XIENCE Xpedition依维莫司洗脱支架在真实世界患者中的安全性:XIENCE Epedition China研究2年随访  

Safety of XIENCE Xpedition Everolimus Eluting Stents in Real-World Patients:Two-year Data from of XIENCE Xpedition China Study

作　　者：刘圣文[1] 姜铁民 杜志明[3] 陈辉[4] 李永军[5] 乔树宾[1] LIU Sheng-wen;JIANG Tie-min;DU Zhi-ming;CHEN Hui;LI Yong-jun;QIAO Shu-bin(Department of Cardiology,Fuwai Hospital,National Center for Cardiovascular Diseases China,Chinese Academy of Medical Sciences&Peking Union Medical College,Beijing 100037,China;Department of Cardiology,The Third Medical Center of PLA General Hospital,Beijing 100039,China;Department of Cardiology,The First Affiliated Hospital of Zhongshan University,Guangzhou 510080,China;Department of Cardiology,Beijing Friendship Hospital,Capital Medical University,Beijing 100050,China;Department of Cardiology,The Second Hospital of Hebei Medical University,Shijiazhuang 050000,China)

机构地区：[1]国家心血管病研究中心中国医学科学院北京协和医学院阜外医院心内科,北京市100037 [2]中国人民解放军总医院第三医学中心心内科,北京市100039 [3]中山大学第一附属医院心内科,广州市510080 [4]首都医科大学北京友谊医院心内科,北京市100050 [5]河北医科大学第二医院心内科,石家庄市050000

出　　处：《中国分子心脏病学杂志》2021年第1期3678-3681,共4页Molecular Cardiology of China

摘　　要：目的XIENCE Xpedition China(XIENCE Expedition Everolimus洗脱冠状动脉支架系统批准上市后研究)旨在评估依维莫司洗脱冠状动脉支架系统(EECSS)在真实世界患者中的安全性和有效性。方法XIENCE Expedition China试验是前瞻性、多中心、真实世界的单臂注册研究。共有2199例未经选择的患者接受EECSS治疗。主要终点事件为学术研究协会(ARC)定义的支架血栓(ST)。其他联合终点事件为心源性死亡或心肌梗死,主要心血管不良事件(MACE,包括死亡、心肌梗死和靶病变血管重建),靶病变失败(TLF,包括心源性死亡、靶血管心肌梗死和靶病变血运重建)。结果仅1例患者出现ARC明确和可能的亚急性支架血栓事件。2年随访未出现额外的晚期和晚期支架血栓形成,心源性死亡或任何心肌梗死、MACE和TLF的发生率分别为1.0%、1.4%和1.3%。结论XIENCE Expedition China试验证实EECSS在中国患者具有良好的安全性。Objective To evaluate the safety and efficacy of Everolimus Eluting Coronary Stent System(EECSS)in a cohort of real-world patients by the XIENCE Xpedition China(XIENCE Xpedition Everolimus Eluting Coronary Stent System Condition of-Approval PostMarket study).Methods The XIENCE Xpedition China trial was a prospective,multicenter,real-world,single-arm registry.Totally,2199 consecutive unselected patients treated exclusively with EECSS were enrolled.The primary endpoint was stent thrombosis(ST)defined by Academic Research Consortium(ARC).The co-primary endpoints were the composite of cardiac death and myocardial infarction,major adverse cardiovascular events(MACE)(the composite of death or myocardial infarction or target lesion revascularization),target lesion failure(TLF)(the composite of cardiac death or target vessel myocardial infarction or target lesion revascularization).Results Only one case of ARCdefined definite and probable sub-acute ST event was reported.No additional late and very late stent thrombosis was observed through a 2-year follow up.The composite endpoint of cardiac death and any myocardial infarction,MACE and TLF was 1.0%,1.4%,and 1.3%at 2 years,respectively.Conclusion Associated with very low clinical events,the use of XIENCE Xpedition in real world China patients demonstrated the safety of the new EECSS in the clinical practice.

关 键 词：冠状动脉疾病 药物涂层支架 依维莫司 

分 类 号：R541.4[医药卫生—心血管疾病]