冠状动脉支架术后紧急心脏电子器械植入围术期替罗非班桥接治疗的安全性研究

Peri-operative anti-thrombotic safety and efficiency of tirofiban for patients undergoing emergency operation of CIED after implantation of drug-eluting stent

目的探讨冠心病药物洗脱支架植入后正在服用双联抗血小板治疗(DAPT)的患者,紧急心脏电子器械(CIED)植入围术期替罗非班桥接治疗的安全性、可行性。方法本研究采用前瞻性研究方法,将2015年9月至2018年3月在河北大学附属医院连续住院的、冠状动脉药物洗脱支架植入后正在服用DAPT(阿司匹林和氯吡格雷)6个月内,并需紧急CIED植入患者40例,按照随机数字表法分为替罗非班组和DAPT组。替罗非班组20例,CIED植入前5d停用氯吡格雷,以替罗非班0.4μg/(kg·min)静脉泵入30min,然后以0.1μg/(kg·min)持续静脉泵入,术前4h停用,术后12~24h口服负荷剂量氯吡格雷300mg,以后每日75mg口服,阿司匹林100mg每日1次连续服用。DAPT组20例,围术期持续应用DAPT(阿司匹林100mg,氯吡格雷75mg)治疗。替罗非班治疗期间每6~8h复查血细胞分析。围术期连续心电和血压监护,每日常规18导联心电图检查,监测血清肌酸激酶同工酶(CK-MB),观察有无ST段变化及主要心脏不良事件,同时观察手术切口渗血、囊袋血肿及严重出血事件。随访3个月观察主要心脏不良事件及囊袋情况。结果替罗非班组植入双腔起搏器(DDD)18例,单腔起搏器(VVI)1例,植入型心脏复律除颤器(ICD)1例。DAPT组植入DDD17例,VVI2例,ICD1例。替罗非班组平均手术时间为70.3min,住院时间9.7d,与DAPT组比较差异无统计学意义(P>0.05)。随访3个月期间两组各有1例患者出现了心绞痛症状,经门诊调整药物治疗后好转。两组无不明原因死亡、支架内血栓、急性心肌梗死及靶血管重建等主要心脏不良事件发生。替罗非班组较DAPT组总出血发生率(20.0%vs.30.0%,P=0.715)、渗血发生率(15.0%vs.20.0%,P=0.677)、囊袋血肿发生率(5.0%vs.10.0%,P=1.000)降低,但两组比较差异无统计学意义(P>0.05)。结论冠状动脉药物洗脱支架术后正在DAPT治疗的患者,行紧急CIED植入围术期静脉应用替罗非班桥接治疗安全、可行,是临床可选的治疗方案。

Objective To evaluate the peri - operative anti - thrombotic safety and efficiency of tirofiban for patients undergoing emergency operation of cardiovascular implantable electronic devices (CIED) after implantation of drag - eluting stent. Methods A total of 40 patients who having taken dual antiplatelet therapy ( DAPT) drugs ( clopidogrel and aspirin) within 6 month after DES and undergoing emergency implantation of CIED in our department were recruited in this study. All patients were divided into two groups. Tirofiban group (20 cases): Clopidogrel was discontinued 5 days before the operation and instead of tirofiban intravenous infusion of 0. 4 μg/( kg·min) over 30 min, followed by 0. 1 mg /( kg·min). The infusion was stopped 4 h before surgery;clopidogrel was returned using a loading dose of 300 mg and then continued at a once daily dose of 75 mg after CIED implantation 12-24 hours according to the bleeding condition. Asprin was continued throughout the perioperative period. DAPT group (20 cases): continuous aspirin and clopidogrel therapy during perioperative period. Close postoperative monitoring is performed. A 18 - lead ECG was recorded every morning during the CCU stay and 6 h or more after any suspicious symptoms or ECG signs of ischemia. Blood test for CK - MB was collected every day. In the case of an increase in CK - MB levels, further samples were collected at 6 - 8 h intervals until the values had normalized. During the period of tirofiban intravenous infusion, blood routine was checked every 6-8 hour. MACE and pocket hemorrhage were followed up for 3 months. Results There was no significant diflerence in age, gender, disease constitution, type of pacemaker operation time and hospitalization time between the two groups. There were no incidences of death, in - stent thrombosis, repeat myocardial infarction, TVR within 3 months after procedure. The total bleeding rate (20.0% vs. 30.0%, P =0.715), the rate of errhysis ( 15.0% vs. 20.0%, P=0.677) and the incidence of pocket hematoma (5.0% vs. 10.0%, P=1.000). The incidence in tirofiban group were less than those in DAPT group, but there was no signiiicant difference between the two groups( P > 0. 05 ). Conclusion Hie use of tiroGban as bridging therapy undergoing emergency operation of CIED after implantation of drug - eluting stent is safe and efficiency in our small study population.