Department of Interventional Neurology, Beijing Tiantan Hospital, Capital Medical University, China National Clinical Research Center for Neurological Diseases, Center of Stroke, Beijing Institute for Brain Disorders, Beijing, China.
Department of Neurology, The Affiliated Hospital of Qingdao University Medical College, Qingdao, China.
Stroke Vasc Neurol. 2018 May 7;3(3):176-184. doi: 10.1136/svn-2017-000137. eCollection 2018 Sep.
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.
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.
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.
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.
NCT01968122; Results.
在中国进行的一项针对伴有侧支循环不良的症状性颅内动脉粥样硬化性狭窄（ICAS）患者的个体化支架置入多中心前瞻性注册研究显示，支架置入的短期安全性和疗效是可以接受的。然而，其长期低事件率是否能够持续仍不确定。我们报告了该注册研究的 1 年结果，以评估伴有严重症状性 ICAS 合并侧支循环不良患者个体化支架置入的长期疗效。
纳入了由颅内颈内动脉、大脑中动脉、颅内椎动脉或基底动脉 70%-99%狭窄引起的伴有侧支循环不良的症状性 ICAS 患者。根据术者确定的血管入路的难易程度和病变形态，选择球囊扩张支架或球囊扩张联合自膨式支架。主要结局为 30 天内卒中、短暂性脑缺血发作和死亡以及 12 个月内同一血管区域内缺血性卒中、出血性卒中和血管性死亡的发生率。
2013 年 9 月至 2015 年 1 月，共纳入 300 例患者（年龄 58.3±9.78 岁）。其中，159 例患者接受球囊扩张支架治疗，141 例患者接受球囊扩张联合自膨式支架治疗。在 1 年随访期间，有 25 例患者发生了主要终点事件。1 年时主要结局的概率为 8.1%（95%CI：5.3%至 11.7%）。在 76 例行数字减影血管造影随访的患者中，27.6%（21/76）患者再狭窄≥50%，18.4%（14/76）患者再狭窄≥70%。没有基线特征与主要结局相关。
伴有严重症状性 ICAS 合并侧支循环不良的患者个体化支架置入后 1 年的事件发生率仍然较低。需要进一步进行比较个体化支架置入与最佳药物治疗的随机试验。
NCT01968122；结果。
