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  • Comparative analysis of long term effectiveness of Neuroform Atlas stent versus low profile visualized intraluminal stent/Woven EndoBridge devices in treatment of wide necked intracranial aneurysms

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Hemorrhagic stroke
Original research
Comparative analysis of long term effectiveness of Neuroform Atlas stent versus low profile visualized intraluminal stent/Woven EndoBridge devices in treatment of wide necked intracranial aneurysms
  1. Mohamed M Salem1,
  2. Brian T Jankowitz1,
  3. Jan-Karl Burkhardt1,
  4. Lori Lyn Price2,
  5. Osama O Zaidat3
  1. 1Department of Neurosurgery, Hospital of the University of Pennsylvania, Philadelphia, Pennsylvania, USA
  2. 2Clinical Affairs, Stryker Neurovascular, Fremont, California, USA
  3. 3Neuroscience, St Vincent Mercy Hospital, Toledo, Ohio, USA
  1. Correspondence to Dr Brian T Jankowitz, Department of Neurosurgery, Hospital of the University of Pennsylvania, Philadelphia, Pennsylvania, USA; Bjankowitz{at}gmail.com

Abstract

Background We compared the outcomes of wide necked aneurysms (WNA) treated with the Neuroform Atlas with those treated with the low profile visualized intraluminal stent (LVIS) or the Woven EndoBridge (WEB).

Methods Objective, prospectively collected, core laboratory adjudicated data from published trials for the Neuroform Atlas, LVIS, and WEB devices were reviewed. ATLAS (Safety and Effectiveness of the Treatment of Wide Neck, Saccular Intracranial Aneurysms With the Neuroform Atlas Stent System) study patients were included if they met other studies’ inclusion criteria. Outcomes included (1) primary effectiveness (complete aneurysmal occlusion without retreatment/>50% parent vessel stenosis), (2) primary safety, (3) complete aneurysmal occlusion, and (4) retreatment rates (outcomes evaluated at the 12 month follow-up). Matching adjusted indirect comparison analysis was used to compare outcomes.

Results Analytical samples included 141 ATLAS subjects meeting WEB-IT (Woven EndoBridge Intrasaccular Therapy Study) criteria (ATLAS/WEB-IT) and 241 meeting LVIS (Pivotal Study of the Low Profile Visualized Intraluminal Support) criteria (ATLAS/LVIS). ATLAS/WEB-IT exhibited significantly higher rates of primary effectiveness and complete occlusion versus WEB (86.6% vs 53.9 %, P<0.0001, and 90.3% vs 53.9%, P<0.0001, respectively). For LVIS, there was no significant differences in primary effectiveness rates between ATLAS and LVIS (84.2% vs 77.7%, respectively, P=0.12). However, ATLAS/LVIS had a significantly higher proportion of patients achieving complete occlusion than LVIS (88.1 vs 79.1, P=0.03). Retreatment rates and primary safety outcomes were not significantly different (P>0.05) for the Atlas versus other devices except for a lower retreatment rate for ATLAS/WEB-IT versus WEB-IT (2.4% vs 9.8%, P=0.01).

Conclusion The Neuroform Atlas provided higher occlusion rates and similar retreatment rates in comparable datasets compared with LVIS and WEB devices when treating WNA.

  • Aneurysm
  • Stent
  • Coil

Data availability statement

Data are available upon reasonable request.

https://doi.org/10.1136/jnis-2023-020716

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    Data availability statement

    Data are available upon reasonable request.

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    Footnotes

    • Twitter @MMSalemMD

    • Contributors All authors contributed to the paper, satisfying the ICMJE guidelines for authorship. MMS, BJ, and LLP were involved in the design of the study, acquisition and analysis of the data, and drafting and revising the manuscript. JKB and OOZ contributed to drafting and revising the manuscript for intellectual content. All authors agree to be accountable for all aspects of the current work, including its accuracy and integrity, and sound investigative methodology. BTJ is the guarantor of the study and accepts full responsibility for the work

    • Funding The ATLAS trial (Safety and Effectiveness of the Treatment of Wide Neck, Saccular Intracranial Aneurysms With the Neuroform Atlas Stent System) was sponsored and funded by Stryker Neurovascular. Although the sponsor was involved in the design, collection, analysis, interpretation, and fact checking of information, the content of this manuscript and its ultimate interpretation, along with the decision to submit it for publication, was made independently by the authors.

    • Competing interests BJ and OOZ are national co-PIs of the ATLAS trial. LLP is a senior clinical statistician at Stryker Neurovascular.

    • Provenance and peer review Not commissioned; externally peer reviewed.