A Pragmatic Randomized Trial Comparing Surgical Clipping and Endovascular Treatment of Unruptured Intracranial Aneurysms

T E Darsaut¹, J M Findlay¹, M W Bojanowski², C Chalaala², D Iancu³, D Roy³, A Weill³, W Boisseau³, A Diouf³, E Magro⁴, M Kotowski³, M B Keough¹, L Estrade⁵, N Bricout⁵, J-P Lejeune⁶, M M C Chow¹, C J O'Kelly¹, J L Rempel⁷, R A Ashforth⁷, H Lesiuk⁸, J Sinclair⁸, U-E Erdenebold⁹, J H Wong¹⁰, F Scholtes¹¹, D Martin¹¹, B Otto¹², A Bilocq¹³, E Truffer¹³, K Butcher¹⁴, A J Fox¹⁵, A S Arthur¹⁶, L Létourneau-Guillon³, F Guilbert³, M Chagnon¹⁷, J Zehr¹⁷, B Farzin¹⁸, G Gevry¹⁸, J Raymond^{19

18}

Affiliations

¹ From the Division of Neurosurgery (T.E.D., J.M.F., M.B.K., M.M.C.C., C.J.O.).
² Service of Neurosurgery (M.W.B., C.C.).
³ Department of Surgery, and Service of Neuroradiology (D.I., D.R., A.W., W.B., A.D., M.K., L.L.-G., F.G., J.R.), Department of Radiology, Centre Hospitalier de l'Université de Montréal, Montreal, Québec, Canada.
⁴ Service of Neurosurgery (E.M.), Centre Hospitalier Universitaire Cavale Blanche, Institut National de la Santé et de la Recherche Médicale Unité Mixte de Recherche 1101 LaTIM, Brest, France.
⁵ Interventional Neuroradiology (L.E., N.B.).
⁶ Service of Neurosurgery (J.-P.L.), Centre Hospitalier Universitaire de Lille, Lille, France.
⁷ Department of Surgery, and Department of Radiology and Diagnostic Imaging (J.L.R., R.A.A.), Mackenzie Health Sciences Centre, University of Alberta Hospital, Edmonton, Alberta, Canada.
⁸ Section of Neurosurgery (H.L., J.S.).
⁹ Department of Surgery, and Department of Medical Imaging (U.-E.E.), Section of Interventional Neuroradiology, Ottawa Hospital, University of Ottawa, Ottawa, Ontario, Canada.
¹⁰ Division of Neurosurgery (J.H.W.), Foothills Medical Centre, University of Calgary, Calgary, Alberta, Canada.
¹¹ Departments of Neurosurgery (F.S., D.M.).
¹² Medical Physics (B.O.), Division of Medical Imaging, Centre Hospitalier Universitaire de Liège, Liège, Belgium.
¹³ Service of Neurosurgery (A.B., E.T.), Centre Hospitalier Régional de Trois-Rivières, Trois-Rivières, Québec, Canada.
¹⁴ Clinical Neurosciences (K.B.), Prince of Wales Clinical School, University of New South Wales, Randwick, New South Wales, Australia.
¹⁵ Department of Medical Imaging (A.J.F.), University of Toronto, Toronto, Ontario, Canada.
¹⁶ Department of Neurosurgery (A.S.A.), University of Tennessee Health Science Center and Semmes-Murphey Clinic, Memphis, Tennessee.
¹⁷ Department of Mathematics and Statistics (M.C., J.Z.), Université de Montréal, Montréal, Québec, Canada.
¹⁸ Research Centre of the University of Montreal Hospital Centre (B.F., G.G., J.R.), Interventional Neuroradiology Research Laboratory, Montreal, Québec, Canada.
¹⁹ Department of Surgery, and Service of Neuroradiology (D.I., D.R., A.W., W.B., A.D., M.K., L.L.-G., F.G., J.R.), Department of Radiology, Centre Hospitalier de l'Université de Montréal, Montreal, Québec, Canada jean.raymond@umontreal.ca.

PMID: 37169541
PMCID: PMC10249696
DOI: 10.3174/ajnr.A7865

Randomized Controlled Trial

A Pragmatic Randomized Trial Comparing Surgical Clipping and Endovascular Treatment of Unruptured Intracranial Aneurysms

T E Darsaut et al. AJNR Am J Neuroradiol. 2023 Jun.

. 2023 Jun;44(6):634-640.

doi: 10.3174/ajnr.A7865. Epub 2023 May 11.

