Atrial fibrillation (AF) is the most common type of arrhythmia with an estimated prevalence in adults between 2% and 4% according to the European Society for Cardiology. The cause is a disorder in the heart's electrical system. AF can lead to an increased risk of stroke and death. Patients with AF are also twice as likely to be hospitalized compared to individuals without AF of the same age and gender.
Anticoagulants, or blood thinners, keep blood clots from getting larger and stop the formation of further clots, preventing strokes or heart failure. It is therefore recommended in those patients with AF who are at moderate or high risk of experiencing stroke. International guidelines for the management of AF highlight the importance of maintaining anticoagulation in these patients unless there are contraindications such as serious bleeding.
Edoxaban is an oral anticoagulant approved in 2015 for prevention of stroke and systemic embolism in patients with non-valvular atrial fibrillation (NVAF).
An European prospective clinical study (ETNA-AF) is ongoing to understand the risks and benefits of using edoxaban in real-world clinical settings and to gain insight into efficacy (i.e. recurrence of blood clots) and safety (i.e. bleeding events and adverse reactions to the medication) in NVAF patients..
The main objective of this study is to replicate the analyses planned in the ETNA-AF study using secondary health data of patients who has been prescribed edoxaban collected in daily practice in the UK and compare the results.
Daiichi-Sankyo is currently undertaking a non-interventional multicountry post-approval safety study (ETNA-AF study - EU-PAS register numbers EUPAS8896), in order to gain insight into the safety of edoxaban in non-preselected patients with non-valvular atrial fibrillation (NVAF) treated with edoxaban.
In this non-interventional retrospective study, we aim to evaluate the safety and efficacy of edoxaban in patients diagnosed with NVAF between 2015 and 2021 in the United Kingdom, using electronic medical record from the Clinical Practice Research Datalink (CPRD) Aurum with linkage to Hospital Episode Statistics (HES) databases. This study will be used to put in perspective the results of the ETNA-AF study pertaining to UK centers.
We will use Hospital Episode Statistics (HES) data to identify clinical events of interest, hospitalizations for all causes or related to specific conditions. Linkage to Office of National Statistic (ONS) will allow the determination of mortality rates (all-causes or Cardiovascular-specific).
The primary analysis will estimate the frequency of occurrence of safety events including major bleeding events, non-major bleeding events, drug-related adverse events and mortality in patients with NVAF treated with edoxaban during an overall observational period of up to 4 years.
The secondary analysis will assess the frequency of occurrence during the follow-up period of the following endpoint: stroke (ischaemic, haemorrhagic and unknown type), systemic embolic events (SEE), Transient ischemic attack (TIA), Myocardial infarction (MI), hospitalizations related to cardiovascular condition (including AF-related hospitalization) and MACE (major adverse cardiovascular events, composite endpoint of non-fatal MI, non-fatal stroke, non-fatal SEE and death due to CV cause or bleeding)
For each endpoint, a Kaplan-Meier plot will be displayed and the proportion of patients with at least one event of interest will be also provided.
Any bleeding; Major bleeding including gastrointestinal bleeding and Intracranial hemorrhage; Non-major bleeding; Adverse drug reactions (listed in the Summary of Product Characteristics); All-cause mortality; Cardiovascular-related mortality; Stroke (All type; Ischemic stroke; Hemorrhagic stroke; unknown type); Systemic embolic events (SEE); Transient ischemic attack (TIA); Myocardial infarction (MI); Hospitalizations related to cardiovascular (CV) condition (including AF related hospitalization); Major adverse cardiovascular events (MACE, composite endpoint of non-fatal MI, non-fatal stroke, non-fatal SEE and death due to CV cause or bleeding)
FLORENT Guelfucci - Chief Investigator - Syneos Health Commercial France SARL
FLORENT Guelfucci - Corresponding Applicant - Syneos Health Commercial France SARL
Armel Ngami - Collaborator - Syneos Health Commercial France SARL
Eva-Maria Fronk - Collaborator - Daiichi Sankyo Europe GmbH (Germany)
Katharina Wenz-Poeschl - Collaborator - Daiichi Sankyo Europe GmbH (Germany)
Petra Laeis - Collaborator - Daiichi Sankyo Europe GmbH (Germany)
Ruediger Smolnik - Collaborator - Daiichi Sankyo Europe GmbH (Germany)
HES Accident and Emergency;HES Admitted Patient Care;HES Diagnostic Imaging Dataset;HES Outpatient;ONS Death Registration Data