Division of Interventional Neuroradiology, Department of Medical Imaging, Hematology and Oncology, Ribeirão Preto Medical School, University of São Paulo, Ribeirao Preto, São Paulo, Brazil.
Division of Interventional Neuroradiology, Hospital Israelita Albert Einstein, São Paulo, São Paulo, Brazil.
J Neurointerv Surg. 2021 Jul;13(7):647-651. doi: 10.1136/neurintsurg-2020-017262. Epub 2021 Feb 25.
Flow diverters (FDs) are effective in the treatment of carotid aneurysms. Compared with carotid aneurysms, the treatment of distal intracranial aneurysms with FDs has been associated with a relatively high incidence of complications. Low thrombogenic modified-surface FDs may reduce ischemic complications and allow for the use of a single antiplatelet medication. The aim of this study was to assess the safety and efficacy of the p48 MW HPC Flow Modulation Device (Phenox GmbH, Bochum, Germany) to treat distal intracranial aneurysms used in combination with prasugrel monotherapy.
This was a single-center, prospective, pivotal, open, single-arm study. Patients were included in this study from December 2019 to September 2020. The primary endpoints were the incidence of any neurologic deficit after treatment until 1 month of follow-up, defined as National Institutes of Health Stroke Scale (NIHSS) ≥1, and the incidence of acute ischemic lesions in magnetic resonance imagin (MRI) images 48 hours after treatment. The secondary endpoint was the rate of complete occlusion of the aneurysms at the 1-month follow-up.
Twenty-one patients harboring 27 distal aneurysms of the anterior circulation were included. Mean age was 57.8 (SD 9.7) years, and 16 patients were female (80%). No patient had neurologic symptoms at the 1-month follow-up. Four patients (20%) had asymptomatic acute brain ischemic lesions on MRI. Complete aneurysm occlusion occurred in 9/27 (33.3%) aneurysms at the 1-month follow-up.
In this pilot safety trial, treatment of distal intracranial aneurysms with p48 MW HPC under monotherapy with prasugrel appeared to be safe.
血流导向装置（FD）在治疗颈动脉动脉瘤方面具有良好的效果。与颈动脉动脉瘤相比，FD 治疗远端颅内动脉瘤与相对较高的并发症发生率相关。低血栓形成改性表面 FD 可减少缺血性并发症，并允许使用单一抗血小板药物。本研究旨在评估 p48MW HPC 血流调节装置（Phenox GmbH，德国波鸿）联合普拉格雷单药治疗治疗远端颅内动脉瘤的安全性和有效性。
这是一项单中心、前瞻性、关键、开放、单臂研究。本研究于 2019 年 12 月至 2020 年 9 月期间纳入患者。主要终点是治疗后直至 1 个月随访期间任何神经功能缺损的发生率，定义为 NIHSS≥1，以及治疗后 48 小时磁共振成像（MRI）图像上急性缺血性病变的发生率。次要终点是 1 个月随访时动脉瘤完全闭塞的比例。
共纳入 21 例患者，共 27 个前循环远端动脉瘤。平均年龄为 57.8（SD 9.7）岁，16 例为女性（80%）。1 个月随访时无患者出现神经症状。4 例（20%）患者 MRI 上有无症状急性脑缺血性病变。27 个动脉瘤中，1 个月随访时完全闭塞的动脉瘤有 9 个（33.3%）。
在本初步安全性试验中，p48MW HPC 在普拉格雷单药治疗下治疗远端颅内动脉瘤似乎是安全的。
