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绕过颅内出血患者最近的卒中中心的效果:RACECAT 随机临床试验的二次分析。

Effect of Bypassing the Closest Stroke Center in Patients with Intracerebral Hemorrhage: A Secondary Analysis of the RACECAT Randomized Clinical Trial.

机构信息

Stroke Unit, Department of Neurosciences, Hospital Germans Trias i Pujol, and Germans Trias i Pujol Research Institute (IGTP), Badalona, Barcelona, Spain.

Stroke Unit, Department of Neurology, Santa Creu i Sant Pau Hospital, Barcelona, Spain.

出版信息

JAMA Neurol. 2023 Oct 1;80(10):1028-1036. doi: 10.1001/jamaneurol.2023.2754.

Abstract

IMPORTANCE

Prehospital transfer protocols are based on rapid access to reperfusion therapies for patients with ischemic stroke. The effect of different protocols among patients receiving a final diagnosis of intracerebral hemorrhage (ICH) is unknown.

OBJECTIVE

To determine the effect of direct transport to an endovascular treatment (EVT)-capable stroke center vs transport to the nearest local stroke center.

DESIGN, SETTING, AND PARTICIPANTS: This was a prespecified secondary analysis of RACECAT, a multicenter, population-based, cluster-randomized clinical trial conducted from March 2017 to June 2020 in Catalonia, Spain. Patients were evaluated by a blinded end point assessment. All consecutive patients suspected of experiencing a large vessel occlusion stroke (Rapid Arterial Occlusion Evaluation Scale [RACE] score in the field >4 on a scale of 0 to 9, with lower to higher stroke severity) with final diagnosis of ICH were included. A total of 1401 patients were enrolled in RACECAT with suspicion of large vessel occlusion stroke. The current analysis was conducted in October 2022.

INTERVENTION

Direct transport to an EVT-capable stroke center (n = 137) or to the closest local stroke center (n = 165).

MAIN OUTCOMES AND MEASURES

The primary outcome was tested using cumulative ordinal logistic regression to estimate the common odds ratio (OR) and 95% CI of the shift analysis of disability at 90 days as assessed by the modified Rankin Scale (mRS) score (range, 0 [no symptoms] to 6 [death]) in the intention-to-treat population. Secondary outcomes, included 90-day mortality, death or severe functional dependency, early neurological deterioration, early mortality, ICH volume and enlargement, rate of neurosurgical treatment, rate of clinical complications during initial transport, and rate of adverse events until day 5.

RESULTS

Of 1401 patients enrolled, 1099 were excluded from this analysis (32 rejected informed consent, 920 had ischemic stroke, 29 had transient ischemic attack, 12 had subarachnoid hemorrhage, and 106 had stroke mimic). Thus, 302 patients were included (204 [67.5%] men; mean [SD] age 71.7 [12.8] years; and median [IQR] RACE score, 7 [6-8]). For the primary outcome, direct transfer to an EVT-capable stroke center (mean [SD] mRS score, 4.93 [1.38]) resulted in worse functional outcome at 90 days compared with transfer to the nearest local stroke center (mean [SD] mRS score, 4.66 [1.39]; adjusted common OR, 0.63; 95% CI, 0.41-0.96). Direct transfer to an EVT-capable stroke center also suggested potentially higher 90-day mortality compared with transfer to the nearest local stroke center (67 of 137 [48.9%] vs 62 of 165 [37.6%]; adjusted hazard ratio, 1.40; 95% CI, 0.99-1.99). The rates of medical complications during the initial transfer (30 of 137 [22.6%] vs 9 of 165 patients [5.6%]; adjusted OR, 5.29; 95% CI, 2.38-11.73) and in-hospital pneumonia (49 of 137 patients [35.8%] vs 29 of 165 patients [17.6%]; OR, 2.61; 95% CI, 1.53-4.44) were higher in the EVT-capable stroke center group.

CONCLUSIONS AND RELEVANCE

In this secondary analysis of the RACECAT randomized clinical trial, bypassing the closest stroke center resulted in reduced chances of functional independence at 90 days for patients who received a final diagnosis of ICH.

TRIAL REGISTRATION

ClinicalTrials.gov Identifier: NCT02795962.

摘要

重要性

院前转运方案基于为缺血性卒中患者快速提供再灌注治疗。对于最终诊断为颅内出血 (ICH) 的患者,不同方案的效果尚不清楚。

目的

确定直接转运至有血管内治疗 (EVT) 能力的卒中中心与转运至最近的当地卒中中心的效果。

设计、地点和参与者:这是西班牙加泰罗尼亚地区 2017 年 3 月至 2020 年 6 月进行的一项多中心、基于人群的、集群随机临床试验 RACECAT 的预先指定的二次分析。通过盲法终点评估进行评估。所有连续疑似发生大血管闭塞性卒中(RACE 评分在现场>4 分,范围为 0 至 9 分,得分越低,卒中严重程度越高)且最终诊断为 ICH 的患者均被纳入。RACECAT 共纳入 1401 例疑似大血管闭塞性卒中的患者。本分析于 2022 年 10 月进行。

干预

直接转运至 EVT 能力卒中中心(n=137)或最近的当地卒中中心(n=165)。

主要结局和测量指标

主要结局采用累积有序逻辑回归进行测试,以估计意向治疗人群中 90 天改良 Rankin 量表(mRS)评分(范围为 0 [无症状] 至 6 [死亡])残疾转移分析的常见优势比(OR)和 95%置信区间。次要结局包括 90 天死亡率、死亡或严重功能依赖、早期神经功能恶化、早期死亡率、ICH 体积和扩大、神经外科治疗率、初始转运期间临床并发症发生率以及 5 天内不良事件发生率。

结果

在纳入的 1401 例患者中,有 1099 例被排除在本分析之外(32 例拒绝知情同意,920 例为缺血性卒中,29 例为短暂性脑缺血发作,12 例为蛛网膜下腔出血,106 例为卒中模拟)。因此,共纳入 302 例患者(204 例男性;平均[SD]年龄 71.7[12.8]岁;中位数[IQR]RACE 评分 7[6-8])。对于主要结局,直接转至 EVT 能力卒中中心(mRS 评分平均[SD]为 4.93[1.38])与转至最近的当地卒中中心(mRS 评分平均[SD]为 4.66[1.39])相比,90 天的功能结局更差(调整后常见 OR,0.63;95%CI,0.41-0.96)。直接转至 EVT 能力卒中中心还可能导致 90 天死亡率高于转至最近的当地卒中中心(137 例中的 67 例[48.9%] vs 165 例中的 62 例[37.6%];调整后危险比,1.40;95%CI,0.99-1.99)。在最初的转运过程中,医源性并发症的发生率(137 例患者中有 30 例[22.6%] vs 165 例患者中有 9 例[5.6%];调整后 OR,5.29;95%CI,2.38-11.73)和院内肺炎(137 例患者中有 49 例[35.8%] vs 165 例患者中有 29 例[17.6%];OR,2.61;95%CI,1.53-4.44)在 EVT 能力卒中中心组中更高。

结论和相关性

在 RACECAT 随机临床试验的二次分析中,对于最终诊断为 ICH 的患者,绕过最近的卒中中心可能会降低 90 天的功能独立性机会。

试验注册

ClinicalTrials.gov 标识符:NCT02795962。

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