Purpose

Intracranial atherosclerosis disease (ICAD) is an essential cause of stroke. The characteristics of effective treatment include low periprocedural risk and a sustained treatment effect. Angioplasty with a conventional balloon for ICAD is safe but has a dauntingly high restenosis rate. Drug-coated balloon (DCB) angioplasty might reduce the risk of restenosis while maintaining the overall safety of the procedure.

Methods

This study included symptomatic ICAD patients with more than 70% stenosis. Intermediate catheters were placed distally, and the lesions were predilated with a conventional balloon, followed by a DCB (SeQuent Please, B Braun, Melsungen, Germany). The primary endpoint was any stroke or death within 30 days or ipsilateral ischemic stroke thereafter. The secondary endpoint was arterial restenosis of more than 50% during follow-up.

Results

A total of 39 sessions of DCB angioplasty were performed for 39 lesions in 35 patients between October 2015 and April 2018 in a single center. All of the DCBs could be navigated to the lesions. Major periprocedural complications were noted in two patients (5.7%, 2/35), and minor periprocedural complications were also noted in two patients (5.7%, 2/35). The average percentages of stenosis of the lesions were 76.6% ± 7% before treatment, 32.4% ± 11.2% after DCB angioplasty, and 25% ± 16% at follow-up. Stenosis over 50% was present in 3 lesions during the follow-up period (8.3%, 3/36).

Conclusion

In this study, the application of DCBs to treat ICAD patients was feasible and safe. A larger scale clinical trial is warranted to further evaluate the safety and efficacy of this treatment.

中文翻译：

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不遗余力：用药物涂层球囊血管成形术治疗颅内动脉粥样硬化疾病。

目的

颅内动脉粥样硬化疾病（ICAD）是中风的重要原因。有效治疗的特点包括围手术期风险低和治疗效果持续。用于 ICAD 的传统球囊血管成形术是安全的，但再狭窄率非常高。药物涂层球囊 (DCB) 血管成形术可能会降低再狭窄的风险，同时保持手术的整体安全性。

方法

该研究包括狭窄超过 70% 的有症状的 ICAD 患者。中间导管放置在远端，病灶用常规球囊预扩张，然后是 DCB（SeQuent Please, B Braun, Melsungen, Germany）。主要终点是 30 天内的任何中风或死亡或此后的同侧缺血性中风。次要终点是随访期间动脉再狭窄超过 50%。

结果

2015 年 10 月至 2018 年 4 月，在一个中心对 35 名患者的 39 个病灶进行了 39 次 DCB 血管成形术。所有的 DCB 都可以导航到病灶。两名患者（5.7%，2/35）出现了严重的围手术期并发症，两名患者（5.7%，2/35）也出现了轻微的围手术期并发症。治疗前病变狭窄的平均百分比为 76.6%±7%，DCB 血管成形术后为 32.4%±11.2%，随访时为 25%±16%。随访期间 3 个病灶的狭窄超过 50%（8.3%，3/36）。

结论

在本研究中，应用 DCBs 治疗 ICAD 患者是可行且安全的。需要进行更大规模的临床试验以进一步评估这种治疗的安全性和有效性。