A Pragmatic Randomized Trial Comparing Surgical Clipping and Endovascular Treatment of Unruptured Intracranial Aneurysms.
Journal
AJNR. American journal of neuroradiology
ISSN: 1936-959X
Titre abrégé: AJNR Am J Neuroradiol
Pays: United States
ID NLM: 8003708
Informations de publication
Date de publication:
06 2023
06 2023
Historique:
received:
27
02
2023
accepted:
10
04
2023
pmc-release:
01
06
2024
medline:
12
6
2023
pubmed:
12
5
2023
entrez:
11
5
2023
Statut:
ppublish
Résumé
Surgical clipping and endovascular treatment are commonly used in patients with unruptured intracranial aneurysms. We compared the safety and efficacy of the 2 treatments in a randomized trial. Clipping or endovascular treatments were randomly allocated to patients with one or more 3- to 25-mm unruptured intracranial aneurysms judged treatable both ways by participating physicians. The study hypothesized that clipping would decrease the incidence of treatment failure from 13% to 4%, a composite primary outcome defined as failure of aneurysm occlusion, intracranial hemorrhage during follow-up, or residual aneurysms at 1 year, as adjudicated by a core lab. Safety outcomes included new neurologic deficits following treatment, hospitalization of >5 days, and overall morbidity and mortality (mRS > 2) at 1 year. There was no blinding. Two hundred ninety-one patients were enrolled from 2010 to 2020 in 7 centers. The 1-year primary outcome, ascertainable in 290/291 (99%) patients, was reached in 13/142 (9%; 95% CI, 5%-15%) patients allocated to surgery and in 28/148 (19%; 95% CI, 13%-26%) patients allocated to endovascular treatments (relative risk: 2.07; 95% CI, 1.12-3.83; Surgical clipping is more effective than endovascular treatment of unruptured intracranial aneurysms in terms of the frequency of the primary outcome of treatment failure. Results were mainly driven by angiographic results at 1 year.
Sections du résumé
BACKGROUND AND PURPOSE
Surgical clipping and endovascular treatment are commonly used in patients with unruptured intracranial aneurysms. We compared the safety and efficacy of the 2 treatments in a randomized trial.
MATERIALS AND METHODS
Clipping or endovascular treatments were randomly allocated to patients with one or more 3- to 25-mm unruptured intracranial aneurysms judged treatable both ways by participating physicians. The study hypothesized that clipping would decrease the incidence of treatment failure from 13% to 4%, a composite primary outcome defined as failure of aneurysm occlusion, intracranial hemorrhage during follow-up, or residual aneurysms at 1 year, as adjudicated by a core lab. Safety outcomes included new neurologic deficits following treatment, hospitalization of >5 days, and overall morbidity and mortality (mRS > 2) at 1 year. There was no blinding.
RESULTS
Two hundred ninety-one patients were enrolled from 2010 to 2020 in 7 centers. The 1-year primary outcome, ascertainable in 290/291 (99%) patients, was reached in 13/142 (9%; 95% CI, 5%-15%) patients allocated to surgery and in 28/148 (19%; 95% CI, 13%-26%) patients allocated to endovascular treatments (relative risk: 2.07; 95% CI, 1.12-3.83;
CONCLUSIONS
Surgical clipping is more effective than endovascular treatment of unruptured intracranial aneurysms in terms of the frequency of the primary outcome of treatment failure. Results were mainly driven by angiographic results at 1 year.
Identifiants
pubmed: 37169541
pii: ajnr.A7865
doi: 10.3174/ajnr.A7865
pmc: PMC10249696
doi:
Types de publication
Randomized Controlled Trial
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
634-640Commentaires et corrections
Type : CommentIn
Type : CommentIn
Informations de copyright
© 2023 by American Journal of Neuroradiology.
Références
Trials. 2011 Mar 04;12:64
pubmed: 21375745
AJNR Am J Neuroradiol. 2020 Dec;41(12):2174-2175
pubmed: 33033042
Stroke. 2003 Jun;34(6):1398-403
pubmed: 12775880
Lancet Neurol. 2011 Jul;10(7):626-36
pubmed: 21641282
Lancet. 2011 May 14;377(9778):1655-62
pubmed: 21571149
World Neurosurg. 2020 Sep;141:e770-e777
pubmed: 32526362
J Neurosurg. 2014 Mar;120(3):618-23
pubmed: 24405069
Radiology. 2013 Oct;269(1):258-65
pubmed: 23821755
Lancet. 2002 Oct 26;360(9342):1267-74
pubmed: 12414200
World Neurosurg. 2017 Feb;98:403-410
pubmed: 27876665
Stroke. 2011 Jun;42(6):1730-5
pubmed: 21493902
World Neurosurg. 2022 Jul;163:e413-e419
pubmed: 35395427
AJNR Am J Neuroradiol. 2021 Sep;42(9):1615-1620
pubmed: 34326106
World Neurosurg. 2022 Apr;160:e49-e54
pubmed: 34971833
Stroke. 2015 Aug;46(8):2368-400
pubmed: 26089327
AJNR Am J Neuroradiol. 2012 Mar;33(3):474-80
pubmed: 22207299
Stroke. 2011 Aug;42(8):2276-9
pubmed: 21680905
J Clin Epidemiol. 2014 Oct;67(10):1150-6
pubmed: 25042688
World Neurosurg. 2018 Jun;114:e508-e517
pubmed: 29530696
Neurochirurgie. 2022 Oct;68(5):488-492
pubmed: 35662528
Cochrane Database Syst Rev. 2021 May 10;5:CD013312
pubmed: 33971026
AJNR Am J Neuroradiol. 2017 Mar;38(3):432-441
pubmed: 28082261
Eur Stroke J. 2022 Sep;7(3):V
pubmed: 36082246
J Neurointerv Surg. 2018 Mar;10(3):252-257
pubmed: 28377443
N Engl J Med. 2007 Nov 1;357(18):1821-8
pubmed: 17978290
J Neurosurg. 2015 Sep;123(3):605-7
pubmed: 26115466
J Neurol Neurosurg Psychiatry. 2017 Aug;88(8):663-668
pubmed: 28634280
J Neurointerv Surg. 2012 May;4(3):178-81
pubmed: 21990519
Neuroradiology. 2021 Sep;63(9):1511-1519
pubmed: 33625550
J Neurosurg. 2008 Jun;108(6):1163-9
pubmed: 18518722
Can J Neurol Sci. 2011 Mar;38(2):236-41
pubmed: 21320826
Stroke. 2015 May;46(5):1221-6
pubmed: 25757900
Radiology. 2015 Oct;277(1):173-80
pubmed: 26057784
J Neurol Neurosurg Psychiatry. 2013 Jan;84(1):42-8
pubmed: 23012447