Evidence map›Paper›PMID 42030046›Full record

ArticleJAMA network open2026

Stroke and Bleeding Risks With Non-Vitamin K Oral Anticoagulants in Nonvalvular Atrial Fibrillation.

Marie C Bradley, Andrew L Simon, Joy Kolonoski, David J Graham, Rongmei Zhang, John G Connolly

Abstract read
In one paragraph

Article in JAMA network open, 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

6 authors.

Marie C BradleyOffice of Medical Policy, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland.
Andrew L SimonDepartment of Population Medicine, Harvard Pilgrim Health Care Institute, Boston, Massachusetts.
Joy KolonoskiDepartment of Population Medicine, Harvard Pilgrim Health Care Institute, Boston, Massachusetts.
David J GrahamOffice of Surveillance and Epidemiology, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland.
Rongmei ZhangOffice of Biostatistics, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland.
John G ConnollyDepartment of Population Medicine, Harvard Pilgrim Health Care Institute, Boston, Massachusetts.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Importance: A study using Medicare data concluded that among patients aged 65 years or older, rivaroxaban had a less favorable benefit-harm profile compared with other non-vitamin K oral anticoagulants (NOACs); however, it is unclear whether this finding persists in younger users. Objective: To compare major extracranial bleeding (MEB), gastrointestinal bleeding (GIB), intracranial hemorrhage (ICH), and thromboembolic stroke in individuals aged younger than 65 years using non-vitamin K oral anticoagulants (NOAC users) for nonvalvular atrial fibrillation (NVAF). Design, Setting, and Participants: This cohort study using health care claims data between October 2010 and February 2022 in the FDA Sentinel System included standard dose NOAC (rivaroxaban, apixaban, and dabigatran) users with NVAF aged 21 to 64 years. Analyses conducted between December 2022 and August 2023. Main Outcomes and Measures: Hazard ratios (HRs) and 95% CIs were estimated for each outcome (MEB, GIB, ICH, and thromboembolic stroke) in inverse probability of treatment-weighted pairwise comparisons: rivaroxaban vs apixaban, rivaroxaban vs dabigatran, and dabigatran vs apixaban. Results: A total of more than 173 000 patients (mean [SD] age, 56.6 [7.23] years; 27.5% female; 72.5% male) were included across the 3 exposure cohorts. The number of NOAC users for each pairwise comparison were rivaroxaban (57 932) vs apixaban (96 057), rivaroxaban (57 399) vs dabigatran (20 188), and dabigatran (20 163) vs apixaban (96 668). Rivaroxaban was associated with higher risks of MEB and GIB compared with apixaban (MEB: HR, 1.91; 95% CI, 1.56-2.34; GIB: HR, 1.92, 95% CI, 1.54-2.39), while differences in thromboembolic stroke prevention were not significant (HR, 1.05; 95% CI, 0.77-1.44). Dabigatran was associated with higher thromboembolic stroke risk (rivaroxaban vs dabigatran: HR, 0.61; 95% CI, 0.39-0.94; dabigatran vs apixaban: HR, 1.74; 95% CI, 1.13-2.68). Conclusions and Relevance: These findings suggest that for patients aged younger than 65 years treated with NOACs for NVAF, apixaban was associated with the most favorable benefit-harm profile. While the results suggest that rivaroxaban may have provided greater stroke prevention than dabigatran, it was associated with higher bleeding risks than apixaban without additional stroke prevention. The higher thromboembolic stroke risks observed with dabigatran in younger patients suggest important age-related differences in effectiveness that warrant further investigation.

Indexed as

AnticoagulantsAtrial FibrillationHemorrhageStrokeAdministration, OralAdultAgedCohort StudiesDabigatranFemaleHumansMaleMiddle AgedPyrazolesPyridonesRivaroxabanAnticoagulantsapixabanDabigatranPyrazolesPyridonesRivaroxaban

Identifiers

PMID42030046
PMCPMC13109794

What Socratic holds

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LicenceCC BY
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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.