Arrhythmias & electrophysiologySecondary analysis
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
- Secondary analysis of the ELAN randomised trial
- post hoc analysis
- core laboratory imaging rating
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
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
| Outcome | adjusted risk difference (95% CI) | |
|---|---|---|
| Poor functional outcome (mRS 3-6), by HT · 90 days — Early vs Late · HT | 11.5% (−0.8% to 23.8%) | |
| Poor functional outcome (mRS 3-6), by HT · 90 days — Early vs Late · HI | 7.4% (−6.4% to 21.2%) | |
| Poor functional outcome (mRS 3-6), by HT · 90 days — Early vs Late · PH | 25.1% (0.2%–50.0%) | |
| Poor functional outcome (mRS 3-6), by HT · 90 days — Early vs Late · no HT | −2.6% (−7.1% to 1.8%) | |
| −200204060Difference (linear scale) |
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
Summarised from the published abstract; every number is checked against it