Randomized data evaluating the impact of the extracorporeal cardiopulmonary resuscitation (ECPR) approach on long-term clinical outcomes in patients with refractory out-of-hospital cardiac arrest (OHCA) are lacking. The objective of this follow-up study was to assess the long-term clinical outcomes of the ECPR-based versus CCPR approach. The Prague OHCA trial was a single-center, randomized, open-label trial. Patients with witnessed refractory OHCA of presumed cardiac origin, without return of spontaneous circulation, were randomized during ongoing resuscitation on scene to conventional CPR (CCPR) or an ECPR-based approach (intra-arrest transport, ECPR if ROSC is not achieved prehospital and immediate invasive assessment). From March 2013 to October 2020, 264 patients were randomized during ongoing resuscitation on scene, and 256 patients were enrolled. Long-term follow-up was performed 5.3 (interquartile range 3.8–7.2) years after initial randomization and was completed in 255 of 256 patients (99.6%). In total, 34/123 (27.6%) patients in the ECPR-based group and 26/132 (19.7%) in the CCPR group were alive (log-rank P = 0.01). There were no significant differences between the treatment groups in the neurological outcome, survival after hospital discharge, risk of hospitalization, major cardiovascular events and quality of life. Of long-term survivors, 1/34 (2.9%) in the ECPR-based arm and 1/26 (3.8%) in the CCPR arm had poor neurological outcome (both patients had a cerebral performance category score of 3). Among patients with refractory OHCA, the ECPR-based approach significantly improved long-term survival. There were no differences in the neurological outcome, major cardiovascular events and quality of life between the groups, but the trial was possibly underpowered to detect a clinically relevant difference in these outcomes. Trial registration ClinicalTrials.gov Identifier: NCT01511666, Registered 19 January 2012.

中文翻译：

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难治性院外心脏骤停中逮捕内转运、体外心肺复苏和立即侵入性评估的效果：布拉格 OHCA 试验的长期随访

目前缺乏评估体外心肺复苏 (ECPR) 方法对难治性院外心脏骤停 (OHCA) 患者长期临床结果影响的随机数据。这项后续研究的目的是评估基于 ECPR 与 CCPR 方法的长期临床结果。布拉格 OHCA 试验是一项单中心、随机、开放标签试验。目击疑似心源性难治性 OHCA 且无自主循环恢复的患者，在现场持续复苏期间被随机分配至传统心肺复苏 (CCPR) 或基于 ECPR 的方法（逮捕后转运，如果院前未实现 ROSC 且立即立即实施 ECPR）侵入性评估）。从2013年3月到2020年10月，264名患者在现场持续复苏过程中被随机分组​​，最终纳入256名患者。长期随访在初次随机分组后 5.3 年（四分位间距 3.8-7.2）进行，256 名患者中有 255 名患者完成了随访（99.6%）。总体而言，基于 ECPR 的组中有 34/123 (27.6%) 例患者存活，CCPR 组中有 26/132 (19.7%) 例患者存活（对数秩 P = 0.01）。治疗组之间在神经系统结局、出院后生存率、住院风险、主要心血管事件和生活质量方面没有显着差异。在长期幸存者中，基于 ECPR 的组中 1/34 (2.9%) 和 CCPR 组中的 1/26 (3.8%) 神经系统结果较差（两名患者的脑功能类别评分均为 3）。在难治性 OHCA 患者中，基于 ECPR 的方法显着改善了长期生存率。各组之间的神经系统结果、主要心血管事件和生活质量没有差异，但该试验可能不足以检测这些结果的临床相关差异。试验注册 ClinicalTrials.gov 标识符：NCT01511666，2012 年 1 月 19 日注册。