Early Administration Of DOACs After Ischaemic Stroke Safe and effective in AF patients

A recent study published in The New England Journal Of Medicine, known as the ELAN trial, has revealed that starting anticoagulation treatment soon after an acute ischemic stroke is not only safe but may also improve outcomes for patients with atrial fibrillation. The effect of early as compared with later initiation of direct oral anticoagulants (DOACs) in persons with atrial fibrillation who have had an acute ischemic stroke is unclear.

The researchers Urs Fischer and team performed an investigator-initiated, open-label trial at 103 sites in 15 countries. Participants were randomly assigned in a 1:1 ratio to early anticoagulation (within 48 hours after a minor or moderate stroke or on day 6 or 7 after a major stroke) or later anticoagulation (day 3 or 4 after a minor stroke, day 6 or 7 after a moderate stroke, or day 12, 13, or 14 after a major stroke). Assessors were unaware of the trial-group assignments. The primary outcome was a composite of recurrent ischemic stroke, systemic embolism, major extracranial bleeding, symptomatic intracranial haemorrhage, or vascular death within 30 days after randomization. Secondary outcomes included the components of the composite primary outcome at 30 and 90 days.

The findings of the study were:

● Of 2013 participants (37% with minor stroke, 40% with moderate stroke, and 23% with major stroke), 1006 were assigned to early anticoagulation and 1007 to later anticoagulation.

● A primary-outcome event occurred in 29 participants (2.9%) in the early-treatment group and 41 participants (4.1%) in the later-treatment group (risk difference, −1.18 percentage points; 95% confidence interval [CI], −2.84 to 0.47) by 30 days.

● Recurrent ischemic stroke occurred in 14 participants (1.4%) in the early-treatment group and 25 participants (2.5%) in the later-treatment group (odds ratio, 0.57; 95% CI, 0.29 to 1.07) by 30 days and in 18 participants (1.9%) and 30 participants (3.1%), respectively, by 90 days (odds ratio, 0.60; 95% CI, 0.33 to 1.06).

● Symptomatic intracranial haemorrhage occurred in 2 participants (0.2%) in both groups by 30 days.

To further enhance the evidence base, the OPTIMAS trial is currently underway in the United Kingdom, focusing on investigating the optimal timing of anticoagulation after acute ischemic stroke. The results of this study, when combined with those of the ELAN trial, will provide clinicians with even more comprehensive data to guide decision-making and improve patient outcomes.

The ELAN trial has shed new light on the early initiation of anticoagulation after ischemic stroke. The study's findings suggest that starting anticoagulation treatment soon after stroke is not only safe but may also offer potential benefits in terms of reducing recurrent strokes and improving overall outcomes for patients with atrial fibrillation.

Reference:

New England Journal of MedicineFischer U, et al "Early vs late anticoagulation in stroke patients with atrial fibrillation" N Engl J Med 2023; DOI: 10.1056/NEJMoa2303048.