Neurosurgery. 2023 Apr 1;69(Suppl 1):22. doi: 10.1227/neu.0000000000002375_101.
Symptomatic intracranial atherosclerotic disease (sICAD) is estimated to cause over 10% of strokes annually in the US alone. Previous investigations employing stenting, most notably SAMMPRIS trial, have produced unfavorable results in regards to both periprocedural complications and risk of recurrent stroke. However, newer generation balloon-mounted drug-eluting stents (BM-DES) have been hypothesized to harbor several technical advantages that may confer improvements in these critical metrics.
Prospectively maintained databases from eight comprehensive stroke centers were reviewed to identify adult patients undergoing RO-ZES for the treatment of sICAD between January,2019 and December,2021. Only patients that presented with either recurrent stroke or TIA, intracranial stenosis 70-99%, with at least one stroke on best medical management were included. The primary outcome was 30-days composite of stroke, ICH, and/or mortality. A propensity-score matched analyses was performed comparing the results of RO-ZES to the intervention arm of SAMMPRIS.
A total of 132 patients met the inclusion criteria for analysis (mean age:64.2 years). Mean severity of stenosis (±SD) was 81.4% (±11.4%). Four (3.03%) stroke and/or deaths were reported within 30 days in RO-ZES group. A propensity-score matched analysis based on age, HLD, HTN, DMII, and smoking demonstrated a statistically significant decreased risk of 30-day stroke and/or death rate in RO-ZES in comparison to SAMMPRIS (2.6% vs. 15.6%, respectively; OR 6.88, 95% CI 1.92-37.54, p < 0.001).
Patients treated with RO-ZES had a decreased rate of 30-day major complications in comparison to SAMMPRIS. Further large-scale prospective studies are warranted to evaluate the safety and efficacy of RO-ZES for the treatment of sICAD.
在美国,症状性颅内动脉粥样硬化性疾病(sICAD)每年估计导致超过 10%的中风。以前的研究采用支架置入术,特别是 SAMMPRIS 试验,在围手术期并发症和中风复发风险方面都产生了不利结果。然而,新一代球囊载药支架(BM-DES)被认为具有多项技术优势,可能在这些关键指标上有所改善。
从 8 个综合卒中中心的前瞻性维护数据库中回顾性分析了 2019 年 1 月至 2021 年 12 月期间接受 RO-ZES 治疗 sICAD 的成年患者。仅纳入因复发性中风或 TIA、颅内狭窄 70-99%、且在最佳药物治疗下至少有一次中风的患者。主要结局为 30 天内卒中、ICH 和/或死亡率的复合事件。对 RO-ZES 与 SAMMPRIS 干预组的结果进行了倾向评分匹配分析。
共有 132 名患者符合分析纳入标准(平均年龄:64.2 岁)。狭窄程度(平均值±标准差)为 81.4%±11.4%。RO-ZES 组有 4 例(3.03%)在 30 天内发生中风和/或死亡。基于年龄、高胆固醇血症、高血压、2 型糖尿病和吸烟的倾向评分匹配分析显示,与 SAMMPRIS 相比,RO-ZES 治疗组 30 天内中风和/或死亡率的风险显著降低(2.6%对 15.6%;OR 6.88,95%CI 1.92-37.54,p<0.001)。
与 SAMMPRIS 相比,接受 RO-ZES 治疗的患者 30 天内主要并发症发生率较低。需要进一步进行大规模前瞻性研究,以评估 RO-ZES 治疗 sICAD 的安全性和有效性。