Department of Angiology, Sankt Gertrauden Krankenhaus GmbH, Berlin, Germany.
Department of Cardiology, Medical Care Center Prof. Mathey, Prof. Schofer, Hamburg, Germany.
JACC Cardiovasc Interv. 2019 Feb 25;12(4):395-403. doi: 10.1016/j.jcin.2018.11.039.
This study evaluated the safety and performance of the Paladin System, a novel angioplasty balloon with an integrated embolic protection filter designed to increase embolic protection during post-dilation.
The risk of major adverse events during carotid artery stenting (CAS) is equivalent to carotid endarterectomy. However, the risk of minor stroke remains higher with CAS. Much of this risk occurs during post-stent dilation.
A total of 106 patients were enrolled in 5 centers in Germany. The study's primary endpoint was all-cause death, myocardial infarction, and stroke at 30 days post-procedure. Pre- and post-procedural diffusion-weighted magnetic resonance imaging evaluated new ischemic lesions in 30 subjects. Filter histomorphometric analysis was performed in 23 patients. Retrospective analyses compared outcome rates to historical controls.
Device and procedural success rates were 100%. The combined major adverse event rate (death, myocardial infarction, and stroke) at discharge and at 30 days was 0% and 1.0%, respectively. The single adverse event was a stroke, which occurred at day 12 and was believed unrelated to the device or procedure. New ischemic lesions were found in 11 (36.7%) patients in the diffusion-weighted magnetic resonance imaging subset. New ipsilateral lesions were seen in 9 (30.0%) patients. Mean lesion volume per patient was 0.010 cm. Debris was present in all filters, and approximately 90% of captured particles were <100 μm.
Use of the Paladin System for post-stent dilation during CAS appears safe, and it may effectively decrease the number of embolic particles reaching the brain, which may help reduce the risk of procedure-related stroke. (A Multi-Center Study to Evaluate Acute Safety and Clinical Performance of Paladin® Carotid Post-Dilation Balloon System With Integrated Embolic Protection; NCT02501148).
本研究评估了 Paladin 系统的安全性和性能，这是一种新型的血管成形球囊，带有集成的栓塞保护滤网，旨在增加后扩张期间的栓塞保护。
颈动脉支架置入术 (CAS) 的主要不良事件风险与颈动脉内膜切除术相当。然而，CAS 后的中风风险仍然较高。其中大部分风险发生在后支架扩张期间。
共纳入德国 5 个中心的 106 例患者。该研究的主要终点是术后 30 天的全因死亡、心肌梗死和中风。30 例患者的术前和术后弥散加权磁共振成像评估新的缺血性病变。23 例患者进行了滤网组织形态学分析。回顾性分析将结果与历史对照进行比较。
器械和手术成功率均为 100%。出院时和 30 天时联合主要不良事件发生率（死亡、心肌梗死和中风）分别为 0%和 1.0%。唯一的不良事件是中风，发生在第 12 天，据信与器械或手术无关。在弥散加权磁共振成像亚组中，11 例患者（36.7%）发现新的缺血性病变。9 例患者（30.0%）出现同侧新病变。每位患者的平均病变体积为 0.010 cm。所有滤网中均有碎片存在，约 90%的捕获颗粒小于 100 μm。
在 CAS 中使用 Paladin 系统进行后支架扩张似乎是安全的，它可能有效地减少到达大脑的栓塞颗粒数量，从而有助于降低与手术相关的中风风险。（一项多中心研究，评价 Paladin®颈动脉后扩张球囊系统与集成栓塞保护的急性安全性和临床性能；NCT02501148）。
