Anterior circulation location-specific results for stent-assisted coiling - carotid versus distal aneurysms: 1-year outcomes from the Neuroform Atlas Stent Pivotal Trial.
Aneurysm
Coil
Device
Intervention
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:
08 Nov 2023
08 Nov 2023
Historique:
received:
15
05
2023
accepted:
19
09
2023
medline:
9
11
2023
pubmed:
9
11
2023
entrez:
8
11
2023
Statut:
aheadofprint
Résumé
The Neuroform Atlas Stent System is an established treatment modality for unruptured anterior and posterior circulation intracranial aneurysms. Location-specific results are needed to guide treatment decision-making. However, it is unclear whether there are differences in safety and efficacy outcomes between carotid and more distal anterior circulation aneurysms. The ATLAS IDE trial was a prospective, multicenter, single-arm, open-label interventional study that evaluated the safety and efficacy of the Neuroform Atlas Stent System. We compared differences in efficacy and safety outcomes of proximal internal carotid artery (ICA) versus distal and bifurcation anterior circulation aneurysms. Of 182 cases, there were 70 aneurysms in the ICA and 112 in the distal anterior circulation (including ICA terminus/bifurcation). There were no significant differences in the primary efficacy endpoint (85.5% vs 83.9%, p=0.78) and complete aneurysm occlusion rates (88.7% vs 87.9%, p=0.78) between proximal ICA aneurysms and distal aneurysms, respectively. Complications were more often encountered in distal and bifurcation aneurysms, but the overall rate of major safety events was low and comparable between the two groups (1.4% vs 6.3%, p=0.14). Recanalization and retreatment rates were also similar between the groups. The results of this study suggest that the Neuroform Atlas Stent System is a safe and efficacious treatment modality for unruptured anterior circulation intracranial aneurysms, regardless of aneurysm location. NCT02340585.
Sections du résumé
BACKGROUND
BACKGROUND
The Neuroform Atlas Stent System is an established treatment modality for unruptured anterior and posterior circulation intracranial aneurysms. Location-specific results are needed to guide treatment decision-making. However, it is unclear whether there are differences in safety and efficacy outcomes between carotid and more distal anterior circulation aneurysms.
METHODS
METHODS
The ATLAS IDE trial was a prospective, multicenter, single-arm, open-label interventional study that evaluated the safety and efficacy of the Neuroform Atlas Stent System. We compared differences in efficacy and safety outcomes of proximal internal carotid artery (ICA) versus distal and bifurcation anterior circulation aneurysms.
RESULTS
RESULTS
Of 182 cases, there were 70 aneurysms in the ICA and 112 in the distal anterior circulation (including ICA terminus/bifurcation). There were no significant differences in the primary efficacy endpoint (85.5% vs 83.9%, p=0.78) and complete aneurysm occlusion rates (88.7% vs 87.9%, p=0.78) between proximal ICA aneurysms and distal aneurysms, respectively. Complications were more often encountered in distal and bifurcation aneurysms, but the overall rate of major safety events was low and comparable between the two groups (1.4% vs 6.3%, p=0.14). Recanalization and retreatment rates were also similar between the groups.
CONCLUSION
CONCLUSIONS
The results of this study suggest that the Neuroform Atlas Stent System is a safe and efficacious treatment modality for unruptured anterior circulation intracranial aneurysms, regardless of aneurysm location.
TRIAL REGISTRATION NUMBER
BACKGROUND
NCT02340585.
