PHRI Scientist Ashkan Shoamanesh wants physicians treating intracranial hemorrhage (ICrH) survivors with atrial fibrillation (Afib) to proceed with caution when it comes to the standard-dose anticoagulation treatment in patients with symptomatic ICrH resulting from cerebral amyloid angiopathy (CAA).
“Survey data indicate that 30–70% of specialists are currently resuming anticoagulation in survivors of lobar and cerebral amyloid angiopathy (CAA)-related ICH with Afib,” he writes. “Physicians should wait until more data become available on the net benefit of anticoagulation in these high-risk subgroups of patients.”
Shoamanesh’s editorial in The Lancet aligns with the recent guidance issued by the Data Safety Monitoring Board (DSMB) of the ongoing ENRICH-AF trial, for which Shoamanesh serves as the principal investigator. This international trial is actively enrolling patients across 239 hospitals in 20 countries, aiming to assess whether Edoxaban is more effective than standard medical therapy in reducing the risk of stroke in high-risk Afib patients who have previously experienced ICrH.
After conducting a safety evaluation of the initial 699 patients, the DSMB provided recommendations to promptly discontinue the drug for participants with lobar intracranial hemorrhage and convexity subarachnoid hemorrhage. Additionally, they discouraged the inclusion of any more patients with these specific subtypes of intracranial hemorrhage in the trial.
“At the time of the DSMB recommendations, there were slightly over 200 patients with CAA-related intracranial hemorrhage leading to the potential for imprecise estimates,” states Shoamanesh, “this information should not discourage the inclusion of these patients in other ongoing randomized controlled trials focused on optimizing stroke prevention in survivors of intracranial hemorrhage with Afib.”
In light of the persistent uncertainty surrounding this issue, a recent collaborative meta-analysis was conducted. This analysis included all pertinent completed randomized trials, specifically focusing on early-phase trials and encompassing a total of 103 patients who suffered from CAA-related ICrH. The results of this meta-analysis, recently published in the Lancet Neurology with Shoamanesh as one of the co-senior authors, do not suggest any overall harm in these patients. However, it’s important to note that the findings are associated with imprecise estimates, and there is heterogeneity in the treatment effect across the trials included.