Importance Direct transfer to angiography suite (DTAS) for patients with suspected large vessel occlusion (LVO) stroke has been described as an effective and safe measure to reduce workflow time in endovascular treatment (EVT). However, it is unknown whether DTAS improves long-term functional outcomes. Objective To explore the effect of DTAS on clinical outcomes among patients with LVO stroke in a randomized clinical trial. Design, Setting, and Participants The study was an investigator-initiated, single-center, evaluator-blinded randomized clinical trial. Of 466 consecutive patients with acute stroke screened, 174 with suspected LVO acute stroke within 6 hours of symptom onset were included. Enrollment took place from September 2018 to November 2020 and was stopped after a preplanned interim analysis. Final follow-up was in February 2021. Interventions Patients were randomly assigned (1:1) to follow either DTAS (89 patients) or conventional workflow (85 patients received direct transfer to computed tomographic imaging, with usual imaging performed and EVT indication decided) to assess the indication of EVT. Patients were stratified according to their having been transferred from a primary center vs having a direct admission. Main Outcomes and Measures The primary outcome was a shift analysis assessing the distribution of the 90-day 7-category (from 0 [no symptoms] to 6 [death]) modified Rankin Scale (mRS) score among patients with LVO whether or not they received EVT (modified intention-to-treat population) assessed by blinded external evaluators. Secondary outcomes included rate of EVT and door-to-arterial puncture time. Safety outcomes included 90-day mortality and rates of symptomatic intracranial hemorrhage. Results In total, 174 patients were included, with a mean (SD) age of 73.4 (12.6) years (range, 19-95 years), and 78 patients (44.8%) were women. Their mean (SD) onset-to-door time was 228.0 (117.9) minutes, and their median admission National Institutes of Health Stroke Scale score was 18 (interquartile range [IQR], 14-21). In the modified intention-to-treat population, EVT was performed for all 74 patients in the DTAS group and for 64 patients (87.7%) in the conventional workflow group (P = .002). The DTAS protocol decreased the median door-to-arterial puncture time (18 minutes [IQR, 15-24 minutes] vs 42 minutes [IQR, 35-51 minutes]; P < .001) and door-to-reperfusion time (57 minutes [IQR, 43-77 minutes] vs 84 minutes [IQR, 63-117 minutes]; P < .001). The DTAS protocol decreased the severity of disability across the range of the mRS (adjusted common odds ratio, 2.2; 95% CI, 1.2-4.1; P = .009). Safety variables were comparable between groups. Conclusions and Relevance For patients with LVO admitted within 6 hours after symptom onset, this randomized clinical trial found that, compared with conventional workflow, the use of DTAS increased the odds of patients undergoing EVT, decreased hospital workflow time, and improved clinical outcome. Trial Registration ClinicalTrials.gov Identifier: NCT04001738.

中文翻译：

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直接进入血管造影套件，无需停止对急性中风患者的计算机断层扫描成像：一项随机临床试验。

重要性 对于疑似大血管闭塞 (LVO) 卒中患者，直接转移至血管造影套件 (DTAS) 已被描述为减少血管内治疗 (EVT) 工作流程时间的有效且安全的措施。然而，尚不清楚 DTAS 是否能改善长期功能结果。目的在一项随机临床试验中探讨 DTAS 对 LVO 脑卒中患者临床结局的影响。设计、设置和参与者 该研究是一项由研究者发起的、单中心、评估者盲的随机临床试验。在连续筛查的 466 名急性卒中患者中，包括 174 名症状发作后 6 小时内疑似 LVO 急性卒中的患者。注册于 2018 年 9 月至 2020 年 11 月进行，并在预先计划的中期分析后停止。最终随访时间为 2021 年 2 月。干预 患者被随机分配 (1:1) 遵循 DTAS（89 名患者）或传统工作流程（85 名患者接受直接转移到计算机断层扫描成像，进行常规成像并决定 EVT 适应症）以评估 EVT 的适应症。患者根据他们从初级中心转移到直接入院进行分层。主要结果和测量 主要结果是评估 LVO 患者 90 天 7 类（从 0 [无症状] 到 6 [死亡]）改良 Rankin 量表 (mRS) 评分的分布情况，无论他们是否接受了由盲法外部评估者评估的 EVT（改良意向治疗人群）。次要结局包括 EVT 发生率和门到动脉穿刺时间。安全性结局包括 90 天死亡率和症状性颅内出血发生率。结果共纳入174例患者，平均（SD）年龄73.4（12.6）岁（范围19-95岁），78例（44.8%）为女性。他们的平均 (SD) 到门口时间为 228.0 (117.9) 分钟，他们的中位入院美国国立卫生研究院卒中量表评分为 18 分（四分位距 [IQR]，14-21）。在改良意向治疗人群中，对 DTAS 组的所有 74 名患者和传统工作流程组的 64 名患者 (87.7%) 进行了 EVT (P = .002)。DTAS 方案减少了门到动脉穿刺的中位时间（18 分钟 [IQR，15-24 分钟] vs 42 分钟 [IQR，35-51 分钟]；P < .001）和门到再灌注时间（57分钟 [IQR，43-77 分钟] vs 84 分钟 [IQR，63-117 分钟]；P < . 001)。DTAS 方案降低了整个 mRS 范围内的残疾严重程度（调整后的共同优势比，2.2；95% CI，1.2-4.1；P = .009）。各组之间的安全性变量具有可比性。结论和相关性 对于症状出现后 6 小时内入院的 LVO 患者，这项随机临床试验发现，与传统工作流程相比，使用 DTAS 增加了患者接受 EVT 的几率，缩短了医院工作流程时间，并改善了临床结果。试验注册 ClinicalTrials.gov 标识符：NCT04001738。这项随机临床试验发现，与传统工作流程相比，使用 DTAS 增加了患者接受 EVT 的几率，减少了医院工作流程时间，并改善了临床结果。试验注册 ClinicalTrials.gov 标识符：NCT04001738。这项随机临床试验发现，与传统工作流程相比，使用 DTAS 增加了患者接受 EVT 的几率，减少了医院工作流程时间，并改善了临床结果。试验注册 ClinicalTrials.gov 标识符：NCT04001738。