Effect of Direct Transportation to Thrombectomy-Capable Center vs Local Stroke Center on Neurological Outcomes in Patients With Suspected Large-Vessel Occlusion Stroke in Nonurban Areas
Natàlia Pérez de la Ossa, Sònia Abilleira, Tudor G. Jovin, Álvaro García‐Tornel, Xavier Jiménez, Xabier Urra, Pere Cardona, Dolores Cocho, Francisco Purroy, Joaquı́n Serena, Luís San Román, Rosa Maria Vivanco‐Hidalgo, Mercè Salvat‐Plana, Ángel Chamorro, Miquel Gallofré, Carlos A. Molina, Erik Cobo, Antoni Dávalos, Marc Ribó, RACECAT Trial Investigators, Jan Vincent Abella, Sheila Abrio, Teresa Acera, A Fierro Aguilar, Sonia Aguirre, Laura Alastrue, Consuelo Almodovar, Marne Cristina Alonso, A. Aloy, Mı́riam Álvarez, Miguel Álvarez, Jeannette Alvarez, Celia Alvarin, Maria Vanessa Ameller, Estefania Remedios Andujar, Anna Arambudo, Villagrasa Vilella Ares, Lorena Arrufat, Silvia Auladell, Izaskun Azcárate, Vanessa Aznar, Andrés Baena, Marc Bagaria, Joan Bañuelos, Andreu Barnés, Nuria Basany, Cristina Beltrán, Sergio Benavent, Silvia Biesot, Roser Blanch, A. J. Cepillo Boluda, Victor Bonet, Isabel Bonilla, Gemma Borch, Raquel Boullon, N Alejo Bru, Stella Brugues, Estel Buhils, Antonio Burgos, Laia Burnat, S. Fénix Caballero, Jordi Calafell, Miriam Calvet, Arnau Calvo, F. Rodríguez Campo, Olga Campos, Iren Camps, Maria Del Mar Campuzano, Bresme Nuria Cano, Montserrat Capdevila, Antonio Carballo, Daniel Carcelen, Jaume Cardus, Francisco Jose Carmona, M. Caro, Clara Isabel Carre, Alexander Carretero, Gemma Casajuana, Teresa Casasas, C. Castanedo, Maria Gloria Castello, Paramio Castillo, G. Diéguez Castrillo, Rosa Maria Castro, M Elena Castro, Xavier Català, Monica Catells, Dolors Catena, Sergio Cazorla, Sandra Cerdeña, Alexandre Chacon, Sunyer Claustre, Enric Clave, Alejandro Closa, E Seder Colomina, Montserrat Comes, L.E. Cora, E Saez De Buruaga Corrales, Lidia Cortes, Rita Cortit
Abstract
Importance: In nonurban areas with limited access to thrombectomy-capable centers, optimal prehospital transport strategies in patients with suspected large-vessel occlusion stroke are unknown. Objective: To determine whether, in nonurban areas, direct transport to a thrombectomy-capable center is beneficial compared with transport to the closest local stroke center. Design, Setting, and Participants: Multicenter, population-based, cluster-randomized trial including 1401 patients with suspected acute large-vessel occlusion stroke attended by emergency medical services in areas where the closest local stroke center was not capable of performing thrombectomy in Catalonia, Spain, between March 2017 and June 2020. The date of final follow-up was September 2020. Interventions: Transportation to a thrombectomy-capable center (n = 688) or the closest local stroke center (n = 713). Main Outcomes and Measures: The primary outcome was disability at 90 days based on the modified Rankin Scale (mRS; scores range from 0 [no symptoms] to 6 [death]) in the target population of patients with ischemic stroke. There were 11 secondary outcomes, including rate of intravenous tissue plasminogen activator administration and thrombectomy in the target population and 90-day mortality in the safety population of all randomized patients. Results: Enrollment was halted for futility following a second interim analysis. The 1401 enrolled patients were included in the safety analysis, of whom 1369 (98%) consented to participate and were included in the as-randomized analysis (56% men; median age, 75 [IQR, 65-83] years; median National Institutes of Health Stroke Scale score, 17 [IQR, 11-21]); 949 (69%) comprised the target ischemic stroke population included in the primary analysis. For the primary outcome in the target population, median mRS score was 3 (IQR, 2-5) vs 3 (IQR, 2-5) (adjusted common odds ratio [OR], 1.03; 95% CI, 0.82-1.29). Of 11 reported secondary outcomes, 8 showed no significant difference. Compared with patients first transported to local stroke centers, patients directly transported to thrombectomy-capable centers had significantly lower odds of receiving intravenous tissue plasminogen activator (in the target population, 229/482 [47.5%] vs 282/467 [60.4%]; OR, 0.59; 95% CI, 0.45-0.76) and significantly higher odds of receiving thrombectomy (in the target population, 235/482 [48.8%] vs 184/467 [39.4%]; OR, 1.46; 95% CI, 1.13-1.89). Mortality at 90 days in the safety population was not significantly different between groups (188/688 [27.3%] vs 194/713 [27.2%]; adjusted hazard ratio, 0.97; 95% CI, 0.79-1.18). Conclusions and Relevance: In nonurban areas in Catalonia, Spain, there was no significant difference in 90-day neurological outcomes between transportation to a local stroke center vs a thrombectomy-capable referral center in patients with suspected large-vessel occlusion stroke. These findings require replication in other settings. Trial Registration: ClinicalTrials.gov Identifier: NCT02795962.