阿加曲班在椎动脉狭窄患者支架置入术中的安全性及对再狭窄的影响

Safety of argatroban in vertebral artery stenting and its effect on postoperative restenosis in patients with vertebral artery stenosis

目的探讨阿加曲班在椎动脉支架置入术中的安全性及对术后再狭窄的影响。方法前瞻性纳入2013年1月至2017年9月东部战区总医院神经内科行椎动脉支架置入术的患者,利用随机数字表法分为阿加曲班和肝素组。阿加曲班组术中接受阿加曲班抗凝治疗,术后连续使用5 d;肝素组在介入手术中进行肝素抗凝,术后使用生理盐水作为安慰剂。术后1、3和6个月时进行临床随访,术后6个月时行数字减影血管造影、CT血管造影或磁共振血管造影检查评估治疗血管的再狭窄。主要终点事件包括术中安全性、术后支架内再狭窄以及随访期间出现的任何临床事件,包括卒中、心血管事件和死亡。主要安全性事件包括各器官出血、过敏反应、肝功能障碍及栓塞事件。采用Kaplan-Meier生存曲线评估随访期间血管事件发生率。结果共105例患者纳入分析,阿加曲班组53例,肝素组52例。两组围手术期间均未发生出血性事件、过敏反应、肝功能障碍及栓塞事件。两组术前椎动脉狭窄程度、术后残余狭窄程度以及术后6个月狭窄程度差异均无统计学意义,但阿加曲班组术后6个月支架内新增狭窄程度显著低于肝素组(13.56%±26.41%对4.25%±15.76%;P=0.031)。两组长期随访期间卒中复发率(P=1.000)及临床事件发生率(P=0.739)差异均无统计学意义。结论在椎动脉支架置入术中使用阿加曲班抗凝治疗是安全的,术后连续使用阿加曲班抗凝可有效降低术后6个月时的新增支架内狭窄程度。

Objective To investigate the safety of argatroban in vertebral artery stenting and its effect on postoperative restenosis.Methods From January 2013 to September 2017,patients undergoing vertebral artery stenting in the Department of Neurology,Jinling Hospital were enrolled prospectively.They were divided into agatraban group and heparin group by random number table method.The argatroban group received argatroban anticoagulation during the procedure,and was continuously used for 5 d after procedure;while the heparin group underwent heparin anticoagulation during the procedure,and used saline as placebo after procedure.Clinical follow-up was performed at 1,3,and 6 months after procedure.Digital subtraction angiography,CT angiography,or magnetic resonance angiography were performed at 6 months to evaluate the restenosis of the treated blood vessels.The primary endpoints included intraoperative safety,in-stent restenosis after procedure,and any clinical events that occurred during the follow-up period,including stroke,cardiovascular events,and death.Major safety events included bleeding from various organs,allergic reactions,liver dysfunction,and embolism events.Kaplan-Meier survival curve was used to evaluate the incidence of vascular events during the follow-up period.Results A total of 105 patients were enrolled in the analysis,including 53 in the argatroban group and 52 in the heparin group.During the periprocedural period,no hemorrhagic events,allergic reactions,liver dysfunction or embolism events occurred in both groups.There were no significant differences in preoperative vertebral artery stenosis degree,postoperative residual stenosis degree,and stenosis degree at 6 months after procedure between the two groups,but the increase of stent stenosis at 6 months after procedure in the agatroban group was significantly lower than that in the heparin group(13.56%±26.41%vs.4.25%±15.76%;P=0.031).There was no significant difference in the incidence of stroke recurrence(P=1.000)and clinical events(P=0.739)between the two groups during the long-term follow-up period.Conclusions It is safe to use agatraban anticoagulant therapy in the vertebral artery stenting.Continuous use of agatraban anticoagulation after procedure may effectively reduce the increase of stent stenosis at 6 months after procedure.