title: Zotarolimus-eluting versus bare-metal stents in uncertain drug-eluting stent candidates.
abstract: BACKGROUND
  The use of drug-eluting stents (DES) in patients at high risk of bleeding or thrombosis has not been prospectively studied; limited data are available in patients who have a low restenosis risk.
  
  
  OBJECTIVE
  This study sought to compare a hydrophilic polymer-based, second-generation zotarolimus-eluting stent (ZES) with a unique drug fast-release profile versus bare-metal stents (BMS) under similar durations of dual-antiplatelet therapy (DAPT).
  
  
  METHODS
  We randomly assigned 1,606 patients with stable or unstable symptoms, and who on the basis of thrombotic bleeding or restenosis risk criteria, qualified as uncertain candidates for DES, to receive ZES or BMS. DAPT duration was on the basis of patient characteristics, rather than stent characteristics, and allowed for a personalized 1-month dual antiplatelet regimen. The primary endpoint was the risk of 1-year major adverse cardiovascular events (MACE), which included death, myocardial infarction (MI), or target vessel revascularization (TVR).
  
  
  RESULTS
  Median DAPT duration was 32 days (interquartile range [IQR]: 30 to 180 days) and did not differ between the groups. In the ZES group, 140 patients (17.5%) reached the primary endpoint, compared with 178 patients (22.1%) in the BMS group (hazard ratio: 0.76; 95% confidence interval: 0.61 to 0.95; p = 0.011) as a result of lower MI (2.9% vs. 8.1%; p < 0.001) and TVR rates (5.9% vs.10.7%; p = 0.001) in the ZES group. Definite or probable stent thrombosis was also significantly reduced in ZES recipients (2.0% vs. 4.1%; p = 0.019).
  
