Department of Neuroradiology, Cantonal Hospital, Aarau, Switzerland.
Department of Neurology, Cantonal Hospital, Aarau, Switzerland.
J Neurointerv Surg. 2018 Dec;10(12):e32. doi: 10.1136/neurintsurg-2017-013699. Epub 2018 Apr 7.
Intracranial atherosclerotic disease is a well-known cause of ischemic stroke. Following the SAMMPRIS trial, medical treatment is favored over stenting. Drug-eluting balloons (DEB) are widely used in coronary angioplasty, showing better results than bare-surface balloons. There is little evidence of DEB employment in intracranial stenosis, especially of paclitaxel-eluted balloons (pDEB). The Neuro Elutax SV (Aachen Resonance) is the first CE certificated pDEB for intracranial use.
To compare pDEB Neuro Elutax SV (ElutaxDEB) with the Wingspan/Gateway stent system (WingspanStent).
A single-center, open-label, retrospective cohort study of 19 patients with symptomatic atherosclerotic intracranial high-grade stenosis treated with either ElutaxDEB or WingspanStent from a tertiary stroke center in Switzerland.
Eight patients (42%) received ElutaxDEB. Median clinical follow-up was 10 months for the WingspanStent and 9.5 months for ElutaxDEB (P=0.36). No differences were found in the clinical baseline characteristics, with a median stenosis grade of 80% for the WingspanStent and 81% for the ElutaxDEB (P=0.87). The compound endpoint 'ischemic re-event and/or restenosis' was significantly lower for ElutaxDEB (13% vs 64%; P=0.03, OR 0.08 (95% CI 0.007 to 0.93; P=0.043) than for the WingspanStent.
The ElutaxDEB may be a promising alternative treatment for patients with symptomatic high-grade intracranial stenosis showing a significantly lower rate of ischemic re-events or restenosis in comparison with the WingspanStent-treated patients with a similar safety profile. Further studies will be needed to definitively elucidate the role of pDEB in the management of symptomatic intracranial high-grade stenosis.
颅内动脉粥样硬化性疾病是缺血性卒中的一个已知病因。在 SAMMPRIS 试验之后，药物治疗优于支架置入。药物洗脱球囊（DEB）在冠状动脉血管成形术中广泛应用，其效果优于普通球囊。在颅内狭窄中，尤其是紫杉醇洗脱球囊（pDEB）的应用，证据很少。Neuro Elutax SV（Aachen Resonance）是首个获得 CE 认证的颅内用紫杉醇洗脱球囊。
比较 pDEBNeuro Elutax SV（ElutaxDEB）与 Wingspan/Gateway 支架系统（WingspanStent）的疗效。
这是一项单中心、开放标签、回顾性队列研究，纳入了瑞士一家三级卒中中心的 19 例症状性动脉粥样硬化性颅内重度狭窄患者，分别接受 ElutaxDEB 或 WingspanStent 治疗。
8 例（42%）患者接受 ElutaxDEB 治疗。WingspanStent 的中位临床随访时间为 10 个月，ElutaxDEB 的中位随访时间为 9.5 个月（P=0.36）。两组的临床基线特征无差异，WingspanStent 的狭窄程度中位数为 80%，ElutaxDEB 的狭窄程度中位数为 81%（P=0.87）。ElutaxDEB 的复合终点“缺血再发事件和/或再狭窄”发生率显著低于 WingspanStent（13% vs 64%；P=0.03，OR 0.08（95%CI 0.007 至 0.93；P=0.043）。
与 WingspanStent 治疗的患者相比，ElutaxDEB 治疗症状性颅内重度狭窄患者可能是一种很有前途的替代治疗方法，其缺血再发事件或再狭窄发生率显著较低，且安全性相当。还需要进一步的研究来明确 pDEB 在治疗症状性颅内重度狭窄中的作用。
