title: 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.
abstract: 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 HELIOS 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 group at three-year follow-up (all P > 0.05). The three-year cardiac death was lower in the HELIOS group, but with 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 clinical endpoints was low for both of the stents in three-year follow-up.
authors.affiliation: Department of Cardiology, Beijing Anzhen Hospital, Capital Medical University, Beijing 100029, China.
authors.forename: Fei
authors.initials: F
authors.lastname: Yuan
authors.affiliation: Department of Cardiology, Beijing Anzhen Hospital, Capital Medical University, Beijing 100029, China.
authors.forename: Xin
authors.initials: X
authors.lastname: Chen
authors.affiliation: Department of Cardiology, Beijing Anzhen Hospital, Capital Medical University, Beijing 100029, China.
authors.forename: Xiantao
authors.initials: X
authors.lastname: Song
authors.affiliation: Department of Cardiology, First Affiliated Hospital of Xi'an Jiaotong University, Xi'an, Shaanxi 710061, China.
authors.forename: Dongqi
authors.initials: D
authors.lastname: Wang
authors.affiliation: Department of Cardiology, First Affiliated Hospital of Lanzhou University, Lanzhou, Gansu 730000, China.
authors.forename: Zheng
authors.initials: Z
authors.lastname: Zhang
authors.affiliation: Department of Cardiology, First Affiliated Hospital of Harbin Medical University, Harbin, Heilongjiang 150001, China.
authors.forename: Weimin
authors.initials: W
authors.lastname: Li
authors.affiliation: Department of Cardiology, People's Hospital of Liaoning Province, Shenyang, Liaoning 110016, China.
authors.forename: Zhanquan
authors.initials: Z
authors.lastname: Li
authors.affiliation: Department of Cardiology, General Hospital of Daqing Oilfield, Daqing, Heilongjiang 163411, China.
authors.forename: Hui
authors.initials: H
authors.lastname: Li
authors.affiliation: Department of Cardiology, People's Hospital of Shaanxi Province, Xi'an, Shaanxi 710068, China.
authors.forename: Xinyi
authors.initials: X
authors.lastname: Chen
authors.affiliation: Department of Cardiology, Peking University First Hospital, Beijing 100044, China.
authors.forename: Yong
authors.initials: Y
authors.lastname: Huo
authors.affiliation: Department of Cardiology, Chao-yang Hospital, Capital Medical University, Being 100020, China.
authors.forename: Lefeng
authors.initials: L
authors.lastname: Wang
authors.affiliation: Department of Cardiology, Chinese People's Liberation Army General Hospital, Beijing 100853, China.
authors.forename: Caiyi
authors.initials: C
authors.lastname: Lu
authors.affiliation: Department of Cardiology, Second Hospital of Shandong University, Jinan, Shandong 250033, China.
authors.forename: Qinghua
authors.initials: Q
authors.lastname: Lu
authors.affiliation: Cardiac Catheterization Laboratory, Cardiovascular Institute and Fuwai Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing 100037, China.
authors.forename: Bo
authors.initials: B
authors.lastname: Xu
authors.affiliation: National Center for Cardiovascular Diseases of China, Beijing 100037, China.
authors.forename: Wei
authors.initials: W
authors.lastname: Li
authors.affiliation: Department of Cardiology, Beijing Anzhen Hospital, Capital Medical University, Beijing 100029, China. Email: shuzheng@medmail.com.cn.
authors.forename: Shuzheng
authors.initials: S
authors.lastname: Lyu
mesh_terms: D000328:Adult; D000368:Aged; D000792:Angiography; D003324:Coronary Artery Disease / Q000601:surgery; D023903:Coronary Restenosis / Q000517:prevention & control; D054855:Drug-Eluting Stents; D006801:Humans; D008875:Middle Aged; D062645:Percutaneous Coronary Intervention; D011108:Polymers / Q000737:chemistry* / Q000627:therapeutic use*; D020123:Sirolimus / Q000627:therapeutic use*; D014025:Titanium / Q000737:chemistry; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D011108:Polymers; C009495:titanium dioxide; D014025:Titanium; D020123:Sirolimus