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西班牙巴塞罗那自治大学Marc Ribo团队比较了直接运送到血栓切除中心与当地卒中中心对非城市地区疑似大血管闭塞性卒中患者神经预后的影响。2022年5月5日出版的《美国医学会杂志》发表了这项成果。

在无法进入血栓切除中心的非城市地区，疑似大血管闭塞性卒中患者的最佳院前转运策略尚不清楚。

为了确定在非城市地区，严重卒中患者直接运送到血栓切除中心与运送到最近的当地卒中中心相比是否有益，研究组进行了一项多中心、基于人群的整群随机试验，包括2017年3月至2020年6月在西班牙加泰罗尼亚最近的当地卒中中心无法进行血栓切除术的地区接受急诊医疗服务的1401名疑似急性大血管闭塞性卒中患者。最终随访日期为2020年9月。

随机分组后，688例患者运送至血栓切除中心，713例运送至最近的当地卒中中心。主要结局是根据改良的Rankin量表（mRS；评分范围为0[无症状]到6[死亡]）对缺血性卒中患者的目标人群进行90天的残疾评估。11项次要结局包括目标人群中静脉注射组织型纤溶酶原激活剂和血栓切除术的发生率，以及所有随机患者中安全人群的90天死亡率。

在第二次中期分析后，因结果无效而停止登记。1401名入选患者被纳入安全性分析，其中1369名（98%）同意参与，并被纳入随机分析，56%为男性，中位年龄为75岁；中位美国国立卫生研究院卒中量表评分为17分。949名（69%）构成纳入初步分析的目标缺血性卒中人群。对于目标人群的主要结局，两组患者mRS中位评分均为3分，校正后的共同优势比（OR）为1.03。在11个报告的次要结局中，两组间有8个没有显示出显著差异。

与初次被送往当地中风中心的患者相比，直接转移到血栓切除中心的患者接受静脉组织纤溶酶原激活剂的几率显著降低（在目标人群中分别为47.5%与60.4%），但接受血栓切除术的几率显著升高（在目标人群中分别为48.8%与39.4%）。在安全人群中，90天死亡率在各组之间没有显著差异（分别为27.3%与27.2%，校正后的危险比为0.97）。

研究结果表明，在西班牙加泰罗尼亚的非城市地区，疑似大血管闭塞性卒中患者被送往当地卒中中心与血栓切除转诊中心的90天神经预后无显著差异。该发现有望在其他环境中复制。

附：英文原文

Title: 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: The RACECAT Randomized Clinical Trial

Author: Natalia Pérez de la Ossa, Sònia Abilleira, Tudor G. Jovin, álvaro García-Tornel, Xavier Jimenez, Xabier Urra, Pere Cardona, Dolores Cocho, Francisco Purroy, Joaquin Serena, Luis San Román Manzanera, Rosa Maria Vivanco-Hidalgo, Mercè Salvat-Plana, Angel Chamorro, Miquel Gallofré, Carlos A. Molina, Erik Cobo, Antoni Davalos, Marc Ribo, RACECAT Trial Investigators, Jane Abella, Sheila Abrio, Teresa Acera, Ada Aguilar, Sonia Aguirre, Laura Alastrue, Consuelo Almodovar, Marne Cristina Alonso, Angels Aloy, Miriam Alvarez, Miguel Alvarez, Jeannette Alvarez, Celia Alvarin, Maria Vanessa Ameller, Estefania Remedios Andujar, Anna Arambudo, Villagrasa Vilella Ares, Lorena Arrufat, Silvia Auladell, Izaskun Azcarate, Vanessa Aznar, Andres Baena, Marc Bagaria, Joan Bauelos, Andreu Barnés, Nuria Basany, Cristina Beltran, Sergio Benavent, Silvia Biesot, Roser Blanch, Ariadna Boluda, Victor Bonet, Isabel Bonilla, Gemma Borch, Raquel Boullon, Nuria Bru, Stella Brugues, Estel Buhils, Antonio Burgos, Laia Burnat, Salvador Caballero, Jordi Calafell, Miriam Calvet, Arnau Calvo, Francisco Campo, Olga Campos, Iren Camps, Maria Del Mar Campuzano, Bresme Nuria Cano, Montserrat Capdevila, Antonio Carballo, Daniel Carcelen, Jaume Cardus, Francisco Jose Carmona, Marc Caro

Issue&Volume: 2022-05-05

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.

DOI: 10.1001/jama.2022.4404

Source: https://jamanetwork.com/journals/jama/fullarticle/2791844

JAMA-Journal of The American Medical Association：《美国医学会杂志》，创刊于1883年。隶属于美国医学协会，最新IF：157.335
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