Lancet

When to start anticoagulation after ischemic stroke in patients with afib: OPTIMAS trial results

November 18, 2024

Among patients with afib, early initiation of direct oral anticoagulants (DOACs) within 4 days after ischemic stroke was noninferior to delayed initiation with regards to the composite outcome of ischemic stroke, intracranial hemorrhage, unclassifiable stroke, or systemic embolism at 90 days. The findings don’t support the current guideline-supported practice of delaying DOAC initiation after ischemic stroke in patients with afib.

This multicenter, open-label, blinded-endpoint, parallel-group, phase 4, randomized controlled trial included adults with afib and a clinical diagnosis of acute ischemic stroke and whose physician was uncertain of the optimal timing for DOAC initiation. Participants were randomly assigned (1:1) to early (≤4 days from stroke symptom onset) or delayed (7–14 days) anticoagulation initiation with any DOAC. Primary outcome was a composite of recurrent ischemic stroke, symptomatic intracranial hemorrhage, unclassifiable stroke, or systemic embolism incidence at 90 days.

Between July 2019 and Jan 2024, 3,648 patients were randomly assigned to early or delayed DOAC initiation, of whom 27 didn’t fulfill eligibility criteria or withdrew consent, leaving 3,621 patients in the modified intention-to-treat analysis. The rate of the primary outcome was 3.3% in both the early and delayed DOAC initiation groups (p = 0.0003 for noninferiority). The rate of symptomatic intracranial hemorrhage was 0.6% in the early DOAC initiation group vs. 0.7% in the delayed DOAC initiation group (p = 0.78).

Source:

Werring DJ, et al; OPTIMAS investigators. (2024, November 2). Lancet. Optimal timing of anticoagulation after acute ischaemic stroke with atrial fibrillation (OPTIMAS): a multicentre, blinded-endpoint, phase 4, randomised controlled trial. https://pubmed.ncbi.nlm.nih.gov/39491870/