Effect of Intra-arterial Alteplase vs Placebo Following Successful Thrombectomy on Functional Outcomes in Patients With Large Vessel Occlusion Acute Ischemic Stroke

作者：Arturo Renú, Mónica Millán, Luís San Román, Jordi Blasco, Joan Martí‐Fábregas, Mikel Terceño, Sergio Amaro, Joaquı́n Serena, Xabier Urra, Carlos Laredo, Roger Barranco, Pol Camps‐Renom, Federico Zarco, Laura Oleaga, Pere Cardona, Carlos Castaño, Juan Macho, Elisa Cuadrado‐Godia, Elío Vivas, Antonio López‐Rueda, Léopoldo Guimaraens, Anna Ramos‐Pachón, Jaume Roquer, Marián Muchada, Alejandro Tomasello, Antonio Dávalos, Ferràn Torres, Ángel Chamorro, CHOICE Investigators, Laura Llull, Martha Vargas, Vı́ctor Obach, Salvatore Rudilosso, Alejandro Rodríguez-Vázquez, Daniel Santana, Napoleón Macías, Elena Serrano, Javier Moreno, Natàlia Pérez de la Ossa, Laura Dorado, María Hernández‐Pérez, Meritxell Gomis, Lucía Muñoz-Narbona, P. Rodríguez-Molinos, Martí Boix, Ernest Palomeras, Fidel Ángel Núñez, Sebastián Remollo, Mariano Werner, Victor Vera, Laura Paúl, Laura Pardo, Montserrat Reina, Saima Bashir, Ursula Bojaryn, Yolanda Silva, M. Dolors Millan i Guasch, Alan Murillo, Juan Álvarez‐Cienfuegos, M. Comas, B. Martínez, Erika Nogué, Óscar Chirife, Helena Quesada, Blanca Lara, Andrés Paipa, Lucía Aja, Paloma Mora, Maria Angel de Miquel, Sònia Aixut, Anna Maria Ferrer, Rebeca Marín, Luís Prats‐Sánchez, Raquel Delgado‐Mederos, Alejandro Martínez‐Domeño, J. Branera, Rodrigo Guerrero, J Villalba, Alejandro Rodríguez, N. Berga, Elena Jiménez‐Xarrié, Gemma Romeral, Ángel Ois, Jordi Jiménez, Carla Avellaneda-Gómez, Núria Cayuela, Ana Rodríguez, Eva Giralt, Merçè Espona, J. Saldaña, David Hernández, Marc Ribó, Carlos Piñana, Noelia Rodríguez, Sandra Boned, Carlos A. Molina, Marta Rubiera, Jesús Juega, David Rodríguez‐Luna, Juan Pagola, Alvaro Garcia-Tonel, Matías Deck, V. Sala, Estela Sanjuán, K. Santana, C. Losada, Pilar Suñé, Tudor G. Jovin, Enrique C. Leira, José Ríos · 发表于：JAMA · 年份：2022 · DOI：10.1001/jama.2022.1645 · 被引用次数：375 · 研究领域：Acute Ischemic Stroke Management、Stroke Rehabilitation and Recovery、Intracerebral and Subarachnoid Hemorrhage Research

Importance: It is estimated that only 27% of patients with acute ischemic stroke and large vessel occlusion who undergo successful reperfusion after mechanical thrombectomy are disability free at 90 days. An incomplete microcirculatory reperfusion might contribute to these suboptimal clinical benefits. Objective: To investigate whether treatment with adjunct intra-arterial alteplase after thrombectomy improves outcomes following reperfusion. Design, Setting, and Participants: Phase 2b randomized, double-blind, placebo-controlled trial performed from December 2018 through May 2021 in 7 stroke centers in Catalonia, Spain. The study included 121 patients with large vessel occlusion acute ischemic stroke treated with thrombectomy within 24 hours after stroke onset and with an expanded Treatment in Cerebral Ischemia angiographic score of 2b50 to 3. Interventions: Participants were randomized to receive intra-arterial alteplase (0.225 mg/kg; maximum dose, 22.5 mg) infused over 15 to 30 minutes (n = 61) or placebo (n = 52). Main Outcomes and Measures: The primary outcome was the difference in proportion of patients achieving a score of 0 or 1 on the 90-day modified Rankin Scale (range, 0 [no symptoms] to 6 [death]) in all patients treated as randomized. Safety outcomes included rate of symptomatic intracranial hemorrhage and death. Results: The study was terminated early for inability to maintain placebo availability and enrollment rate because of the COVID-19 pandemic. Of 1825 pati...