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
{"title":"经静脉入路治疗脑动静脉畸形：与经动脉栓塞的随机比较。","authors":"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","doi":"10.1161/STROKEAHA.124.049109","DOIUrl":null,"url":null,"abstract":"<p><strong>Background: </strong>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%.</p><p><strong>Methods: </strong>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.</p><p><strong>Results: </strong>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%]; <i>P</i>=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%]; <i>P</i>=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%]; <i>P</i>=0.624).</p><p><strong>Conclusions: </strong>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.</p><p><strong>Registration: </strong>URL: https://www.clinicaltrials.gov; Unique identifier: NCT03691870.</p>","PeriodicalId":21989,"journal":{"name":"Stroke","volume":" ","pages":"1396-1403"},"PeriodicalIF":7.8000,"publicationDate":"2025-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Transvenous Approach for the Treatment of Cerebral Arteriovenous Malformations: A Randomized Comparison With Transarterial Embolization.\",\"authors\":\"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\",\"doi\":\"10.1161/STROKEAHA.124.049109\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Background: </strong>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%.</p><p><strong>Methods: </strong>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.</p><p><strong>Results: </strong>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%]; <i>P</i>=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%]; <i>P</i>=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%]; <i>P</i>=0.624).</p><p><strong>Conclusions: </strong>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.</p><p><strong>Registration: </strong>URL: https://www.clinicaltrials.gov; Unique identifier: NCT03691870.</p>\",\"PeriodicalId\":21989,\"journal\":{\"name\":\"Stroke\",\"volume\":\" \",\"pages\":\"1396-1403\"},\"PeriodicalIF\":7.8000,\"publicationDate\":\"2025-06-01\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Stroke\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://doi.org/10.1161/STROKEAHA.124.049109\",\"RegionNum\":1,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"2025/3/27 0:00:00\",\"PubModel\":\"Epub\",\"JCR\":\"Q1\",\"JCRName\":\"CLINICAL NEUROLOGY\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Stroke","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1161/STROKEAHA.124.049109","RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"2025/3/27 0:00:00","PubModel":"Epub","JCR":"Q1","JCRName":"CLINICAL NEUROLOGY","Score":null,"Total":0}
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=0.578) 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.
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.
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