CTU Bern

ELAN trial: Results published

Early Versus Late Initiation of Direct Oral Anticoagulants After Ischemic Stroke in People With Atrial Fibrillation (ELAN study): sub-analyses in Stroke Sizes and Hemorrhagic Transformation.

20.06.2024 – After the completion and publication of the results of the ELAN trial, the team pursued the work on its data and achieved to publish the first two important sub-analyses.

The first one focuses on the infarct size (measured as minor, moderate and late) and the safety and efficacy associated to early vs late initiation of direct oral anticoagulation (DOAC). In this analysis, 1962 participants were included in the main analysis. The primary outcome (composite of recurrent ischemic stroke, symptomatic intracranial hemorrhage, extracranial bleeding, systemic embolism, or vascular death within 30 days) occurred in 10 of 371 participants (2.7%) with early DOAC initiation vs 11 of 364 (3.0%) with late DOAC initiation among those with minor stroke (odds ratio [OR], 0.89; 95% CI, 0.38-2.10); in 11 of 388 (2.8%) with early DOAC initiation vs 14 of 392 (3.6%) with late DOAC initiation among those with moderate stroke (OR, 0.80; 95% CI, 0.35-1.74); and in 8 of 219 (3.7%) with early DOAC initiation vs 16 of 228 (7.0%) with late DOAC initiation among those with major stroke (OR, 0.52; 95% CI, 0.21-1.18).

The second analysis had the objective to understand the treatment effect of early vs late initiation of DOAC in people with and without hemorrhagic transformation (HT). In the analysis, the outcome was estimated based on HT, subclassified as hemorrhagic infarction (HI) or parenchymal hemorrhage (PH) on pre-randomization imaging (core-lab rating) using adjusted risk differences (aRD) between treatment arms. The results show that overall, 247/1970 (12.5%) participants had HT (114 HI 1, 77 HI 2, 34 PH 1, 22 PH 2). For the primary outcome, the estimated adjusted risk difference (early versus late) was −2.2% (−7.8 to 3.5%) in people with HT (HI: −4.7%, −10.8 to 1.4%; PH: 6.1%, −8.4 to 20.7%), and −0.9% (−2.6 to 0.8%) in people without.

CTU Bern was involved and significantly contributed in the planning and statistical analysis of the sub-analyses of the trial.

You can view the publications here: