Trial of Thrombectomy for Stroke with a Large Infarct of Unrestricted Size.
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Costalat Vincent, Jovin Tudor G, Albucher J F, Cognard Christophe, Henon Hilde, Nouri Nasreddine, Gory Benjamin, Richard Sebastien, Marnat Gaultier, Sibon Igor, Di Maria Federico, Annan Mariam, Boulouis Grégoire, Cardona Pere, Obadia Michael, Piotin Michel, Bourcier Romain, Guillon Benoit, Godard Sophie, Pasco-Papon Anne, Eker Omer F, Cho Tae-Hee, Turc Guillaume, Naggara Olivier, Velasco Stéphane, Lamy Matthias, Clarençon Frédéric, Alamowitch Sonia, Renu Arturo, Suissa Laurent, Brunel Hervé, Gentric Jean-Christophe, Timsit Serge, Lamy Chantal, Chivot Cyril, Macian-Montoro Francisco, Mounayer Charbel, Ozkul-Wermester Ozlem, Papagiannaki Chrysanthi, Wolff Valérie, Pop Raoul, Ferrier Anna, Chabert Emmanuel, Ricolfi Frédéric, Béjot Yannick, Lopez-Cancio Elena, Vega Pedro, Spelle Laurent, Denier Christian, Millán Mònica, Arenillas Juan F, Mazighi Mikael, Houdart Emmanuel, Del Mar Freijo Maria, Duhamel Alain, Sanossian Nerses, Liebeskind David S, Labreuche Julien, Lapergue Bertrand, Arquizan Caroline, LASTE Trial Investigators
Аннотация
METHODS: We assigned, in a 1:1 ratio, patients with proximal cerebral vessel occlusion in the anterior circulation and a large infarct (as defined by an Alberta Stroke Program Early Computed Tomographic Score of ≤5; values range from 0 to 10) detected on magnetic resonance imaging or computed tomography within 6.5 hours after symptom onset to undergo endovascular thrombectomy and receive medical care (thrombectomy group) or to receive medical care alone (control group). The primary outcome was the score on the modified Rankin scale at 90 days (scores range from 0 to 6, with higher scores indicating greater disability). The primary safety outcome was death from any cause at 90 days, and an ancillary safety outcome was symptomatic intracerebral hemorrhage.
RESULTS: A total of 333 patients were assigned to either the thrombectomy group (166 patients) or the control group (167 patients); 9 were excluded from the analysis because of consent withdrawal or legal reasons. The trial was stopped early because results of similar trials favored thrombectomy. Approximately 35% of the patients received thrombolysis therapy. The median modified Rankin scale score at 90 days was 4 in the thrombectomy group and 6 in the control group (generalized odds ratio, 1.63; 95% confidence interval [CI], 1.29 to 2.06; P<0.001). Death from any cause at 90 days occurred in 36.1% of the patients in the thrombectomy group and in 55.5% of those in the control group (adjusted relative risk, 0.65; 95% CI, 0.50 to 0.84), and the percentage of patients with symptomatic intracerebral hemorrhage was 9.6% and 5.7%, respectively (adjusted relative risk, 1.73; 95% CI, 0.78 to 4.68). Eleven procedure-related complications occurred in the thrombectomy group.
CONCLUSIONS: In patients with acute stroke and a large infarct of unrestricted size, thrombectomy plus medical care resulted in better functional outcomes and lower mortality than medical care alone but led to a higher incidence of symptomatic intracerebral hemorrhage. (Funded by Montpellier University Hospital; LASTE ClinicalTrials.gov number, NCT03811769.).