Journal Article

Surgical clipping or endovascular coiling for unruptured intracranial aneurysms: a pragmatic randomised trial

Magro, Elsa, Guilbert, Francois, Chagnon, Miguel, Weill, Alain, O’Kelly, Cian J, Butcher, Ken, Bojanowski, Michel W, Kotowski, Marc, Darsaut, Tim E, Scholtes, Felix, Gevry, Guylaine, Wong, John H, Chaalala, Chiraz, Arthur, Adam S, Findlay, J Max, Sinclair, John, Raymond, Jean, Lesiuk, Howard, Tian, Lu, Fox, Allan J, Chow, Michael M, Roy, Daniel, Iancu, Daniela, Martin, Didier, Nolet, Suzanne

2017

Overview

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.

• Publisher: BMJ Publishing Group LTD,BMJ Publishing Group
• Subject: Adult / Aneurysms / Angioplasty / Chirurgie / Clinical outcomes / Collaboration / endovascular coiling / Female / Follow-Up Studies / Handbooks / Hospitalization / Human health sciences / Humans / Hydrogels / Intracranial Aneurysm - diagnosis / Intracranial Aneurysm - mortality / Intracranial Aneurysm - therapy / Intracranial Aneurysm/diagnosis/mortality/therapy / Intracranial Hemorrhages - etiology / Male / Medical imaging / Microsurgery / Middle Aged / Morbidity / Mortality / Neurologic Examination / Neurologie / Neurology / Outcome and Process Assessment (Health Care) / Patients / pragmatic trial / randomized controlled trial / Sciences de la santé humaine / Stroke / Studies / Surgery / surgical clipping / Surgical Instruments / Survival Analysis / Treatment Failure / Treatment Outcome / unruptured intracranial aneurysm