title: Randomized clinical trial comparing abluminal biodegradable polymer sirolimus-eluting stents with durable polymer sirolimus-eluting stents: Nine months angiographic and 5-year clinical outcomes.
abstract: BACKGROUND
  The biodegradable polymer drug-eluting stents (DES) were developed to improve vascular healing. However, further data and longer-term follow-up are needed to confirm safety and efficacy of these stents. This randomized clinical trial aimed to compare safety and efficacy of 2 sirolimus-eluting stents (SES): Cordimax-a novel abluminal biodegradable polymer SES and Cypher Select-a durable polymer SES, at 9 months angiographic and 5-year clinical follow-up.
  
  
  METHODS
  We randomized 402 patients with coronary artery disease to percutaneous coronary intervention with Cordimax (n = 202) or Cypher select (n = 200). Angiographic follow-up was performed at 9 months after the index procedure and clinical follow-up annually up to 5 years. The primary endpoint was angiographic in-stent late luminal loss (LLL). Secondary endpoints included angiographic restenosis rate, target vessel revascularization (TVR), and major adverse cardiac events (MACEs; defined as cardiac death, myocardial infarction, or TVR) at 5-year follow-up.
  
  
  RESULTS
  Cordimax was noninferior to Cypher select for in-stent LLL (0.25 ± 0.47 vs 0.18 ± 0.49 mm; P = 0.587) and in-stent mean diameter stenosis (22.19 ± 12.21% vs 19.89 ± 10.79%; P = 0.064) at 9 months angiographic follow-up. The MACE rates were not different at 1 year (5.9% vs 4.0%, P = 0.376); however, MACE rates from 2 to 5 years were lower in the Cordimax group (6.8% vs 13.1%; P = 0.039).
  
  
  CONCLUSIONS
  Abluminal biodegradable polymer SES is noninferior to durable polymer SES at 9-month angiographic and 1-year clinical follow-up. However, MACE rates from 2 to 5 years were less in the abluminal biodegradable polymer group.
authors.affiliation: Department of Health Science and Technology, Faculty of Medicine, Aalborg University, Niels, Denmark Shanghai Institute of Cardiovascular Diseases, Zhongshan Hospital Key Laboratory of Public Health Safety, Ministry of Education, School of Public Health, Fudan University, Shanghai Institute of Chemistry, Chinese Academy of Sciences, Beijing, China Biomedical Research Center, College of Medicine, Qatar University, Shareh AIJamiaa, Doha, Qatar.
authors.forename: Haijun
authors.initials: H
authors.lastname: Zhang
authors.forename: Xiangfei
authors.initials: X
authors.lastname: Wang
authors.forename: Wei
authors.initials: W
authors.lastname: Deng
authors.forename: Shenguo
authors.initials: S
authors.lastname: Wang
authors.forename: Junbo
authors.initials: J
authors.lastname: Ge
authors.forename: Egon
authors.initials: E
authors.lastname: Toft
mesh_terms: D020341:Absorbable Implants; D000368:Aged; D017023:Coronary Angiography / Q000706:statistics & numerical data*; D003324:Coronary Artery Disease / Q000601:surgery*; D023903:Coronary Restenosis / Q000453:epidemiology / Q000209:etiology; D054855:Drug-Eluting Stents; D004389:Durable Medical Equipment; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007166:Immunosuppressive Agents / Q000008:administration & dosage; D008297:Male; D008875:Middle Aged; D062645:Percutaneous Coronary Intervention / Q000009:adverse effects / Q000295:instrumentation*; D011108:Polymers; D011183:Postoperative Complications / Q000453:epidemiology / Q000209:etiology*; D011474:Prosthesis Design; D020123:Sirolimus / Q000008:administration & dosage; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D007166:Immunosuppressive Agents; D011108:Polymers; D020123:Sirolimus