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June 27, 2026EP EuropaceOpen Access

Association of diabetes mellitus status and clinical outcomes of edoxaban in patients with atrial fibrillation: a sub-analysis from the ETNA-AF Asian registry

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Why the study?

DM and AF increase thromboembolic risk, but DM-related vascular complications and comorbidities may also influence bleeding risk during anticoagulation therapy.

Does diabetes mellitus status increase the risk of thromboembolic and bleeding events in patients with atrial fibrillation treated with edoxaban?

Population

3299 patients with AF receiving edoxaban at baseline

Comparison

DM (insulin-treated or not) vs no DM

Design

Prospective, observational, non-interventional registry sub-analysis

Follow-up

2-year follow-up

Authors

TCT F C ChaoECE K ChoiHTH F Tse

Discussion

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Overview

DM associated with higher major GI bleeding on edoxaban in AF; hypothesis-generating and should not yet change practice.

Key Points

  • This study aims to evaluate how diabetes mellitus status affects clinical outcomes in atrial fibrillation patients treated with edoxaban over two years.
  • Prospective, observational study involving patients with atrial fibrillation in South Korea, Taiwan, Thailand, and Hong Kong receiving edoxaban.
  • Clinical outcomes were analyzed using annualized event rates and Kaplan-Meier curves, stratified by diabetes status.
  • Cox proportional hazards regression was employed to assess differences in outcomes based on diabetes management.
  • Patients with diabetes had a higher rate of major gastrointestinal bleeding (HR 2.97, 95% CI 1.32–6.69, P=0.009) compared to those without diabetes.
  • The net clinical outcome was significantly worse for patients with diabetes (HR 1.37, 95% CI 1.01–1.87, P=0.046).
  • No significant increase in ischemic stroke risk was found in diabetic patients compared to non-diabetic patients.

Structured PICO

Does diabetes mellitus status increase the risk of thromboembolic and bleeding events in patients with atrial fibrillation treated with edoxaban?

P
Population
3,299 patients with atrial fibrillation from South Korea, Taiwan, Thailand, and Hong Kong receiving edoxaban at baseline.
I
Intervention
Presence of diabetes mellitus (stratified by insulin use: DM on insulin and DM not on insulin), with all patients receiving background edoxaban therapy.
C
Comparator
Patients without diabetes mellitus, receiving background edoxaban therapy.
O
Outcome
Clinical outcomes including ischaemic stroke (IS)/transient ischaemic attack (TIA)/systemic embolic events (SEE), major bleeding, and all-cause death (ACD) over a 2-year follow-up.hard clinical

In Asian patients with atrial fibrillation taking edoxaban, diabetes mellitus is associated with a significantly higher risk of major GI bleeding and worse net clinical outcomes, but not a significantly higher risk of stroke.

Cite This Study

Chao et al. (2026) studied this question.

synapsesocial.com/papers/6a3f97ce125782b61d8659dehttps://doi.org/10.1093/europace/euag105.339
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Also Consider

Synapse has enriched 5 closely related papers on similar clinical questions. Consider them for comparative context:

  1. 1Heterogeneity of outcomes within diabetic patients with atrial fibrillation on edoxaban: a sub-analysis from the ETNA-AF Europe registry2022 · 2 citations
  2. 2Clinical Outcome of Edoxaban vs. Vitamin K Antagonists in Patients with Atrial Fibrillation and Diabetes Mellitus: Results from a Multicenter, Propensity-Matched, Real-World Cohort Study2020 · 16 citations
  3. 3Impact of renal impairment and other high bleeding risk factors on clinical outcomes among Asian patients with atrial fibrillation on edoxaban: a post hoc analysis of the ETNA-AF program2026
  4. 4Outcomes of patients with atrial fibrillation with and without diabetes: A propensity score matching of the COOL‐AF registry2021 · 4 citations
  5. 5Adverse Events and Clinical Correlates in Asian Patients with Atrial Fibrillation and Diabetes Mellitus: A Report from Asia Pacific Heart Rhythm Society Atrial Fibrillation Registry2024 · 5 citations