Endovascular treatment of brain arteriovenous malformations : clinical outcomes of patients included in the registry of a pragmatic randomized trial
OBJECTIVE: The role of endovascular treatment in the management of patients with brain arteriovenous malformations (AVMs) remains uncertain. AVM embolization can be offered as stand-alone curative therapy or prior to surgery or stereotactic radiosurgery (SRS) (pre-embolization). The Treatment of Brain AVMs Study (TOBAS) is an all-inclusive pragmatic study that comprises two randomized trials and multiple registries.
METHODS: Results from the TOBAS curative and pre-embolization registries are reported. The primary outcome for this report is death or dependency (modified Rankin Scale [mRS] score > 2) at last follow-up. Secondary outcomes include angiographic results, perioperative serious adverse events (SAEs), and permanent treatment-related complications leading to an mRS score > 2.
RESULTS: From June 2014 to May 2021, 1010 patients were recruited in TOBAS. Embolization was chosen as the primary curative treatment for 116 patients and pre-embolization prior to surgery or SRS for 92 patients. Clinical and angiographic outcomes were available in 106 (91%) of 116 and 77 (84%) of 92 patients, respectively. In the curative embolization registry, 70% of AVMs were ruptured, and 62% were low-grade AVMs (Spetzler-Martin grade I or II), while the pre-embolization registry had 70% ruptured AVMs and 58% low-grade AVMs. The primary outcome of death or disability (mRS score > 2) occurred in 15 (14%, 95% CI 8%-22%) of the 106 patients in the curative embolization registry (4 [12%, 95% CI 5%-28%] of 32 unruptured AVMs and 11 [15%, 95% CI 8%-25%] of 74 ruptured AVMs) and 9 (12%, 95% CI 6%-21%) of the 77 patients in the pre-embolization registry (4 [17%, 95% CI 7%-37%] of 23 unruptured AVMs and 5 [9%, 95% CI 4%-20%] of 54 ruptured AVMs) at 2 years. Embolization alone was confirmed to occlude the AVM in 32 (30%, 95% CI 21%-40%) of the 106 curative attempts and in 9 (12%, 95% CI 6%-21%) of 77 patients in the pre-embolization registry. SAEs occurred in 28 of the 106 attempted curative patients (26%, 95% CI 18%-35%, including 21 new symptomatic hemorrhages [20%, 95% CI 13%-29%]). Five of the new hemorrhages were in previously unruptured AVMs (n = 32; 16%, 95% CI 5%-33%). Of the 77 pre-embolization patients, 18 had SAEs (23%, 95% CI 15%-34%), including 12 new symptomatic hemorrhages [16%, 95% CI 9%-26%]). Three of the hemorrhages were in previously unruptured AVMs (3/23; 13%, 95% CI 3%-34%).
CONCLUSIONS: Embolization as a curative treatment for brain AVMs was often incomplete. Hemorrhagic complications were frequent, even when the specified intent was pre-embolization before surgery or SRS. Because the role of endovascular treatment remains uncertain, it should preferably, when possible, be offered in the context of a randomized trial.
