脑动静脉畸形的保守治疗：一项实用性试验的前瞻性观察登记结果。

IF 3.5 2区医学 Q1 CLINICAL NEUROLOGY Journal of neurosurgery Pub Date : 2024-10-11 DOI:10.3171/2024.5.JNS24623

Tim E Darsaut, Jean-Christophe Gentric, Jonathan Heppner, Camille Lopez, Roland Jabre, Daniela Iancu, Daniel Roy, Alain Weill, Michel W Bojanowski, Chiraz Chaalala, Pierre-Olivier Comby, David Roberge, Christophe Cognard, Anne-Christine Januel, Jean-Francois Sabatier, Hubert Desal, Vincent Roualdes, Jean-Christophe Ferre, Quentin Alias, Chrysanthi Papagiannaki, Stéphane Derrey, Stanislas Smajda, Sorin Aldea, Thomas Gaberel, Charlotte Barbier, Xavier Barreau, Gaultier Marnat, Vincent Jecko, Rene Anxionnat, Isabelle Merlot, Thanh N Nguyen, Mohamad Abdalkader, Chloe Dumot, Roberto Riva, Thomas Graillon, Lucas Troude, Basile Kerleroux, Irene Ollivier, Remy Beaujeux, Grégoire Boulouis, Alexia Planty-Bonjour, Laurent Spelle, Vanessa Chalumeau, Olivier Naggara, Pierre-Henri Lefevre, Marine Le Corre, Eimad Shotar, Andrew P Carlson, Alessandra Biondi, Laurent Thines, Rabih G Tawk, Thien Huynh, Robert Fahed, J Max Findlay, Emmanuel Chabert, Justine Zehr, Guylaine Gevry, Ruby Klink, Geraldine Viard, Elsa Magro, Jean Raymond

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引用次数: 0

摘要

目的：脑动静脉畸形治疗研究（TOBAS）招募的许多患者都接受了保守治疗。本研究旨在监测这些患者的情况：TOBAS由两项随机对照试验和多个前瞻性登记处组成。所有脑动静脉畸形（AVM）患者均可参与。本报告涉及选择保守治疗的患者。主要试验结果指标是 10 年后的相关死亡或依赖性（修改后的 Rankin 量表 [mRS] 评分 > 2）。次要结果包括颅内出血、非出血性神经事件和严重不良事件（SAE）。本报告采用患者年数、Kaplan-Meier 生存曲线和 Cox 对数秩检验来显示结果。本研究不设盲法：2014年6月至2021年5月，共招募了1010名患者，其中498人（49%）被纳入前瞻性观察登记。排除后，仍有 434 名（87%）患者可供分析。大多数患者患有未破裂的 AVM（378/434 [87%]），其中 195 例（52%）为低级别（Spetzler-Martin I 级或 II 级）。在平均 3.2 年的随访期间（共 1368 个患者年），434 名患者中有 23 名（5%）出现了主要结果，相当于每 100 个患者年有 1.7 例（95% CI 1.1-2.5）。未破裂的动静脉畸形的发病率为每 100 患者年 1.1 例（95% CI 0.7-1.9），低级别未破裂的动静脉畸形的发病率为每 100 患者年 0.6 例（95% CI 0.2-1.7）。有破裂史（HR 5.6 [95% CI 2.4-13.0]，p < 0.001）、颅内下 AVM（HR 2.9 [95% CI 1.1-7.3]，p = 0.027）和年龄≥55 岁（HR 3.2 [95% CI 1.4-7.6]，p = 0.007）的患者更容易出现不良预后。434 例患者中有 35 例（8%）发生了颅内大出血（发生率为每 100 患者年 2.6 [95% CI 1.9-3.6]；未破裂的 AVM 为每 100 患者年 2.0 [95% CI 1.3-2.9]，低级别未破裂的 AVM 为每 100 患者年 1.3 [95% CI 0.6-2.6]）。在破裂（HR 4.4 [95% CI 2.1-8.9]，p < 0.001）、大（HR 2.6 [95% CI 1.1-6.6]，p = 0.039）、高级别（HR 2.5 [95% CI 1.2-5.3]，p = 0.013）和有深静脉引流的 AVM 中，AVM 大出血更为常见（HR 2.1 [95% CI 1.1-4.2]，p = 0.032）。434 例患者中有 48 例（11%）发生 SAE（发生率为每 100 患者年 3.6 [95% CI 2.7-4.8]）。未破裂的动静脉畸形的发生率为每 100 患者年 2.8 例（95% CI 2.0-4.0），低级别未破裂的动静脉畸形的发生率为每 100 患者年 1.8 例（95% CI 1.0-3.2）：近一半的 TOBAS 参与者接受了观察。结论：近一半的 TOBAS 参与者接受了观察，神经系统意外事件的发生率在预期范围内。

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Conservative management of brain arteriovenous malformations: results of the prospective observation registry of a pragmatic trial.

