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Clinical Trial
. 2025 Jun;56(6):1396-1403.
doi: 10.1161/STROKEAHA.124.049109. Epub 2025 Mar 27.

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

Collaborators, Affiliations
Clinical Trial

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

Jean Raymond et al. Stroke. 2025 Jun.

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.

Keywords: brain; intracranial arteriovenous malformations; intracranial hemorrhages; morbidity.

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Conflict of interest statement

Dr Rouchaud reports compensation from MicroVention, Inc, for consultant services and compensation from Balt USA, LLC, for consultant services. Dr Iancu reports compensation from Balt SAS, Stryker, and MicroVention, Inc, for consultant services. Dr Roberge reports compensation from AstraZeneca Canada, F. Hoffmann-La Roche, Novocure, Inc, Recordati Rare Diseases, Inc, and Accuray Incorporated for consultant services and securities holdings in MisoChip and AFX Medical. Dr Rempel reports compensation from Penumbra, Inc, Rapid Medical Ltd, and Vena for consultant services. Dr Barreau reports compensation from MicroVention, Inc, Balt Group, and Stryker Corporation for consultant services. Dr Marnat reports compensation from Stryker, Balt USA, LLC, and MicroVention, Inc, for consultant services and compensation from Phenox, Inc, Johnson & Johnson Medical Devices & Diagnostics Group-Latin America, LLC, Penumbra, Inc, Bracco Imaging, and Medtronic for other services. Dr Gentric reports compensation from Phenox, Inc, Stryker, Balt USA, LLC, and Medtronic for consultant services. Dr Ognard reports grants from Société Française de Neuroradiologie (SFNR), Philips, Servier Affaires Medicales, Innoveo, Philippe Foundation, Medtronic, and GIRCI GO; travel support from Phenox, Inc; and compensation from Balt USA, LLC, for consultant services. Dr Piotin reports stock holdings in Basecamp Vascular. Dr Escalard reports compensation from BCV Systems for consultant services. Dr Pereira reports compensation from Stryker, Balt USA, LLC, and Medtronic for consultant services. Dr Nguyen reports compensation from the American Stroke Association, Genentech, and Kaneka for other services and compensation from Aruna and Brainomix for consultant services. Dr Mounayer reports compensation from Medtronic, MicroVention, Inc, and Balt USA, LLC, for consultant services. The other authors report no conflicts.

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