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May 20, 2026Journal of Thrombosis and ThrombolysisOpen Access

Atherosclerosis in edoxaban-treated AF patients is linked to ~50% greater stroke or systemic embolism risk.

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Why the study?

To estimate major clinical event rates in edoxaban-treated patients with AF and atherosclerotic disease in routine practice, and evaluate their representation in ENGAGE AF-TIMI 48.

How do major clinical event rates compare between AF patients with and without atherosclerotic disease treated with edoxaban in routine practice, and how do they compare to trial participants?

Population

13,164 AF patients receiving edoxaban in routine care

Comparison

CAD/PAD vs without CAD/PAD, and vs CAD/PAD patients in ENGAGE AF-TIMI 48

Design

Prospective cohort study

Key result

Edoxaban-treated atrial fibrillation patients with concomitant atherosclerotic disease in routine clinical practice had a higher rate of stroke or systemic embolism (HR 1.5) compared to those without atherosclerotic disease.

Authors

TVTim A.C. de VriesJGJoris R. de GrootRPRon Pisters

Discussion

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Overview

CAD/PAD was associated with higher stroke/systemic embolism risk on edoxaban; this leaves open whether intensified strategies warrant prospective testing.

Key Points

  • The aim was to estimate clinical event rates for patients with atrial fibrillation and atherosclerotic disease treated with edoxaban in routine care.
  • Prospective cohort study of AF patients receiving edoxaban in routine care
  • Compared CAD/PAD patients in ETNA-AF-Europe with those without CAD/PAD and patients from ENGAGE AF-TIMI 48
  • Analyzed clinical outcomes including stroke, acute coronary syndrome, and major bleeding rates.
  • Patients with CAD/PAD had higher rates of stroke/systemic embolism (HR 1.5, 95%-CI 1.14-1.88) and acute coronary syndrome (HR 3.3, 95%-CI 2.60-4.27)
  • ETNA-AF-Europe patients had fewer comorbidities and lower rates of stroke/systemic embolism compared to ENGAGE-AF TIMI-48
  • All-cause death rate was higher in ETNA-AF-Europe (6.02%/year) compared to ENGAGE-AF TIMI-48 (3.53%/year).

Study Design

Type

Cohort (n=13,164)

Multicenter

Yes

Structured PICO

How do major clinical event rates compare between AF patients with and without atherosclerotic disease treated with edoxaban in routine practice, and how do they compare to trial participants?

P
Population
13,164 patients with atrial fibrillation receiving edoxaban in routine care (ETNA-AF-Europe cohort), of which 23.3% had coronary or peripheral artery disease (CAD/PAD).
I
Intervention
Edoxaban
C
Comparator
Patients without CAD/PAD in ETNA-AF-Europe, and CAD/PAD patients in the ENGAGE AF-TIMI 48 trial
O
Outcome
Major clinical event rates including stroke/systemic embolism, acute coronary syndrome, major bleeding, cardiovascular death, and all-cause deathhard clinical

Main Result

Effect estimate: HR 1.5 (95% CI 1.14-1.88)

Absolute Event Rate: 0.87% vs 0.59%

AF patients with CAD/PAD treated with edoxaban in routine practice have higher event rates than those without CAD/PAD, but differ significantly in risk profile and mortality patterns from trial populations.

Limitations

  • Indirect comparison between ETNA-AF-Europe and ENGAGE AF-TIMI 48 with differing eligibility criteria, time periods, regions, and variable definitions
  • Lack of standardized medical definitions for coronary or peripheral artery disease in ETNA-AF-Europe
  • Only aggregated data available from ENGAGE AF-TIMI 48 without patient-level details or confidence intervals
  • Potential sampling bias due to exclusion of certain participants and early study discontinuation
  • Lack of information on the timing of prior events
  • Post-hoc sub-study design without adjustment for multiple testing

Cite This Study

Vries et al. (2026) conducted a cohort in Atrial fibrillation with atherosclerotic disease (n=13,164). Edoxaban vs. Patients without coronary or peripheral artery disease was evaluated on Stroke/systemic embolism (HR 1.5, 95% CI 1.14-1.88). Edoxaban-treated atrial fibrillation patients with concomitant atherosclerotic disease in routine clinical practice had a higher rate of stroke or systemic embolism (HR 1.5) compared to those without atherosclerotic disease.

synapsesocial.com/papers/6a0d5040f03e14405aa9bf4bhttps://doi.org/10.1007/s11239-026-03269-5
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