Background Atherosclerotic intracranial arterial stenosis (ICAS) is one of the most common causes of stroke worldwide and is associated with a high risk of recurrent stroke. Patients with a recent transient ischemic attack (TIA) or stroke and severe stenosis (70 to 99% of the diameter of a major intracranial artery) are at particularly high risk for recurrent stroke in the territory of the stenotic artery (approximately 23% at 1 year) despite medical treatment. Therefore, alternative therapies are urgently needed for these patients. Objective To determine the efficacy and safety of angioplasty with stenting in medically refractory ICAS and to compare its effectiveness with optimal medical treatment. Subjects and methods Fifty patients with symptomatic ICAS despite medical treatment (i.e, recurrent stroke or TIA) were enrolled and equally randomized in a prospective study where twenty-five patients underwent angioplasty with stenting and twenty-five patients received optimal medical treatment. Clinical assessment with NIHSS and mRS were done at 0, 3, and 6 months, and transracial Doppler (TCD) assessment of ICAS was done at 0 and 3 months after treatment. Results The interventional group had a better clinical outcome with mean NIHSS scores (5.2 ± 4.2, 4.43 ± 4.28 and 3.9 ± 4.7) at baseline, 3 and 6 months, respectively, in comparison to the medical group with mean NIHSS (4.5 ± 4.2, 11.42 ± 6.3, and 8.5 ± 5.1) and better functional outcome with mean mRS scores (1.3 ± 0.96, 1.2 ± 1.13, and 1.0 ± 1.13) at baseline, 3 and 6 months, respectively, in comparison to the medical group (0.84 ± 0.75, 2.28 ± 1.2, and 2 ± 1.24). TCD assessment of ICAS showed a marked reduction of the percentage of stenosis on 3 months of follow-up among the interventional groups (only 5.6% had > 70% stenosis) in comparison to the medical group (85.7% had > 70% stenosis). Recurrent ischemic events on 6 months of follow-up were 16% among interventional groups in comparison to 84% among medical groups. The mortality rate was 8% among interventional groups due to subarachnoid hemorrhages (SAH) related to procedure in comparison to 28% among medical groups secondary to ischemic events. The intraoperative success rate was 96% with the failure of stent deployment in 1 patient due to the tortuous anatomy of vessels. Early post interventional complication rate, i.e, SAH was 8%. Late post interventional restenosis and occlusion rates were 8% on 3 months of follow-up. Conclusion Endovascular stenting of medically refractory ICAS is more efficacious and effective with better clinical and functional outcomes than optimal medical treatment; however, its safety is still debatable. Trial registration Done at ClinicalTrials.gov . Trial ID (NCT Number) NCT04393025 .

中文翻译：

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医学难治性颅内动脉狭窄 (ICAS) 疾病的血管内支架置入术（临床和超声研究）

背景 动脉粥样硬化性颅内动脉狭窄 (ICAS) 是世界范围内最常见的中风原因之一，并且与复发性中风的高风险相关。近期短暂性脑缺血发作 (TIA) 或中风和严重狭窄（颅内大动脉直径的 70% 至 99%）的患者在狭窄动脉区域发生卒中复发的风险特别高（大约 23% 在 1年）尽管接受了治疗。因此，这些患者迫切需要替代疗法。目的 确定血管成形术联合支架植入术治疗难治性 ICAS 的疗效和安全性，并与最佳药物治疗进行比较。受试者和方法 50 名尽管接受药物治疗但仍有症状的 ICAS 患者（即，复发性卒中或 TIA）被纳入一项前瞻性研究，并在该研究中随机分配，其中 25 名患者接受了血管成形术和支架植入术，25 名患者接受了最佳药物治疗。NIHSS 和 mRS 的临床评估在治疗后 0、3 和 6 个月进行，ICAS 的经种族多普勒 (TCD) 评估在治疗后 0 和 3 个月进行。结果干预组在基线、3 个月和 6 个月时的平均 NIHSS 评分分别为（5.2±4.2、4.43±4.28 和 3.9±4.7），与具有平均 NIHSS（4.5±4.2， 11.42 ± 6.3 和 8.5 ± 5.1) 和更好的功能结果，平均 mRS 评分（1.3 ± 0.96、1.2 ± 1.13 和 1.0 ± 1.13）分别在基线、3 和 6 个月，与医疗组 (0.84 ± 0.75、2.28 ± 1.2 和 2 ± 1.24）。ICAS 的 TCD 评估显示，与医疗组（85.7% 的狭窄 > 70%）相比，介入组（只有 5.6% 的狭窄 > 70%）在随访 3 个月时的狭窄百分比显着降低。在 6 个月的随访中，干预组的缺血性事件复发率为 16%，而医疗组为 84%。由于与手术相关的蛛网膜下腔出血 (SAH)，介入组的死亡率为 8%，而继发于缺血性事件的医疗组的死亡率为 28%。术中成功率为96%，1例因血管解剖结构曲折导致支架置入失败。早期介入后并发症发生率，即 SAH 为 8%。在 3 个月的随访中，晚期介入术后再狭窄和闭塞率为 8%。结论 药物难治性ICAS血管内支架置入术比最佳药物治疗更有效、更有效，临床和功能结局更好；然而，它的安全性仍有争议。试验注册在 ClinicalTrials.gov 完成。试用 ID（NCT 编号）NCT04393025。