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  • Treatment of distal unruptured intracranial aneurysms using a surface-modified flow diverter under prasugrel monotherapy: a pilot safety trial

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New devices and techniques
Case series
Treatment of distal unruptured intracranial aneurysms using a surface-modified flow diverter under prasugrel monotherapy: a pilot safety trial
  1. Luis Henrique de Castro-Afonso1,
  2. Guilherme Seizem Nakiri1,
  3. Thiago Giansante Abud1,2,
  4. Lucas Moretti Monsignore1,
  5. Rafael Kiyuze Freitas1,
  6. Ricardo Santos de Oliveira3,
  7. Benedicto Oscar Colli3,
  8. Antônio Carlos dos Santos4,
  9. Daniel Giansante Abud1
  1. 1 Division of Interventional Neuroradiology, Department of Medical Imaging, Hematology and Oncology, Ribeirão Preto Medical School, University of São Paulo, Ribeirao Preto, São Paulo, Brazil
  2. 2 Division of Interventional Neuroradiology, Hospital Israelita Albert Einstein, São Paulo, São Paulo, Brazil
  3. 3 Division of Neurosurgery, Department of Surgery, Ribeirão Preto Medical School, University of São Paulo, Ribeirao Preto, São Paulo, Brazil
  4. 4 Division of Neuroradiology, Department of Medical Imaging, Hematology and Oncology, Ribeirão Preto Medical School, University of São Paulo, Ribeirao Preto, São Paulo, Brazil
  1. Correspondence to Professor Daniel Giansante Abud, Division of Interventional Neuroradiology, Department of Medical Imaging, Hematology and Oncology, Universidade de São Paulo Faculdade de Medicina de Ribeirão Preto, Ribeirao Preto 14040-900, Brazil; danielgabud{at}gmail.com

Abstract

Background Flow diverters (FDs) are effective in the treatment of carotid aneurysms. Compared with carotid aneurysms, the treatment of distal intracranial aneurysms with FDs has been associated with a relatively high incidence of complications. Low thrombogenic modified-surface FDs may reduce ischemic complications and allow for the use of a single antiplatelet medication. The aim of this study was to assess the safety and efficacy of the p48 MW HPC Flow Modulation Device (Phenox GmbH, Bochum, Germany) to treat distal intracranial aneurysms used in combination with prasugrel monotherapy.

Methods This was a single-center, prospective, pivotal, open, single-arm study. Patients were included in this study from December 2019 to September 2020. The primary endpoints were the incidence of any neurologic deficit after treatment until 1 month of follow-up, defined as National Institutes of Health Stroke Scale (NIHSS) ≥1, and the incidence of acute ischemic lesions in magnetic resonance imagin (MRI) images 48 hours after treatment. The secondary endpoint was the rate of complete occlusion of the aneurysms at the 1-month follow-up.

Results Twenty-one patients harboring 27 distal aneurysms of the anterior circulation were included. Mean age was 57.8 (SD 9.7) years, and 16 patients were female (80%). No patient had neurologic symptoms at the 1-month follow-up. Four patients (20%) had asymptomatic acute brain ischemic lesions on MRI. Complete aneurysm occlusion occurred in 9/27 (33.3%) aneurysms at the 1-month follow-up.

Conclusion In this pilot safety trial, treatment of distal intracranial aneurysms with p48 MW HPC under monotherapy with prasugrel appeared to be safe.

  • aneurysm
  • flow diverter

Data availability statement

Unpublished or unprocessed data, protocols and images are available upon request from the corresponding author.

https://doi.org/10.1136/neurintsurg-2020-017262

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    Data availability statement

    Unpublished or unprocessed data, protocols and images are available upon request from the corresponding author.

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    Footnotes

    • Twitter @GNakiri, @neuroabud

    • Contributors LHdC-A participated in study conception, and drafting and approval of the manuscript. GSN, TGA, LMM, RKF, RSdO, BOC, and ACdS participated in data acquisition, figure/table editing, revision of the manuscript, and final approval. DGA participated in study conception, data acquisition, critical revision of the manuscript, and approval of the final work.

    • Funding Regarding funding sources, the entire study was conducted in the context of clinical care practice of our Institution. The manufacturer phenox BmbH (Bochum-Germany) supported the study providing all devices p48 MW HPC, prasugrel and VerifyNow tests used in this study. However, the phenox BmbH did not participated in any data collection, management, analysis, interpretation or report results. The phenox did not have any authority regarding decision to publish the results obtained by the coordination center. The coordination center was the 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.

    • Supplemental material This content has been supplied by the author(s). It has not been vetted by BMJ Publishing Group Limited (BMJ) and may not have been peer-reviewed. Any opinions or recommendations discussed are solely those of the author(s) and are not endorsed by BMJ. BMJ disclaims all liability and responsibility arising from any reliance placed on the content. Where the content includes any translated material, BMJ does not warrant the accuracy and reliability of the translations (including but not limited to local regulations, clinical guidelines, terminology, drug names and drug dosages), and is not responsible for any error and/or omissions arising from translation and adaptation or otherwise.