新型生物可降解涂层靶向释放雷帕霉素支架治疗中等复杂冠状动脉病变的长期安全性和有效性：TARGETⅡ研究5年随访结果  

Safety and efficacy of a novel abluminal groove-filled biodegradable polymer sirolimus-eluting stent for the treatment of de novo coronary lesions： 5-year results of the TARGET Ⅱ trial

作　　者：许连军[1] 高展[1] 宋莹[1] 王欢欢[1] 许晶晶[1] 高立建[1] 张茵[1] 宋雷[1] 赵雪燕[1] 陈珏[1] 袁晋青[1] 乔树宾[1] 杨跃进[1] 徐波[1] 高润霖[1] Xu Lianjun;Gao Zhan;Song Ying;Wang Huanhuan;Xu Jingjing;Gao Lijian;Zhang Yin;Song Lei;Zhao Xueyan;Chen Jue;Yuan Jinqing;Qiao Shubin;Yang Yuejin;Xu Bo;Gao Runlin(on behalf of the TARGET II investigators.Department of Cardiology,Fuwai Hospital,Cardiovascular Institute,National Center for Cardiovascular Disease,Chinese Academy of Medical Sciences and Peking Union Medical College,Beiiin~ 100037,China)

机构地区：[1]中国医学科学院北京协和医学院国家心血管病中心阜外医院心内科,100037

出　　处：《中华心血管病杂志》2018年第7期523-528,共6页Chinese Journal of Cardiology

摘　　要：目的评价生物可降解涂层钴铬合金雷帕霉素洗脱支架FIREHAWK治疗中等复杂冠状动脉病变（包括小血管病变、长病变和多支病变）的长期安全性和有效性，并探讨SYNTAX评分对其长期预后的预测价值。方法TARGET Ⅱ研究是一项前瞻性、多中心、单臂临床研究。国内24个医学中心参与，2011年8月至2012年2月期间共入选新发冠状动脉（冠脉）病变患者730例，全部接受FIREHAWK支架治疗。收集患者一般临床资料（包括糖尿病、小血管病变、长病变以及多支病变）。主要终点为靶病变失败（TLF）作为器械源性复合终点，包括心原性死亡、靶血管心肌梗死（TV-MI）及缺血驱动的靶病变血运重建（TLR）。次要终点，其一为患者源性复合终点，包括全因死亡、心肌梗死、随访期再次血运重建；另一个为美国和欧洲学者组成的学术研究联盟（ARC）定义的确定或可能的支架内血栓（包括早期、晚期和极晚期）。对参考血管直径≥1.5 mm的血管中每个〉50%狭窄的病变均进行SYNTAX评分，≤7分为低分、〉7分且≤12分为中分、〉12分为高分。临床随访直至术后5年。采用多因素Cox回归分析不同因素对主要终点的影响。结果本研究共入选患者730例，SYNTAX评分（10.9±6.9）分，完成5年随访的患者683例（93.6%）。发生TLF 58例（8.5%），包括心原性死亡14例（2.0%）、靶血管相关心肌梗死30例（4.4%）、缺血驱动的靶病变血运重建23例（3.4%）。发生患者源性复合终点112例（16.4%），确定或可能的支架内血栓5例（0.7%）。多因素Cox回归分析结果显示糖尿病（HR=1.123,95%CI 0.623~2.026,P=0.699）、小血管病变（HR=0.909,95%CI 0.526~1.570,P=0.732）、长病变（HR=1.561,95%CI 0.922~2.640,P=0.097）以及多支病变（HR=1.062, 95%CI 0.611~1.846,P=0.830）不增加TLF风险，且SYNTAX评分高不增加TLF风险（中分比低分HR=1.203，95%CI 0.607~2.385，PObjectiveThis study sought to evaluate the safety and efficacy of FIREHAWK, a novel abluminal groove-filled biodegradable polymer sirolimus-eluting stent （SES） in patients with moderate-complex coronary lesions （including patients with small vessel disease, long lesion and multi vessel disease）, and to validate the ability of the SYNTAX score （SS） to predict clinical outcomes in patients treated with FIREHAWK stent. MethodsTARGETⅡ was a prospective, multicenter, single-arm clinical trial, a total of 730 patients who underwent percutaneous coronary intervention （PCI） of de novo lesions in native coronary arteries in 24 medical centers in China from August 2011 to February 2012 were enrolled in this study. All patients were exclusively treated with the FIREHAWK stent. Clinical data including patients with diabetes, small vessel disease, long lesion and multi vessel disease were analyzed. The primary composite endpoint was the target lesion failure （TLF） of cardiac death, target vessel-related myocardial infarction （TV-MI）, or target lesion revascularization （TLR）. The secondary composite endpoint was patient-oriented endpoint （PoCE）, a composite of all death, all myocardial in farction （MI）, or any repeat revascularization; definite/probable stent thrombosis （ST） （including acute, late, and very late thrombosis） . SS was calculated in lesions with stenosis more than 50% with coronary artery diameter greater than 1.5 mm. Patients were grouped by tertiles of SS （≤7, 〉7 to ≤12, 〉12）. Follow-up was performed up to 5 years. ResultsA total of 730 patients were enrolled in the TARGET Ⅱ trial. The average SS was 10.9±6.9. 683 （93.6%） patients completed 5-year clinical follow-up. The 5-year incidence of TLF was 8.5%（58/683）. The incidence of TLF components was as follows： cardiac death 2.0%（14/683）, TV-MI 4.4%（30/683）, TLR 3.4%（23/683）. The incidence of PoCE was 16.4%（112/683）. The incidence of definite/probable stent thrombosis was 0.7%�

关 键 词：冠状动脉疾病 生物可降解涂层支架 

分 类 号：R543.3[医药卫生—心血管疾病]