Evidence mapPaperPMID 41844701Full record

ArticleScientific reports2026

Real-world use of rivaroxaban for primary thromboprophylaxis and cardiac thrombosis treatment in congenital and acquired heart disease: a prospective cohort study.

Neil Derridj, Sophie Malekzadeh-Milani, Dominique Lasne, Sabrina Da Costa, Diala Khraiche, Hugues Ndjoli, Damien Bonnet, Fanny Bajolle

Abstract read
In one paragraph

Article in Scientific reports, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.

0numbers the graph read from it
0cells of the map it votes in
0citing 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

0 citing papers in PubMed.

No citing paper in PubMed yet.

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.

Neil DerridjM3C-Necker, Cardiologie Congénitale et Pédiatrique, Hôpital universitaire Necker Enfants-malades, AP-HP, Paris, France. neil.derridj@aphp.fr.
Sophie Malekzadeh-MilaniM3C-Necker, Cardiologie Congénitale et Pédiatrique, Hôpital universitaire Necker Enfants-malades, AP-HP, Paris, France.
Dominique LasneHematology Laboratory, Hôpital universitaire Necker Enfants-Malades, AP-HP, Paris, France.
Sabrina Da CostaPaediatric Endocrinology, Hôpital universitaire Necker Enfants-Malades, AP-HP, Paris, France.
Diala KhraicheM3C-Necker, Cardiologie Congénitale et Pédiatrique, Hôpital universitaire Necker Enfants-malades, AP-HP, Paris, France.
Hugues NdjoliM3C-Necker, Cardiologie Congénitale et Pédiatrique, Hôpital universitaire Necker Enfants-malades, AP-HP, Paris, France.
Damien BonnetM3C-Necker, Cardiologie Congénitale et Pédiatrique, Hôpital universitaire Necker Enfants-malades, AP-HP, Paris, France.
Fanny BajolleM3C-Necker, Cardiologie Congénitale et Pédiatrique, Hôpital universitaire Necker Enfants-malades, AP-HP, Paris, France.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

To evaluate the incidence of bleeding and thrombotic events in children with congenital or acquired heart disease (CAHD) receiving direct oral anticoagulants by rivaroxaban, and identify associated covariates. This prospective cohort study included children with CAHD treated with rivaroxaban between September 2023 and March 2025, excluding venous thromboembolism. Patients were anticoagulant-naïve or switched from antithrombotic therapy. Serious adverse events (SAE) included significant bleeding events (major bleeding (MB) and clinically relevant non-major bleeding (CRNMB)) and thrombotic events. Cox proportional hazards models were used, with sensitivity analyses excluding patients with prior events under previous antithrombotic therapy. 125 patients were included with: 88(70.4%) patients with Fontan physiology. Seventy-two (58%) patients were switched to rivaroxaban from previous antithrombotic therapy. Median age at initiation was 9.3(IQR:5.5–13.9) years with a median follow-up of 8.5(IQR:3.9–13) months. Twenty SAEs were recorded (3 MB, 13 CRNMB, 4 thrombotic events). The incidences of significant bleeding events and thrombosis event were of 13.9%(95%CI[7,9%–24,4%]) and 4.2%(95%CI[1.6%–11,2%]) per patient year, respectively. At 12 months, 88.9%(95%CI[79.8%–94%]) of patients were free of significant bleeding events. Multivariable analysis identified female gender (HR = 13.2(95%CI[2.8–62.4])) and age > 12 years (HR = 7.1(95%CI[1.9–26.3])) as risk factors for significant bleeding events. Abnormal uterine bleeding accounted for 56.2% of significant bleeding events. Sensitivity analyses yielded similar results. Rivaroxaban therapy appears feasible in children with CAHD, but was associated with higher bleeding and thrombotic events than previously reported in clinical trials. Particular attention should be given to teenage girls at higher risk of abnormal uterine bleeding.

Indexed as

Factor Xa InhibitorsHeart Defects, CongenitalHeart DiseasesRivaroxabanThrombosisAdolescentChildChild, PreschoolFemaleHemorrhageHumansIncidenceMaleProspective StudiesFactor Xa InhibitorsRivaroxabanAnticoagulants, HemorrhageHeart Defects, CongenitalPediatrics

Identifiers

PMID41844701
PMCPMC13133138

What Socratic holds

Textmetadata
LicenceCC BY-NC-ND
Read underepoch 390

Registered trials

None linked

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.