Surgical 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 Arthur, Francois Guilbert & 5 others Lu Tian, Miguel Chagnon, Suzanne Nolet, Guylaine Gevry, Jean Raymond

Research output: Contribution to journalArticle

19 Citations (Scopus)

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.

Original languageEnglish (US)
Pages (from-to)663-668
Number of pages6
JournalJournal of Neurology, Neurosurgery and Psychiatry
Volume88
Issue number8
DOIs
StatePublished - Aug 1 2017

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Pragmatic Clinical Trials
Intracranial Aneurysm
Morbidity
Treatment Failure
Aneurysm
Hospitalization
Mortality
Intracranial Hemorrhages

All Science Journal Classification (ASJC) codes

  • Surgery
  • Clinical Neurology
  • Psychiatry and Mental health

Cite this

Surgical clipping or endovascular coiling for unruptured intracranial aneurysms : A pragmatic randomised trial. / Darsaut, Tim E.; Findlay, J. Max; Magro, Elsa; Kotowski, Marc; Roy, Daniel; Weill, Alain; Bojanowski, Michel W.; Chaalala, Chiraz; Iancu, Daniela; Lesiuk, Howard; Sinclair, John; Scholtes, Felix; Martin, Didier; Chow, Michael M.; O'Kelly, Cian J.; Wong, John H.; Butcher, Ken; Fox, Allan J.; Arthur, Adam; Guilbert, Francois; Tian, Lu; Chagnon, Miguel; Nolet, Suzanne; Gevry, Guylaine; Raymond, Jean.

In: Journal of Neurology, Neurosurgery and Psychiatry, Vol. 88, No. 8, 01.08.2017, p. 663-668.

Research output: Contribution to journalArticle

Darsaut, TE, Findlay, JM, Magro, E, Kotowski, M, Roy, D, Weill, A, Bojanowski, MW, Chaalala, C, Iancu, D, Lesiuk, H, Sinclair, J, Scholtes, F, Martin, D, Chow, MM, O'Kelly, CJ, Wong, JH, Butcher, K, Fox, AJ, Arthur, A, Guilbert, F, Tian, L, Chagnon, M, Nolet, S, Gevry, G & Raymond, J 2017, 'Surgical clipping or endovascular coiling for unruptured intracranial aneurysms: A pragmatic randomised trial', Journal of Neurology, Neurosurgery and Psychiatry, vol. 88, no. 8, pp. 663-668. https://doi.org/10.1136/jnnp-2016-315433
Darsaut, Tim E. ; Findlay, J. Max ; Magro, Elsa ; Kotowski, Marc ; Roy, Daniel ; Weill, Alain ; Bojanowski, Michel W. ; Chaalala, Chiraz ; Iancu, Daniela ; Lesiuk, Howard ; Sinclair, John ; Scholtes, Felix ; Martin, Didier ; Chow, Michael M. ; O'Kelly, Cian J. ; Wong, John H. ; Butcher, Ken ; Fox, Allan J. ; Arthur, Adam ; Guilbert, Francois ; Tian, Lu ; Chagnon, Miguel ; Nolet, Suzanne ; Gevry, Guylaine ; Raymond, Jean. / Surgical clipping or endovascular coiling for unruptured intracranial aneurysms : A pragmatic randomised trial. In: Journal of Neurology, Neurosurgery and Psychiatry. 2017 ; Vol. 88, No. 8. pp. 663-668.
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T1 - Surgical clipping or endovascular coiling for unruptured intracranial aneurysms

T2 - A pragmatic randomised trial

AU - Darsaut, Tim E.

AU - Findlay, J. Max

AU - Magro, Elsa

AU - Kotowski, Marc

AU - Roy, Daniel

AU - Weill, Alain

AU - Bojanowski, Michel W.

AU - Chaalala, Chiraz

AU - Iancu, Daniela

AU - Lesiuk, Howard

AU - Sinclair, John

AU - Scholtes, Felix

AU - Martin, Didier

AU - Chow, Michael M.

AU - O'Kelly, Cian J.

AU - Wong, John H.

AU - Butcher, Ken

AU - Fox, Allan J.

AU - Arthur, Adam

AU - Guilbert, Francois

AU - Tian, Lu

AU - Chagnon, Miguel

AU - Nolet, Suzanne

AU - Gevry, Guylaine

AU - Raymond, Jean

PY - 2017/8/1

Y1 - 2017/8/1

N2 - 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.

AB - 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.

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