全降解涂层雷帕霉素药物洗脱冠状动脉支架治疗急性冠脉综合征的疗效及安全性研究

Safety and Efficacy of Biodegradable Polymer-based Rapamycin-eluting Stent in Treatment of Acute Coronary Syndrome

目的研究全降解涂层雷帕霉素药物洗脱冠状动脉支架(TIVOLI支架)治疗急性冠脉综合征的疗效及安全性。方法选择我院收治的80例急性冠脉综合征且行冠状动脉造影检查的患者,根据置入支架类型分为TIVOLI组和EXCEL组,并行冠状动脉介入治疗(PCI)。跟踪随访6个月,观察两组主要心脏不良事件(MACE)及支架内再狭窄发生情况。结果两组患者均成功实施PCI治疗并配合临床随访,其中TIVOLI组2例患者随访3个月时因外科手术退出随访,EXCEL组1例患者术后3d心源性死亡退出随访,其余均完成了随访。两组患者MACE的发生率分别为7.5%及5.0%,差异无统计学意义(P>0.05)。结论 TIVOLI支架治疗急性冠脉综合征患者疗效及安全性与EXCEL支架无明显差异。

Objective To evaluate the safety and efficacy of biodegradable polymer - based rapamycm - eluting stent （TIVOLI stent） in treatment of acute coronary syndrome by the way of contrast. Methods 80 acute coronary syndrome patients received coronary angiogram and percutaneous coronary intervention, according to stent type is divided into TIVOLI group and EXCEL group, and percutaneous coronary intervention （PCI）. Clinical follow - up was performed for 6 months, the in - sent thrombosis, major adverse cardiac event （MACE） and so on were assessed. Results Two groups of patients were successfully treated with PCI and clinical follow - up, including 2 cases of TIVOLI group patients were followed up for 3 months after surgical operation from the follow - up, EXCEL group of 1 patients with postoperative 3d cardiac death out of follow - up, the rest were completed the follow - up. In two group the incidences of major adverse cardiac events were 7.5% and 5.0% （ P 〉 0. 05 ） during 6 months, there was no significant difference （ P 〉 0. 05 ）. Conclusion Syndrome curative effect and safety of stents with EXCEL had no significant difference of TIVOLI stent in the treatment of acute coronary artery.