Tim E Darsaut1, Michael B Keough1, William Boisseau2, J Max Findlay1, Michel W Bojanowski3, Chiraz Chaalala3, Daniela Iancu2, Alain Weill2, Daniel Roy2, Laurent Estrade4, Jean-Paul Lejeune5, Anne-Christine Januel6, Andrew P Carlson7, Eric Sauvageau8, Hosam Al-Jehani9, Kirill Orlov10, Sorin Aldea11, Michel Piotin12, Thomas Gaberel13, Guylaine Gevry2, Jean Raymond2. 1. Division of Neurosurgery, Department of Surgery, University of Alberta Hospital, Mackenzie Health Sciences Centre, Edmonton, Canada. 2. Department of Radiology, Service of Interventional Neuroradiology, Centre Hospitalier de l'Université de Montréal (CHUM), Montreal, Canada. 3. Department of Surgery, Service of Neurosurgery, Centre Hospitalier de l'Université de Montréal (CHUM), Montreal, Canada. 4. Department of Interventional Neuroradiology, CHU de Lille, Hôpital Salengro, Lille, France. 5. Department of Neurosurgery, CHU de Lille, Hôpital Salengro, Lille, France. 6. Department of Interventional Neuroradiology, CHU de Toulouse, Hôpital Purpan, Toulouse, France. 7. Department of Neurosurgery, University of New Mexico Hospital, Albuquerque, New Mexico, USA. 8. Lyerly Neurosurgery, Baptist Health, Jacksonville, Florida, USA. 9. Department of Neurosurgery and Radiology, King Fahad University Hospital, Imam Abdulrahman bin Faisal University, Dammam, Saudi Arabia. 10. Endovascular Neurosurgery Research Center, Federal Center of Brain Research and Neurotechnologies of the Federal Medical Biological Agency of Russia, Moscow, Russia. 11. Department of Neurosurgery, Rothschild Foundation Hospital, Paris, France. 12. Department of Interventional Neuroradiology, Rothschild Foundation Hospital, Paris, France. 13. Department of Neurosurgery, CHU de Caen, Caen, France.
Abstract
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.
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.
Authors: W Boisseau; T E Darsaut; R Fahed; J M Findlay; R Bourcier; G Charbonnier; S Smajda; J Ognard; D Roy; F Gariel; A P Carlson; E Shotar; G Ciccio; G Marnat; P B Sporns; T Gaberel; V Jecko; A Weill; A Biondi; G Boulouis; A L Bras; S Aldea; T Passeri; S Boissonneau; N Bougaci; J C Gentric; J D B Diestro; A T Omar; H M Al-Jehani; G El Hage; D Volders; Z Kaderali; I Tsogkas; E Magro; Q Holay; J Zehr; D Iancu; J Raymond Journal: AJNR Am J Neuroradiol Date: 2022-09-22 Impact factor: 4.966