What does this research mean for the field?

Patients with atrial fibrillation and a history of ischaemic stroke or transient ischaemic attack had significantly higher annualised rates of stroke and TIA compared to those without. Novelty: ClaimNovelty.CONFIRMATORY. Consensus alignment: ConsensusAlignment.SUPPORTS_CONSENSUS.

What question did this study set out to answer?

This analysis aims to evaluate the safety and efficacy of edoxaban in patients with atrial fibrillation, comparing those with and without a history of ischaemic stroke or transient ischaemic attack.

February 6, 2026

Long-term real-world outcomes of edoxaban in atrial fibrillation patients with and without prior ischaemic stroke: A 4-year follow-up analysis from ETNA-AF Europe

Resultado clave

Edoxaban-treated AF patients with prior IS/TIA had significantly higher stroke and TIA rates (e.g., IS 1.33% vs 0.41%, HR 1.8; P=0.0083) but similar bleeding risk.

Puntos clave

This analysis aims to evaluate the safety and efficacy of edoxaban in patients with atrial fibrillation, comparing those with and without a history of ischaemic stroke or transient ischaemic attack.
Multicentre, prospective, non-interventional study design
Analysis of data from 13,164 patients across multiple European sites
Assessment of annualised rates and hazard ratios for stroke and bleeding outcomes
Adjustment for age, body weight, creatinine clearance, HAS-BLED score, and CHA2DS2-VASc score
Patients with a history of ischaemic stroke/transient ischaemic attack had significantly higher annualised rates of ischaemic stroke (1.33% vs 0.41%)
Compared to those without IS/TIA, they exhibited higher rates of any stroke (1.56% vs 0.53%) and TIA (1.19% vs 0.24%)
Subjects with IS/TIA history showed an increased risk of systemic embolic events (2.38% vs 0.67%)
No significant differences were observed in bleeding risks between the two groups.

PICO estructurado

Does a history of IS/TIA increase the risk of recurrent cerebrovascular events or bleeding in atrial fibrillation patients treated with edoxaban?

Población

13,164 patients with atrial fibrillation from Europe, including 1,074 with a history of ischaemic stroke (IS) or transient ischaemic attack (TIA) and 12,090 without.

Intervención

Edoxaban

Comparador

Patients without a history of IS/TIA (observational comparison within an edoxaban-treated cohort)

Resultado

Stroke (haemorrhagic, ischaemic, any), TIA, and bleeding (major, major GI, intracranial haemorrhage, clinically relevant nonmajor bleeding, and any bleeding) at 4 yearshard clinical

In atrial fibrillation patients treated with edoxaban, a history of IS/TIA is associated with a significantly higher risk of recurrent cerebrovascular events but no increased risk of bleeding or mortality over 4 years.

Resultado numérico

Tasa de eventos absoluta: 0% vs 0%

Resumen

Abstract Background Patients with atrial fibrillation (AF) with a history of ischaemic stroke (IS) or transient ischaemic attack (TIA) exhibit a higher risk of recurrent stroke events. The ETNA-AF-Europe (NCT02944019) four-year follow-up (4yFU) highlighted the long-term safety and effectiveness of edoxaban in patients with AF, showing relatively low rates of death, stroke, major bleeding, and intracranial haemorrhage. Purpose This analysis from the ETNA-AF-Europe 4-year follow-up compares thrombo-embolic and bleeding outcomes with edoxaban in patients with AF with or without a history of IS and TIA, providing insights into their unique risk profile and response to edoxaban. Methods The ETNA-AF-Europe study was a multicentre, prospective, non-interventional study to evaluate safety and effectiveness of edoxaban in patients with AF across multiple sites in Europe. This analysis summarises baseline characteristics with medical history and 4-year annualised rates, and hazard ratios (HR) of stroke (haemorrhagic, ischaemic, any), TIA, and bleeding (including major bleeding MB, major gastrointestinal GI bleeding, intracranial haemorrhage ICH, clinically relevant nonmajor bleeding CRNMB, and any bleeding) in patients with or without IS/TIA history adjusted for age, body weight, creatinine clearance, HAS-BLED score, and CHA2DS2-VASc score. No multiplicity adjustment was made. Results Data from 13,164 patients (1,074 with prior IS/TIA and 12,090 without) from Europe were analysed. Patients with IS/TIA history were older, had a lower mean body weight, body mass index, and creatinine clearance (P0.0001 for all; Table). Patients with IS/TIA history also had approximately 2 points and 1 point higher baseline stroke (CHA2DS2-VASc) and bleeding (HAS-BLED) risk scores, respectively (P0.0001 for both; Table) with higher prevalence of all reported cardiovascular comorbidities (Table). When compared with patients without a history of IS/TIA, patients with IS/TIA history had significantly higher annualised rates of IS (1.33% vs 0.41%; HR (95% CI):1.8 (1.2, 2.8) P=0.0083), any stroke (1.56% vs 0.53%;HR (95% CI)=1.9 (1.3, 2.9), P=0.0015), TIA (1.19% vs 0.24%; HR (95% CI)=5.8 (3.4, 10.0), P0.0001), IS/TIA/systemic embolic event (SEE) (2.38% vs 0.67%; HR (95% CI)=2.5 (1.7, 3.5), P0.0001), and IS/TIA/SEE/MI (2.92% vs 1.00%;HR (95% CI)=1.9, (1.4, 2.6) P0.0001). All-cause mortality, cardiovascular mortality, haemorrhagic stroke, MB, major GI bleeding, ICH, CRNMB, and any bleeding did not differ significantly in patients with and without IS/TIA history. Effectiveness and safety outcome hazard ratios are shown in the Figure. Conclusions Patients with AF and a history of IS/TIA are at high risk of recurrent cerebrovascular events. While bleeding risks remain unaffected, additional approaches such as addressing comorbidities and exploring rhythm control therapy or left atrial appendage exclusion could further mitigate stroke risk.

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