article · European Stroke Journal
Abstract Background and aims Pediatric patients with congenital and acquired heart disease (CAHD) are at elevated risk for thromboembolic events, including ischemic stroke, due to abnormal hemodynamics, surgical interventions, and long-term catheter use. While traditional anticoagulants are limited by parenteral administration and monitoring demands, direct oral anticoagulants (DOACs) offer a promising alternative. However, their role in stroke prevention among pediatric CAHD populations remains underexplored. Methods Databases were searched through July 1, 2025, for RCTs comparing DOACs (dabigatran, rivaroxaban, apixaban, and edoxaban) to vitamin K antagonists, low-molecular-weight heparin, or aspirin in patients under 18 with CAHD. Relative risks (RRs) with 95% confidence intervals (CIs) were pooled using random-effects models. Subgroup analyses focused on congenital heart disease (CHD). Results Four RCTs comprising 732 pediatric patients were included. DOACs significantly reduced overall thromboembolic events (RR = 0.42, 95% CI: 0.18–0.97; p = 0.04). Stroke was rare but occurred only in control groups, with a pooled RR favoring DOACs (RR = 0.15, 95% CI: 0.01–3.63). In the CHD subgroup, DOACs showed a non-significant trend toward fewer thromboembolic events (RR = 0.29, 95% CI: 0.06–1.29). Major bleeding and clinically relevant non-major bleeding were not significantly different between DOAC and control arms in both overall and CHD-specific populations. Conclusions DOACs appear to offer a safe and effective strategy for thromboembolic prophylaxis, including stroke prevention, in pediatric patients with CAHD. These findings support the integration of DOACs into pediatric stroke prevention strategies, particularly in high-risk cardiac populations where adherence and long-term management are critical. Conflict of interest All authors: nothing to disclose
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DOI: 10.1093/esj/aakag023.960
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