Objective. To compare the safety and efficacy between the SpiderFX EPD and Emboshield NAV6 filter in the collection of embolic debris created from lower limb atherectomy procedures in patients with PAD. Materials and Methods. Between January 2014 and October 2015, 507 patients with symptomatic peripheral artery disease were treated with directional atherectomy (SilverHawk), rotational atherectomy (JetStream), or laser atherectomy (Turbo Elite) based on operator discretion. Emboshield NAV6 (n = 161) and SpiderFX (n = 346) embolic protection devices were used with each of the 3 atherectomy devices. The primary study endpoint was 30-day freedom from major adverse events (MAEs). An MAE was defined as death, MI, TVR, thrombosis, dissection, distal embolization, perforation at the level of the filter, and unplanned amputation. A descriptive comparison of the MAE rates between Emboshield NAV6 and SpiderFX embolic protection devices was conducted. Results. The freedom from major adverse event (MAE) rate was 92.0% (CI: 86.7%, 95.7%) in patients who received an Emboshield NAV6 filter compared to 91.6% (CI: 88.2%, 94.3%) in patients who received the SpiderFX filter (). The lower limit of 86.7% freedom from major adverse event rate in the Emboshield NAV6 group was above the performance goal of 83% (). Conclusions. There were no significant clinical outcome differences between Emboshield NAV6 and SpiderFX EPD filters in the treatment of lower extremities. This evaluation indicates the safety and efficacy to use either filter device to treat PAD patients with lower extremity lesions.

中文翻译：

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NAV6栓塞保护过滤器和SpiderFX EPD过滤器在股浅动脉病变中的比较分析

目标。比较 SpiderFX EPD 和 Emboshield NAV6 过滤器在收集 PAD 患者下肢斑块切除术产生的栓塞碎片方面的安全性和有效性。材料和方法。2014 年 1 月至 2015 年 10 月期间，507 名有症状的外周动脉疾病患者接受了定向旋切术 (SilverHawk)、旋切术 (JetStream) 或激光旋切术 (Turbo Elite) 的治疗。Emboshield NAV6 ( n  = 161) 和 SpiderFX ( n = 346) 栓塞保护装置与 3 个旋磨设备中的每一个一起使用。主要研究终点是 30 天无主要不良事件 (MAE)。MAE 被定义为死亡、MI、TVR、血栓形成、夹层、远端栓塞、过滤器水平穿孔和计划外截肢。对 Emboshield NAV6 和 SpiderFX 栓塞保护装置之间的 MAE 率进行了描述性比较。结果。接受 Emboshield NAV6 过滤器的患者无主要不良事件 (MAE) 率为 92.0%（CI：86.7%，95.7%），而接受 SpiderFX 过滤器的患者为 91.6%（CI：88.2%，94.3%） (）。Emboshield NAV6 组中 86.7% 的主要不良事件发生率的下限高于 83% 的性能目标（）。 结论。Emboshield NAV6 和 SpiderFX EPD 过滤器在治疗下肢时没有显着的临床结果差异。该评估表明使用任一过滤装置治疗具有下肢病变的 PAD 患者的安全性和有效性。