| Medienart: |
E-Artikel |
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| Erscheinungsjahr: |
2023 |
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| Erschienen: |
2023 |
| Enthalten in: |
Zur Gesamtaufnahme - volume:138 |
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| Enthalten in: |
Journal of neurosurgery - 138(2023), 5 vom: 01. Mai, Seite 1393-1402 |
| Sprache: |
Englisch |
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| Beteiligte Personen: |
Raymond, Jean [VerfasserIn] |
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| Links: |
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| Anmerkungen: |
Date Completed 04.05.2023 Date Revised 04.05.2023 published: Electronic-Print ClinicalTrials.gov: NCT02098252 Citation Status MEDLINE |
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| doi: |
10.3171/2022.9.JNS22987 |
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| funding: |
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| Förderinstitution / Projekttitel: |
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| PPN (Katalog-ID): |
NLM35635847X |
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| 100 | 1 | |a Raymond, Jean |e verfasserin |4 aut | |
| 245 | 1 | 0 | |a Endovascular treatment of brain arteriovenous malformations |b clinical outcomes of patients included in the registry of a pragmatic randomized trial |
| 264 | 1 | |c 2023 | |
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| 500 | |a Date Completed 04.05.2023 | ||
| 500 | |a Date Revised 04.05.2023 | ||
| 500 | |a published: Electronic-Print | ||
| 500 | |a ClinicalTrials.gov: NCT02098252 | ||
| 500 | |a Citation Status MEDLINE | ||
| 520 | |a OBJECTIVE: The role of endovascular treatment in the management of patients with brain arteriovenous malformations (AVMs) remains uncertain. AVM embolization can be offered as stand-alone curative therapy or prior to surgery or stereotactic radiosurgery (SRS) (pre-embolization). The Treatment of Brain AVMs Study (TOBAS) is an all-inclusive pragmatic study that comprises two randomized trials and multiple registries | ||
| 520 | |a METHODS: Results from the TOBAS curative and pre-embolization registries are reported. The primary outcome for this report is death or dependency (modified Rankin Scale [mRS] score > 2) at last follow-up. Secondary outcomes include angiographic results, perioperative serious adverse events (SAEs), and permanent treatment-related complications leading to an mRS score > 2 | ||
| 520 | |a RESULTS: From June 2014 to May 2021, 1010 patients were recruited in TOBAS. Embolization was chosen as the primary curative treatment for 116 patients and pre-embolization prior to surgery or SRS for 92 patients. Clinical and angiographic outcomes were available in 106 (91%) of 116 and 77 (84%) of 92 patients, respectively. In the curative embolization registry, 70% of AVMs were ruptured, and 62% were low-grade AVMs (Spetzler-Martin grade I or II), while the pre-embolization registry had 70% ruptured AVMs and 58% low-grade AVMs. The primary outcome of death or disability (mRS score > 2) occurred in 15 (14%, 95% CI 8%-22%) of the 106 patients in the curative embolization registry (4 [12%, 95% CI 5%-28%] of 32 unruptured AVMs and 11 [15%, 95% CI 8%-25%] of 74 ruptured AVMs) and 9 (12%, 95% CI 6%-21%) of the 77 patients in the pre-embolization registry (4 [17%, 95% CI 7%-37%] of 23 unruptured AVMs and 5 [9%, 95% CI 4%-20%] of 54 ruptured AVMs) at 2 years. Embolization alone was confirmed to occlude the AVM in 32 (30%, 95% CI 21%-40%) of the 106 curative attempts and in 9 (12%, 95% CI 6%-21%) of 77 patients in the pre-embolization registry. SAEs occurred in 28 of the 106 attempted curative patients (26%, 95% CI 18%-35%, including 21 new symptomatic hemorrhages [20%, 95% CI 13%-29%]). Five of the new hemorrhages were in previously unruptured AVMs (n = 32; 16%, 95% CI 5%-33%). Of the 77 pre-embolization patients, 18 had SAEs (23%, 95% CI 15%-34%), including 12 new symptomatic hemorrhages [16%, 95% CI 9%-26%]). Three of the hemorrhages were in previously unruptured AVMs (3/23; 13%, 95% CI 3%-34%) | ||
| 520 | |a CONCLUSIONS: Embolization as a curative treatment for brain AVMs was often incomplete. Hemorrhagic complications were frequent, even when the specified intent was pre-embolization before surgery or SRS. Because the role of endovascular treatment remains uncertain, it should preferably, when possible, be offered in the context of a randomized trial | ||
| 650 | 4 | |a Randomized Controlled Trial | |
| 650 | 4 | |a Journal Article | |
| 650 | 4 | |a brain arteriovenous malformation | |
| 650 | 4 | |a care trial | |
| 650 | 4 | |a endovascular neurosurgery | |
| 650 | 4 | |a endovascular treatment registry | |
| 650 | 4 | |a randomized trial | |
| 650 | 4 | |a ruptured AVM | |
| 650 | 4 | |a unruptured AVM | |
| 650 | 4 | |a vascular disorders | |
| 700 | 1 | |a Gentric, Jean-Christophe |e verfasserin |4 aut | |
| 700 | 1 | |a Magro, Elsa |e verfasserin |4 aut | |
| 700 | 1 | |a Nico, Lorena |e verfasserin |4 aut | |
| 700 | 1 | |a Bacchus, Emma |e verfasserin |4 aut | |
| 700 | 1 | |a Klink, Ruby |e verfasserin |4 aut | |
| 700 | 1 | |a Cognard, Christophe |e verfasserin |4 aut | |
| 700 | 1 | |a Januel, Anne-Christine |e verfasserin |4 aut | |
| 700 | 1 | |a Sabatier, Jean-François |e verfasserin |4 aut | |
| 700 | 1 | |a Iancu, Daniela |e verfasserin |4 aut | |
| 700 | 1 | |a Weill, Alain |e verfasserin |4 aut | |
| 700 | 1 | |a Roy, Daniel |e verfasserin |4 aut | |
| 700 | 1 | |a Bojanowski, Michel W |e verfasserin |4 aut | |
| 700 | 1 | |a Chaalala, Chiraz |e verfasserin |4 aut | |
| 700 | 1 | |a Barreau, Xavier |e verfasserin |4 aut | |
| 700 | 1 | |a Jecko, Vincent |e verfasserin |4 aut | |
| 700 | 1 | |a Papagiannaki, Chrysanthi |e verfasserin |4 aut | |
| 700 | 1 | |a Derrey, Stéphane |e verfasserin |4 aut | |
| 700 | 1 | |a Shotar, Eimad |e verfasserin |4 aut | |
| 700 | 1 | |a Cornu, Philippe |e verfasserin |4 aut | |
| 700 | 1 | |a Eker, Omer F |e verfasserin |4 aut | |
| 700 | 1 | |a Pelissou-Guyotat, Isabelle |e verfasserin |4 aut | |
| 700 | 1 | |a Piotin, Michel |e verfasserin |4 aut | |
| 700 | 1 | |a Aldea, Sorin |e verfasserin |4 aut | |
| 700 | 1 | |a Beaujeux, Rémy |e verfasserin |4 aut | |
| 700 | 1 | |a Proust, François |e verfasserin |4 aut | |
| 700 | 1 | |a Anxionnat, René |e verfasserin |4 aut | |
| 700 | 1 | |a Costalat, Vincent |e verfasserin |4 aut | |
| 700 | 1 | |a Corre, Marine Le |e verfasserin |4 aut | |
| 700 | 1 | |a Gauvrit, Jean-Yves |e verfasserin |4 aut | |
| 700 | 1 | |a Morandi, Xavier |e verfasserin |4 aut | |
| 700 | 1 | |a Brunel, Hervé |e verfasserin |4 aut | |
| 700 | 1 | |a Roche, Pierre-Hugues |e verfasserin |4 aut | |
