Hassan Ameer E, Zacharatos Haralabos, Grigoryan Mikayel, Tekle Wondwossen G, Khan Amir, Siddiq Farhan, Rodriguez Gustavo J, Tummala Ramachandra, Jagadeesan Bharathi, Suri M Fareed K, Qureshi Adnan I
Valley Baptist Brain and Spine Network, University of Texas Health Science Center - San Antonio, Harlingen, TX, MN, USA.
Vassar Brothers Medical Center, Poughkeepsie, NY, MN, USA.
Interv Neurol. 2017 Mar;6(1-2):42-48. doi: 10.1159/000452308. Epub 2016 Dec 8.
One-month dual antiplatelet treatment, with aspirin and clopidogrel, following internal carotid artery stent placement is the current standard of care to prevent in-stent thrombosis. Cilostazol, an antiplatelet drug, has been demonstrated to have a safety profile comparable to aspirin and clopidogrel.
To evaluate the safety and clinical efficacy of cilostazol and aspirin therapy following internal carotid artery stent placement up to 1 month postprocedure.
A phase I open-label, nonrandomized two-center prospective study was conducted. All subjects received aspirin (325 mg/day) and cilostazol (200 mg/day) 3 days before extracranial stent placement. Two antiplatelet agents were continued for 1 month postprocedure followed by aspirin daily monotherapy. The primary efficacy end point was the 30-day composite occurrence of death, cerebral infarction, transient ischemic attack, and in-stent thrombosis. The primary safety end point was bleeding.
Twelve subjects (mean age ± SD, 66 ± 12 years; 9 males) were enrolled and underwent internal carotid artery angioplasty and stent placement. None of the subjects who successfully followed the study protocol experienced any complications at the 1- and 3-month follow-ups. One patient had a protocol deviation due to concurrent use of enoxaparin (1 mg/kg twice daily) in addition to aspirin and cilostazol, resulting in a fatal symptomatic intracerebral hemorrhage following successful stent placement on postprocedure day 1. One patient discontinued cilostazol after the first dose secondary to dizziness.
The use of cilostazol and aspirin for internal carotid artery stent placement appears to be safe, but protocol compliance needs to be emphasized.
目前，颈内动脉支架置入术后采用阿司匹林和氯吡格雷进行为期1个月的双重抗血小板治疗是预防支架内血栓形成的标准治疗方案。抗血小板药物西洛他唑已被证明具有与阿司匹林和氯吡格雷相当的安全性。
评估颈内动脉支架置入术后1个月内使用西洛他唑和阿司匹林治疗的安全性和临床疗效。
进行了一项I期开放标签、非随机的两中心前瞻性研究。所有受试者在颅外支架置入术前3天接受阿司匹林（325毫克/天）和西洛他唑（200毫克/天）治疗。术后继续使用两种抗血小板药物1个月，之后改为每日单一使用阿司匹林治疗。主要疗效终点是30天内死亡、脑梗死、短暂性脑缺血发作和支架内血栓形成的复合发生率。主要安全终点是出血。
共纳入12名受试者（平均年龄±标准差，66±12岁；9名男性），并接受了颈内动脉血管成形术和支架置入术。所有成功遵循研究方案的受试者在1个月和3个月随访时均未出现任何并发症。1例患者因除阿司匹林和西洛他唑外还同时使用依诺肝素（1毫克/千克，每日两次）出现方案偏离，导致术后第1天成功置入支架后发生致命性症状性脑出血。1例患者在首剂西洛他唑后因头晕停药。
西洛他唑和阿司匹林用于颈内动脉支架置入术似乎是安全的，但需要强调方案的依从性。
