Clinical Study On Treatment For Symptomatic Intracranial Atherosclerotic Stenosis With The Wingspan Stent System

ObjectiveAs one of the first centers in the treatment of high-grade symptomatic intracranial atherosclerotic stenosis with Gateway-ballon wingspan systerm,we aim to assess the safety,feasibility and short-term,mid-term efficacy of this systerm,and evaluate the efficacy of stenting for symptomatic intracranial artery stenosis by comparing with home-made Apollo stent,the medical treatment in WASID trial and NIH multi-center Wingspan stenting trail.MethodsSixty-nine patients with symptomatic intracranial atherosclerotic stenosis (≥70%) treated with the Gateway balloon-Wingspan system from June 2007 to February 2009 were enrolled in this study.The clinical data,interventional procedure and the follow-up data were collected,especially the qualifying events and the recurrent event associated with the intracranial stenosis.Imaging modalities including MRI for detecting cerebral infarction,CTP/PWI for assessing cerebral perfusion,DSA for observing morphology of stenosis,and DSA combining with high-resolution MRI for differentiating the cause of stenosis were performed.The severity of involved stenosis of pre and post-operation were studied.The NIHSS and mRS score of pre-operation,24h post-operation,30d post-operation,and the final follow-up were calculated and analyzed.The probability,classification of complication and the high-risk factors of the stenting were explored.The in-stent stenosis was identified by follow-up angiography at 6 months post-operation.The success rate was compared with the Apollo stenting procedure.The efficacy was evaluated by comparing with the medical treatment in WASID trial and the Wingspan stenting in NIH registry.ResultsOf the 26 patients evaluated the cause of stenosis,18 cases were prone to atherosclerotic stenosis.Only 1 case failed in a total of 69 procedures with the success rate 98.6%.The difference was not significant comparing with the 91.2%of the Apollo stenting,(P＞0.05).The average degrees of stenosis of pre-operation and post-operation were 81.5±11.29%and 28.71±13.65%respectively(P＜0.05).To compare NIHSS score and mRS score of pre-operation with that of 24h post-operation, 30d post-operation,and the final follow-up,there're no significant difference between them(P＞0.05).Of the 5 patients with complication,1 case died of hyperperfusion resulting in subarachnoid hemorrhage,and the other 4 cases suffered from perforator stroke with slightly neurological deficit.During the average 11.5 months follow-up,the cumulative rate of complication was 7.2%,and the in-stent restenosis rate was 17.2%at 6 months.To compare with the medical treatment in WASID trial, the rates of the primary end point,ischemic stroke and ischemic stroke in territory of stenotic artery were lower(P＜0.05).In the 4 high-risk subgroup of medical treatment, the efficacy of Wingspan stenting were better than medicine in three subgroups with stenosis larger than 70%,time from qualifying event to enrollment less than 17 days,NIH Stroke Scale score larger than 1(P＜0.05).Comparing with the wingspan stenting in NIH trial,the difference was not significant(P＞0.05). ConclusionsAngioplasty and stenting for high-grade symptomatic intracranial artery stenosis with the Gateway-Wingspan stent system are safe and effective method with high technical success rate for treating symptomatic intracranial artery stenosis.The rate of death and stoke in preprocedure is acceptive,and perforator stroke is still the first complication with silghtly neurological deficit.The rates of the primary end point, ischemic stroke and ischemic stroke in territory of stenotic artery in this method were lower than the WASID medical series,and the effect is better for treating high-risk patients.The higher restenosis rate should be improved in the future with the improvement of operating techniques and instruments.