One year follow-up results with Lixiana shows low rates of bleeding in non-valvular atrial fibrillation.- Daiichi Sankyo

Daiichi Sankyo Europe announced one-year follow-up results from an analysis of 12,574 European non-valvular atrial fibrillation (NVAF) patients, mostly elderly, treated with Lixiana (edoxaban). Overall, results from ETNA-AF at one year showed low rates of bleeding (major and gastrointestinal [GI]), intracranial haemorrhage (ICH) and ischaemic events during the first year of edoxaban therapy.

Per year, in the 12,574 patients from 825 sites in Europe: ISTH-defined major bleeding occurred in only 125 (1.05%) patients, ICH occurred in 28 (0.23%) patients, and major GI bleeding occurred in 47 (0.39%) patients. Ischaemic stroke occurred in 65 (0.54%) patients, transient ischaemic attack (TIA) occurred in 44 (0.37%) patients, and haemorrhagic stroke occurred in 13 (0.11%) patients. Rates of systemic embolic events (SEE) and myocardial infarction (MI) were generally low. Per year in Europe: SEE occurred in 13 (0.11%) patients; MI occurred in 63 (0.53%) patients. 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.

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