ELAN
Trial question
What is the effect of early initiation of direct oral anticoagulation in patients with AF who have had an AIS?
Study design
Multi-center
Open label
RCT
Population
Characteristics of study participants
45.0% female
55.0% male
N = 2013
2013 patients (915 female, 1098 male).
Inclusion criteria: patients with AF who have had an AIS.
Key exclusion criteria: AF due to reversible causes; valvular disease requiring surgery; mechanical heart valve; moderate or severe MS; AF and conditions other than AF that require anticoagulation; contraindication to DOACs; pregnancy or lactation.
Interventions
N=1006 early treatment (anticoagulation initiation within 48 hours after a minor or moderate stroke or day 6 or 7 after major stroke).
N=1007 later treatment (anticoagulation initiation on 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).
Primary outcome
Recurrent ischemic stroke, systemic embolism, major extracranial bleeding, symptomatic intracranial hemorrhage, or vascular death at day 30
2.9%
4.1%
4.1 %
3.1 %
2.0 %
1.0 %
0.0 %
Early
treatment
Later
treatment
No significant
difference ↔
No significant difference in recurrent ischemic stroke, systemic embolism, major extracranial bleeding, symptomatic ICH, or vascular death at day 30 (2.9% vs. 4.1%; OR 0.7, 95% CI 0.44 to 1.14).
Secondary outcomes
Significant decrease in recurrent ischemic stroke, systemic embolism, major extracranial bleeding, symptomatic ICH, or vascular death at day 90 (3.7% vs. 5.6%; OR 0.65, 95% CI 0.42 to 0.99).
No significant difference in major extracranial bleeding at day 30 (0.3% vs. 0.5%; OR 0.63, 95% CI 0.15 to 2.38).
No significant difference in recurrent ischemic stroke at day 30 (1.4% vs. 2.5%; OR 0.57, 95% CI 0.29 to 1.07).
Safety outcomes
No significant difference in serious adverse event by day 90.
Conclusion
In patients with AF who have had an AIS, early treatment was not superior to later treatment with respect to recurrent ischemic stroke, systemic embolism, major extracranial bleeding, symptomatic ICH, or vascular death at day 30.
Reference
Urs Fischer, Masatoshi Koga, Daniel Strbian et al. Early versus Later Anticoagulation for Stroke with Atrial Fibrillation. N Engl J Med. 2023 Jun 29;388(26):2411-2421.
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