Hoag Memorial Hospital, Newport Beach, California 92663, USA.
Catheter Cardiovasc Interv. 2010 May 1;75(6):817-22. doi: 10.1002/ccd.22386.
The multicenter EPIC (FiberNet Embolic Protection System in Carotid Artery Stenting Trial) single-arm trial evaluated the 30-day outcomes of a new design concept for embolic protection during carotid artery stenting (CAS).
Embolic protection filters available for use during CAS include fixed and over-the-wire systems that rely on embolic material capture within a "basket" structure. The FiberNet Embolic Protection System (EPS), which features a very low crossing profile, consists of a three-dimensional fiber-based filter distally mounted on a 0.014 inch guidewire with integrated aspiration during filter retrieval.
The trial enrolled 237 patients from 26 centers. Demographics, clinical and lesion characteristics, as well as adverse events through a 30-day follow-up were recorded. The mean age of the patients was 74 years, 64% were male and 20% had symptomatic carotid artery disease.
The combined major adverse event (MAE) rate at 30 days for all death, stroke, and myocardial infarction was 3.0%. There were three major strokes (two ischemic and one hemorrhagic) and two minor strokes (both ischemic) for a 2.1% 30-day stroke rate. The procedural technical success rate was 97.5% and macroscopic evidence of debris was reported in 90.9% of the procedures.
The FiberNet EPS, used with commercially available stents, produced low stroke rates following CAS in high surgical risk patients presenting with carotid artery disease. The unique filter design including aspiration during retrieval may have contributed to the low 30-day stroke rate reported during CAS in patients considered at high risk for complications following carotid endarterectomy (CEA).
多中心 EPIC（纤维网栓塞保护系统在颈动脉支架置入术中的试验）单臂试验评估了一种新的栓塞保护设计概念在颈动脉支架置入术（CAS）中的 30 天结果。
可用于 CAS 的栓塞保护过滤器包括固定和过线系统，这些系统依赖于在“篮”结构内捕获栓塞材料。纤维网栓塞保护系统（EPS）具有非常低的交叉轮廓，由远端安装在 0.014 英寸导丝上的三维纤维滤器组成，在滤器取回过程中集成抽吸。
该试验从 26 个中心招募了 237 名患者。记录了人口统计学、临床和病变特征以及 30 天随访期间的不良事件。患者的平均年龄为 74 岁，64%为男性，20%有症状性颈动脉疾病。
所有死亡、中风和心肌梗死的联合主要不良事件（MAE）发生率为 3.0%。有 3 例大中风（2 例缺血性和 1 例出血性）和 2 例小中风（均为缺血性），30 天中风发生率为 2.1%。手术技术成功率为 97.5%，90.9%的手术报告有碎片的宏观证据。
纤维网 EPS 与市售支架一起使用，在患有颈动脉疾病且手术风险高的患者中，CAS 后中风率较低。独特的滤器设计包括取回过程中的抽吸，可能有助于报告的高风险患者（CEA 后并发症风险高）在 CAS 中 30 天内的低中风率。