| 700 | 1 | |a Graillon, Thomas |e verfasserin |4 aut | |
| 700 | 1 | |a Chabert, Emmanuel |e verfasserin |4 aut | |
| 700 | 1 | |a Herbreteau, Denis |e verfasserin |4 aut | |
| 700 | 1 | |a Desal, Hubert |e verfasserin |4 aut | |
| 700 | 1 | |a Trystram, Denis |e verfasserin |4 aut | |
| 700 | 1 | |a Barbier, Charlotte |e verfasserin |4 aut | |
| 700 | 1 | |a Gaberel, Thomas |e verfasserin |4 aut | |
| 700 | 1 | |a Nguyen, Thanh N |e verfasserin |4 aut | |
| 700 | 1 | |a Viard, Geraldine |e verfasserin |4 aut | |
| 700 | 1 | |a Gevry, Guylaine |e verfasserin |4 aut | |
| 700 | 1 | |a Darsaut, Tim E |e verfasserin |4 aut | |
| 700 | 0 | |a TOBAS Collaborative Group |e verfasserin |4 aut | |
| 700 | 0 | |a Collaborators in the TOBAS Collaborative Group |e verfasserin |4 aut | |
| 700 | 1 | |a Raymond, Jean |e investigator |4 oth | |
| 700 | 1 | |a Roy, Daniel |e investigator |4 oth | |
| 700 | 1 | |a Weill, Alain |e investigator |4 oth | |
| 700 | 1 | |a Iancu, Daniela |e investigator |4 oth | |
| 700 | 1 | |a Bojanowski, Michel W |e investigator |4 oth | |
| 700 | 1 | |a Chaalala, Chiraz |e investigator |4 oth | |
| 700 | 1 | |a Darsaut, Tim E |e investigator |4 oth | |
| 700 | 1 | |a O'Kelly, Cian J |e investigator |4 oth | |
| 700 | 1 | |a Chow, Michael M C |e investigator |4 oth | |
| 700 | 1 | |a Findlay, J Max |e investigator |4 oth | |
| 700 | 1 | |a Rempel, Jeremy L |e investigator |4 oth | |
| 700 | 1 | |a Fahed, Robert |e investigator |4 oth | |
| 700 | 1 | |a Lesiuk, Howard |e investigator |4 oth | |
| 700 | 1 | |a Drake, Brian |e investigator |4 oth | |
| 700 | 1 | |a Santos, Marlene Dos |e investigator |4 oth | |
| 700 | 1 | |a Gentric, Jean-Christophe |e investigator |4 oth | |
| 700 | 1 | |a Nonent, Michel |e investigator |4 oth | |
| 700 | 1 | |a Ognard, Julien |e investigator |4 oth | |
| 700 | 1 | |a El-Aouni, Mourad Cheddad |e investigator |4 oth | |
| 700 | 1 | |a Magro, Elsa |e investigator |4 oth | |
| 700 | 1 | |a Seizeur, Romuald |e investigator |4 oth | |
| 700 | 1 | |a Timsit, Serge |e investigator |4 oth | |
| 700 | 1 | |a Pradier, Olivier |e investigator |4 oth | |
| 700 | 1 | |a Desal, Hubert |e investigator |4 oth | |
| 700 | 1 | |a Boursier, Romain |e investigator |4 oth | |
| 700 | 1 | |a Thillays, François |e investigator |4 oth | |
| 700 | 1 | |a Roualdes, Vincent |e investigator |4 oth | |
| 700 | 1 | |a Piotin, Michel |e investigator |4 oth | |
| 700 | 1 | |a Blanc, Raphael |e investigator |4 oth | |
| 700 | 1 | |a Aldea, Sorin |e investigator |4 oth | |
| 700 | 1 | |a Cognard, Christophe |e investigator |4 oth | |
| 700 | 1 | |a Januel, Anne-Christine |e investigator |4 oth | |
| 700 | 1 | |a Sabatier, Jean-François |e investigator |4 oth | |
| 700 | 1 | |a Calviere, Lionel |e investigator |4 oth | |
| 700 | 1 | |a Gauvrit, Jean Yves |e investigator |4 oth | |
| 700 | 1 | |a Raoult, Hélène |e investigator |4 oth | |
| 700 | 1 | |a Eugene, François |e investigator |4 oth | |
| 700 | 1 | |a Bras, Anthony Le |e investigator |4 oth | |
| 700 | 1 | |a Ferre, Jean-Christophe |e investigator |4 oth | |
| 700 | 1 | |a Paya, Christophe |e investigator |4 oth | |
| 700 | 1 | |a Morandi, Xavier |e investigator |4 oth | |
| 700 | 1 | |a Lecouillard, Isabelle |e investigator |4 oth | |
| 700 | 1 | |a Nouhaud, Elodie |e investigator |4 oth | |
| 700 | 1 | |a Ronziere, Thomas |e investigator |4 oth | |
