脑动静脉畸形的保守治疗：一项实用试验前瞻性观察登记的结果
Conservative management of brain arteriovenous malformations: results of the prospective observation registry of a pragmatic trial.
作者信息
Darsaut Tim E, Gentric Jean-Christophe, Heppner Jonathan, Lopez Camille, Jabre Roland, Iancu Daniela, Roy Daniel, Weill Alain, Bojanowski Michel W, Chaalala Chiraz, Comby Pierre-Olivier, Roberge David, Cognard Christophe, Januel Anne-Christine, Sabatier Jean-Francois, Desal Hubert, Roualdes Vincent, Ferre Jean-Christophe, Alias Quentin, Papagiannaki Chrysanthi, Derrey Stéphane, Smajda Stanislas, Aldea Sorin, Gaberel Thomas, Barbier Charlotte, Barreau Xavier, Marnat Gaultier, Jecko Vincent, Anxionnat Rene, Merlot Isabelle, Nguyen Thanh N, Abdalkader Mohamad, Dumot Chloe, Riva Roberto, Graillon Thomas, Troude Lucas, Kerleroux Basile, Ollivier Irene, Beaujeux Remy, Boulouis Grégoire, Planty-Bonjour Alexia, Spelle Laurent, Chalumeau Vanessa, Naggara Olivier, Lefevre Pierre-Henri, Le Corre Marine, Shotar Eimad, Carlson Andrew P, Biondi Alessandra, Thines Laurent, Tawk Rabih G, Huynh Thien, Fahed Robert, Findlay J Max, Chabert Emmanuel, Zehr Justine, Gevry Guylaine, Klink Ruby, Viard Geraldine, Magro Elsa, Raymond Jean
机构信息
1Department of Surgery, Division of Neurosurgery, University of Alberta Hospital, Edmonton, Alberta, Canada.
2Department of Interventional Neuroradiology, CHU Cavale Blanche, Inserm, UMR 1304 (GETBO), Brest, France.
出版信息
J Neurosurg. 2024 Oct 11;142(3):637-646. doi: 10.3171/2024.5.JNS24623. Print 2025 Mar 1.
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.
目的
许多纳入脑动静脉畸形治疗研究（TOBAS）的患者采用保守治疗。本研究的目的是监测这些患者的情况。
方法
TOBAS包括两项随机对照试验和多个前瞻性登记处。所有脑动静脉畸形（AVM）患者均可参与。本报告涉及选择进行保守治疗的患者。主要试验结局指标是10年时的相关死亡或依赖（改良Rankin量表[mRS]评分>2）。次要结局包括颅内出血、非出血性神经事件和严重不良事件（SAE）。本报告中，结局结果采用患者年数、Kaplan-Meier生存曲线和Cox对数秩检验呈现。未设盲法。
结果
2014年6月至2021年5月，共招募1010例患者，其中498例（49%）被纳入前瞻性观察登记处。排除后，434例（87%）患者留作分析。大多数患者为未破裂AVM（378/434 [87%]），其中195例（52%）为低级别（Spetzler-Martin I或II级）。在平均3.2年的随访期（共1368患者年）内，434例患者中有23例（5%）发生主要结局，相当于每100患者年发生率为1.7（95%CI 1.1 - 2.5）。未破裂AVM的发生率为每100患者年1.1（95%CI 0.7 - 1.9），低级别未破裂AVM的发生率为每100患者年0.6（95%CI 0.2 - 1.7）。有破裂史的患者（HR 5.6 [95%CI 2.4 - 13.0]，p < 0.001）、幕下AVM患者（HR 2.9 [95%CI 1.1 - 7.3]，p = 0.027）和年龄≥55岁患者（HR 3.2 [95%CI 1.
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