference ◽

Secondary Outcome ◽

Safety And Efficacy ◽

Safety Outcome ◽

Efficacy Outcome ◽

Recurrent Venous Thromboembolism ◽

Subdural Bleeding ◽

Recurrent Vte

Abstract Anticoagulant treatment of pediatric cerebral venous thrombosis has not been evaluated in randomized trials. We evaluated the safety and efficacy of rivaroxaban and standard anticoagulants in the predefined subgroup of children with cerebral venous thrombosis (CVT) who participated in the EINSTEIN-Jr trial. Children with CVT were randomized (2:1), after initial heparinization, to treatment with rivaroxaban or standard anticoagulants (continued on heparin or switched to vitamin K antagonist). The main treatment period was 3 months. The primary efficacy outcome, symptomatic recurrent venous thromboembolism (VTE), and principal safety outcome, major or clinically relevant nonmajor bleeding,were centrally evaluated by blinded investigators. Sinus recanalization on repeat brain imaging was a secondary outcome. Statistical analyses were exploratory. In total, 114 children with confirmed CVT were randomized. All children completed the follow-up. None of the 73 rivaroxaban recipients and 1 (2.4%; CVT) of the 41 standard anticoagulant recipients had symptomatic, recurrent VTE after 3 months (absolute difference, 2.4%; 95% confidence interval [CI], −2.6% to 13.5%). Clinically relevant bleeding occurred in 5 (6.8%; all nonmajor and noncerebral) rivaroxaban recipients and in 1 (2.5%; major [subdural] bleeding) standard anticoagulant recipient (absolute difference, 4.4%; 95% CI, −6.7% to 13.4%). Complete or partial sinus recanalization occurred in 18 (25%) and 39 (53%) rivaroxaban recipients and in 6 (15%) and 24 (59%) standard anticoagulant recipients, respectively. In summary, in this substudy of a randomized trial with a limited sample size, children with CVT treated with rivaroxaban or standard anticoagulation had a low risk of recurrent VTE and clinically relevant bleeding. This trial was registered at clinicaltrials.gov as #NCT02234843.

Download Full-text