Study ‘meaningfully advances the field’
In an accompanying editorial, Eva A. Mistry, MBBS, University of Cincinnati, said the current study “meaningfully advances the field” and provides an estimation of safety of intravenous thrombolysis among patients who have taken DOACs within 48 hours of hospital admission.
She lists strengths of the study as inclusion of a large number of patients across several geographically diverse institutions with heterogeneous standard practices for thrombolysis with recent DOAC use and narrow confidence intervals regarding observed rates of sICH.
“Further, the upper bound of this confidence interval for the DOAC group is below 4%, which is a welcome result and provides supportive data for clinicians who already practice thrombolysis for patients with recent DOAC ingestion,” Dr. Mistry adds.
However, she points out several study limitations, which she says limit immediate, widespread clinical applicability.
These include use of a nonconcurrent control population, which included patients from centers that did not contribute to the DOAC group and the inclusion of Asian patients who likely received a lower thrombolytic dose.
Dr. Seiffge noted that the researchers did adjust for Asian patients but not for the thrombolytic dosage. “I personally do not think this affects the results, as Asian patients have a lower dosage because they have a higher bleeding risk. The lower bleeding risk with DOACs was seen in all continents.”
Dr. Mistry also suggests that the DOAC group itself is prone to selection bias from preferential thrombolysis of patients receiving DOAC who are at lower risk of sICH.
But Dr. Seiffge argued: “I think, actually, the opposite is true. The DOAC patients were older, had more severe comorbidities, and an increased bleeding risk.”
Dr. Mistry concluded, “Despite the limitations of the study design and enrolled population, these data may be used by clinicians to make individualized decisions regarding thrombolysis among patients with recent DOAC use. Importantly, this study lays the foundation for prospective, well-powered studies that definitively determine the safety of thrombolysis in this population.”
The study was supported by a grant from the Bangerter-Rhyner Foundation. Dr. Seiffge received grants from Bangerter Rhyner Foundation during the conduct of the study and personal fees from Bayer, Alexion, and VarmX outside the submitted work. Dr. Mistry receives grant funding from the National Institute of Neurological Disorders and Stroke and serves as a consultant for RAPID AI.
A version of this article first appeared on Medscape.com.