Objective To determine outcomes and safety of endovascular treatment for acute ischaemic stroke, due to proximal intracranial vessel occlusion in the anterior circulation, in routine clinical practice.
Design Ongoing, prospective, observational cohort study.
Setting 16 centres that perform endovascular treatment in the Netherlands.
Participants 1488 patients included in the Multicentre Randomised Controlled Trial of Endovascular Treatment for Acute Ischaemic Stroke in the Netherlands (MR CLEAN) Registry who had received endovascular treatment, including stent retriever thrombectomy, aspiration, and all alternative methods for acute ischaemic stroke within 6.5 hours from onset of symptoms between March 2014 and June 2016.
Main outcome measures The primary outcome was the modified Rankin Scale (mRS) score, ranging from 0 (no symptoms) to 6 (death) at 90 days after the onset of symptoms. Secondary outcomes were excellent functional outcome (mRS score 0-1), good functional outcome (mRS score 0-2), and favourable functional outcome (mRS score 0-3) at 90 days; score on the extended thrombolysis in cerebral infarction scale at the end of the intervention procedure; National Institutes of Health Stroke Scale score 24-48 hours after intervention; and complications that occurred during intervention, hospital admission, or three months’ follow up period. Outcomes and safety variables in the MR CLEAN Registry were compared with the MR CLEAN trial intervention and control arms.
Results A statistically significant shift was observed towards better functional outcome in patients in the MR CLEAN Registry compared with the MR CLEAN trial intervention arm (adjusted common odds ratio 1.30, 95% confidence interval 1.02 to 1.67) and the MR CLEAN trial control arm (1.85, 1.46 to 2.34). The reperfusion rate, with successful reperfusion defined as a score of 2B-3 on the extended thrombolysis in cerebral infarction score, was 58.7%, the same as for patients in the MR CLEAN trial. Duration from onset of stroke to start of endovascular treatment and from onset of stroke to successful reperfusion or last contrast bolus was one hour shorter for patients in the MR CLEAN Registry. Symptomatic intracranial haemorrhage occurred in 5.8% of patients in the MR CLEAN Registry compared with 7.7% in the MR CLEAN trial intervention arm and 6.4% in the MR CLEAN trial control arm.
Conclusion In routine clinical practice, endovascular treatment for patients with acute ischaemic stroke is at least as effective and safe as in the setting of a randomised controlled trial.

中文翻译：

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常规临床实践中针对急性缺血性卒中的血管内治疗：前瞻性观察性队列研究（MR CLEAN注册中心）

目的在常规临床实践中确定前循环中近端颅内血管闭塞引起的急性缺血性卒中的腔内治疗的结果和安全性。
设计正在进行的，前瞻性的，观察性队列研究。在荷兰
设置了16个进行血管内治疗的中心。
参与者1488名患者参加了荷兰急性缺血性卒中的血管中心治疗多中心随机对照试验（MR CLEAN）登记册，这些患者在6.5小时内接受了血管内治疗，包括支架式血栓切除术，抽吸术和所有其他替代方法，用于急性缺血性中风在2014年3月至2016年6月之间出现症状。
主要结局指标主要结局指标是改良的Rankin量表（mRS）评分，在症状发作90天后从0（无症状）至6（死亡）不等。次要结局为90天时良好的功能性结局（mRS评分0-1），良好的功能性结局（mRS评分0-2）和良好的功能性结局（mRS评分0-3）；干预程序结束时对脑梗死范围内的溶栓程度进行扩展评分；美国国立卫生研究院卒中量表在干预后24-48小时得分；以及在干预，入院或三个月随访期间发生的并发症。将MR CLEAN注册中心中的结果和安全性变量与MR CLEAN试验干预和对照组进行了比较。
结果与MR CLEAN试验干预组（调整后的共同优势比1.30，95％置信区间1.02至1.67）和MR CLEAN试验对照组相比，在MR CLEAN注册中心患者中观察到朝向更好的功能结局有统计学上的显着变化。 1.46至2.34）。与MR CLEAN试验中的患者相同，再灌注率为58.7％，成功的再灌注率定义为脑梗死扩展溶栓时的2B-3得分。对于MR CLEAN注册表中的患者，从中风发作到开始血管内治疗的时间，以及从中风发作到成功的再灌注或最后一次造影剂的持续时间要短一小时。MR CLEAN注册中心中有5.8％的患者发生了症状性颅内出血，而MR CLEAN试验干预组和6.中有7.7％的患者出现了颅内出血。
结论在常规临床实践中，急性缺血性卒中患者的腔内治疗至少与随机对照试验的设置一样有效和安全。