Transvenous Approach for the Treatment of Cerebral Arteriovenous Malformations: A Randomized Comparison With Transarterial Embolization.

IF 7.8 1区医学 Q1 CLINICAL NEUROLOGY

Stroke Pub Date : 2025-06-01 Epub Date: 2025-03-27 DOI:10.1161/STROKEAHA.124.049109

Jean Raymond, Tim E Darsaut, Suzana Saleme, Aymeric Rouchaud, Daniela Iancu, Daniel Roy, Alain Weill, Leonardo Olijnyk, Roland Jabre, Michel W Bojanowski, Chiraz Chaalala, David Roberge, Kamel Boubagra, Olivier Heck, Jeremy L Rempel, Chrysanthi Papagiannaki, Xavier Barreau, Gaultier Marnat, Jean-Christophe Gentric, Julien Ognard, Lorena Nico, Marc Bintner, Pascale Gauthier Lasalarie, Jean-Brice Veyrieres, Michel Piotin, Simon Escalard, Vitor M Pereira, Daniel G Abud, Justine Zehr, Miguel Chagnon, Thanh N Nguyen, David Mathieu, Guylaine Gevry, Ruby Klink, Emmanuelle Lorian, Charbel Mounayer

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引用次数: 0

Abstract

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%]; P=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%]; P=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%]; P=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.

查看原文本刊更多论文

经静脉入路治疗脑动静脉畸形：与经动脉栓塞的随机比较。

背景：经静脉栓塞（TVE）是治疗脑动静脉畸形（AVMs）的一种新方法。TVE的安全性和有效性尚未与经动脉栓塞（TAE）进行比较。本试验的主要假设是TVE会使AVM闭塞的比例从40%增加到80%。方法：TATAM（经静脉入路治疗脑avm）是一项研究者发起的、多中心、前瞻性、2期、开放标签、对照随机试验，比较TVE与单独TAE（1:1）。有症状或无症状的经2次血管内治疗可治愈的avm患者由病例选择委员会进行审查。参与中心有经验（约20例）或由专家监考。主要结果是AVM完全闭塞，在3至6个月时通过导管血管造影证实。没有致盲。主要分析是意向治疗。结果：2019年5月至2023年4月，在7个法国和2个加拿大中心招募了77名患者。排除后，对69例患者的结果进行分析；TVE组35例，TAE组34例。参与者的平均年龄为43.3岁；69例中有29例（42%）为女性。有两次交叉。35例TVE患者中有29例达到主要结局（83% [95% CI, 67%-92%]）， 34例TAE患者中有20例达到主要结局（59% [95% CI, 42%-74%]）；P = 0.036)。35例TVE患者中有7例（20% [95% CI, 10%-36%]）和34例TAE患者中有9例（27% [95% CI, 15%-43%]）出现不良结局（3-6个月时修改的Rankin量表评分bbbb2）；P=0.513)， 35例TVE患者中有12例（34% [95% CI, 21% ~ 51%]）和34例TAE患者中有14例（41% [95% CI, 26% ~ 58%]）发生严重不良事件；P = 0.624)。结论：TVE在3 ~ 6个月的血管造影结果上优于TAE。两组发病率相似，但均较高。需要更多的研究来确定治疗性栓塞在治疗脑动静脉畸形患者中的作用。注册：网址：https://www.clinicaltrials.gov；唯一标识符：NCT03691870。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Stroke 医学-临床神经学

CiteScore

13.40

自引率

6.00%

发文量

2021

审稿时长

3 months

期刊介绍： Stroke is a monthly publication that collates reports of clinical and basic investigation of any aspect of the cerebral circulation and its diseases. The publication covers a wide range of disciplines including anesthesiology, critical care medicine, epidemiology, internal medicine, neurology, neuro-ophthalmology, neuropathology, neuropsychology, neurosurgery, nuclear medicine, nursing, radiology, rehabilitation, speech pathology, vascular physiology, and vascular surgery. The audience of Stroke includes neurologists, basic scientists, cardiologists, vascular surgeons, internists, interventionalists, neurosurgeons, nurses, and physiatrists. Stroke is indexed in Biological Abstracts, BIOSIS, CAB Abstracts, Chemical Abstracts, CINAHL, Current Contents, Embase, MEDLINE, and Science Citation Index Expanded.