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

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.

scholarly journals Cerebral Venous Thrombosis Case Series at a Tertiary Care Hospital: Exploring Treatment Safety and Efficacy of Direct Oral Anticoagulants

Blood ◽  
2019 ◽  
Vol 134 (Supplement_1) ◽  
pp. 3658-3658
Author(s):  
Mohammed Abdullah Alsheef ◽  
Mukhtar Alomar ◽  
Abdul Rehman Z. Zaidi ◽  
Ghaydaa Juma Kullab ◽  
Mohammed AlHazzaa ◽  
...  
Keyword(s):  
Venous Thrombosis ◽  
Cerebral Venous Thrombosis ◽  
Oral Anticoagulants ◽  
Direct Oral Anticoagulants ◽  
Tertiary Care ◽  
Case Series ◽  
Case Report Form ◽  
Care Hospital ◽  
Safety And Efficacy ◽  
Number Of Patients

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.

Two doses of rivaroxaban versus aspirin for prevention of recurrent venous thromboembolism

2015 ◽  
Vol 114 (09) ◽  
pp. 645-650 ◽  
Author(s):  
Rupert Bauersachs ◽  
Jan Beyer-Westendorf ◽  
Henri Bounameaux ◽  
Timothy Brighton ◽  
Alexander Cohen ◽  
...  
Keyword(s):  
Venous Thromboembolism ◽  
Anticoagulant Therapy ◽  
Low Dose ◽  
Double Blind ◽  
Once Daily ◽  
Safety Outcome ◽  
Dose Aspirin ◽  
Recurrent Venous Thromboembolism ◽  
Low Dose Aspirin ◽  
Recurrent Vte

SummaryPatients with unprovoked venous thromboembolism (VTE) are at high risk for recurrence. Although rivaroxaban is effective for extended VTE treatment at a dose of 20 mg once daily, use of the 10 mg dose may further improve its benefit-to-risk ratio. Low-dose aspirin also reduces rates of recurrent VTE, but has not been compared with anticoagulant therapy. The EINSTEIN CHOICE study is a multicentre, randomised, double-blind, active-controlled, event-driven study comparing the efficacy and safety of two once daily doses of rivaroxaban (20 and 10 mg) with aspirin (100 mg daily) for the prevention of recurrent VTE in patients who completed 6–12 months of anticoagulant therapy for their index acute VTE event. All treatments will be given for 12 months. The primary efficacy objective is to determine whether both doses of rivaroxaban are superior to aspirin for the prevention of symptomatic recurrent VTE, while the principal safety outcome is the incidence of major bleeding. The trial is anticipated to enrol 2,850 patients from 230 sites in 31 countries over a period of 27 months. In conclusion, the EINSTEIN CHOICE study will provide new insights into the optimal antithrombotic strategy for extended VTE treatment by comparing two doses of rivaroxaban with aspirin (clinicaltrials.gov NCT02064439).

Iliofemoral Deep Venous Thrombosis: Safety and Efficacy Outcome during 5 Years of Catheter-directed Thrombolytic Therapy

1997 ◽  
Vol 8 (3) ◽  
pp. 405-418 ◽  
Author(s):  
Haraldur Bjarnason ◽  
Janice R. Kruse ◽  
David A. Asinger ◽  
Gwen K. Nazarian ◽  
Charles A. Dietz ◽  
...  
Keyword(s):  
Thrombolytic Therapy ◽  
Venous Thrombosis ◽  
Deep Venous Thrombosis ◽  
Safety And Efficacy ◽  
Efficacy Outcome

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

2019 ◽  
Vol 76 (12) ◽  
pp. 1457 ◽  
Author(s):  
José M. Ferro ◽  
Jonathan M. Coutinho ◽  
Francesco Dentali ◽  
Adam Kobayashi ◽  
Andrey Alasheev ◽  
...  
Keyword(s):  
Venous Thrombosis ◽  
Cerebral Venous Thrombosis ◽  
Dabigatran Etexilate ◽  
Safety And Efficacy

scholarly journals Risk of recurrent venous thromboembolism in COPD patients: results from a prospective cohort study

2017 ◽  
Vol 50 (1) ◽  
pp. 1700094 ◽  
Author(s):  
Raphael Le Mao ◽  
Cécile Tromeur ◽  
Amélie Bazire ◽  
Maelenn Gouillou ◽  
Marie Guegan ◽  
...  
Keyword(s):  
Venous Thromboembolism ◽  
Prospective Cohort ◽  
Multivariate Analyses ◽  
Anticoagulation Therapy ◽  
Secondary Outcome ◽  
Risk Of Death ◽  
Copd Patients ◽  
Increased Risk ◽  
Recurrent Venous Thromboembolism ◽  
Recurrent Vte

