Optimal Timing of Anticoagulation After Acute Ischemic Stroke - OPTIMAS

Nov 05, 2024
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Author/Summarized by Author:
Anthony A. Bavry, MD,MPH,FACC
Summary Reviewer:
Kim A. Eagle, MD, MACC
Trial Sponsor:
British Heart Foundation
Date Published:
11/02/2024
Original Posted Date:
11/05/2024
References

Contribution To Literature:

The OPTIMAS trial showed that early initiation of a DOAC after acute ischemic stroke associated with atrial fibrillation is noninferior to late initiation of a DOAC.

Description:

The goal of the trial was to evaluate early compared with late initiation of direct oral anticoagulants (DOACs) among patients with acute ischemic stroke associated with atrial fibrillation.

Study Design

  • Randomized
  • Parallel
  • Open-label

Patients with acute ischemic stroke associated with atrial fibrillation were randomized to early (≤4 days from stroke onset) initiation of any DOAC (n = 1,824) vs. late (7-14 days from stroke onset) initiation of any DOAC (n = 1,824).

  • Total number of enrollees: 3,648
  • Duration of follow-up: 90 days
  • Mean patient age: 79 years
  • Percentage female: 45%
  • Percentage with diabetes: 22%

Inclusion criteria:

  • Patients ≥18 years of age with acute ischemic stroke associated with atrial fibrillation

Exclusion criteria:

  • Coagulopathy or current use of a vitamin K antagonist
  • Thrombocytopenia
  • Hemorrhagic transformation of the acute infarct
  • Acute intracranial hemorrhage unrelated to the acute infarct
  • Cirrhosis
  • Contraindication to a DOAC

Other salient features/characteristics:

  • The most commonly initiated DOAC: apixaban in 63%

Principal Findings:

The primary outcome, recurrent ischemic stroke, symptomatic intracranial hemorrhage, unclassifiable stroke, or systemic embolism incidence at 90 days, was 3.3% in the early group vs. 3.3% in the delayed group (p for noninferiority = 0.0003; p for superiority = 0.96).

Secondary outcomes:

  • Symptomatic intracranial hemorrhage: 0.6% of the early group vs. 0.7% of the late group (p = 0.78)
  • Major extracranial hemorrhage: 0.4% of the early group vs. 0.7% of the late group (p = 0.16)

Interpretation:

Among patients with acute ischemic stroke associated with atrial fibrillation, early initiation of a DOAC was noninferior to late initiation of a DOAC. The primary outcome of recurrent ischemic stroke, symptomatic intracranial hemorrhage, unclassifiable stroke, or systemic embolism incidence at 90 days was similar between the early vs. late DOAC initiation groups. The incidence of intracranial and extracranial hemorrhage was also similar between treatment groups. These results challenge the current practice to delay DOAC initiation after ischemic stroke with atrial fibrillation.

References:

Werring DJ, Dehbi HM, Ahmed N, et al., on behalf of the OPTIMAS investigators. Optimal timing of anticoagulation after acute ischemic stroke with atrial fibrillation (OPTIMAS): a multicenter, blinded-endpoint, phase 4, randomized controlled trial. Lancet 2024;404:1731-41.

Clinical Topics: Anticoagulation Management, Arrhythmias and Clinical EP, Anticoagulation Management and Atrial Fibrillation, Atrial Fibrillation/Supraventricular Arrhythmias, Vascular Medicine

Keywords: Anticoagulants, Atrial Fibrillation, Ischemic Stroke


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