title: Angiographic and clinical comparison of novel Orsiro Hybrid sirolimus-eluting stents and Resolute Integrity zotarolimus-eluting stents in all-comers with coronary artery disease (ORIENT trial): study protocol for a randomized controlled trial.
abstract: BACKGROUND
  The Orsiro Hybrid sirolimus-eluting stent is a newly developed third-generation drug-eluting stent, featuring a unique dual-polymer mix. An active bioabsorbable polymer delivers the anti-proliferative drug, sirolimus, via controlled release, while a passive biocompatible polymeric coating shields the metallic strut from surrounding tissue, preventing interaction. To date, the Orsiro Hybrid sirolimus-eluting stent has excelled in terms of late lumen loss at 9 months in a first-in-man single-arm trial. However, the efficacy and safety data for Orsiro Hybrid sirolimus-eluting stents in a broader population of all-comers are limited. The present study offers an angiographic and clinical comparison of the Orsiro Hybrid sirolimus-eluting stent and the Resolute Integrity zotarolimus-eluting stent in the treatment of patients with coronary artery disease.
  
  
  METHODS
  The ORIENT trial is a multicenter, randomized, open-label, parallel-arm study designed to demonstrate the non-inferiority of the Orsiro Hybrid sirolimus-eluting stent relative to the Resolute Integrity zotarolimus-eluting stent. A total of 375 patients with a spectrum of coronary artery disease will undergo prospective, random assignment to a Orsiro Hybrid sirolimus-eluting stent or Resolute Integrity zotarolimus-eluting stent (2:1 ratio), for a primary endpoint of in-stent late lumen loss at 9 months by quantitative coronary angiography. Secondary 12-month clinical endpoints are death, target lesion revascularization, target vessel revascularization, myocardial infarction, stent thrombosis and target lesion failure (a composite of cardiac death, target lesion revascularization and target vessel-related myocardial infarction).
  
  
  CONCLUSIONS
  The ORIENT trial is the first study to date comparing the Orsiro Hybrid sirolimus-eluting stent with the Resolute Integrity zotarolimus-eluting stent for efficacy and safety in a population of all-comers with coronary artery disease.
  
  
  BACKGROUND
  Clinicaltrials.gov NCT01826552.
authors.forename: Joo Myung
authors.initials: JM
authors.lastname: Lee
authors.forename: Sang-Don
authors.initials: SD
authors.lastname: Park
authors.forename: Sang Yup
authors.initials: SY
authors.lastname: Lim
authors.forename: Joon-Hyung
authors.initials: JH
authors.lastname: Doh
authors.forename: Jin Man
authors.initials: JM
authors.lastname: Cho
authors.forename: Ki-Seok
authors.initials: KS
authors.lastname: Kim
authors.forename: Jang-Whan
authors.initials: JW
authors.lastname: Bae
authors.forename: Woo-Young
authors.initials: WY
authors.lastname: Chung
authors.affiliation: Division of Cardiology, Department of Internal Medicine, College of Medicine, Seoul National University and Cardiovascular Center, Seoul National University Bundang Hospital, 166 Gumi-ro, Bundang-gu, Seongnam-si, Gyeonggi-do 463-707, Republic of Korea. ytjmd@snubh.org.
authors.forename: Tae-Jin
authors.initials: TJ
authors.lastname: Youn
mesh_terms: D002317:Cardiovascular Agents / Q000008:administration & dosage*; D002985:Clinical Protocols; D017023:Coronary Angiography; D003324:Coronary Artery Disease / Q000175:diagnosis / Q000401:mortality / Q000628:therapy*; D023903:Coronary Restenosis / Q000209:etiology; D003328:Coronary Thrombosis / Q000209:etiology; D054855:Drug-Eluting Stents; D006801:Humans; D009203:Myocardial Infarction / Q000209:etiology; D062645:Percutaneous Coronary Intervention / Q000009:adverse effects / Q000295:instrumentation* / Q000401:mortality; D011446:Prospective Studies; D011474:Prosthesis Design; D056910:Republic of Korea; D012107:Research Design; D020123:Sirolimus / Q000008:administration & dosage / Q000031:analogs & derivatives*; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D002317:Cardiovascular Agents; C489443:zotarolimus; D020123:Sirolimus