Mechanical Thrombectomy in Ischemic Stroke With a Medium or Distal Arterial Occlusion

Importance: Evidence regarding efficacy and safety of thrombectomy in acute ischemic stroke (AIS) due to medium or distal vessel occlusions (MDVOs) is lacking. Objective: To evaluate the benefit of thrombectomy, in addition to medical treatment over medical treatment alone, in patients with an AIS related to a primary and isolated MDVO. Design, Setting, and Participants: Randomized clinical trial conducted at 22 stroke centers in France from November 2021 to April 2025, with planned enrollment of 488 patients. The trial has been stopped after the planned interim analysis on the recommendation of the data and safety monitoring board for futility and increased rate of symptomatic intracranial hemorrhage with thrombectomy. Eligible adult patients had an AIS due to a primary MDVO within 8 hours of symptom onset or within 24 hours of last seen well if no hyperintense signal was present on fluid-attenuated inversion recovery imaging. Intervention: Thrombectomy in addition to medical treatment (n = 123) or medical treatment alone (n = 121). Main Outcomes and Measures: The primary end point was a good clinical outcome at 3 months, defined as a modified Rankin Scale score of 0 to 2, assessed by an independent, blinded assessor. Secondary end points included mortality rate at 3 months and adverse and serious adverse events. Results: Of the 244 patients randomized (median age, 75 years [IQR, 67-81]; 56% male; median National Institutes of Health Stroke Scale score, 8 [IQR, 6-12]), 100 of the 123 patients in the thrombectomy group (81%) received thrombectomy and none of the 121 patients in the control group received thrombectomy; 217 (89%) completed follow-up. At 3 months, 72 of 116 patients (62%) in the thrombectomy group had a good clinical outcome vs 81 of 119 patients (68%) in the control group (odds ratio, 0.73 [95% CI, 0.40-1.31]; P = .29; adjusted absolute difference, -6.8% [95% CI, -19.4% to 5.7%]). The incidence of symptomatic intracranial hemorrhages was higher among the 100 patients who actually received thrombectomy than in those who did not (11% vs 3%, P = .008), as was incidence of subarachnoid hemorrhages (13% vs 2%, P < .001) and embolus migration (5% vs 1%, P = .04). Mortality rate did not significantly differ between the 2 groups (6% vs 8%; P = .49). Conclusions and Relevance: Thrombectomy did not lead to a higher rate of good clinical outcome at 3 months compared with medical treatment alone in patients with acute ischemic stroke related to an MDVO. Hemorrhagic complications were more frequent after thrombectomy. Trial Registration: ClinicalTrials.gov Identifier: NCT05030142.

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Journal
JAMA
Published
2026-07-22
DOI
https://doi.org/10.1001/jama.2026.8977
Primary Topic
Acute Ischemic Stroke Management
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article
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article

Mechanical Thrombectomy in Ischemic Stroke With a Medium or Distal Arterial Occlusion

Gioia Mione, Peggy Reiner, Titien Tuilier, M Lamy et al.
JAMA
Acute Ischemic Stroke Management
article

Mechanical Thrombectomy in Ischemic Stroke With a Medium or Distal Arterial Occlusion

Gioia Mione, Peggy Reiner, Titien Tuilier, M Lamy, Pauline Bourst, Manon Escalere, Agnès Aghetti, William Boisseau, Alessandro Sgreccia, Louis Fontaine, Marcela Voicu, Emilien Micard, E Chabert, Monica Manisor, Agnès Dechartres, Marian Douarinou, Victoria Vernier, Sébastien Soize, Marion Boulanger, Anca Hasiu, Rémy Beaujeux, Charlotte Barbier, Aymeric Wittwer, Oana Harsan, Omer Eker, Stéphanie Guey, Marie Reitter, Christian Denier, Iona Podar, Pop Rd, B Chen, Anna Ferrier, Serge Timsit, R Anxionnat, Cédric Fauché, Vittorio Civelli, Lisa Humbertjean-Selton, O COSKUN, Roxana Gheoca, I Durand-Zaleski, C Arquizan, Silvia Pizzuto, Marc‐Antoine Labeyrie, Federico Di Maria, Christine Rodriguez-Régent, Solène de Gaalon, Wiener Es, Dan Mihoc, Guillaume Thébault, Cedric Batot, Adrien Wang, Delphine Lopez, Pierre Louis Alexandre, Grégoire Barthel, Amandine Baptiste, Lisa Neumann, David Weisenburger-Lile, Nabil Kassem, Georges Rodesch, Hilde Henon, Valérie Wolff, Vincent Costalat, Bertrand Lapergue, Irène Pierre-Paul, Fouzi Bala, Catherine Morais, Christophe Cognard, Nicolas Bricout, Igor Sibon, Benjamin Gory, Alexis Guédon, Maia Tchikviladze, Jean-Christophe Lacour, Véronique Quenardelle, Alexandre Voulot, Aymeric Rouchaud, Francisco Macian-Montoro, Liang Liao, Candice Sabben, Sonia Alamowitch, Solène Moulin, Jean-Christophe Gentric, Laurent Spelle, Ian Leonard-Lorant, Constance Lesoil-Markowski, Arturo Consoli, Madalina Brezeanu, Sébastien Richard, DISCOUNT Investigators, Fernando Pico, Adriana Tabarna, Marco Pasi, Frédéric Clarençon, François Zhu, Sophie Planel, Emmanuelle Schmitt, Anne-Laure Derelle, Tae-Hee Cho, Guillaume Turc, Gaultier Marnat
article en

