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Patient Evidence Summary
Doctor, do the newer blood thinners work for children and adolescents and are they safe?
Direct oral anticoagulants (DOACs) appear to be effective and safe for children and adolescents for prevention of blood clots due to congenital heart disease and for treatment of DVT or PE.
*Please note that not all of the DOACs have been approved by health authorities for children and adolescents at the time of this posting.
Study highlights
Fewer children and adolescents taking DOACs for treatment of DVT or PE had recurrent blood clots compared to children or adolescents taking standard of care anticoagulants (e.g., low-molecular weight heparin (LMWH) or warfarin). The rate of major bleeding did not differ between the groups.
In children and adolescents taking DOACs to prevent blood clots due to congenital heart disease, there was no difference in the number of blood clots or the rate of major bleeding compared to standard of care anticoagulants.
More children discontinued taking DOACs compared to standard of care anticoagulants for treatment of DVT or PE for reasons other than clotting or bleeding.
Understanding the problem
DOACs have been proven effective and safe in adults for prevention and treatment of blood clots. These drugs are easier to use than the standard of care anticoagulants (e.g., low-molecular weight heparin (LMWH) or warfarin) because they require few or no needles, fewer blood tests, and are less likely to interact with other medications. However, the studies enrolling children and adolescents comparing DOACs with the standard care anticoagulants have been small in size (i.e., number of participants). Combining the results of multiple small studies together makes it more likely that the findings are reliable and accurate.
The reviewers wanted to know if combining the studies together that compared DOACs to standard of care anticoagulants to prevent blood clots due to congenital heart disease or to treat DVT or PE in children and adolescents would show that these drugs are effective and safe.
Who? The review includes 6 studies that enrolled children or adolescents (471 with congenital heart disease and 790 with DVT or PE). The proportion of females in the studies ranged from 35% to 57% and the average age ranged from 1.7 years to 12 years.
What? The review compared DOACs with standard of care anticoagulants.
DOACs | vs | Standard of care anticoagulants |
|---|---|---|
Apixaban (Eliquis®) or Dabigatran (Pradaxa®) or Edoxaban (Lixiana®) or Rivaroxaban (Xarelto®) pills taken by mouth in doses according to body weight. *Treatment of DVT/PE with Dabigatran or Edoxaban required 5 to 7 days of needles (LMWH) first. | Low-molecular weight heparin (LMWH) needles given once or twice per day. Warfarin: one or more pills taken by mouth with frequent blood testing. Some people received LMWH first and then were transitioned to warfarin. |
DOACs vs Standard of care anticoagulants in children and adolescents with congenital heart disease or with DVT/PE
Outcomes | Rate of events with DOACs | Rate of events with Standard of care (LMWH/warfarin) | Results |
|---|---|---|---|
| Children and adolescents with congenital heart disease | |||
Blood clot | 4 out of 1000 children | 19 out of 1000 children | No difference* in blood clots between children taking DOACs and children taking standard of care anticoagulants |
| Major bleeding | 5 out of 1000 children | 6 out of 1000 children | No difference* in major bleeding between children taking DOACs and children taking standard of care anticoagulants |
| Children and adolescents with DVT or PE | |||
Recurrent blood clots | 9 out of 1000 children | 21 out of 1000 children | Fewer children taking DOACs had recurrent blood clots than children taking standard of care anticoagulants |
| Major bleeding in people with previous DVT or PE | 10 out of 1000 children | 19 out of 1000 children | No difference* in major bleeding between children taking DOACs and children taking standard of care anticoagulants |
*Although the rates for the 2 groups look different, the differences were not statistically significant—this means that the difference could simply be due to chance rather than due to the different treatments.
This Evidence Summary is based on the following article:
Giossi R, Menichelli D, D'Amico F, et al. Efficacy and safety of direct oral anticoagulants in the pediatric population: a systematic review and a meta-analysis. J Thromb Haemost. 2023 Oct;21(10):2784-2796. doi: 10.1016/j.jtha.2023.07.011. Epub 2023 Jul 20. PubMed
Lori-Ann Linkins, MD, MSc (Clin Epi), FRCPC
Dr. Linkins is an Associate Professor of Medicine (thrombosis) at McMaster University in Hamilton, Canada. She holds a Masters Degree in Health Research Methodology and is a Deputy Editor with the Health Information Research Unit, McMaster. She is Co-Editor of the ACP Journal Club and Co-lead on the CanVECTOR Knowledge Translation Platform.
Published: Wednesday, December 6, 2023
Please note that the information contained herein is not to be interpreted as an alternative to medical advice from a professional healthcare provider. If you have any questions about any medical matter, you should consult your professional healthcare providers, and should never delay seeking medical advice, disregard medical advice or discontinue medication based on information provided here.
, McMaster University