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J. Neurol. Neurosurg. Psychiatr. · Aug 2017
Multicenter Study Comparative Study Pragmatic Clinical TrialSurgical clipping or endovascular coiling for unruptured intracranial aneurysms: a pragmatic randomised trial.
- Tim E Darsaut, J Max Findlay, Elsa Magro, Marc Kotowski, Daniel Roy, Alain Weill, Michel W Bojanowski, Chiraz Chaalala, Daniela Iancu, Howard Lesiuk, John Sinclair, Felix Scholtes, Didier Martin, Michael M Chow, Cian J O'Kelly, John H Wong, Ken Butcher, Allan J Fox, Adam S Arthur, Francois Guilbert, Lu Tian, Miguel Chagnon, Suzanne Nolet, Guylaine Gevry, and Jean Raymond.
- Department of Surgery, Division of Neurosurgery, University of Alberta, Edmonton, Canada.
- J. Neurol. Neurosurg. Psychiatr. 2017 Aug 1; 88 (8): 663-668.
BackgroundUnruptured 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.MethodsWe 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.ResultsThe 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.ConclusionSurgical 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.© Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is permitted unless otherwise expressly granted.
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