Sirignano Pasqualino, Stabile Eugenio, Mansour Wassim, Capoccia Laura, Faccenna Federico, Intrieri Francesco, Ferri Michelangelo, Saccà Salvatore, Sponza Massimo, Mortola Paolo, Ronchey Sonia, Grillo Placido, Chiappa Roberto, Losa Sergio, Setacci Francesco, Pirrelli Stefano, Taurino Maurizio, Ruffino Maria Antonella, Udini Marco, Palombo Domenico, Ippoliti Arnaldo, Montelione Nunzio, Setacci Carlo, de Donato Gianmarco, Ruggeri Massimo, Speziale Francesco
Vascular and Endovascular Surgery Unit, Department of Surgery Paride Stefanini, Sapienza University of Rome, Rome, Italy.
Division of Cardiology, Department of Advanced Biomedical Sciences, University Federico II, Naples, Italy.
JACC Cardiovasc Interv. 2020 Sep 28;13(18):2170-2177. doi: 10.1016/j.jcin.2020.05.026. Epub 2020 Aug 26.
This study sought to evaluate 30-day safety and efficacy of dual-layer mesh-covered carotid stent systems for carotid artery stenting (CAS) in the clinical practice.
When compared with carotid endarterectomy, CAS has been associated with a higher rate of post procedural neurologic events; these could be related to plaque's debris prolapsing through stent's mesh. Consequently, the need for increased plaque coverage has resulted in the development of dual-layer mesh-covered carotid stent systems.
From January 2017 to June 2019, a physician-initiated, prospective, multispecialty registry enrolled 733 consecutive patients undergoing CAS using the CGuard embolic prevention system in 20 centers. The primary endpoint was stroke up to 30 days; secondary endpoints were technical and procedural success; external carotid artery occlusion; and in-hospital and 30-day transient ischemic attack (TIA), acute myocardial infarction (AMI), and death rates.
Symptoms were present in 131 (17.87%) patients. An embolic protection device was used in 731 (99.72%) patients. Procedural success was 100%, technical success was obtained in all but 1 (99.86%) patient, who died in hospital due to a hemorrhagic stroke. Six TIAs, 2 minor strokes, and 1 AMI occurred during in-hospital stay, and external carotid artery occlusion was evident in 8 (1.09%) patients. Between hospital discharge and 30-day follow-up, 2 TIAs, 1 minor stroke, and 3 AMIs occurred. Therefore, the cumulative stroke rate was 0.54%.
This real-world registry suggests that use of CGuard embolic prevention system in clinical practice is safe and associated with a minimal occurrence of adverse neurological events up to 30-day follow-up.
本研究旨在评估在临床实践中双层网孔覆盖颈动脉支架系统用于颈动脉支架置入术（CAS）的30天安全性和有效性。
与颈动脉内膜切除术相比，CAS术后神经事件发生率较高；这些可能与斑块碎片通过支架网孔脱垂有关。因此，对增加斑块覆盖的需求促使了双层网孔覆盖颈动脉支架系统的研发。
2017年1月至2019年6月，一项由医生发起的前瞻性多专业注册研究纳入了20个中心连续733例行CAS并使用CGuard栓塞预防系统的患者。主要终点是30天内的卒中；次要终点是技术和手术成功、颈外动脉闭塞以及住院期间和30天内的短暂性脑缺血发作（TIA）、急性心肌梗死（AMI）和死亡率。
131例（17.87%）患者有症状。731例（99.72%）患者使用了栓塞保护装置。手术成功率为100%，除1例（99.86%）患者外均获得技术成功，该例患者因出血性卒中在医院死亡。住院期间发生6次TIA、2次轻度卒中及1次AMI，8例（1.09%）患者出现颈外动脉闭塞。出院至30天随访期间，发生2次TIA、1次轻度卒中和3次AMI。因此，累积卒中发生率为0.54%。
这项真实世界注册研究表明，在临床实践中使用CGuard栓塞预防系统是安全的，且在30天随访期间不良神经事件发生率极低。
