Division of Neurosurgery, Department of Surgery, University of Alberta Hospital, Mackenzie Health Sciences Centre, Edmonton, Canada.
Department of Radiology, Service of Interventional Neuroradiology, Centre Hospitalier de l'Université de Montréal (CHUM), Montreal, Canada.
World Neurosurg. 2022 Apr;160:e49-e54. doi: 10.1016/j.wneu.2021.12.083. Epub 2021 Dec 28.
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.
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.
Patients with MCA aneurysms can be optimally managed within a care trial protocol.
对于大脑中动脉（MCA）动脉瘤患者，最佳治疗方法是手术还是血管内治疗仍不确定，几乎没有证据可以指导决策。一项提供 50%手术机会和 50%血管内治疗机会的 MCA 动脉瘤患者随机对照试验，可能会在存在不确定性的情况下优化结果。
大脑中动脉动脉瘤试验（MCAAT）是一项由研究者发起的、多中心、平行组、前瞻性、1:1 随机对照临床试验。所有适合手术和血管内治疗的 MCA 动脉瘤成年患者，无论破裂与否，均可纳入。主要复合结局是“治疗成功”：（i）采用分配的治疗方式闭塞或排除动脉瘤；（ii）随访期间无颅内出血；（iii）随访期间无需对目标动脉瘤进行再治疗；（iv）血管造影随访时无残留动脉瘤；（v）1 年时独立（mRS<3）。该试验检验了同一假设的 2 个版本（一个针对破裂性 MCA 动脉瘤患者，一个针对未破裂性 MCA 动脉瘤患者）：与血管内治疗（任何方法）相比，手术治疗将使达到治疗成功的患者比例从 55%增加到 70%（破裂性）或从 75%增加到 90%（未破裂性 MCA 动脉瘤患者），绝对增加 15%。在这项实用试验中，除非是 1 年的血管造影结果，将由核心实验室评估，否则结局评估由治疗医生进行。该试验将由一个独立的数据安全监测委员会进行监测，以确保参与者的安全。MCAAT 在 clinicaltrials.gov 注册：NCT05161377。
MCA 动脉瘤患者可以通过护理试验方案得到最佳管理。
