One-year follow-up results from an analysis of 12,574 European non-valvular atrial fibrillation (NVAF) patients, mostly elderly, treated with edoxaban (Lixiana) showed low rates of potentially life-threatening bleeding and low cardiovascular events.

The results from the ongoing Global ETNA-AF (Edoxaban Treatment in routiNe clinical prActice) registry, providing a snapshot of characteristics and outcomes from a broad range of NVAF patients receiving edoxaban in routine clinical care, were presented at the Great Wall International Congress of Cardiology (GW-ICC) 2019, in Beijing, China.

Overall, results from ETNA-AF at one year showed low rates of bleeding (major and gastrointestinal) intracranial haemorrhage and ischaemic events during the first year of edoxaban therapy.

Per year, in the 12,574 patients from 825 sites in Europe, major bleeding occurred in only 125 (1.05%) patients, intracranial haemorrhage occurred in 28 (0.23%) patients, and major gastrointestinal bleeding occurred in 47 (0.39%) patients. Ischaemic stroke occurred in 65 (0.54%) patients, transient ischaemic attack occurred in 44 (0.37%) patients, and haemorrhagic stroke occurred in 13 (0.11%) patients.

Rates of systemic embolic events (13 (0.11%) patients) and myocardial infarction (63 (0.53%) patients) were generally low. Additionally, mortality rates were low. In total, per year in Europe all-cause mortality occurred in 425 (3.55%) patients and cardiovascular mortality occurred in 200 (1.67%) patients.

Cardiovascular events were low in older patients

While rates of stroke, bleeding and all-cause and cardiovascular mortality increased with age, an age-related increase in intracranial haemorrhage was not apparent and rates were low in each age group.

“In routine clinical practice, the rates of major and clinically-relevant non-major (CRNM) bleeding in elderly edoxaban-treated patients were lower than those observed in clinical trial settings. Additionally, rates of all other cardiovascular events were also low in these patients,” said Professor Raffaele De Caterina, Professor of Cardiology, Institute of Cardiology at the University of Pisa, Italy. “Atrial fibrillation is the most common form of arrhythmia in patients over the age of 65, and its prevalence increases with age. As such, it is critical that we understand the safety and efficacy profile of edoxaban in elderly populations.”

The wider Global ETNA-AF programme, which at present is the largest and most comprehensive repository of routine clinical practice data on the use, effectiveness, and safety of a single NOAC in patients with atrial fibrillation, collected data from 24,962 patients in 2,242 sites in Japan, Korea/Taiwan and Europe.