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
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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.
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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.
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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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Data availability
The datasets used and analyzed in this study are available from the corresponding author upon reasonable request. All data generated or analyzed during this study are included in the article.
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Funding
Project of Hunan Provincial Health Commission (B2019111). Hunan Provincial Natural Science Foundation Project (2020JJ5504, 2022JJ40385); Guangxi Science and Technology Planning Project (2017AB45033).
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Conception and study design: J.C., G.S.B., X.Q.; data search and extraction: J.C., F.W.; data analysis: J.C., G.S.B., F.W.; manuscript revision: X.Q. All authors were involved in writing the paper, and in reading and approving the final version of this manuscript.
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Chen, J., Bi, G., Wu, F. et al. Direct oral anticoagulants versus standard anticoagulation in children treated for acute venous thromboembolism. Pediatr Res 93, 1491–1498 (2023). https://doi.org/10.1038/s41390-022-02294-3
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DOI: https://doi.org/10.1038/s41390-022-02294-3
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