Mr. Gegg-Mitchell
Clinical question: What is the safety and efficacy of early compared with later initiation of direct oral anticoagulants (DOACs) in patients with atrial fibrillation and ischemic stroke?
Background: There is a paucity of high-quality evidence regarding the timing of initiating anticoagulation in patients with atrial fibrillation and ischemic stroke. Clinical approaches focus on balancing concerns for bleeding with early initiation of anticoagulation and concerns for recurrent stroke with later initiation.
Study design: Multi-center, open-label, randomized trial
Setting: Stroke centers in Asia, Europe, and the Middle East
Synopsis: Patients were randomized to one of two groups. In the early-treatment group (n=1,006), DOACs were started within 48 hours of a minor or moderate stroke, and on day 6 or 7 after a major stroke. In the later-treatment group (n=1,007), DOACs were started on day 3 or 4 after a minor stroke, on day 6 or 7 after a moderate stroke, and on day 12, 13, or 14 after a major stroke. The primary outcome included the following components as a composite (with occurrence within 30 days of randomization): symptomatic intracranial bleeding, major extracranial bleeding, recurrent ischemic stroke, systemic embolism, and vascular death. In the early-treatment group, 2.9% of participants experienced a primary-outcome event within 30 days of randomization, and in the later-treatment group, 4.1% of participants experienced a primary-outcome event within 30 days of randomization. Upon analysis, the incidence of a primary-outcome event at 30 days was estimated to occur between 2.8 percentage points lower and 0.5 percentage points higher for early rather than later DOAC initiation (95% confidence interval).
Bottom line: Despite the lack of testing for superiority or non-inferiority, findings (based on estimated treatment effects) support early initiation of DOACs in patients with atrial fibrillation and ischemic stroke.
Citation: Fischer U, Koga M, et al. Early versus later anticoagulation for stroke with atrial fibrillation. N Engl J Med. 2023;388(26):2411-21.
Mr. Gegg-Mitchell is the lead advanced practice provider for inpatient hematology/oncology at Stanford Health Care in Palo Alto, Calif.