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Published on: February 28, 2012
Direct oral anticoagulants versus standard anticoagulation in children treated for acute venous thromboembolism
Jie Chen1,2, Guoshan Bi1,2, Fei Wu3
1Department of Vascular Surgery, The First Affiliated Hospital of Guangxi Medical University, No. 6 Shuangyong Road, Nanning, 530000, Guangxi, China.
Insights
Direct oral anticoagulants (DOACs) show promise in treating pediatric venous thromboembolism (PVTE), reducing recurrent VTE without increasing mortality or major bleeding. However, nonmajor bleeding events were more frequent with DOACs in this population.
Area of Science:
- Pediatric Hematology
- Pharmacology
- Clinical Trials
Background:
- Direct oral anticoagulants (DOACs) are standard for adult venous thromboembolism (VTE) but understudied in pediatric VTE (PVTE).
- Existing research on PVTE primarily focuses on epidemiology and traditional anticoagulants, with limited data on novel oral anticoagulants.
Approach:
- A systematic meta-analysis of randomized controlled trials (RCTs) was conducted, searching multiple databases until 2021.
- Seven RCTs involving 1139 pediatric patients with VTE were analyzed using the Mantel-Haenszel method and random-effects model.
Key Points:
- DOACs significantly reduced recurrent VTE (RR 0.42) compared to standard anticoagulation in pediatric patients.
- No significant differences were observed in mortality (RR 0.50) or major bleeding (RR 0.46) between DOACs and standard treatments.
- A higher incidence of clinically relevant nonmajor bleeding was noted with DOACs (RR 2.71), particularly with rivaroxaban.
Conclusions:
- DOACs represent a viable alternative to standard anticoagulation for treating pediatric VTE, offering comparable safety profiles regarding major adverse events.
- Dabigatran and rivaroxaban demonstrated similar efficacy, though rivaroxaban was associated with a higher rate of nonmajor bleeding.
Abstract:
Direct oral anticoagulants (DOACs) are widely used to treat venous thromboembolism (VTE) in adults. Little attention is given to pediatric VTE (PVTE). The objective of this study is to study the efficacy and safety of DOACs in published PVTE randomized control trials (RCTs). PubMed, Embase, China National Knowledge Infrastructure, the Cochrane Library, SinoMed, and ClinicalTrials.gov were searched until 2021, to identify RCTs that enrolled patients with VTE <18 years of age who received DOACs versus standard anticoagulation. Outcomes were evaluated using the Mantel-Haenszel method of random-effects model. Our study evaluated seven RCTs that included 1139 cases of PVTE, which had a low risk of publication and assessment bias. Compared with standard anticoagulation, patients receiving DOACs presented a lower rate of recurrent VTE (relative risk [RR], 0.42 [confidence interval {CI}, 0.20 to 0.89]), similar mortality rate (RR, 0.50 [CI, 0.07 to 3.57]), major bleeding (RR, 0.46 [CI, 0.14 to 1.57]), and higher clinically relevant nonmajor bleeding (RR, 2.71 [CI, 1.05 to 7.02]) with low heterogeneity. Limiting to subgroups, dabigatran and rivaroxaban yielded similar findings, except for a higher incidence of nonmajor bleeding during rivaroxaban use. DOACs could be an alternative to standard anticoagulation in PVTE. Dabigatran and rivaroxaban have similar effects. IMPACT: In venous thromboembolism (VTE), direct oral anticoagulants (DOACs) are widely used as a substitution for standard anticoagulation in most situations for adults; however, little attention is paid to the pediatric population. For pediatric VTE, previous meta-analyses have emphasized the epidemiology, risk factors, and the use of traditional anticoagulants, and seldom reported the use of novel oral anticoagulants. This is the first meta-analysis of randomized controlled trials that focuses on the efficacy outcomes and safety endpoints of DOACs compared with standard anticoagulation in pediatric VTE.
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