One year follow up on ETNA-AF-Europe registry with Lixiana shows efficacy in non-valvular atrial fibrillation.- Daiichi Sankyo

Daiichi Sankyo Europe announced the publication of one-year follow up results from the ongoing ETNA-AF-Europe registry with Lixiana/Savaysa (edoxaban) for patients with non-valvular Atrial Fibrillation, published in the European Heart Journal - Cardiovascular Pharmacotherapy. According to the authors' assessment, the one-year follow-up ETNA-AF-Europe dataset demonstrates a low and constant rate of intracranial haemorrhage (ICH) in both ageing and younger patients with AF. The overall rates of major bleeding, stroke, and systemic embolism, as well as all-cause mortality, were considered by the authors to be low and linearly increasing during the one-year follow-up. Major bleeding events were reported in 132 patients (1.05%/year), of which 51 (0.4%/year) were gastro-intestinal and 30 (0.2%/year) were ICH. Stroke or systemic embolism occurred in 103 patients (0.82%/year). In total, 442 patients died (3.5%/year), of whom 206 patients (1.63%/year) died of cardiovascular causes. Findings observed in ETNA-AF-Europe were in line with those reported for a cohort of patients of the ENGAGE AF-TIMI 48 study, who did not self-identify as Asians. Notably, the permanent discontinuation rate at one year was considered by the authors to be relatively low (9.1%) compared with a similar PASS registry with a different DOAC, which reported a discontinuation rate of 20.1% at one year. The wider global ETNA-AF programme has so far collected data from 24,962 patients in 2,242 sites in Japan, Korea/Taiwan and Europe. The study is part of the Edoxaban Clinical Research Programme, which includes more than 10 randomised, controlled trials, registries and non-randomised clinical studies.