Surgical clipping or endovascular coiling for unruptured intracranial aneurysms: a pragmatic randomised trial.
J Neurol Neurosurg Psychiatry
; 88(8): 663-668, 2017 08.
Article
in En
| MEDLINE
| ID: mdl-28634280
ABSTRACT
BACKGROUND:
Unruptured intracranial aneurysms (UIAs) are increasingly diagnosed and are commonly treated using endovascular treatment or microsurgical clipping. The safety and efficacy of treatments have not been compared in a randomised trial. How to treat patients with UIAs suitable for both options remains unknown.METHODS:
We randomly allocated clipping or coiling to patients with one or more 3-25 mm UIAs judged treatable both ways. The primary outcome was treatment failure, defined as initial failure of aneurysm treatment, intracranial haemorrhage or residual aneurysm on 1-year imaging. Secondary outcomes included neurological deficits following treatment, hospitalisation >5 days, overall morbidity and mortality and angiographic results at 1 year.RESULTS:
The trial was designed to include 260 patients. An analysis was performed for slow accrual 136 patients were enrolled from 2010 through 2016 and 134 patients were treated. The 1-year primary outcome, available for 104 patients, was reached in 5/48 (10.4% (4.5%-22.2%)) patients allocated surgical clipping, and 10/56 (17.9% (10.0%-29.8%)) patients allocated endovascular coiling (OR 0.54 (0.13-1.90), p=0.40). Morbidity and mortality (modified Rankin Scale>2) at 1 year occurred in 2/48 (4.2% (1.2%-14.0%)) and 2/56 (3.6% (1.0%-12.1%)) patients allocated clipping and coiling, respectively. New neurological deficits (15/65 vs 6/69; OR 3.12 (1.05-10.57), p=0.031), and hospitalisations beyond 5 days (30/65 vs 6/69; OR 8.85 (3.22-28.59), p=0.0001) were more frequent after clipping.CONCLUSION:
Surgical clipping or endovascular coiling of UIAs did not show differences in morbidity at 1 year. Trial continuation and additional randomised evidence will be necessary to establish the supposed superior efficacy of clipping.Key words
Full text:
1
Collection:
01-internacional
Database:
MEDLINE
Main subject:
Surgical Instruments
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Intracranial Aneurysm
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Angioplasty
/
Microsurgery
Type of study:
Clinical_trials
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Diagnostic_studies
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Etiology_studies
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Observational_studies
/
Prognostic_studies
Limits:
Adult
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Female
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Humans
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Male
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Middle aged
Language:
En
Journal:
J Neurol Neurosurg Psychiatry
Year:
2017
Document type:
Article
Affiliation country:
Canada