Patients with AF who experience AIS are at heightened risk of recurrent strokes, making timely initiation of anticoagulation vital. However, the ideal window to start OAC therapy remains debated due to concerns over bleeding complications, particularly intracranial hemorrhage. The inclusion of the recently completed OPTIMAS trial, the largest RCT to date on this topic, adds considerable weight to the findings.
The researchers systematically reviewed PubMed, Scopus, and Cochrane Central databases up to October 2024, identifying three RCTs encompassing 6,442 participants. Of these, 50.17% received early OAC. Using the Mantel–Haenszel method, pooled odds ratios (ORs) with 95% confidence intervals (CI) were calculated for major outcomes.
The key findings of the study were as follows:
- There was no statistically significant difference between early and late initiation of OAC for the composite outcome of recurrent ischemic events, major bleeding, and death (OR 0.82).
- The risk of stroke recurrence was similar in both groups (OR 0.80).
- Early OAC initiation did not increase the risk of symptomatic intracranial hemorrhage (OR 0.93).
- It did not increase the risk of major extracranial bleeding (OR 0.73).
- There was no increase in overall mortality with early initiation (OR 0.96).
- Subgroup analysis revealed that early OAC was associated with a 49% reduction in the risk of composite outcomes in female patients (OR 0.51).
- The observed benefit among women suggests the need for further studies to assess gender-specific effects of early therapy.
The authors concluded that starting OAC soon after AIS in AF patients appears to be safe, as it does not significantly increase bleeding or mortality risks. However, its overall efficacy in reducing recurrent strokes remains inconclusive, with possible benefits restricted to select patient subgroups. The inclusion of OPTIMAS bolsters the current evidence base and supports individualized decision-making until more extensive data are available.
"Clinicians are advised to weigh the risks and benefits of early anticoagulation on a case-by-case basis, considering patient-specific factors such as stroke severity, bleeding risk, and comorbidities. Further large-scale trials are necessary to refine guidelines and clarify which patient populations may benefit most from early intervention," the authors wrote.
Reference:
Pereira, V., Marino, M., Hornik, A. et al. Comparison of early vs late anticoagulation for secondary stroke prevention in patients with atrial fibrillation: a systematic review and meta-analysis of randomized controlled trials. J Thromb Thrombolysis (2025). https://doi.org/10.1007/s11239-025-03139-6
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