Abstract

Importance: Evidence regarding efficacy and safety of thrombectomy in acute ischemic stroke (AIS) due to medium or distal vessel occlusions (MDVOs) is lacking. Objective: To evaluate the benefit of thrombectomy, in addition to medical treatment over medical treatment alone, in patients with an AIS related to a primary and isolated MDVO. Design, Setting, and Participants: Randomized clinical trial conducted at 22 stroke centers in France from November 2021 to April 2025, with planned enrollment of 488 patients. The trial has been stopped after the planned interim analysis on the recommendation of the data and safety monitoring board for futility and increased rate of symptomatic intracranial hemorrhage with thrombectomy. Eligible adult patients had an AIS due to a primary MDVO within 8 hours of symptom onset or within 24 hours of last seen well if no hyperintense signal was present on fluid-attenuated inversion recovery imaging. Intervention: Thrombectomy in addition to medical treatment (n = 123) or medical treatment alone (n = 121). Main Outcomes and Measures: The primary end point was a good clinical outcome at 3 months, defined as a modified Rankin Scale score of 0 to 2, assessed by an independent, blinded assessor. Secondary end points included mortality rate at 3 months and adverse and serious adverse events. Results: Of the 244 patients randomized (median age, 75 years [IQR, 67-81]; 56% male; median National Institutes of Health Stroke Scale score, 8 [IQR, 6-12]), 100 of the 123 patients in the thrombectomy group (81%) received thrombectomy and none of the 121 patients in the control group received thrombectomy; 217 (89%) completed follow-up. At 3 months, 72 of 116 patients (62%) in the thrombectomy group had a good clinical outcome vs 81 of 119 patients (68%) in the control group (odds ratio, 0.73 [95% CI, 0.40-1.31]; P = .29; adjusted absolute difference, -6.8% [95% CI, -19.4% to 5.7%]). The incidence of symptomatic intracranial hemorrhages was higher among the 100 patients who actually received thrombectomy than in those who did not (11% vs 3%, P = .008), as was incidence of subarachnoid hemorrhages (13% vs 2%, P < .001) and embolus migration (5% vs 1%, P = .04). Mortality rate did not significantly differ between the 2 groups (6% vs 8%; P = .49). Conclusions and Relevance: Thrombectomy did not lead to a higher rate of good clinical outcome at 3 months compared with medical treatment alone in patients with acute ischemic stroke related to an MDVO. Hemorrhagic complications were more frequent after thrombectomy. Trial Registration: ClinicalTrials.gov Identifier: NCT05030142.

JAMA
Université de Tours (FR), Inserm (FR), Université Fédérale de Toulouse Midi-Pyrénées (FR), Université Sorbonne Nouvelle (FR), Université de Montpellier (FR), Université Paris Cité (FR), Université de Lille (FR), Center for Discrete Mathematics and Theoretical Computer Science (US), Hotel Dieu Hospital (CA), Centre Hospitalier Universitaire de Nantes (FR), Université de Poitiers (FR), Sorbonne Université (FR), Centre Hospitalier Universitaire de Montpellier (FR), Assistance Publique – Hôpitaux de Paris (FR), Hospices Civils de Lyon (FR), Centre Hospitalier Universitaire de Reims (FR), Imagerie Adaptative Diagnostique et Interventionnelle (FR), Hôpital Lariboisière (FR), Pitié-Salpêtrière Hospital (FR), Fondation de Rothschild (FR), Institut de Psychiatrie et Neurosciences de Paris (FR), Hôpitaux Universitaires Henri-Mondor (FR), Centre Hospitalier Régional Universitaire de Brest (FR), Institut Pierre Louis d‘Épidémiologie et de Santé Publique (FR), FHU Neurovasc (FR), Hôpital Foch (FR), Centre Hospitalier de Versailles (FR), Bicêtre Hospital (FR), Défaillance Cardiovasculaire Aiguë et Chronique, Université de Limoges (FR), Université de Strasbourg (FR), Université de Lorraine (FR), Université de Reims Champagne-Ardenne (FR), Nantes Université (FR), Université de Caen Normandie (FR)
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Acute Ischemic Stroke Management
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