Identifiants
pubmed: 37940387
pii: jnis-2023-020591
doi: 10.1136/jnis-2023-020591
pii:
doi:
Banques de données
ClinicalTrials.gov
['NCT02340585']
Types de publication
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Investigateurs
Ricardo Hanel
(R)
Eric Sauvageau
(E)
Amin Nima Aghaebrahim
(AN)
Nancy Ebreo
(N)
Karen Bell
(K)
Lanaya Lewis
(L)
Mercy Vincent Zaidat
(MV)
Eugene Lin
(E)
Tina M Steinhauser
(TM)
Dee Tilley
(D)
Julie Goins Whitmore
(JG)
Brandi Breseman
(B)
Melissa A Thomas
(MA)
Ashutosh Jadhav
(A)
Bradley Gross
(B)
Lisa Baxendell
(L)
Patricia Feineigle
(P)
Vicki Gilchrist
(V)
Brian Jankowitz
(B)
Andrew Ducruet
(A)
David Panczkowski
(D)
Hazem Shoirah
(H)
Alhamza Al Bayati
(AA)
Amin Aghaebrahim
(A)
Tudor Jovin
(T)
Greg Weiner
(G)
Cynthia Kenmuir
(C)
Prasanna Tadi
(P)
Gregory Walker
(G)
Kelsea Haibach
(K)
Carlynn Graves
(C)
Yvonne Cannon
(Y)
Ahmad Khaldi
(A)
Rishi Gupta
(R)
Marianne Bain
(M)
Laura Murphy
(L)
Andrew K Johnson
(AK)
Barbara A Foster
(BA)
Tasha Futch
(T)
Portia Thomas
(P)
Richard Bellon Don Frei
(RB)
Benjamin Atchie
(B)
Ian Kaminsky
(I)
Lisa Kodis
(L)
Mark Talley
(M)
Tiffany Talley
(T)
Alex Edinger
(A)
David Loy
(D)
Dan Huddle
(D)
Michelle Lexin
(M)
Brad Fasbinder
(B)
Alicia Drew
(A)
Joanna Snead
(J)
Ashley Bitner
(A)
Sarah Weiss
(S)
Nouara Sadaoui
(N)
Adel Malek
(A)
Emma Jost Price
(EJ)
Keri Sullivan
(K)
Haley Huggins
(H)
Lindsey Soll
(L)
Sarah Gans
(S)
Michelle Bettle
(M)
Gabor Toth
(G)
Mark Bain
(M)
Peter Rasmussen
(P)
M Shazam Hussain
(M)
Nina Moore
(N)
Thomas Masaryk
(T)
Mohamed Elgabaly
(M)
Erin Bynum
(E)
Russell Cerejo
(R)
Julian Hardman
(J)
Seby John
(S)
Andrew Bauer
(A)
Erin Mayock
(E)
Vikram Puvenna
(V)
Jenny Peih Tsai
(JP)
Adnan Siddiqui
(A)
Elad Levy
(E)
Kenneth Snyder
(K)
Jason Davies
(J)
Mary Hartney
(M)
Jonna Sakowski
(J)
Courtney Drozdowski
(C)
Heather Ross
(H)
Linda Bookhagen
(L)
Ajith Thomas
(A)
Christopher Ogilvy
(C)
Patricia Baum
(P)
John Reavey Cantwell
(JR)
Dennis Rivet
(D)
Charlotte Gilman
(C)
Michael Alexander
(M)
Franklin Moser
(F)
Marcel Maya
(M)
Michael Schiraldi
(M)
Vicki Manoukian
(V)
Paula Eboli
(P)
Justin Caplan
(J)
Bowen Jiang
(B)
Matthew Bender
(M)
Ellen Sheehan
(E)
Jessica Wollett
(J)
Geoffrey Colby
(G)
Lauren Dise
(L)
Anna Bugaeva
(A)
Barbara Michniewicz
(B)
Thomas Hemmingson
(T)
Sudhakar Satti
(S)
Thinesh Sivapatham
(T)
Robie Zent
(R)
Ann Marie Le Noir
(AML)
David Kung
(D)
Bryan Pukenas
(B)
Robert Hurst
(R)
Timothy Prior
(T)
Whitney Sarchiapone
(W)
Yelena Gorelik
(Y)
Francis Quattrone
(F)
Michelle J Smith
(MJ)
Ajit Puri
(A)
Francesco Massari
(F)
Mary Howk
(M)
David Rex
(D)
Kimberly Ty
(K)
Jen Donham
(J)
Wen Li
(W)
Justin Fraser
(J)
Stephen Grupke
(S)
Jennifer Isaacs
(J)
Abdulnasser Alhajeri
(A)
Caroline Rodgers
(C)
Linda Joyce McCown
(LJ)
Richard Klucznik
(R)
Orlando Diaz
(O)
Gavin Britz
(G)
Yi Zhang
(Y)
Michelle Prystash
(M)
Vivian Escamilla
(V)
Adrienne New
(A)
Liliana Calderon
(L)
Elmira Ramos
(E)
Ramon Guardiola
(R)
Bhavin Shah
(B)
Lenis Sosa
(L)
