Background A new generation of modified surface flow diverters (FDs) and monotherapy using new antiplatelets may reduce both ischemic and hemorrhagic complications during the treatment of intracranial aneurysms. Previous preliminary safety analysis of distal unruptured intracranial aneurysms treated with the FD p48 MW HPC (phenox-Wallaby, Bochum, Germany) under antiplatelet monotherapy with prasugrel showed promising results. However, the long term outcomes of distal intracranial aneurysms treated with FDs under antiplatelet monotherapy are not known.
Methods This was a single center, prospective, pivotal, open single arm study. The primary (safety) endpoint was absence of any new neurological deficits after treatment until the 24 month follow-up. The primary (efficacy) endpoint was the incidence of complete aneurysm occlusion 24 months after treatment. The secondary (efficacy) endpoints were any incidence of aneurysm dome reduction 24 months after treatment.
Results 21 patients harboring 27 distal aneurysms of the anterior circulation were included. No patient had neurologic deficits in the time from treatment to the 24 month follow-up. Complete aneurysm occlusion occurred in 20 (74%) of 27 aneurysms at the 24 month follow-up. Four aneurysms (14.8%) had dome reduction, and three aneurysms (11.1%) remained unchanged.
Conclusions In this pilot trial, treatment of distal unruptured intracranial aneurysms with an FD under monotherapy with prasugrel, followed by monotherapy with aspirin, appeared to be safe and effective. Randomized studies with long term follow-up are needed to confirm these results.
- Flow Diverter
Data availability statement
Unpublished or unprocessed data, protocols, or images are available upon request from the corresponding author.
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Contributors LHdC-A participated in the concept of the study, and drafted and approved the manuscript. JPM, GSN, TGA, LMM, RKF, RSdO, and BOC participated in data acquisition, editing figures and tables, and revision and final approval of the manuscript. DGA participated in the concept of the study, acquired the data, critically revised the manuscript, and approved the final work.
Funding The entire study was conducted in the context of clinical care practice at our institution. The manufacturer phenox (Bochum-Germany) supported the study, providing all p48 MW HPC devices, prasugrel, and the VerifyNow tests used in this study. phenox did not participate in any data collection, management, analysis, interpretation, or reporting of results. phenox did not have any authority regarding the decision to publish the results obtained by the coordination center. The coordination center had sole responsible for all data collection, register, analysis, interpretation, and publication of the manuscript.
Competing interests None declared.
Provenance and peer review Not commissioned; externally peer reviewed.