经静脉途径治疗脑动静脉畸形：与经动脉栓塞术的随机对照比较
Transvenous Approach for the Treatment of Cerebral Arteriovenous Malformations: A Randomized Comparison With Transarterial Embolization.
作者信息
Raymond Jean, Darsaut Tim E, Saleme Suzana, Rouchaud Aymeric, Iancu Daniela, Roy Daniel, Weill Alain, Olijnyk Leonardo, Jabre Roland, Bojanowski Michel W, Chaalala Chiraz, Roberge David, Boubagra Kamel, Heck Olivier, Rempel Jeremy L, Papagiannaki Chrysanthi, Barreau Xavier, Marnat Gaultier, Gentric Jean-Christophe, Ognard Julien, Nico Lorena, Bintner Marc, Gauthier Lasalarie Pascale, Veyrieres Jean-Brice, Piotin Michel, Escalard Simon, Pereira Vitor M, Abud Daniel G, Zehr Justine, Chagnon Miguel, Nguyen Thanh N, Mathieu David, Gevry Guylaine, Klink Ruby, Lorian Emmanuelle, Mounayer Charbel
机构信息
Department of Radiology, Service of Neuroradiology (J.R., D.I., D. Roy, A.W., L.O.), Centre Hospitalier de l'Université de Montréal, Quebec, Canada.
Division of Neurosurgery, Department of Surgery, University of Alberta Hospital, Mackenzie Health Sciences Centre, Edmonton, Canada (T.E.D.).
出版信息
Stroke. 2025 Jun;56(6):1396-1403. doi: 10.1161/STROKEAHA.124.049109. Epub 2025 Mar 27.
BACKGROUND
Transvenous embolization (TVE) is a new treatment of brain arteriovenous malformations (AVMs). The safety and efficacy of TVE have not been compared with transarterial embolization (TAE). The primary hypothesis of this trial was that TVE would increase the proportion of AVM occlusion from 40% to 80%.
METHODS
The TATAM (Transvenous Approach for the Treatment of Cerebral AVMs) was an investigator-initiated, multicenter, prospective, phase 2, open-label, controlled randomized trial comparing TVE versus TAE alone (1:1). Patients with symptomatic or asymptomatic AVMs considered curable with 2 endovascular sessions were reviewed by a case selection committee. Participating centers were experienced (>20 cases) or proctored by experts. The primary outcome was complete occlusion of the AVM, confirmed by catheter angiography at 3 to 6 months. There was no blinding. Primary analyses were intent-to-treat.
RESULTS
From May 2019 to April 2023, 77 patients were recruited in 7 French and 2 Canadian centers. After exclusions, results from 69 patients were analyzed; 35 were allocated TVE and 34 TAE. The mean age of participants was 43.3 years; 29 of 69 (42%) were female. There were 2 crossovers. The primary outcome was reached in 29 of 35 patients with TVE (83% [95% CI, 67%-92%]) compared with 20 of 34 patients allocated TAE (59% [95% CI, 42%-74%]; =0.036). Poor outcomes (modified Rankin Scale score >2 at 3-6 months) occurred in 7 of 35 patients with TVE (20% [95% CI, 10%-36%]) and 9 of 34 patients with TAE (27% [95% CI, 15%-43%]; =0.578) and related serious adverse events in 12 of 35 patients with TVE (34% [95% CI, 21%-51%]) and 14 of 34 patients with TAE (41% [95% CI, 26%-58%]; =0.624).
CONCLUSIONS
TVE was more effective than TAE in terms of angiographic results at 3 to 6 months. Morbidity was similar but high for both groups. More studies are needed to determine the role of curative embolization in managing patients with brain AVM.
REGISTRATION
URL: https://www.clinicaltrials.gov; Unique identifier: NCT03691870.
背景
经静脉栓塞术（TVE）是治疗脑动静脉畸形（AVM）的一种新方法。TVE的安全性和有效性尚未与经动脉栓塞术（TAE）进行比较。本试验的主要假设是，TVE将使AVM闭塞的比例从40%提高到80%。
方法
TATAM（经静脉途径治疗脑动静脉畸形）是一项由研究者发起的、多中心、前瞻性、2期、开放标签、对照随机试验，比较TVE与单纯TAE（1:1）。有症状或无症状的AVM患者若经2次血管内治疗被认为可治愈，则由病例选择委员会进行评估。参与中心经验丰富（>20例）或由专家指导。主要结局是AVM完全闭塞，在3至6个月时通过导管血管造影证实。本研究未设盲法。主要分析采用意向性分析。
结果
2019年5月至2023年4月，7个法国中心和2个加拿大中心招募了77例患者。排除后，分析了69例患者的结果；35例分配接受TVE，34例接受TAE。参与者的平均年龄为43.3岁；69例中有29例（42%）为女性。有2例交叉病例。接受TVE的35例患者中有29例（83%[95%CI，67%-92%]）达到主要结局，而分配接受TAE的34例患者中有20例（59%[95%CI，42%-74%]；P=0.036）。接受TVE的35例患者中有7例（20%[95%CI，10%-36%]）预后不良（3至6个月时改良Rankin量表评分>2），接受TAE 的34例患者中有9例（27%[95%CI，15%-43%]；P=0.578），接受TVE的35例患者中有12例（34%[95%CI，21%-51%]）发生相关严重不良事件，接受TAE的34例患者中有14例（41%[95%CI，26%-58%]；P=0.624）。
结论
在3至6个月的血管造影结果方面，TVE比TAE更有效。两组的发病率相似但都很高。需要更多研究来确定根治性栓塞在治疗脑AVM患者中的作用。
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