Early initiation of direct oral anticoagulants in Asian patients with acute ischemic stroke and atrial fibrillation yielded a 30-day primary composite outcome rate of 4.8% versus 8.3% for late initiation (aOR 0.53), demonstrating consistent treatment effects across Asian and non-Asian regions without increasing symptomatic intracranial hemorrhage.
RCT (n=1,975)
Open-label, assessor-blinded
Randomized to early or late DOAC initiation
Yes
Does early DOAC initiation improve outcomes compared to late initiation in Asian versus non-Asian patients with acute ischemic stroke and atrial fibrillation?
Early DOAC initiation in acute ischemic stroke patients with atrial fibrillation shows consistent treatment effects across Asian and non-Asian populations, supporting its generalizability without region-specific timing modifications.
Effect estimate: aOR 0.53 (95% CI 0.19-1.47)
Absolute Event Rate: 4.8% vs 8.3%
Background and Purpose We aimed to evaluate whether early versus late initiation of direct oral anticoagulant (DOAC) after acute ischemic stroke (AIS) yields different safety and efficacy outcomes in Asian versus non-Asian patients.Methods We analyzed Early versus Late initiation of direct oral Anticoagulants in post-ischaemic stroke patients with atrial fibrillatioN (ELAN) trial data from 2,013 AIS patients with atrial fibrillation (AF) randomized to early (≤48 hours for minor/moderate stroke, 6–7 days for major stroke) or late DOAC initiation (3–4 days for minor ischemic stroke, 6–7 days for moderate ischemic stroke, 12–14 days for major ischemic stroke). Patients were categorized by region as Asian (Japan and India) or non-Asian. The primary outcome was a composite of major extracranial bleeding, symptomatic uncerintracranial hemorrhage (SICH), recurrent ischemic stroke, systemic embolism (SE), or vascular death at 30 days (trial registration: ClinicalTrials.gov number, NCT03148457).Results Among 1,975 patients, 245 were Asian (192 from Japan and 53 from India) and 1,730 were non-Asian. The primary outcome occurred in 6.5% of Asian patients (4.8% early vs. 8.3% late) and 3.1% of non-Asian patients (2.7% vs. 3.6%) (pp=0.02) and SE (2.0% 0.8% vs. 3.3% vs. 0.5% 0.4% vs. 0.6%, p=0.02) accounted for this difference. No significant differences were observed in major extracranial bleeding, SICH, recurrent ischemic stroke, SE, or vascular death. No significant interaction was observed between region and treatment allocation.Conclusions Although Asian patients had worse baseline profiles and outcomes, treatment effects did not differ by region, supporting the generalizability of early DOAC initiation in Asian AIS patients without region-specific timing modifications.
Yoshimoto et al. (Fri,) conducted a rct in Acute ischemic stroke with atrial fibrillation (n=1,975). Early DOAC initiation vs. Late DOAC initiation was evaluated on Composite of major extracranial bleeding, symptomatic intracranial hemorrhage, recurrent ischemic stroke, systemic embolism, or vascular death at 30 days (Asian subgroup) (aOR 0.53, 95% CI 0.19-1.47). Early initiation of direct oral anticoagulants in Asian patients with acute ischemic stroke and atrial fibrillation yielded a 30-day primary composite outcome rate of 4.8% versus 8.3% for late initiation (aOR 0.53), demonstrating consistent treatment effects across Asian and non-Asian regions without increasing symptomatic intracranial hemorrhage.