1. In this randomized controlled trial of patients with atrial fibrillation who had an acute ischemic stroke, early versus late anticoagulation resulted in a comparable incidence of 30-day adverse events.
2. Risk of death from any cause or disability was similar at 90 days between the early and late anticoagulation groups.
Evidence Rating Level: 1 (Excellent)
Study Rundown: Patients with atrial fibrillation are at an increased risk for developing ischemic stroke and emboli. Anticoagulation with direct oral anticoagulants (DOACs) is essential for prophylaxis. However, following an acute ischemic stroke, it is unclear whether early initiation of anticoagulation is advantageous in preventing early stroke recurrence compared to later initiation. Particularly, when an increased risk of intracranial hemorrhage associated with early anticoagulation is considered. This study was an open-label randomized trial to compare early anticoagulation against later anticoagulation among patients with pre-existing or newly diagnosed atrial fibrillation. The results found that the composite primary outcome assessing ischemic, embolic, and hemorrhagic events and vascular death by 30 days did not differ significantly between the two groups. The risks of individual events were also comparable. Study limitations included the exclusion of patients with hemorrhagic transformation of the infarct or those already receiving anticoagulation as well as the predominantly White study population. Overall, these results demonstrated that early anticoagulation may not significantly impact clinical outcomes compared to later anticoagulation among stroke patients with atrial fibrillation.
Click here to read the study in NEJM
In-Depth [randomized controlled trial]: The current study was an open-label, randomized controlled trial comparing the effects of early anticoagulation versus later anticoagulation following an acute ischemic stroke in patients with atrial fibrillation. Ischemic stroke was confirmed via imaging and categorized as minor, moderate, or large based on infarct size and the affected cerebral arteries. Exclusion criteria included previous anticoagulation at stroke onset, parenchymal hematoma within infarcted tissue, or concurrent intracranial hemorrhage. Overall, 2,013 patients (37% with minor stroke, 40% with moderate stroke, and 23% with major stroke) were randomized 1:1 to receive early or later anticoagulation with a DOAC (guided by the stroke category). The primary outcome was the composite of recurrent ischemic stroke, systemic embolism, major extracranial bleeding, symptomatic intracranial hemorrhage, or vascular death by 30 days. Secondary outcomes included components of the primary outcome at 30 and 90 days, and disability (assessed by the modified Rankin scale). The primary outcome event occurred in 2.9% of the early-anticoagulation group and 4.1% of the later-anticoagulation group (risk difference, -1.18 percentage points; 95% Confidence Interval [CI], -2.84 to 0.47). Recurrent ischemic stroke occurred in 1.4% of the early-anticoagulation group and 2.5% of the later-coagulation group (odds ratio, 0.57; 95% CI, 0.29 to 1.07) at 30 days. At 90 days, the odds ratio was 0.60 (95% CI, 0.33 to 1.06). Secondary outcomes did not differ significantly between the two groups. In summary, these results demonstrated that for patients with atrial fibrillation who had an ischemic stroke, there were no significant differences in outcomes with early anticoagulation compared to later anticoagulation.
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