Objective: Many patients recruited in the Treatment of Brain Arteriovenous Malformations Study (TOBAS) are managed conservatively. The aim of this study was to monitor what happened to those patients.

Methods: TOBAS comprises two randomized controlled trials and multiple prospective registries. All patients with brain arteriovenous malformations (AVMs) can participate. This report concerns patients selected for conservative management. The primary trial outcome measure is related death or dependency (modified Rankin Scale [mRS] score > 2) at 10 years. Secondary outcomes include intracranial hemorrhages, nonhemorrhagic neurological events, and serious adverse events (SAEs). For this report, outcome results are presented using patient-years, Kaplan-Meier survival curves, and Cox log-rank tests. There was no blinding.

Results: From June 2014 to May 2021, 1010 patients were recruited, of whom 498 (49%) were proposed the prospective observation registry. After exclusions, 434 (87%) patients remained for analysis. The majority of patients had unruptured AVMs (378/434 [87%]), of which 195 (52%) were low grade (Spetzler-Martin grade I or II). During a mean follow-up period of 3.2 years (total 1368 patient-years), the primary outcome occurred in 23 of 434 (5%) patients, corresponding to an incidence of 1.7 (95% CI 1.1-2.5) per 100 patient-years. For unruptured AVMs the incidence was 1.1 (95% CI 0.7-1.9) per 100 patient-years, and for low-grade unruptured AVMs it was 0.6 (95% CI 0.2-1.7) per 100 patient-years. Poor outcomes were more frequent in patients with a history of rupture (HR 5.6 [95% CI 2.4-13.0], p < 0.001), infratentorial AVMs (HR 2.9 [95% CI 1.1-7.3], p = 0.027), and age ≥ 55 years (HR 3.2 [95% CI 1.4-7.6], p = 0.007). Major intracranial hemorrhage occurred in 35 of 434 (8%) patients (incidence of 2.6 [95% CI 1.9-3.6] per 100 patient-years; 2.0 [95% CI 1.3-2.9] per 100 patient-years for unruptured AVMs and 1.3 [95% CI 0.6-2.6] per 100 patient-years for low-grade unruptured AVMs). Major AVM hemorrhages were more frequent in ruptured (HR 4.4 [95% CI 2.1-8.9], p < 0.001), large (HR 2.6 [95% CI 1.1-6.6], p = 0.039), and high-grade (HR 2.5 [95% CI 1.2-5.3], p = 0.013) AVMs and those with deep venous drainage (HR 2.1 [95% CI 1.1-4.2], p = 0.032). SAEs occurred in 48 of 434 (11%) patients (incidence of 3.6 [95% CI 2.7-4.8] per 100 patient-years). For unruptured AVMs the incidence was 2.8 (95% CI 2.0-4.0) per 100 patient-years, and for low-grade unruptured AVMs it was 1.8 (95% CI 1.0-3.2) per 100 patient-years.

Conclusions: Nearly half of TOBAS participants were observed. Rates of untoward neurological events were within expected boundaries.

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来源期刊

Journal of neurosurgery 医学-临床神经学

CiteScore

7.20

自引率

7.30%

发文量

1003

审稿时长

1 months

期刊介绍： The Journal of Neurosurgery, Journal of Neurosurgery: Spine, Journal of Neurosurgery: Pediatrics, and Neurosurgical Focus are devoted to the publication of original works relating primarily to neurosurgery, including studies in clinical neurophysiology, organic neurology, ophthalmology, radiology, pathology, and molecular biology. The Editors and Editorial Boards encourage submission of clinical and laboratory studies. Other manuscripts accepted for review include technical notes on instruments or equipment that are innovative or useful to clinicians and researchers in the field of neuroscience; papers describing unusual cases; manuscripts on historical persons or events related to neurosurgery; and in Neurosurgical Focus, occasional reviews. Letters to the Editor commenting on articles recently published in the Journal of Neurosurgery, Journal of Neurosurgery: Spine, and Journal of Neurosurgery: Pediatrics are welcome.