TY - JOUR
T1 - Middle Cerebral Artery Aneurysm Trial (MCAAT)
T2 - A Randomized Care Trial Comparing Surgical and Endovascular Management of MCA Aneurysm Patients
AU - Darsaut, Tim E.
AU - Keough, Michael B.
AU - Boisseau, William
AU - Findlay, J. Max
AU - Bojanowski, Michel W.
AU - Chaalala, Chiraz
AU - Iancu, Daniela
AU - Weill, Alain
AU - Roy, Daniel
AU - Estrade, Laurent
AU - Lejeune, Jean Paul
AU - Januel, Anne Christine
AU - Carlson, Andrew P.
AU - Sauvageau, Eric
AU - Al-Jehani, Hosam
AU - Orlov, Kirill
AU - Aldea, Sorin
AU - Piotin, Michel
AU - Gaberel, Thomas
AU - Gevry, Guylaine
AU - Raymond, Jean
N1 - Funding Information:
Conflict of interest statement: The authors declare that the article content was composed in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest.
Publisher Copyright:
© 2021 Elsevier Inc.
PY - 2022/4
Y1 - 2022/4
N2 - BACKGROUND: Whether the best management of middle cerebral artery (MCA) aneurysm patients is surgical or endovascular remains uncertain, with little evidence to guide decision-making. A randomized care trial offering MCA aneurysm patients a 50% chance of surgical and a 50% chance of endovascular management may optimize outcomes in the presence of uncertainty.METHODS: The Middle Cerebral Artery Aneurysm Trial (MCAAT) is an investigator-initiated, multicenter, parallel group, prospective, 1:1 randomized controlled clinical trial. All adult patients with MCA aneurysms, ruptured or unruptured, amenable to surgical and endovascular treatment can be included. The composite primary outcome is "Treatment Success": (i) occlusion or exclusion of the aneurysm using the allocated treatment modality; (ii) no intracranial hemorrhage during follow-up; (iii) no retreatment of the target aneurysm during follow-up, (iv) no residual aneurysm on angiographic follow-up; and (v) independence (mRS <3) at 1 year. The trial tests 2 versions of the same hypothesis (one for ruptured and one for unruptured MCA aneurysm patients): Surgical management will lead to a 15% absolute increase in the proportion of patients reaching Treatment Success from 55% to 70% (ruptured) or from 75% to 90% (unruptured aneurysm patients) compared with endovascular treatment (any method). In this pragmatic trial, outcome evaluations are by treating physicians, except for 1-year angiographic results which will be core lab assessed. The trial will be monitored by an independent data safety monitoring committee to assure safety of participants. MCAAT is registered at clinicaltrials.gov: NCT05161377.CONCLUSIONS: Patients with MCA aneurysms can be optimally managed within a care trial protocol.
AB - BACKGROUND: Whether the best management of middle cerebral artery (MCA) aneurysm patients is surgical or endovascular remains uncertain, with little evidence to guide decision-making. A randomized care trial offering MCA aneurysm patients a 50% chance of surgical and a 50% chance of endovascular management may optimize outcomes in the presence of uncertainty.METHODS: The Middle Cerebral Artery Aneurysm Trial (MCAAT) is an investigator-initiated, multicenter, parallel group, prospective, 1:1 randomized controlled clinical trial. All adult patients with MCA aneurysms, ruptured or unruptured, amenable to surgical and endovascular treatment can be included. The composite primary outcome is "Treatment Success": (i) occlusion or exclusion of the aneurysm using the allocated treatment modality; (ii) no intracranial hemorrhage during follow-up; (iii) no retreatment of the target aneurysm during follow-up, (iv) no residual aneurysm on angiographic follow-up; and (v) independence (mRS <3) at 1 year. The trial tests 2 versions of the same hypothesis (one for ruptured and one for unruptured MCA aneurysm patients): Surgical management will lead to a 15% absolute increase in the proportion of patients reaching Treatment Success from 55% to 70% (ruptured) or from 75% to 90% (unruptured aneurysm patients) compared with endovascular treatment (any method). In this pragmatic trial, outcome evaluations are by treating physicians, except for 1-year angiographic results which will be core lab assessed. The trial will be monitored by an independent data safety monitoring committee to assure safety of participants. MCAAT is registered at clinicaltrials.gov: NCT05161377.CONCLUSIONS: Patients with MCA aneurysms can be optimally managed within a care trial protocol.
KW - Endovascular management
KW - MCA aneurysm
KW - Randomized trial
KW - Surgical clipping
KW - Prospective Studies
KW - Follow-Up Studies
KW - Humans
KW - Treatment Outcome
KW - Intracranial Aneurysm/diagnostic imaging
KW - Endovascular Procedures/methods
KW - Middle Cerebral Artery/diagnostic imaging
KW - Adult
KW - Retrospective Studies
KW - Aneurysm, Ruptured/diagnostic imaging
KW - Neurosurgical Procedures/methods
KW - Embolization, Therapeutic/methods
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UR - http://www.scopus.com/inward/citedby.url?scp=85122959831&partnerID=8YFLogxK
U2 - 10.1016/j.wneu.2021.12.083
DO - 10.1016/j.wneu.2021.12.083
M3 - Article
C2 - 34971833
AN - SCOPUS:85122959831
SN - 1878-8750
VL - 160
SP - e49-e54
JO - World neurosurgery
JF - World neurosurgery
ER -