Evidence map›Paper›PMID 42032668›Full record

ReviewThrombosis journal2026

Efficacy and safety of direct oral anticoagulants in pediatric congenital and acquired heart disease: a systematic review and meta-analysis of randomized controlled trials.

Hanan El-Sayed Bakry, Mai Ibrahim Abdellah, Hani Abdelshafook Khalaf, Ahmed Ali Assem, Mohamad Mahmoud ElGamal, Mohamed Ibrahim Abdo, Mohamed Hamouda Elkasaby, Atef A Hassan

Abstract readReview
In one paragraph

Review in Thrombosis journal, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

1 citing paper in PubMed.

  1. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

8 authors.

Hanan El-Sayed BakryPediatric Department, Damietta General Hospital, Damietta, Egypt.
Mai Ibrahim AbdellahCardiology Department, Faculty of Medicine (For Girls), Al-Azhar University, Cairo, Egypt.
Hani Abdelshafook KhalafCardiology Department, Faculty of Medicine, Al-Azhar University, Cairo, Egypt.
Ahmed Ali AssemDepartment of Clinical Pathology, Faculty of medicine, Al-Azhar university, Damietta, Egypt.
Mohamad Mahmoud ElGamalDepartment of Pharmacology, Damietta Faculty of Medicine, Al-Azhar University, Damietta, Egypt.
Mohamed Ibrahim AbdoDepartment of Vascular Surgery, Faculty of Medicine (for Boys), Al-Azhar University, Cairo, Egypt.
Mohamed Hamouda ElkasabyFaculty of Medicine, Al-Azhar University, Cairo, Egypt.
Atef A HassanFaculty of Medicine, Al-Azhar University, Cairo, Egypt. atefabdo26399@gmail.com.ORCID http://orcid.org/0000-0003-3393-9105

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundChildren 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.

objectiveTo evaluate the efficacy and safety of DOACs compared with standard-of-care (SOC) anticoagulation in pediatric patients with CAHD.

methodsWe 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).

resultsFour 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).

conclusionsDOACs seem to be effective and safe for thromboprophylaxis in pediatric patients with CAHD. They reduce the risk of thromboembolism without increasing bleeding complications.

Indexed as

Apixaban, Congenital heart diseaseDabigatran, EdoxabanDirect oral anticoagulantsRivaroxaban

Identifiers

PMID42032668
PMCPMC13123206

What Socratic holds

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LicenceCC BY-NC-ND
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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the Socratic graph.