Four-year follow-up data reinforces the consistent effectiveness and safety of treatment with edoxaban in patients with atrial fibrillation (AF)

Daiichi Sankyo Europe (hereafter, Daiichi Sankyo) today announced new edoxaban data presented at the European Society of Cardiology (ESC) Congress 2023. These include findings from the four-year follow-up data from routine clinical practice via the ETNA-AF observational non-interventional study, reinforcing the efficacy and safety profile of edoxaban seen in randomised clinical trials in atrial fibrillation (AF) patient populations over the long-term.^1,2

Data from a multivariate analysis of the ETNA-AF involving 13,164 patients across ten European countries, show treatment with either 30 mg or 60 mg of edoxaban over four years in patients with AF is associated with a low annualised rate of all-cause death, ischaemic stroke and major bleeding.¹ Annualised rates of all-cause and cardiovascular deaths in the overall populations were 4.1%/year and 1.0%/year, respectively; higher in the edoxaban 30 mg versus 60 mg cohort.¹ The annualised rates of stroke, transient ischaemic attack and systemic embolic events were also low (0.6%/year, 0.3%/year and 0.1%/year) with proportions similar across both dosing cohorts.¹

In addition, major bleeding rates, intracranial haemorrhage (ICH) and major gastrointestinal bleeding rates were also low (0.9%/year, 0.2%/year and 0.4%/year, respectively). However, there was a higher incidence of major bleeding and major GI bleeding in patient treated with 30 mg edoxaban compared to 60 mg.¹ Notably, these higher event rates were potentially due to the older population with greater perceived frailty receiving 30 mg dosing (27.0% frail in 30 mg vs. 6.6% in 60 mg dose groups).¹

Frailty is common in patients with AF and requires a tailored approach to treatment as outlined in the EHRA Practical Guide on the Use of NOACS in AF.⁴ Sub-analysis data from the ETNA-AF Europe study highlight that both physician perceived frailty and objective frailty has a similar trend in terms of outcome events.² An assessment of frailty within ETNA-AF Europe showed that more patients were perceived as frail versus those who were objectively determined as frail by the Modified Frailty Index (10.7% [n=1,410] vs. 4.1% [n=540]).² Across both patient groups, frailty was associated with additional comorbidities including diabetes, heart failure and hypertension. However, the proportion of patients with comorbidities was higher in patients with objective frailty. Non-recommended dosing of edoxaban was found to be more often prescribed in the frail patient population versus non-frail patients. Data show that after four years of edoxaban treatment, even though ICH risk was increased in frail subjects, its cumulative incidence was low.²

“The four-year ETNA-AF data again reinforces the clinical benefit of using NOACs in AF patients, particularly for those where comorbidities such as diabetes, heart failure or frailty must also be carefully managed; providing further reassurance for our clinical practice,” said Professor Raffaele De Caterina, Professor of Cardiology, University of Pisa and Director of University Cardiology Division, Pisa University Hospital, Italy. “The findings, along with the insights into the need for better categorisation and treatment of our frail AF patients highlights the need for decision making to be grounded in guidelines and applied personally to each patient we see.”

Data from global programmes adds to the body of evidence for edoxaban.

The following studies are also being presented at the ESC Congress 2023, further adding to the wealth of safety and efficacy data for edoxaban:

• Persistence to edoxaban treatment in patients with atrial fibrillation: Analysis from the global ETNA-AF program.⁵
• Baseline demographic and clinical characteristics as predictors of adverse outcomes to improve management of patients with AF receiving edoxaban: A sub-analysis of the ETNA-AF registry.⁶
• Clinical outcomes in patients receiving oral anticoagulation stratified by the presence of dose reduction criteria and older age: a sub-analysis of ENVISAGE-TAVI AF.⁷
• Edoxaban vs. vitamin-K antagonist in atrial fibrillation patients: An integrated analysis of outcomes parameters of randomized controlled clinical trials.⁸

“The breadth of evidence presented at this year’s European Society of Cardiology Congress demonstrates the real need to continue to understand treatments beyond clinical trials and into routine care,” said Dr Stefan Seyfried, Vice President, Medical Affairs, Specialty Medicines, Daiichi Sankyo Europe GmbH. “At Daiichi Sankyo we are dedicated to sharing scientific data and enriching the understanding of our treatments, and NOACs, among clinicians, empowering them to make informed decisions in clinical practice with the joint goal of reducing the impact of CVD felt by patients and their loved ones.”

