Arrhythmias & electrophysiology

Early Versus Late Initiation of Direct Oral Anticoagulants After Ischemic Stroke in People With Atrial Fibrillation and Hemorrhagic Transformation: Prespecified Subanalysis of the Randomized Controlled ELAN Trial

CirculationPublished Secondary analysis of the ELAN randomised trial

An erratum to this article was published (Circulation, 2 Jul 2024 ↗)

Authors' conclusion

We found no evidence of major treatment effect heterogeneity or safety concerns with early compared with late direct oral anticoagulation initiation in people with and without HT. However, early direct oral anticoagulation initiation may worsen functional outcomes in people with PH.

Study context

Population
People with ischemic stroke and AF, by hemorrhagic transformation (HT: hemorrhagic infarction [hemorrhagic infarction (HI)] or parenchymal hemorrhage [parenchymal hemorrhage (PH)]) on prerandomization imaging247 (12.5%) with HT
Participants
1,970 people
Comparison
Early vs late DOAC initiation, by hemorrhagic transformation
Primary endpoint
Composite of:
  • Recurrent ischemic stroke
  • Symptomatic intracranial hemorrhage
  • Major extracranial bleeding
  • Systemic embolism
  • Vascular death
Follow-up
30 days
Methodological detailspost hoc analysis, core laboratory imaging rating
  • Post hoc analysis
  • Core laboratory imaging rating

Primary result

As reported in the abstract

Primary composite outcome, by HT
Early vs LateAdjusted risk difference (95% CI)
HT
−2.2%(−7.8% to 3.5%)
HI
−4.7%(−10.8% to 1.4%)
PH
6.1%(−8.5% to 20.6%)
No HT
−0.9%(−2.6% to 0.8%)

Secondary outcomes

OutcomeAdjusted risk difference (95% CI)
Poor functional outcome (mRS 3-6), by HT · 90 daysEarlyvs LateHT11.5% (−0.8% to 23.8%)
Poor functional outcome (mRS 3-6), by HT · 90 daysEarlyvs LateHI7.4% (−6.4% to 21.2%)
Poor functional outcome (mRS 3-6), by HT · 90 daysEarlyvs LatePH25.1% (0.2%–50.0%)
Poor functional outcome (mRS 3-6), by HT · 90 daysEarlyvs LateNo HT−2.6% (−7.1% to 1.8%)

Safety

Symptomatic intracranial hemorrhage

Numbers identical in people with and without HT

Original publication

Early Versus Late Initiation of Direct Oral Anticoagulants After Ischemic Stroke in People With Atrial Fibrillation and Hemorrhagic Transformation: Prespecified Subanalysis of the Randomized Controlled ELAN Trial. Circulation. Published 16 May 2024. doi:10.1161/circulationaha.124.069324

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