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Systematic Review of Randomized Clinical Trials on Direct Oral Anticoagulants in Pediatric Heart Diseases
Chaokun Guan1, Linjuan Guo2, Shucheng Liang3
1Department of Cardiology, Wuhan Third Hospital & Tongren Hospital of Wuhan University, Wuhan, Hubei, China.
Insights
Direct oral anticoagulants show promise for preventing thrombosis in children with heart conditions. These medications appear effective and safe for pediatric anticoagulation therapy.
Area of Science:
- Cardiology
- Pediatric Medicine
- Pharmacology
Background:
- Direct oral anticoagulants (DOACs) are established for adult thrombosis prophylaxis.
- Their efficacy and safety in pediatric patients with heart disease remain under investigation.
Purpose of the Study:
- To systematically review randomized clinical trials (RCTs) on DOACs for thrombosis prevention in pediatric heart patients.
- To assess the effectiveness and safety of DOACs in this population.
Main Methods:
- Comprehensive search of PubMed, Embase, Cochrane Library, ClinicalTrials.gov, and WHO ICTRP until June 2024.
- Included RCTs were analyzed; a narrative review was conducted if fewer than 5 studies were identified.
Main Results:
- Four studies were included, evaluating rivaroxaban, edoxaban, dabigatran, and aspirin.
- DOACs demonstrated favorable outcomes in thrombotic event rates and comparable major bleeding rates across studies.
- Specific trials showed reduced thrombotic events and similar bleeding profiles compared to standard care or aspirin.
Conclusions:
- Direct oral anticoagulants show potential as a safe and effective treatment for thromboembolism in pediatric patients with cardiac conditions.
- Further research supports DOACs as a promising alternative for anticoagulation in this vulnerable group.
Background:
Direct oral anticoagulants (DOACs) have been widely applied in adults for thrombosis prophylaxis. However, the effect of DOACs in pediatric patients with congenital or acquired heart diseases who need anticoagulation therapy remains unclear.
Methods:
We systematically searched the databases of PubMed, Embase, and the Cochrane Library, as well as the ClinicalTrials.gov registry and the World Health Organization's International Clinical Trials Registry Platform until June 2024 to identify relevant randomized clinical trials (RCTs). If the number of included studies was less than 5, we performed a narrative review to assess the effect of DOACs in pediatric patients.
Results:
Four studies were included. In the UNIVERSE study, thrombotic events occurred in 2% of the rivaroxaban group and 9% of the aspirin group, with bleeding events in 36% and 41%, respectively. The ENNOBLE-ATE study showed no thromboembolic events in the edoxaban group and 1.7% in the SOC group (rate difference: -0.07%, 95% CI: -0.22 to 0.07%). Major bleeding rates were similar (rate difference: -0.03%, 95% CI: -0.18 to 0.12%). The SAXOPHONE trial showed no thromboembolic events in either group and similar major bleeding rates (-0.8%, 95% CI: -8.1 to 3.3%). In the DIVERSITY trial, 81% of dabigatran patients achieved the primary outcome versus 59.3% in the SOC group (Odds ratio: 0.342, 95% CI: 0.081-1.229). No major bleeding occurred in either group.
Conclusion:
Existing studies suggest that the use of DOACs hold promise as an effective and safe alternative for preventing and treating thromboembolism in pediatric patients with heart conditions.
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