In addition, findings from NOAH-AFNET 6, a clinical study to investigate the efficacy and safety of oral anticoagulation in patients with atrial high-rate episodes (AHRE) but without ECG-documented AF, have been presented in an ESC Hotline session and simultaneously published in the New England Journal of Medicine. ^9,10,11 This Investigator Initiated Study (IIS) involved a patient population outside the approved indications for edoxaban and demonstrated that those patients are better managed without anticoagulation. The study showed that anticoagulation treatment did not further reduce the low rate of stroke in AHRE patients.^10,11 However, and as expected, it increased bleeding compared to the study arm without anticoagulation.^10,11 Furthermore, it makes the case for the need for ECG-documented AF before treatment initiation with anticoagulation in this patient population as well as further research to understand stroke risk in AHRE.^10,11

-ENDS-

About ETNA-AF: https://www.daiichi-sankyo.eu/media/edoxaban-info/

About AF: https://www.daiichi-sankyo.eu/media/edoxaban-info/

About Edoxaban: https://www.daiichi-sankyo.eu/media/edoxaban-info/

About ENVISAGE-TAVI AF: https://www.daiichi-sankyo.eu/media/edoxaban-info/

About Daiichi Sankyo

Daiichi Sankyo is an innovative global healthcare company contributing to the sustainable development of society that discovers, develops, and delivers new standards of care to enrich the quality of life around the world. With more than 120 years of experience, Daiichi Sankyo leverages its world-class science and technology to create new modalities and innovative medicines for people with cancer, cardiovascular, and other diseases with high unmet medical need. For more information, please visit www.daiichisankyo.com.

References

¹ Kirchhof P., et al. Long-term effectiveness and safety of edoxaban in patients with atrial fibrillation: 4-year follow-up of more than 13,000 patients from the ETNA-AF-Europe study. Presented at ESC Congress 2023.
² Fuamgalli S., et al. Effect of perceived and objectively-assess frailty on outcomes in edoxaban-treated patients with atrial fibrillation: data from the ETNA-AF-Europe 4-year follow-up. Presented at ESC Congress 2023.
³ De Caterina R., et al. Design and rationale of the Edoxaban Treatment in routine clinical proactive for patients with Atrial Fibrillation in Europe (ETNA-AF-Europe) study. J Cardiovasc Med. 20(2):97–104.
⁴ Steffel J., et al. European Heart Rhythm Association Practical Guide on the Use of Non-Vitamin K antagonist Oral Anticoagulants in Patients with Atrial Fibrillation. Europace. 2021; 23: 1612–1676.
⁵ Diemberger I., et al. Persistence to edoxaban treatment in patients with atrial fibrillation: Analysis from the Global ETNA-AF program. Presented at ESC Congress 2023.
⁶ Morrone D., et al. Baseline demographic and clinical characteristics as predictors of adverse outcomes to improve management of patients with AF receiving edoxaban: A subanalysis of the ETNA-AF registry. Presented at ESC Congress 2023.
⁷ Van Mieghem N.M., et al. Clinical outcomes in patients receiving oral anticoagulation stratified by the presence of dose reduction criteria and older age: a subanalysis of ENVISAGE-TAVI AF. Presented at ESC Congress 2023.
⁸ Dangas G., et al. Edoxaban vs. Vitamin-K Antagonist in Atrial Fibrillation Patients: An Integrated Analysis of Outcomes Parameters of Randomized Controlled Clinical Trials. Presented at ESC Congress 2023.
⁹ Atrial Fibrillation Network. Patients with rare and short atrial arrhythmias do not benefit from anticoagulation. Available at: https://www.kompetenznetz-vorhofflimmern.de/en/artikel/327 Last accessed August 2023.
¹⁰ Kirchhof P, et al. Anticoagulation with edoxaban in patients with atrial high rate episodes. N Engl J Med. August 25, 2023. DOI: 10.1056/NEJMoa2303062.
¹¹ Kirchhof P., et al. NOAH-AFNET 6: Oral anticoagulation in patients with atrial high rate episodes. Hot line 1. Presented at ESC Congress 2023.

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Contact information

Dr. Wolfgang Schiessl
Daiichi Sankyo Europe GmbH
PR & Portfolio Communication Lead, Specialty Medicines
+49 151 1714 7317