Melissa Whipple
(M)
Alejandro Spiotta
(A)
Jonathan Lena
(J)
Ayesha Vohra
(A)
Meredith Robinson
(M)
Aquilla Turk
(A)
Mohamad Chaudry
(M)
Kyle Fargen
(K)
Raymond Turner
(R)
Emily Young
(E)
Adrian Parker
(A)
Angela Robinson
(A)
Andrew Dippre
(A)
Anita Deveaux
(A)
Amora Mayo Perez
(AM)
Peter Kan
(P)
Bridget Solis
(B)
Melyssa Fink
(M)
Edward Duckworth
(E)
Samantha Macias
(S)
Gilberto De Freitas
(G)
Stephen Harold
(S)
Sree Vidya
(S)
Muhammad Asif Taqi
(MA)
Anastasia Vechera
(A)
Samuel Hou
(S)
Sajid Suriya
(S)
Syed Quadri
(S)
Adam S Arthur
(AS)
Lucas Elijovich
(L)
Daniel Hoit
(D)
Christopher Nickele
(C)
Amanda Nolte
(A)
Jessica Jameson
(J)
Barrett Patel
(B)
Hani Rashed
(H)
Jay Vachhani
(J)
Vinodh Thomas Doss
(VT)
Richard W Crowley
(RW)
Bartosz Jacher
(B)
Demetrius Lopes
(D)
Carol Macpherson
(C)
Amanda Arand
(A)
Christy Anton
(C)
Michael Chen
(M)
John Dao
(J)
Francisco Acosta
(F)
Danial Hallam
(D)
Basavaraj Ghodke
(B)
Michael Levitt
(M)
Kellie Sheehan
(K)
Louis Kim
(L)
Richard Callison
(R)
Amer Alshekhlee
(A)
Michelle Raymond
(M)
Sushant Kale
(S)
Michael Froehler
(M)
Matt Fusco
(M)
Rohan Chitale
(R)
Drew Anderson
(D)
Sally Natalie Hall
(S)
Sally Sarah Baggette
(SS)
Dima Sbenaty
(D)
Kathryn McNabb
(K)
Morgan A Pittman
(MA)
Joy Grabenstein
(J)
David McKeel
(D)
Informations de copyright
© Author(s) (or their employer(s)) 2023. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.
Déclaration de conflit d'intérêts
Competing interests: RAH is a consultant for Medtronic, Stryker, Cerenovous, Microvention, Balt, Phenox, Rapid Medical and Q’Apel, Imperative Care, Phenox, and Rapid Medical. He is on the advisory board for MiVI, eLum, Three Rivers, Shape Medical, and Corindus. He is in receipt of unrestricted research grants from the National Institutes of Health (NIH), Interline Endowment, Microvention, Stryker, CNX, and Balt. He is an investor/stockholder for InNeuroCo, Cerebrotech, eLum, Endostream, Three Rivers Medical Inc, Scientia, RisT, BlinkTBI, and Corindus. BTJ is a consultant for Stryker and a consultant/proctor for Medtronic. ES reports a speaker’s agreement with Stryker. BG is a consultant for Medtronic, Microvention, and Stryker. RGG is a consultant and receives personal fees from Cerenovus. DF reports consultant/speakers bureau for Stryker, Siemens, Penumbra, and Scientia; and serves on the SNIS board of directors. LLP is a Principal Biostatistician employed at Stryker Neurovascular and holds stock in Stryker. SWH reports core lab services for Stryker, Route 92; is an Imperative Care consultant; is a stockholder for Filtro and ThrombX; and serves on the SNIS board of directors. OOZ reports research grants from Stryker, Medtronic, Cerenovus, Penumbra, and Genentech; he is a consultant and speaker for Cerenovus, Stryker, Penumbra, and Medtronic; data safety monitoring board for Premier; has an ownership interest in Galaxy Therapeutics Inc.; and serves on SVIN committees. The other authors report no conflicts of interest.