  
  CONCLUSIONS
  Compared with BMS, DES implantation using a stent with a biocompatible polymer and fast drug-eluting characteristics, combined with an abbreviated, tailored DAPT regimen, resulted in a lower risk of 1-year MACE in uncertain candidates for DES implantation. (Zotarolimus-eluting Endeavor Sprint Stent in Uncertain DES Candidates [ZEUS] Study; NCT01385319).
authors.affiliation: Thoraxcenter, Erasmus Medical Center, Rotterdam, the Netherlands. Electronic address: m.valgimigli@erasmusmc.nl.
authors.forename: Marco
authors.initials: M
authors.lastname: Valgimigli
authors.affiliation: Interventional Cardiology Unit, Azienda Ospedaliero-Universitaria di Ferrara, Ferrara, Italy; Cardiology Department, Crete Naval Hospital, Crete, Greece.
authors.forename: Athanasios
authors.initials: A
authors.lastname: Patialiakas
authors.affiliation: Cardiology Center and University of Szeged, Szeged, Hungary.
authors.forename: Attila
authors.initials: A
authors.lastname: Thury
authors.affiliation: Division of Cardiology, Cork University Hospital, Cork, Ireland.
authors.forename: Eugene
authors.initials: E
authors.lastname: McFadden
authors.affiliation: Interventional Cardiology, San Giovanni Bosco Hospital, Torino, Italy.
authors.forename: Salvatore
authors.initials: S
authors.lastname: Colangelo
authors.affiliation: Interventional Cardiology Unit, Azienda Ospedaliero-Universitaria di Ferrara, Ferrara, Italy.
authors.forename: Gianluca
authors.initials: G
authors.lastname: Campo
authors.affiliation: Interventional Cardiology Unit, Azienda Ospedaliero-Universitaria di Ferrara, Ferrara, Italy.
authors.forename: Matteo
authors.initials: M
authors.lastname: Tebaldi
authors.affiliation: Cardiology Center and University of Szeged, Szeged, Hungary.
authors.forename: Imre
authors.initials: I
authors.lastname: Ungi
authors.affiliation: Azienda Unità Sanitaria Locale di Modena-Ospedale, Baggiovara, Italy.
authors.forename: Stefano
authors.initials: S
authors.lastname: Tondi
authors.affiliation: Division of Cardiology, University Hospital, Geneva, Switzerland.
authors.forename: Marco
authors.initials: M
authors.lastname: Roffi
authors.affiliation: Interventional Cardiology Unit, Azienda Ospedaliero-Universitaria di Parma, Parma, Italy.
authors.forename: Alberto
authors.initials: A
authors.lastname: Menozzi
authors.affiliation: Policlinico S. Marco Zingonia, Bergamo, Italy.
authors.forename: Nicoletta
authors.initials: N
authors.lastname: de Cesare
authors.affiliation: Interventional Cardiology, San Giovanni Bosco Hospital, Torino, Italy.
authors.forename: Roberto
authors.initials: R
authors.lastname: Garbo
authors.affiliation: Azienda Ospedaliera Ordine Mauriziano, Torino, Italy.
authors.forename: Emanuele
authors.initials: E
authors.lastname: Meliga
authors.affiliation: Interventional Cardiology, Ist. Clinico S. Ambrogio, IRCCS San Donato, Milan, Italy.
authors.forename: Luca
authors.initials: L
authors.lastname: Testa
authors.affiliation: Hospital de Santa Cruz, Carnaxide, Lisbon, Portugal.
authors.forename: Henrique Mesquita
authors.initials: HM
authors.lastname: Gabriel
authors.affiliation: IRCCS Multimedica Sesto San Giovanni, Milan, Italy.
authors.forename: Flavio
authors.initials: F
authors.lastname: Airoldi
authors.affiliation: Fondazione IRCCS Policlinico San Matteo, Pavia, Italy.
authors.forename: Marco
authors.initials: M
authors.lastname: Ferlini
authors.affiliation: Cardiovascular Departments of San Donato Hospital, Arezzo, Italy.
authors.forename: Francesco
authors.initials: F
authors.lastname: Liistro
authors.affiliation: Ospedali Riuniti, Savigliano, Italy.
authors.forename: Antonio
authors.initials: A
authors.lastname: Dellavalle
authors.affiliation: Virga Jesse Ziekenhuis, Hasselt, Belgium.
authors.forename: Pascal
authors.initials: P
authors.lastname: Vranckx
authors.affiliation: Clinica Mediterranea, Napoli, Italy.
authors.forename: Carlo
authors.initials: C
authors.lastname: Briguori
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D001241:Aspirin / Q000008:administration & dosage / Q000009:adverse effects; D001672:Biocompatible Materials / Q000627:therapeutic use; D000077144:Clopidogrel; D017023:Coronary Angiography / Q000379:methods; D003324:Coronary Artery Disease / Q000175:diagnosis / Q000601:surgery*; D023903:Coronary Restenosis / Q000175:diagnosis / Q000209:etiology / Q000517:prevention & control; D054855:Drug-Eluting Stents / Q000009:adverse effects*; D005260:Female; D006470:Hemorrhage / Q000209:etiology / Q000517:prevention & control; D006801:Humans; D007166:Immunosuppressive Agents / Q000627:therapeutic use; D008297:Male; D062645:Percutaneous Coronary Intervention / Q000009:adverse effects / Q000379:methods; D010975:Platelet Aggregation Inhibitors / Q000008:administration & dosage / Q000009:adverse effects; D011183:Postoperative Complications / Q000175:diagnosis / Q000517:prevention & control; D018570:Risk Assessment; D012307:Risk Factors; D020123:Sirolimus / Q000031:analogs & derivatives* / Q000627:therapeutic use; D013988:Ticlopidine / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives*; D016896:Treatment Outcome
chemical_list: D001672:Biocompatible Materials; D007166:Immunosuppressive Agents; D010975:Platelet Aggregation Inhibitors; D000077144:Clopidogrel; C489443:zotarolimus; D013988:Ticlopidine; D001241:Aspirin; D020123:Sirolimus
keywords: drug-eluting stent(s); dual-antiplatelet therapy; high bleeding risk; high thrombotic risk; zotarolimus-eluting stent(s)