| 700 | 1 | |a Trystram, Denis |e investigator |4 oth | |
| 700 | 1 | |a Naggara, Olivier |e investigator |4 oth | |
| 700 | 1 | |a Rodriguez-Regent, Christine |e investigator |4 oth | |
| 700 | 1 | |a Kerleroux, Basile |e investigator |4 oth | |
| 700 | 1 | |a Barbier, Charlotte |e investigator |4 oth | |
| 700 | 1 | |a Gaberel, Thomas |e investigator |4 oth | |
| 700 | 1 | |a Emery, Evelyne |e investigator |4 oth | |
| 700 | 1 | |a Touze, Emmanuel |e investigator |4 oth | |
| 700 | 1 | |a Papagiannaki, Chrysanthi |e investigator |4 oth | |
| 700 | 1 | |a Derrey, Stéphane |e investigator |4 oth | |
| 700 | 1 | |a Eker, Omer F |e investigator |4 oth | |
| 700 | 1 | |a Riva, Roberto |e investigator |4 oth | |
| 700 | 1 | |a Pellisou-Guyotat, Isabelle |e investigator |4 oth | |
| 700 | 1 | |a Guyotat, Jacques |e investigator |4 oth | |
| 700 | 1 | |a Berhouma, Monsef |e investigator |4 oth | |
| 700 | 1 | |a Dumot, Chloé |e investigator |4 oth | |
| 700 | 1 | |a Biondi, Alessandra |e investigator |4 oth | |
| 700 | 1 | |a Thines, Laurent |e investigator |4 oth | |
| 700 | 1 | |a Bougaci, Nassim |e investigator |4 oth | |
| 700 | 1 | |a Charbonnier, Guillaume |e investigator |4 oth | |
| 700 | 1 | |a Bracard, Serge |e investigator |4 oth | |
| 700 | 1 | |a Anxionnat, René |e investigator |4 oth | |
| 700 | 1 | |a Gory, Benjamin |e investigator |4 oth | |
| 700 | 1 | |a Civit, Thierry |e investigator |4 oth | |
| 700 | 1 | |a Bernier-Chastagner, Valérie |e investigator |4 oth | |
| 700 | 1 | |a Barreau, Xavier |e investigator |4 oth | |
| 700 | 1 | |a Marnat, Gaultier |e investigator |4 oth | |
| 700 | 1 | |a Jecko, Vincent |e investigator |4 oth | |
| 700 | 1 | |a Penchet, Guillaume |e investigator |4 oth | |
| 700 | 1 | |a Gimbert, Edouard |e investigator |4 oth | |
| 700 | 1 | |a Huchet, Aymeri |e investigator |4 oth | |
| 700 | 1 | |a Herbreteau, Denis |e investigator |4 oth | |
| 700 | 1 | |a Boulouis, Grégoire |e investigator |4 oth | |
| 700 | 1 | |a Bibi, Richard |e investigator |4 oth | |
| 700 | 1 | |a Ifergan, Héloïse |e investigator |4 oth | |
| 700 | 1 | |a Janot, Kévin |e investigator |4 oth | |
| 700 | 1 | |a Velut, Stéphane |e investigator |4 oth | |
| 700 | 1 | |a Brunel, Hervé |e investigator |4 oth | |
| 700 | 1 | |a Roche, Pierre-Hugues |e investigator |4 oth | |
| 700 | 1 | |a Graillon, Thomas |e investigator |4 oth | |
| 700 | 1 | |a Peyriere, Hadrien |e investigator |4 oth | |
| 700 | 1 | |a Kaya, Jean-Marc |e investigator |4 oth | |
| 700 | 1 | |a Touta, Adamou |e investigator |4 oth | |
| 700 | 1 | |a Troude, Lucas |e investigator |4 oth | |
| 700 | 1 | |a Boissonneau, Sébastien |e investigator |4 oth | |
| 700 | 1 | |a Clarençon, Frédéric |e investigator |4 oth | |
| 700 | 1 | |a Shotar, Eimad |e investigator |4 oth | |
| 700 | 1 | |a Sourour, Nader |e investigator |4 oth | |
| 700 | 1 | |a Lenck, Stéphanie |e investigator |4 oth | |
| 700 | 1 | |a Premat, Kévin |e investigator |4 oth | |
| 700 | 1 | |a Boch, Anne-Laure |e investigator |4 oth | |
| 700 | 1 | |a Cornu, Philippe |e investigator |4 oth | |
| 700 | 1 | |a Nouet, Aurélien |e investigator |4 oth | |
| 700 | 1 | |a Costalat, Vincent |e investigator |4 oth | |
| 700 | 1 | |a Bonafe, Alain |e investigator |4 oth | |
| 700 | 1 | |a Dargazanli, Cyril |e investigator |4 oth | |
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