Endovascular therapy for Acute ischemic Stroke Trial (EAST): study protocol for a prospective, multicentre control trial in China

Abstract

Background and purpose5 recent trials have shown the benefit of endovascular treatment for acute ischaemic stroke (AIS) due to large vessel occlusion of the anterior circulation. This study aims to evaluate the safety and efficacy of Solitaire thrombectomy in patients with moderate-to-severe stroke in the Chinese population, which has a high prevalence of intracranial atherosclerosis.Methods and analysisThis multicentre prospective control study will involve 17 stroke centres in China, and plans to recruit 150 patients in the intervention group, and 150 patients in the medical group, in which patients meet enrolment criteria but refuse intervention. Patients with AIS due to large vessel occlusion indicated for treatment with Solitaire stent retriever within 12 hours of symptom onset, and who meet the inclusion and exclusion criteria, will be enrolled in this study. The primary efficacy endpoint is functional independence as defined by a modified Rankin Scale (mRS) score ≤2 at 90 days or by functional improvement as defined by mRS, using shift analysis. The procedural efficacy endpoint is arterial recanalisation of the occluded target vessel measured by a modified Thrombolysis in Cerebral Infarction (mTICI) score equal or superior to 2b right following the use of the study device. The primary safety endpoint is symptomatic intracranial haemorrhage (sICH) within 24±3 hours postprocedure.Ethics and disseminationThe protocol was approved by the Ethics Committee at the coordinating centre and by the local Institutional Review Board of each participating centre.Trial registration numberNCT02350283.

Cost-effectiveness of mechanical thrombectomy within 6 hours of acute ischaemic stroke in China

“…Proximal large vessel atherosclerotic stenosis or occlusion accounts for 35%–40% of all acute ischaemic strokes, 17 among which approximately 40% are admitted to the hospital within 6 hours in China. 18 Therefore, approximately 14%–16% of patients with ischaemic stroke were eligible for mechanical thrombectomy and might benefit from this procedure.…”

“…The base case of the model was a cohort of 100 000 patients with acute ischaemic stroke with proximal anterior circulation occlusion (36% female), with mean age of 63 years old, being admitted to the hospital within 6 hours after onset of stroke. The baseline characteristics were the same as patients enrolled in the treated arm of the Endovascular therapy for Acute ischaemic Stroke Trial (EAST), a non-randomised interventional study that aimed to evaluate the safety and efficacy of Solitaire thrombectomy in Chinese patients with acute stroke) 17 who were admitted to the hospital within 6 hours. Among the patients admitted to the hospital within 6 hours after the onset of stroke, we assumed that 85.4% patients were admitted within 4.5 hours in both arms according to the data from the China National Stroke Registry (CNSR); a nationwide registry that has recruited 21 902 consecutive patients with acute cerebrovascular events from 132 hospitals in China between September 2007 and August 2008, 18 all of whom were assumed to receive intravenous tPA treatment, whereas all patients in the intervention arm received mechanical thrombectomy treatment.…”

“… 18 The additional costs of mechanical thrombectomy, including costs for devices, procedure and special periprocedural care, were estimated using the data from the EAST study and the Thrombolysis Implementation and Monitor of acute ischaemic Stroke in China (TIMS-CHINA; a national prospective registry of 1440 acute ischaemic stroke patients with thrombolytic therapy with intravenous tPA recruited from 67 centres in China between May 2007 and April 2012) study. 17 28 The additional costs of tPA treatment and occurrence of sICH were estimated using the data from the CNSR and the TIMS-CHINA studies. We did not include the indirect economic costs such as lost work productivity in the present study.…”

Mechanical thrombectomy and rescue therapy for intracranial large artery occlusion with underlying atherosclerosis

“…Those who accepted the treatment were enrolled in the intervention group and those who refused were included in the medical therapy group. Details of the protocol have been published previously 18. In this analysis, we included only patients in the intervention group who underwent stent retrieval.…”

Acute Ischaemic Stroke Cooperation Group of Endovascular Treatment (ANGEL) registry: study protocol for a prospective, multicentre registry in China

“…11 It is proved that MT could also benefit Chinese population with acute large vascular occlusion. 12 13 We should organise the systems of care to facilitate MT's delivery. The Acute Ischaemic Stroke Cooperation Group of Endovascular Treatment (ANGEL) registry was designed to evaluate the endovascular treatment delivery and to improve endovascular treatment algorithm in clinical practice in China.…”