title: Randomized comparison of Zotarolimus-Eluting Endeavor Sprint versus bare-metal stent implantation in uncertain drug-eluting stent candidates: rationale, design, and characterization of the patient population for the Zotarolimus-eluting Endeavor Sprint stent in uncertain DES candidates study.
abstract: BACKGROUND
  The use of drug-eluting stent (DES) instead of bare-metal stent (BMS) in patients at high stent thrombosis or bleeding risk as well as in those at low restenosis risk (ie, uncertain DES candidates) remains a matter of debate. Zotarolimus-Eluting Endeavor Sprint stent (E-ZES) (Santa Rosa, CA) is a hydrophilic polymer-based second-generation device with unique drug fast-release profile, which may allow for a shorter dual antiplatelet therapy (DAPT) duration without safety concerns.
  
  
  OBJECTIVE
  The primary objective is to assess whether E-ZES implantation followed by a shorter than currently recommended course of DAPT will decrease the incidence of 12-month major adverse cardiovascular events as compared with BMS in undefined DES recipients. Actual duration of DAPT regimen will be dictated by patients' characteristics and not by stent type and, as such, can be as short as 30 days after intervention in both stent groups.
  
  
  METHODS
  The ZEUS study is an open-label randomized clinical trial conducted at 20 clinical sites in Italy, Switzerland, Portugal, and Hungary. With 1,600 individuals, this study will have 85% power to detect a 33% difference in the primary end point consisting of the composite of death, nonfatal myocardial infarction, or target vessel revascularization.
  
  
  CONCLUSIONS
  The ZEUS trial aims to assess whether the use of E-ZES, followed by a DAPT duration regimen based on patients' characteristics and not by stent type, is superior to conventional BMS implantation in undefined DES recipients who qualify for the presence of high thrombosis, bleeding, or low restenosis risk criteria.
authors.affiliation: Interventional Cardiology Unit, Azienda Ospedaliero-Universitaria di Ferrara, Ferrara, Italy; Thoraxcenter, Erasmus Medical Center, Rotterdam, The Netherlands. Electronic address: vlgmrc@unife.it.
authors.forename: Marco
authors.initials: M
authors.lastname: Valgimigli
authors.forename: Athanasios
authors.initials: A
authors.lastname: Patialiakas
authors.forename: Attila
authors.initials: A
authors.lastname: Thury
authors.forename: Salvatore
authors.initials: S
authors.lastname: Colangelo
authors.forename: Gianluca
authors.initials: G
authors.lastname: Campo
authors.forename: Matteo
authors.initials: M
authors.lastname: Tebaldi
authors.forename: Imre
authors.initials: I
authors.lastname: Ungi
authors.forename: Stefano
authors.initials: S
authors.lastname: Tondi
authors.forename: Marco
authors.initials: M
authors.lastname: Roffi
authors.forename: Alberto
authors.initials: A
authors.lastname: Menozzi
authors.forename: Nicoletta
authors.initials: N
authors.lastname: de Cesare
authors.forename: Roberto
authors.initials: R
authors.lastname: Garbo
authors.forename: Emanuele
authors.initials: E
authors.lastname: Meliga
authors.forename: Luca
authors.initials: L
authors.lastname: Testa
authors.forename: Henrique M
authors.initials: HM
authors.lastname: Gabriel
authors.forename: Flavio
authors.initials: F
authors.lastname: Airoldi
authors.forename: Marco
authors.initials: M
authors.lastname: Ferlini
authors.forename: Francesco
authors.initials: F
authors.lastname: Liistro
authors.forename: Antonio
authors.initials: A
authors.lastname: Dellavalle
authors.forename: Pascal
authors.initials: P
authors.lastname: Vranckx
authors.forename: Carlo
authors.initials: C
authors.lastname: Briguori
mesh_terms: D054855:Drug-Eluting Stents; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D006814:Hungary; D007558:Italy; D008297:Male; D008670:Metals; D008875:Middle Aged; D009203:Myocardial Infarction / Q000150:complications* / Q000628:therapy; D010975:Platelet Aggregation Inhibitors / Q000008:administration & dosage* / Q000009:adverse effects; D011174:Portugal; D012107:Research Design; D018570:Risk Assessment; D020123:Sirolimus / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives*; D013557:Switzerland; D013927:Thrombosis / Q000188:drug therapy*; D013997:Time Factors; D016896:Treatment Outcome; D035501:Uncertainty
chemical_list: D008670:Metals; D010975:Platelet Aggregation Inhibitors; C489443:zotarolimus; D020123:Sirolimus