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

Darsaut, T.E.; Findlay, J.M.; Bojanowski, M.W.; Chalaala, C.; Iancu, D.; Roy, D.; Weill, A.; Boisseau, W.; Diouf, A.; Magro, E.; Kotowski, M.; Keough, M.B.; Estrade, L.; Bricout, N.; Lejeune, J.-P.; Chow, M.M.C.; O’Kelly, C.J.; Rempel, J.L.; Ashforth, R.A.; Lesiuk, H.; Sinclair, J.; Erdenebold, U.-E.; Wong, J.H.; Scholtes, F.; Martin, D.; Otto, B.; Bilocq, A.; Truffer, E.; Butcher, K.; Fox, A.J.; Arthur, A.S.; Létourneau-Guillon, L.; Guilbert, F.; Chagnon, M.; Zehr, J.; Farzin, B.; Gevry, G.; Raymond, J.

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

detalle del documento

IDENTIFICACIÓN

oai:pubmedcentral.nih.gov:1024...

Tema

Interventional

Autor

Darsaut, T.E. Findlay, J.M. Bojanowski, M.W. Chalaala, C. Iancu, D. Roy, D. Weill, A. Boisseau, W. Diouf, A. Magro, E. Kotowski, M. Keough, M.B. Estrade, L. Bricout, N. Lejeune, J.-P. Chow, M.M.C. O’Kelly, C.J. Rempel, J.L. Ashforth, R.A. Lesiuk, H. Sinclair, J. Erdenebold, U.-E. Wong, J.H. Scholtes, F. Martin, D. Otto, B. Bilocq, A. Truffer, E. Butcher, K. Fox, A.J. Arthur, A.S. Létourneau-Guillon, L. Guilbert, F. Chagnon, M. Zehr, J. Farzin, B. Gevry, G. Raymond, J.

Langue

Editor

American Society of Neuroradiology

Categoría

AJNR: American Journal of Neuroradiology

Año

2023

fecha de cotización

10/6/2024

Palabras clave

surgical failure surgery risk primary outcome relative 95% ci treatment patients clipping aneurysms intracranial unruptured endovascular

Métrico

Resumen

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.

Darsaut, T.E.,Findlay, J.M.,Bojanowski, M.W.,Chalaala, C.,Iancu, D.,Roy, D.,Weill, A.,Boisseau, W.,Diouf, A.,Magro, E.,Kotowski, M.,Keough, M.B.,Estrade, L.,Bricout, N.,Lejeune, J.-P.,Chow, M.M.C.,O’Kelly, C.J.,Rempel, J.L.,Ashforth, R.A.,Lesiuk, H.,Sinclair, J.,Erdenebold, U.-E.,Wong, J.H.,Scholtes, F.,Martin, D.,Otto, B.,Bilocq, A.,Truffer, E.,Butcher, K.,Fox, A.J.,Arthur, A.S.,Létourneau-Guillon, L.,Guilbert, F.,Chagnon, M.,Zehr, J.,Farzin, B.,Gevry, G.,Raymond, J., 2023, A Pragmatic Randomized Trial Comparing Surgical Clipping and Endovascular Treatment of Unruptured Intracranial Aneurysms, American Society of Neuroradiology