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CONFERENCE UPDATE: ESC 2023

4-year edoxaban treatment revealed to be well-tolerated among patients with non-valvular AF: The ETNA-AF-Europe study

17 Nov 2023

STUDY DESIGN

Non-vitamin K antagonist oral anticoagulants (NOACs) are currently the first-line medications in stroke prevention for patients with atrial fibrillation (AF).¹ However, long-term non-interventional data in patients with AF is limited.¹ The ETNA-AF-Europe study was a prospective, observational, multicentre safety study, designed to assess the safety profile of edoxaban in patients with non-valvular AF (NVAF) in the real-world setting.¹

A total of 13,164 patients with NVAF were enrolled in this study, of which 73.1% received 60mg of edoxaban once daily (OD), 23.1% of patients received 30mg of edoxaban OD and 3.8% of patients had missed their doses during the study period.¹ The cohort which received 30mg had a lower creatinine clearance rate, a higher median age, higher proportion of frailty, and higher Congestive heart failure, Hypertension, Age, Diabetes, previous Stroke/transient ischemic attack, Vascular disease and Sex category (CHA₂DS₂-VASc) score.¹Throughout the 4 years of study duration, patients were followed up every 12 ± 2 months, enabling long-term monitoring of real-world scenarios on edoxaban use.¹ The primary endpoints of this study consisted of the annualized incidence rate of all-cause death, cardiovascular (CV) death, intracranial hemorrhage (ICH), major bleeding, and major gastrointestinal (GI) bleeding events.¹ Secondary endpoints include the annualized incidence rate of stroke, transient ischemic attack (TIA), and systemic embolic event (SEE).¹

The endpoints of this study were the annualized incidence rates of all-cause and CV death, ICH, major bleeding and major GI bleeding.¹ Secondary endpoints include the annualized incidence rate of stroke, TIA and SEE¹

Primary endpoint:

The all-cause mortality rate and CV mortality rate were 4.1%/year and 1.0%/year respectively in the overall population¹

A relatively higher all-cause and CV mortality was reported in the 30mg edoxaban cohort when compared to its 60mg counterpart (All-cause: 8.4%/year vs. 2.8%/year; CV: 2.0%/year vs. 0.7%/year)¹

An annualized incidence rate of 3%/year for any bleeding events was observed in the overall population. The overall incidence rate of major bleeding events, ICH and major GI bleeding all retained <1%/year (Major bleeding events: 0.9%/year; ICH: 0.2%/year; Major GI bleeding: 0.4%/year)¹

When compared to the 60mg edoxaban cohort, slightly higher rates of major bleeding events and major GI bleeding were observed in the 30mg edoxaban cohort (Major bleeding events: 0.7%/year vs. 1.3%/year; Major GI bleeding: 0.3%/year vs. 0.6%/year)¹

The higher incident rates in the 30mg edoxaban group could be attributed to the demographic (i.e., an older population with greater perceived frailty)¹

Secondary endpoints:

The annualized incidence rates of stroke, TIAs, and SEEs of the overall population were minuscule and <1%/year (Stroke: 0.6%/year; TIA: 0.3%/year; SEE: 0.1%/year)¹

The annualized incidence rates of stroke, TIAs, and SEEs were similar, with slightly higher rates of stroke in the 30mg cohort vs. the 60mg cohort (0.9%/year vs. 0.6%/year)¹

Similarly, the higher incident rates in the 30mg edoxaban group could also be attributed to the demographic (i.e., an older population with greater perceived frailty)¹

"The 4-year follow-up data provided robust evidence for the clinical effectiveness and safety of edoxaban in patients with AF."

^{Dr. Raffaele De Caterina

Cardiology Division,

University Hospital of Pisa,

Pisa, Italy}

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