Key result
DOACs cut thromboembolic events ~58% vs SOC in pediatric congenital and acquired heart disease.
Why the study?
Traditional anticoagulants present administration and monitoring challenges in pediatric patients, and the role of DOACs in pediatric congenital and acquired heart disease remains uncertain.
Do direct oral anticoagulants (DOACs) reduce thromboembolic events without increasing bleeding compared to standard-of-care anticoagulation in pediatric patients with congenital and acquired heart disease?
Meta-Analysis (n=732)
Yes
Do direct oral anticoagulants (DOACs) reduce thromboembolic events without increasing bleeding compared to standard-of-care anticoagulation in pediatric patients with congenital and acquired heart disease?
Effect estimate: RR 0.42 (95% CI 0.18-0.97)
p-value: p=0.04
DOACs appear to be an effective and safe alternative to standard anticoagulation for thromboprophylaxis in pediatric patients with congenital and acquired heart disease, significantly reducing thromboembolic events without increasing bleeding risk.
Supports DOAC preference over VKA/LMWH in pediatric CAHD; extends adult RCT benefits to this population.
Children with congenital and acquired heart disease (CAHD) are at high risk for venous thromboembolism (VTE). Traditional anticoagulants such as vitamin K antagonists (VKAs) and low-molecular-weight heparin (LMWH) present challenges in pediatrics due to burdensome administration, frequent monitoring, and adherence issues. Direct oral anticoagulants (DOACs) have transformed adult anticoagulation, but their role in pediatric CAHD remains uncertain. To evaluate the efficacy and safety of DOACs compared with standard-of-care (SOC) anticoagulation in pediatric patients with CAHD. We systematically searched PubMed, Scopus, Web of Science, and Embase through July 1, 2025. Eligible studies included RCTs comparing DOACs (dabigatran, rivaroxaban, apixaban, edoxaban) with VKAs, LMWH, or aspirin in patients < 18 years with CAHD. Relative risks (RRs) with 95% confidence intervals (CIs) were pooled using random-effects models. Prespecified subgroup analyses were performed for children with congenital heart disease (CHD). Four RCTs, including 732 patients, were analyzed. In the overall population (patients with congenital and acquired heart disease), DOACs significantly reduced thromboembolic events compared to standard-of-care anticoagulation (RR = 0.42, 95% CI: 0.18–0.97; p = 0.04). In the prespecified congenital heart disease (CHD) subgroup, a trend toward reduced events was observed but did not reach statistical significance (RR = 0.29, 95% CI: 0.06–1.29). Individual thromboembolic outcomes (stroke, pulmonary embolism, deep vein thrombosis, and intracardiac thrombus) were rare, with no significant differences between DOAC and control groups in either the overall population or the CHD subgroup (all p > 0.05). Regarding safety, major bleeding rates were similar between DOAC and control groups in the overall population (RR = 0.91, 95% CI: 0.25–3.35) and the CHD subgroup (RR = 1.36, 95% CI: 0.06–32.65). Clinically relevant non-major bleeding was also comparable between DOAC and control groups overall (RR = 0.62, 95% CI: 0.23–1.68) and in the CHD subgroup (RR = 0.75, 95% CI: 0.19–2.49). DOACs seem to be effective and safe for thromboprophylaxis in pediatric patients with CAHD. They reduce the risk of thromboembolism without increasing bleeding complications.
No takes yet. Share an insight, caveat, or question.
Bakry et al. (2026) conducted a meta-analysis in Pediatric congenital and acquired heart disease (CAHD) (n=732). Direct oral anticoagulants (DOACs) vs. Standard-of-care anticoagulation (vitamin K antagonists, low-molecular-weight heparins, or aspirin) was evaluated on Thromboembolic events (RR 0.42, 95% CI 0.18-0.97, p=0.04). Direct oral anticoagulants significantly reduced thromboembolic events (RR 0.42) compared to standard-of-care anticoagulation in pediatric patients with congenital and acquired heart disease.
Synapse has enriched 5 closely related papers on similar clinical questions. Consider them for comparative context: