药物涂层球囊治疗症状性颅内动脉粥样硬化性狭窄的临床研究

Clinical study of drug-coated balloon in the treatment of symptomatic intracranial atherosclerotic stenosis

目的评价药物涂层球囊(DCB)治疗症状性颅内动脉粥样硬化性狭窄的围手术期安全性和疗效。方法回顾性纳入2018年1月至2021年8月在郑州大学人民医院接受DCB治疗的49例症状性颅内动脉粥样硬化性狭窄患者, 其中颈内动脉颅内段5例、大脑中动脉21例、椎动脉颅内段11例、基底动脉12例。先行普通球囊预扩张病变后再行DCB成形术, 术后30、90、180、360 d进行临床随访, 术后180 d行影像学随访。分析技术成功率(定义为球囊扩张治疗后残余狭窄<50%患者所占比例)、围手术期安全性(1个月内所有的卒中、TIA和死亡)、随访卒中复发及再狭窄等情况。结果所有患者均成功实施手术。狭窄程度由术前80%(75%, 85%)改善为术后即刻20%(15%, 30%), 技术成功率91.8%(45/49), 11例(22.4%, 11/49)因严重限流性血管夹层或非限流性夹层, 术者担心夹层随后进展给予支架植入。3例(6.1%, 3/49)因明显的血管弹性回缩植入支架。围手术期1例(2.0%, 1/49)患者发生症状性脑梗死, 经治疗后症状好转。无致死致残性卒中发生。所有患者均获得临床随访, 中位随访时间12个月, 2例(4.1%, 2/49)患者发生责任血管区域卒中事件, 1例(2.0%, 1/49)患者发生非责任血管区域卒中事件。38例(77.6%, 38/49)患者获得影像随访, 中位影像随访时间6个月, 发生2例再狭窄(1例症状性再狭窄), 再狭窄发生率5.3%(2/38)。结论 DCB治疗症状性颅内动脉粥样硬化性狭窄患者技术成功率高, 围手术期安全性良好, 短期随访卒中复发率低, 提示可能具有较好可行性、安全性和疗效。

Objective To evaluate the safety and efficacy of drug-coated balloon(DCB)in the treatment of symptomatic intracranial atherosclerotic stenosis.Methods Forty-nine patients with symptomatic intracranial atherosclerotic stenosis treated with DCB in the People′s Hospital of Zhengzhou University from January 2018 to August 2021 were retrospectively included.The location and number of lesions were as follows:21 cases of the middle cerebral artery,11 cases of the intracranial segment of vertebral artery,12 cases of the basilar artery,and 5 cases of the intracranial segment of internal carotid artery.Pre-dilatation of the lesion with a normal balloon followed by DCB angioplasty.Clinical follow-up(outpatient or telephone)was carried out at 30 days,3 months,6 months,and 1 year after the operation.Imaging follow-up was carried out at 6 months postoperatively.The surgical success rate(defined as the proportion of patients with residual stenosis<50%after balloon dilatation),perioperative safety(any strokes,TIA,and deaths within 1 month),stroke recurrence,and restenosis were analyzed.Results The operation was performed in all patients successfully.The median stenosis level was 80%(75%,85%)preoperatively and 20%(15%,30%)at the time after the operation.The success rate of the operation was 91.8%(45/49).Stenting was given in 11 cases(22.4%,11/49)for severe flow-limiting vascular entrapment,or non-flow-limiting entrapment,owing to the concern of subsequent progression of the entrapment.Three cases(6.1%,3/49)had significant vascular elastic retraction and implement stent implantation.One patient(2.0%,1/49)developed symptomatic cerebral infarction during perioperative period,and the symptoms improved after treatment.No fatal or disabling stroke occurred.All patients were followed-up successfully.The median follow-up time was 12 months.Two patients(4.1%,2/49)had a stroke in the responsible vascular area,and 1(2.0%,1/49)patient had a stroke in the non-responsible vascular area.Thirty-eight patients(77.6%,38/49)had followed-up images.The median follow-up time of postoperative imaging was 6 months.Restenosis occurred in two cases(1 case had symptomatic restenosis),and the incidence of restenosis was 5.3%(2/38).Conclusions DCB in the treatment of symptomatic intracranial atherosclerotic stenosis has a high technical success rate,good perioperative safety,and low stroke recurrence rate in short-term follow-up,demonstrating the good feasibility,safety,and efficacy of DCB.