药物涂层球囊治疗颅内动脉粥样硬化性狭窄的安全性和有效性研究

Study on the Safety and Efficacy of Drug-Coated Balloons in the Treatment of Intracranial Atherosclerotic Stenosis

摘要: 目的：通过研究药物涂层球囊治疗颅内动脉粥样硬化性狭窄的安全性和有效性，为颅内动脉粥样硬化狭窄介入治疗探索更优化方案。方法：本研究收集了青岛大学附属医院神经介入科2019~2023年间符合本研究入排标准的颅内动脉狭窄药物涂层球囊(DCB)成形术患者53例，并匹配同期采用常规裸金属支架(BMS)成形术患者61例。回顾性分析了两组间在围手术期安全性、卒中复发以及再狭窄和管腔变化方面的差异。结果：DCB组和BMS组基线资料、围手术期并发症、术前狭窄率、术后1年卒中或死亡发生率方面均无统计学差异(P > 0.05)。DCB组靶血管术后残余狭窄20 (10%~20%)大于BMS组靶血管术后残余狭窄10 (10%~20%)，差异有统计学意义(P = 0.005)。但是DCB组的再狭窄率7.5% (4/53)小于BMS组再狭窄率24.6% (15/61)，差异具有统计学意义(P = 0.013)。症状性再狭窄无统计学差异(P > 0.05)。DCB组随访中狭窄程度10 (10%~27.5%)也优于BMS组的20 (10%~45%)，差异有统计学意义(P = 0.037)。DCB组管腔丢失率0 (−10%⁓10%)小于BMS组的5 (0%⁓32.5%)，差异有统计学意义(P = 0.001)。结论：在颅内动脉粥样硬化性狭窄的介入治疗中，药物涂层球囊与传统裸金属支架相比，可以更好地减少管腔丢失，降低靶血管再狭窄率，可能是一种安全有效的替代方案。

Abstract: Objective: By investigating the safety and efficacy of drug-coated balloons in the treatment of intracranial atherosclerotic stenosis, this study aims to explore more optimized strategies for the interventional management of intracranial atherosclerotic stenosis. Methods: This study collected 53 patients with drug-coated balloon ( DCB ) angioplasty for intracranial artery stenosis who met the inclusion criteria of this study from 2019 to 2023 in the Department of Neurointervention, Affiliated Hospital of Qingdao University, and matched 61 patients with conventional bare metal stent ( BMS ) angioplasty during the same period. The differences between the two groups were compared in terms of perioperative safety, stroke recurrence, restenosis rates, and changes in lumen diameter. Results: There were no statistically significant differences between the DCB group and the BMS group in baseline characteristics, perioperative complications, preoperative stenosis rates, or the incidence of stroke or death at one year postoperatively (P > 0.05). The residual stenosis of the target vessel in the DCB group was 20% (10%~20%), which was significantly higher than that in the BMS group at 10% (10%~20%) (P = 0.005). However, the restenosis rate in the DCB group was 7.5% (4/53), significantly lower than that in the BMS group at 24.6% (15/61) (P = 0.013). No statistically significant difference was observed in symptomatic restenosis between the two groups (P > 0.05). During follow-up, the degree of stenosis in the DCB group was 10% (10%~27.5%), which was significantly better than that in the BMS group at 20% (10%~45%) (P = 0.037). Additionally, the lumen loss rate in the DCB group was 0% (−10%⁓10%), significantly lower than that in the BMS group at 5% (0%⁓32.5%) (P = 0.001). Conclusion: In the interventional treatment of intracranial atherosclerotic stenosis, drug-coated balloons (DCBs) may serve as a safe and effective alternative to conventional bare-metal stents (BMS), as they demonstrate superior outcomes in reducing lumen loss and lowering the restenosis rate of target vessels.