Author: Dr.Michele Romoli
Twitter: @micheleromoli

By Dr. Michele Romoli

Navigating the delicate equilibrium between potential benefits, such as averting serious thromboembolic events like ischemic stroke, and potential harms, including an increased risk of recurrent intracranial hemorrhage or other major bleeding, can be challenging, especially in patients with atrial fibrillation (AF) and previous ICH. Additionally, considering factors like timing and patient-specific variables, such as brain imaging markers of cerebral small vessel disease, further complicates the determination of treatment safety.

These uncertainties contribute significantly to the considerable variation in clinical practices globally. Notably, in Europe, only 14% of eligible patients receive oral anticoagulation, whereas in Japan, this percentage rises sharply to 91%. Addressing these uncertainties is crucial for informed decision-making in clinical settings, emphasizing the necessity for a more standardized and evidence-based approach to treatment strategies.

In a significant stride toward understanding anticoagulant therapy post-intracranial hemorrhage, the SoSTART trial took center stage at the European Stroke Organisation Conference 2021. The study, officially known as the Start or Stop Anticoagulants Randomised Trial, aimed to assess the safety and efficacy of initiating oral anticoagulants (OAC) in patients with atrial fibrillation (AF) following an intracranial hemorrhage.

Over the course of the trial, 203 participants were randomly assigned to either start OAC or abstain from it. The one-year follow-up revealed that the recurrence rate of symptomatic intracranial hemorrhage was overall low, and did not reach statistical significance between the two groups.

Interestingly, the results hinted at a potential benefit of starting OAC in preventing symptomatic major vascular events when compared to avoiding it. However, a nuanced consideration arises as the data suggested a potential trade-off – an increase in fatal intracranial hemorrhages.

This pivotal trial underscores the importance of ongoing research and recruitment into trials to establish definitive evidence. The delicate balance between preventing major vascular events and avoiding fatal intracranial hemorrhages remains a focal point for future studies, promising to shape the landscape of anticoagulant therapy post-intracranial hemorrhage.

Link to full interview 

Link to 60 seconds clip from ESOC 2021 session