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.

Aneurysm Coil Stent

Journal

Journal of neurointerventional surgery
ISSN: 1759-8486
Titre abrégé: J Neurointerv Surg
Pays: England
ID NLM: 101517079

Informations de publication

Date de publication:
21 Sep 2023
Historique:
received: 20 06 2023
accepted: 08 09 2023
medline: 22 9 2023
pubmed: 22 9 2023
entrez: 21 9 2023
Statut: aheadofprint

Résumé

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

Sections du résumé

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

Identifiants

pubmed: 37734932
pii: jnis-2023-020716
doi: 10.1136/jnis-2023-020716
pii:
doi:

Types de publication

Journal Article

Langues

eng

Sous-ensembles de citation

IM

Informations de copyright

© Author(s) (or their employer(s)) 2023. No commercial re-use. See rights and permissions. Published by BMJ.

Déclaration de conflit d'intérêts

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

Auteurs

Mohamed M Salem (MM)

Department of Neurosurgery, Hospital of the University of Pennsylvania, Philadelphia, Pennsylvania, USA.

Brian T Jankowitz (BT)

Department of Neurosurgery, Hospital of the University of Pennsylvania, Philadelphia, Pennsylvania, USA Bjankowitz@gmail.com.

Jan-Karl Burkhardt (JK)

Department of Neurosurgery, Hospital of the University of Pennsylvania, Philadelphia, Pennsylvania, USA.

Lori Lyn Price (LL)

Clinical Affairs, Stryker Neurovascular, Fremont, California, USA.

Osama O Zaidat (OO)

Neuroscience, St Vincent Mercy Hospital, Toledo, Ohio, USA.

Classifications MeSH