Authors

Affiliations

¹ From the Division of Neurosurgery (T.E.D., J.M.F., M.B.K., M.M.C.C., C.J.O.).
² Service of Neurosurgery (M.W.B., C.C.).
³ Department of Surgery, and Service of Neuroradiology (D.I., D.R., A.W., W.B., A.D., M.K., L.L.-G., F.G., J.R.), Department of Radiology, Centre Hospitalier de l'Université de Montréal, Montreal, Québec, Canada.
⁴ Service of Neurosurgery (E.M.), Centre Hospitalier Universitaire Cavale Blanche, Institut National de la Santé et de la Recherche Médicale Unité Mixte de Recherche 1101 LaTIM, Brest, France.
⁵ Interventional Neuroradiology (L.E., N.B.).
⁶ Service of Neurosurgery (J.-P.L.), Centre Hospitalier Universitaire de Lille, Lille, France.
⁷ Department of Surgery, and Department of Radiology and Diagnostic Imaging (J.L.R., R.A.A.), Mackenzie Health Sciences Centre, University of Alberta Hospital, Edmonton, Alberta, Canada.
⁸ Section of Neurosurgery (H.L., J.S.).
⁹ Department of Surgery, and Department of Medical Imaging (U.-E.E.), Section of Interventional Neuroradiology, Ottawa Hospital, University of Ottawa, Ottawa, Ontario, Canada.
¹⁰ Division of Neurosurgery (J.H.W.), Foothills Medical Centre, University of Calgary, Calgary, Alberta, Canada.
¹¹ Departments of Neurosurgery (F.S., D.M.).
¹² Medical Physics (B.O.), Division of Medical Imaging, Centre Hospitalier Universitaire de Liège, Liège, Belgium.
¹³ Service of Neurosurgery (A.B., E.T.), Centre Hospitalier Régional de Trois-Rivières, Trois-Rivières, Québec, Canada.
¹⁴ Clinical Neurosciences (K.B.), Prince of Wales Clinical School, University of New South Wales, Randwick, New South Wales, Australia.
¹⁵ Department of Medical Imaging (A.J.F.), University of Toronto, Toronto, Ontario, Canada.
¹⁶ Department of Neurosurgery (A.S.A.), University of Tennessee Health Science Center and Semmes-Murphey Clinic, Memphis, Tennessee.
¹⁷ Department of Mathematics and Statistics (M.C., J.Z.), Université de Montréal, Montréal, Québec, Canada.
¹⁸ Research Centre of the University of Montreal Hospital Centre (B.F., G.G., J.R.), Interventional Neuroradiology Research Laboratory, Montreal, Québec, Canada.
¹⁹ Department of Surgery, and Service of Neuroradiology (D.I., D.R., A.W., W.B., A.D., M.K., L.L.-G., F.G., J.R.), Department of Radiology, Centre Hospitalier de l'Université de Montréal, Montreal, Québec, Canada jean.raymond@umontreal.ca.

PMID: 37169541
PMCID: PMC10249696
DOI: 10.3174/ajnr.A7865

Abstract

Background and purpose: Surgical clipping and endovascular treatment are commonly used in patients with unruptured intracranial aneurysms. We compared the safety and efficacy of the 2 treatments in a randomized trial.

Materials and methods: Clipping or endovascular treatments were randomly allocated to patients with one or more 3- to 25-mm unruptured intracranial aneurysms judged treatable both ways by participating physicians. The study hypothesized that clipping would decrease the incidence of treatment failure from 13% to 4%, a composite primary outcome defined as failure of aneurysm occlusion, intracranial hemorrhage during follow-up, or residual aneurysms at 1 year, as adjudicated by a core lab. Safety outcomes included new neurologic deficits following treatment, hospitalization of >5 days, and overall morbidity and mortality (mRS > 2) at 1 year. There was no blinding.

Results: Two hundred ninety-one patients were enrolled from 2010 to 2020 in 7 centers. The 1-year primary outcome, ascertainable in 290/291 (99%) patients, was reached in 13/142 (9%; 95% CI, 5%-15%) patients allocated to surgery and in 28/148 (19%; 95% CI, 13%-26%) patients allocated to endovascular treatments (relative risk: 2.07; 95% CI, 1.12-3.83; P = .021). Morbidity and mortality (mRS >2) at 1 year occurred in 3/143 and 3/148 (2%; 95% CI, 1%-6%) patients allocated to surgery and endovascular treatments, respectively. Neurologic deficits (32/143, 22%; 95% CI, 16%-30% versus 19/148, 12%; 95% CI, 8%-19%; relative risk: 1.74; 95% CI, 1.04-2.92; P = .04) and hospitalizations beyond 5 days (69/143, 48%; 95% CI, 40%-56% versus 12/148, 8%; 95% CI, 5%-14%; relative risk: 0.18; 95% CI, 0.11-0.31; P < .001) were more frequent after surgery.

Conclusions: Surgical clipping is more effective than endovascular treatment of unruptured intracranial aneurysms in terms of the frequency of the primary outcome of treatment failure. Results were mainly driven by angiographic results at 1 year.

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Figures

**FIG 2.**
Subgroup analyses of primary outcome. NA indicates not applicable.

**FIG 3.**
Clinical status at baseline, hospital discharge, and 1-year follow-up.

See this image and copyright information in PMC

Comment in

Open vascular neurosurgery is not dead! Long live open vascular neurosurgery!
Gaberel T. Gaberel T. Neurochirurgie. 2023 Jul;69(4):101454. doi: 10.1016/j.neuchi.2023.101454. Epub 2023 May 18. Neurochirurgie. 2023. PMID: 37271054 No abstract available.
Appreciation and Concerns Regarding the Published Study "CURES".
Arrese I, Sarabia R. Arrese I, et al. AJNR Am J Neuroradiol. 2023 Aug;44(8):E35. doi: 10.3174/ajnr.A7925. Epub 2023 Jul 27. AJNR Am J Neuroradiol. 2023. PMID: 37500284 Free PMC article. No abstract available.

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A Pragmatic Randomized Trial Comparing Surgical Clipping and Endovascular Treatment of Unruptured Intracranial Aneurysms

Affiliations

A Pragmatic Randomized Trial Comparing Surgical Clipping and Endovascular Treatment of Unruptured Intracranial Aneurysms

Authors

Affiliations

Abstract

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Medical

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