Novel completed biodegradable polymer sirolimus-eluting stent versus durable polymer sirolimus-eluting stent in de novo lesions： nine-month angiographic and three-year clinical outcomes of HOPE trial  

作　　者：Yuan Fei Chen Xin Song Xiantao Wang Dongqi Zhang Zheng Li Weimin Li Zhanquan Li Hui Chen Xinyi Huo Yong Wang Lefeng Lu Caiyi Lu Qinghua Xu Bo Li Wei Lyu Shuzheng 

机构地区：[1]Capital Med Univ, Dept Cardiol, Beijing Anzhen Hosp, Beijing 100029, Peoples R China [2]Xi An Jiao Tong Univ, Dept Cardiol, Affiliated Hosp 1, Xian 710061, Shaanxi, Peoples R China [3]Lanzhou Univ, Dept Cardiol, Affiliated Hosp 1, Lanzhou 730000, Gansu, Peoples R China [4]Harbin Med Univ, Dept Cardiol, Affiliated Hosp 1, Harbin 150001, Heilongjiang, Peoples R China [5]Peoples Hosp Liaoning Prov, Dept Cardiol, Shenyang 110016, Liaoning, Peoples R China [6]Gen Hosp Daqing Oilfield, Dept Cardiol, Daqing 163411, Heilongjiang, Peoples R China [7]Peoples Hosp Shaanxi Prov, Dept Cardiol, Xian 710068, Shaanxi, Peoples R China [8]Peking Univ, Dept Cardiol, Hosp 1, Beijing 100044, Peoples R China [9]Capital Med Univ, Dept Cardiol, Chaoyang Hosp, Being 100020, Peoples R China [10]Chinese Peoples Liberat Army Gen Hosp, Dept Cardiol, Beijing 100853, Peoples R China [11]Shandong Univ, Dept Cardiol, Hosp 2, Jinan 250033, Shandong, Peoples R China [12]Chinese Acad Med Sci, Cardiac Catheterizat Lab, Cardiovasc Inst, Beijing 100037, Peoples R China [13]Chinese Acad Med Sci, Fuwai Hosp, Beijing 100037, Peoples R China [14]Peking Union Med Coll, Beijing 100037, Peoples R China [15]Natl Ctr Cardiovasc Dis China, Beijing 100037, Peoples R China

出　　处：《Chinese Medical Journal》2014年第14期2561-2566,共6页中华医学杂志（英文版）

摘　　要：Background Drug-eluting stents（DES） with durable polymer have significantly reduced restenosis and target vessel revascularization compared with bare metal stents. Durable polymer has been linked with persistent inflammation of vessel wall and delayed endothelial healing that may increase the risk of late and very late stent thrombosis. This study sought to evaluate the efficacy and safety of HELLOS completed biodegradable polymer sirolimus-eluting stent （SES） in de novo coronary lesions.Methods Totally, 287 patients with one or two de novo coronary lesions （lesion length ≤38 mm and reference vessel diameter 2.5-4.0 mm） were enrolled in the HOPE study, a prospective, multicenter, randomized, non-inferiority trial. Patients were randomized to treatment either with HELIOS completed biodegradable polymer SES （n=142） or PARTNER durable polymer SES （n=145）. The primary endpoint was angiographic in-stent late lumen loss （LLL） at 9-month follow-up. The secondary endpoint included stent thrombosis and major adverse cardiac events including cardiac death, myocardial infarction （MI） and target lesion revascularization （TLR）.Results The 9-month in-stent LLL in the HELIOS group was similar to the PARTNER group, （0.16±0.22） mm vs. （0.19±0.30） mm （P=0.28）. The difference and 95% confidence interval were -0.03 （-0.09, 0.04）, and the P value for non-inferiority 〈0.01. Major adverse cardiovascular event （MACE） occurred in 7.9% vs. 8.2%, MI in 2.4% vs. 3.0%, TLR in 5.5% vs. 3.0%, and stent thrombosis in 0 vs. 1.5%; and events were comparable between the HELIOS group and PARTNER aroup at three-year follow-up （all P 〉0.05）. The three-year cardiac death was lower in the HELIOS group, butwith no significant difference, 0 vs. 3.0% （P=0.12）. Conclusions In the HOPE trial, the novel completed biodegradable polymer SES HELIOS was non-inferior to the durable polymer SES PARTNER with respect to nine-month in-stent LLL in de novo coronary lesions. The incidence of other clinBackground Drug-eluting stents（DES） with durable polymer have significantly reduced restenosis and target vessel revascularization compared with bare metal stents. Durable polymer has been linked with persistent inflammation of vessel wall and delayed endothelial healing that may increase the risk of late and very late stent thrombosis. This study sought to evaluate the efficacy and safety of HELLOS completed biodegradable polymer sirolimus-eluting stent （SES） in de novo coronary lesions.Methods Totally, 287 patients with one or two de novo coronary lesions （lesion length ≤38 mm and reference vessel diameter 2.5-4.0 mm） were enrolled in the HOPE study, a prospective, multicenter, randomized, non-inferiority trial. Patients were randomized to treatment either with HELIOS completed biodegradable polymer SES （n=142） or PARTNER durable polymer SES （n=145）. The primary endpoint was angiographic in-stent late lumen loss （LLL） at 9-month follow-up. The secondary endpoint included stent thrombosis and major adverse cardiac events including cardiac death, myocardial infarction （MI） and target lesion revascularization （TLR）.Results The 9-month in-stent LLL in the HELIOS group was similar to the PARTNER group, （0.16±0.22） mm vs. （0.19±0.30） mm （P=0.28）. The difference and 95% confidence interval were -0.03 （-0.09, 0.04）, and the P value for non-inferiority 〈0.01. Major adverse cardiovascular event （MACE） occurred in 7.9% vs. 8.2%, MI in 2.4% vs. 3.0%, TLR in 5.5% vs. 3.0%, and stent thrombosis in 0 vs. 1.5%; and events were comparable between the HELIOS group and PARTNER aroup at three-year follow-up （all P 〉0.05）. The three-year cardiac death was lower in the HELIOS group, butwith no significant difference, 0 vs. 3.0% （P=0.12）. Conclusions In the HOPE trial, the novel completed biodegradable polymer SES HELIOS was non-inferior to the durable polymer SES PARTNER with respect to nine-month in-stent LLL in de novo coronary lesions. The incidence of other clin

关 键 词：biodegradable polymer titanium oxides films drug-eluting stents 

分 类 号：TQ317[化学工程—高聚物工业] TD353.2[矿业工程—矿井建设]