Fahed Robert, Darsaut Tim E, Mounayer Charbel, Chapot René, Piotin Michel, Blanc Raphaël, Mendes Pereira Vitor, Abud Daniel G, Iancu Dana, Weill Alain, Roy Daniel, Nico Lorena, Nolet Suzanne, Gevry Guylaine, Raymond Jean
1 Department of Interventional Neuroradiology, Fondation Rothschild Hospital, Paris, France.
2 Department of Surgery, University of Alberta Hospital, Edmonton, Canada.
Interv Neuroradiol. 2019 Jun;25(3):305-309. doi: 10.1177/1591019918821738. Epub 2019 Feb 4.
Transvenous embolisation is a promising technique but the benefits remain uncertain. We hypothesised that transvenous embolisation leads to a higher rate of arteriovenous malformation angiographic occlusion than transarterial embolisation.
The Transvenous Approach for the Treatment of cerebral Arteriovenous Malformations (TATAM) is an investigator initiated, multicentre, prospective, phase 2, randomised controlled clinical trial. To test the hypothesis that transvenous embolisation is superior to transarterial embolisation for arteriovenous malformation obliteration, 76 patients with arteriovenous malformations considered curable by up to two sessions of endovascular therapy will be randomly allocated 1:1 to treatment with either transvenous embolisation (with or without transarterial embolisation) (experimental arm) or transarterial embolisation alone (control arm). The primary endpoint of the trial is complete arteriovenous malformation occlusion, assessed by catheter cerebral angiography. Complete occlusions will be confirmed at 3 months, while incompletely occluded arteriovenous malformations, considered treatment failures, will then be eligible for complementary treatments by surgery, radiation therapy, or even transvenous embolisation. Standard procedural safety outcomes will also be assessed. Patient selection will be validated by a case selection committee, and participating centres with limited experience in transvenous embolisation will be proctored.
The TATAM trial is a transparent research framework designed to offer a promising but still unvalidated treatment to selected arteriovenous malformation patients. Clinical Trial Registration-URL: http://www.clinicaltrials.gov . Unique identifier: NCT03691870.
经静脉栓塞是一种很有前景的技术，但益处仍不明确。我们假设经静脉栓塞导致动静脉畸形血管造影闭塞率高于经动脉栓塞。
经静脉途径治疗脑动静脉畸形（TATAM）是一项由研究者发起的、多中心、前瞻性、2期、随机对照临床试验。为了检验经静脉栓塞在动静脉畸形闭塞方面优于经动脉栓塞这一假设，76例被认为可通过最多两次血管内治疗治愈的动静脉畸形患者将按1:1随机分配至经静脉栓塞（联合或不联合经动脉栓塞）治疗组（试验组）或单纯经动脉栓塞治疗组（对照组）。试验的主要终点是通过导管脑血管造影评估的动静脉畸形完全闭塞。完全闭塞将在3个月时得到确认，而不完全闭塞的动静脉畸形被视为治疗失败，随后将有资格接受手术、放射治疗甚至经静脉栓塞等补充治疗。还将评估标准程序安全性结果。患者选择将由病例选择委员会进行验证，对经静脉栓塞经验有限的参与中心将进行指导。
TATAM试验是一个透明的研究框架，旨在为选定的动静脉畸形患者提供一种有前景但仍未经验证的治疗方法。临床试验注册网址：http://www.clinicaltrials.gov 。唯一标识符：NCT03691870。
