阿加曲班对颅内外支架置入术后再狭窄的影响:前瞻随机对照研究

周露露,徐格林,孙文,等.阿加曲班对颅内外支架置入术后再狭窄的影响:前瞻随机对照研究[J].国际脑血管病杂志,2013,21(4):260-265.

颅内动脉硬化 颈动脉狭窄 血管成形术 支架 抗凝药 抗凝血酶类 阿加曲班 血管造影术 数字减影 危险因素 复发

周露露 徐格林 孙文 刘德志 陈兆耀 蔡乾昆 李敏 熊云云 朱武生

南方医科大学南京临床医学院,南京军区南京总医院神经内科(周露露、徐格林、孙文、刘德志、蔡乾昆、李敏、

2013

万方

目的 探讨阿加曲班对颅内外支架置入术后支架内再狭窄(in-stent restenosis,ISR)的影响.方法 2010年8月至2011年12月实施脑血管支架置入术的140例患者,随机分为阿加曲班组(n=70)和对照组(n=70).阿加曲班组从术前2d至术后3d连续接受阿加曲班静脉滴注治疗(20 mg/d),对照组不接受阿加曲班治疗.6～9个月后住院复查数字减影血管造影(digital subtractionangiography,DSA)评估ISR发生情况,同时比较两组患者的血管事件发生率和影响因素.结果 共131例患者在术后6～9个月时完成DSA或其他影像学复查,两组患者随访率相当(x2 =0.119,P＞0.999).阿加曲班组ISR发生率显著性低于对照组(7.6％对24.6％x2=7.064,P=0.008).阿加曲班组患者围手术期间未出现出血性事件、过敏反应和肝功能障碍.两组患者随访期间的血管事件发生率无显著性差异(x2=0.202,P=0.653).多变量COX回归分析显示,未接受阿加曲班治疗(风险比3.021,95％可信区间1.098 ～8.292；P=0.032)和病变血管部位(风险比2.762,95％可信区间1.065～7.159;P =0.037)是术后9个月内发生ISR的独立危险因素.结论 阿加曲班可能通过抑制血栓形成防止颅内外支架置入术后ISR的发生. Objective To investigate the effect of argatroban on in-stent restenosis (ISR) after extracranial and intracranial stenting,Methods A total of 140 patients who performed cerebrovascular stenting from August 2010 to December 2011 were randomly assigned to either an argatroban group (n =70) or a control goup (n =70).The patients in the argatroban group continuously received argatroban intravenous infusion therapy (20 mg/d)for 2 days before procedure and 3 days after procedure,while those in the control group did not treated with argatroban.The patients were reexamined in the hospital with digital subtraction angiography (DSA) to assess the occurrence of ISR after 6 to 9 months.The vascular event rate and influencing factors of the patients were compared in both groups at the same time.Results A totally 131 patients completed DSA or other imaging reexamination from 6 to 9 months after procedure.The follow-up rate was almost the same in the patients of both goups (x2 =0.119,P ＞0.999).The incidence of ISR in the argatroban group was significantly lower than that in the control group (7.6％ vs.24.6％ ;x2 =7.064,P =0.008).The patients in the argatroban group did not have any ischemic events,allergies,and fiver dysfunction during perioperative period.There were no significant differences in the vascular event rate during the follow-up in the patients of both groups (x2 =0.202,P =0.653).Multivariate Cox regression analysis showed that without receiving argatroban therapy (hazard ratio [HR] 3.021,95％ [CI] 1.098-8.292; P =0.032) and vascular lesion sites (HR 2.762,95％ CI 1.065-7.159; P =0.037) were the independence risk factors for ISR at 9 months after procedure.Conclusions Argatroban may prevent the occurrence of ISR after extracranial and intracranial stenting by the inhibition of thrombosis.