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

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 =0.513) 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.