Stenting for symptomatic intracranial arterial stenosis in China:1-year outcome of a multicentre registry study

background and purpose A multicentre prospective registry study of individually tailored stenting for a patient with symptomatic intracranial atherosclerotic stenosis(ICAS)combined with poor collaterals in China showed that the short-term safety and efficacy of stenting was acceptable.However,it remained uncertain whether the low event rate could be of a long term.We reported the 1-year outcome of this registry study to evaluate the long-term efficacy of individually tailored stenting for patients with severe symptomatic ICAS combined with poor collaterals.Methods Patients with symptomatic ICAS caused by 70%-99% stenosis located at the intracranial internal carotid,middle cerebral,intracranial vertebral or basilar arteries combined with poor collaterals were enrolled.Balloon-mounted stent or balloon plus self-expanding stent were selected based on the ease of vascular access and lesion morphology determined by the operators.The primary outcome was the rate of 30-day stroke,transient ischaemic attack and death,and 12-month ischaemic stroke within the same vascular territory,haemorrhagic stroke and vascular death after stenting.results From September 2013 to January 2015,300 patients(ages 58.3±9.78 years)were recruited.Among them,159 patients were treated with balloon-mounted stent and 141 with balloon plus self-expanding stent.During the 1-year follow-up,25 patients had a primary end point event.The probability of primary outcome at 1 year was 8.1%(95% CI 5.3% to 11.7%).In 76 patients with digital subtraction angiography follow-up,27.6%(21/76)had re-stenosis≥50% and 18.4%(14/76)had re-stenosis≥70%.No baseline characteristic was associated with the primary outcome.Conclusion The event rate remains low over 1 year of individually tailored stenting for patients with severe symptomatic ICAS combined with poor collaterals.Further randomised trial of comparing individually tailored stenting with best medical therapy is needed.

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

Background and purpose:5 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 analysis:This 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 dissemination:The protocol was approved by the Ethics Committee at the coordinating centre and by the local Institutional Review Board of each participating centre.Trial registration number:NCT02350283.

Staged angioplasty versus regular carotid artery stenting in patients with carotid artery stenosis at high risk of hyperperfusion:a randomised clinical trial

Background and purpose Hyperperfusion(HP)is a devastating complication associated with carotid artery stenting(CAS)or endarterectomy.The efficacy and safety of staged angioplasty(SAP)in patients with CAS at high risk of HP remains unclear.We sought to determine whether SAP is superior to regular CAS in patients with high risk of HP.Methods A randomised,multicentre open-label clinical trial with blinded outcome assessment(STEP)was conducted.Patients with severe carotid stenosis at high risk of HP were randomly assigned(1:1)to the SAP or regular CAS group.The primary endpoint was hyperperfusion syndrome(HPS)and intracerebral haemorrhage(ICH)within 30 days after the procedure.Results From November 2014 to January 2017,a total of 64 patients were enrolled in 11 centres.33 patients were allocated to the SAP group and 31 to the regular CAS group.At 30 days,the rate of primary endpoint was 0.0%(0/33)in the SAP group and 9.7%(3/31)in the regular CAS group(absolute risk reduction(ARR),9.7%;95%CI−20.1% to 0.7%;p=0.11).As one of the secondary endpoints,the incidence of HP phenomenon(HPP)was lower in the SAP group than the regular CAS group(0.0%vs 22.6%,ARR,−22.6%;95% CI−36.8%to−10.2%;p=0.04).Conclusion The rate of HPS and ICH was not significantly lower in SAP group;the extended secondary endpoint of HPP,however,significantly reduced,which suggested that SAP may be a safe and effective carotid revascularisation procedure to prevent HP.