We aimed to assess the risk of recurrent venous thromboembolism (VTE) in patients with chronic obstructive pulmonary disease (COPD) following cessation of anticoagulation therapy.In a prospective cohort of 1468 patients with a documented episode of VTE, followed for up to 5 years after cessation of anticoagulation therapy, the diagnosis of COPD was confirmed in 136. The main outcome was recurrent VTE. The secondary outcome was overall mortality. Univariate and multivariate analyses were performed to identify the risk factors of recurrence.Of the 1468 patients included, recurrent VTE was observed in 306 (34 with COPD and 272 without) during a median follow-up period of 36.5 months. The incidence rate of recurrent VTE was 9.1% (95% CI 6.5–12.8) for COPD patients and 7.0% (95% CI 6.2–7.9) for non-COPD patients. COPD was not associated with an increased risk of VTE recurrence on univariate or multivariate analyses (hazard ratio: 1.0 (95% CI 0.7–1.4)). The risk of death, adjusted for demographic and clinical characteristics, showed no increase in COPD patients, as compared to non-COPD patients.In patients with COPD who had an acute episode of VTE, the risk of recurrent VTE was not any higher than that in non-COPD patients.

Risk factors associated with recurrent venous thromboembolism after a first cerebral venous thrombosis event: A cohort study

2019 ◽  
Vol 178 ◽  
pp. 85-90 ◽  
Author(s):  
Giselli S. Pires ◽  
Daniel D. Ribeiro ◽  
João A.Q. Oliveira ◽  
Luís C. Freitas ◽  
Rodrigo Vaez ◽  
...  
Keyword(s):  
Risk Factors ◽  
Cohort Study ◽  
Venous Thromboembolism ◽  
Venous Thrombosis ◽  
Cerebral Venous Thrombosis ◽  
Factors Associated ◽  
Recurrent Venous Thromboembolism

scholarly journals Safety and efficacy of anticoagulant therapy in pediatric catheter-related venous thrombosis (EINSTEIN-Jr CVC-VTE)

2020 ◽  
Vol 4 (19) ◽  
pp. 4632-4639
Author(s):  
Katharina Thom ◽  
Anthonie W. A. Lensing ◽  
Ildar Nurmeev ◽  
Fanny Bajolle ◽  
Damien Bonnet ◽  
...  
Keyword(s):  
Anticoagulant Therapy ◽  
Odds Ratio ◽  
Venous Catheter ◽  
Anticoagulant Treatment ◽  
Central Venous ◽  
Safety And Efficacy ◽  
Safety Outcome ◽  
Clot Burden ◽  
Recurrent Vte ◽  
Repeat Imaging

Abstract Anticoagulant treatment of pediatric central venous catheter–related venous thromboembolism (CVC-VTE) has not been specifically evaluated. In EINSTEIN-Jr, 500 children with any VTE received rivaroxaban or standard anticoagulants. A predefined analysis of the CVC-VTE cohort was performed. Children with CVC-VTE (age, birth to 17 years) were administered rivaroxaban or standard anticoagulants during the 1-month (children <2 years) or 3-month (all other children) study period. Predefined outcomes were recurrent VTE, change in thrombotic burden on repeat imaging, and bleeding. Predictors for continuation of anticoagulant therapy beyond the study period were evaluated. One hundred twenty-six children with symptomatic (n = 76, 60%) or asymptomatic (n = 50, 40%) CVC-VTE received either rivaroxaban (n = 90) or standard anticoagulants (n = 36). There was no recurrent VTE (0%; 95% confidence interval [CI], 0.0%-2.8%). Three children had the principal safety outcome: none had major bleeding and 3 children had clinically relevant nonmajor bleeding (2.4%; 95% CI, 0.7%-6.5%), all in the rivaroxaban arm. Complete or partial vein recanalization occurred in 57 (55%) and 38 (37%) of 103 evaluable children, respectively. Results were similar for symptomatic and asymptomatic CVC-VTE. Continuation of anticoagulant therapy beyond the study period occurred in 61 (48%) of children and was associated with residual VTE but only in children <2 years (odds ratio [OR], 20.9; P = .003) and continued CVC use (OR, 6.7; P = .002). Anticoagulant therapy appeared safe and efficacious and was associated with reduced clot burden in most children with symptomatic or asymptomatic CVC-VTE. Residual VTE and continued CVC use were associated with extended anticoagulation. This trial was registered at www.clinicaltrials.gov as #NCT02234843.

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