Ten-year analysis of saccular aneurysms in the Barrow Ruptured Aneurysm Trial.
Barrow Ruptured Aneurysm Trial
ISAT
International Subarachnoid Aneurysm Trial
SAH
clip occlusion
coil embolization
intracranial aneurysm
randomized trial
saccular aneurysms
subarachnoid hemorrhage
vascular disorders
Journal
Journal of neurosurgery
ISSN: 1933-0693
Titre abrégé: J Neurosurg
Pays: United States
ID NLM: 0253357
Informations de publication
Date de publication:
08 Mar 2019
08 Mar 2019
Historique:
received:
26
06
2018
accepted:
21
08
2018
pubmed:
9
3
2019
medline:
9
3
2019
entrez:
9
3
2019
Statut:
epublish
Résumé
The authors present the 10-year results of the Barrow Ruptured Aneurysm Trial (BRAT) for saccular aneurysms. The 1-, 3-, and 6-year results of the trial have been previously reported, as have the 6-year results with respect to saccular aneurysms. This final report comparing the safety and efficacy of clipping versus coiling is limited to an analysis of those patients presenting with subarachnoid hemorrhage (SAH) from a ruptured saccular aneurysm. In the study, 362 patients had saccular aneurysms and were randomized equally to the clipping and the coiling cohorts (181 each). The primary outcome analysis was based on the assigned treatment group; poor outcome was defined as a modified Rankin Scale (mRS) score > 2 and was independently adjudicated. The extent of aneurysm obliteration was adjudicated by a nontreating neuroradiologist. There was no statistically significant difference in poor outcome (mRS score > 2) or deaths between these 2 treatment arms during the 10 years of follow-up. Of 178 clip-assigned patients with saccular aneurysms, 1 (< 1%) was crossed over to coiling, and 64 (36%) of the 178 coil-assigned patients were crossed over to clipping. After the initial hospitalization, 2 of 241 (0.8%) clipped saccular aneurysms and 23 of 115 (20%) coiled saccular aneurysms required retreatment (p < 0.001). At the 10-year follow-up, 93% (50/54) of the clipped aneurysms were completely obliterated, compared with only 22% (5/23) of the coiled aneurysms (p < 0.001). Two patients had documented rebleeding, both died, and both were in the assigned and treated coiled cohort (2/83); no patient in the clipped cohort (0/175) died (p = 0.04). In 1 of these 2 patients, the hemorrhage was not from the target aneurysm but from an incidental basilar artery aneurysm, which was coiled at the same time. There was no significant difference in clinical outcomes between the 2 assigned treatment groups as measured by mRS outcomes or deaths. Clinical outcomes in the patients with posterior circulation aneurysms were better in the coiling group at 1 year, but after 1 year this difference was no longer statistically significant. Rates of complete aneurysm obliteration and rates of retreatment favored patients who actually underwent clipping compared with those who underwent coiling.Clinical trial registration no.: NCT01593267 (clinicaltrials.gov).
Identifiants
pubmed: 30849758
doi: 10.3171/2018.8.JNS181846
pii: 2018.8.JNS181846
doi:
pii:
Banques de données
ClinicalTrials.gov
['NCT01593267']
Types de publication
Journal Article
Langues
eng
Sous-ensembles de citation
IM