title: Is Bare-Metal Stent Implantation Still Justifiable in High Bleeding Risk Patients Undergoing Percutaneous Coronary Intervention?: A Pre-Specified Analysis From the ZEUS Trial.
abstract: OBJECTIVE
  This study sought to investigate the ischemic and bleeding outcomes of patients fulfilling high bleeding risk (HBR) criteria who were randomized to zotarolimus-eluting Endeavor Sprint stent (E-ZES) or bare-metal stent (BMS) implantation followed by an abbreviated dual antiplatelet therapy (DAPT) duration for stable or unstable coronary artery disease.
  
  
  BACKGROUND
  DES instead of BMS use remains controversial in HBR patients, in whom long-term DAPT poses safety concerns.
  
  
  METHODS
  The ZEUS (Zotarolimus-Eluting Endeavor Sprint Stent in Uncertain DES Candidates) is a multinational, randomized single-blinded trial that randomized among others, in a stratified manner, 828 patients fulfilling pre-defined clinical or biochemical HBR criteria-including advanced age, indication to oral anticoagulants or other pro-hemorrhagic medications, history of bleeding and known anemia-to receive E-ZES or BMS followed by a protocol-mandated 30-day DAPT regimen. The primary endpoint of the study was the 12-month major adverse cardiovascular event rate, consisting of death, myocardial infarction, or target vessel revascularization.
  
  
  RESULTS
  Compared with patients without, those with 1 or more HBR criteria had worse outcomes, owing to higher ischemic and bleeding risks. Among HBR patients, major adverse cardiovascular events occurred in 22.6% of the E-ZES and 29% of the BMS patients (hazard ratio: 0.75; 95% confidence interval: 0.57 to 0.98; p = 0.033), driven by lower myocardial infarction (3.5% vs. 10.4%; p < 0.001) and target vessel revascularization (5.9% vs. 11.4%; p = 0.005) rates in the E-ZES arm. The composite of definite or probable stent thrombosis was significantly reduced in E-ZES recipients, whereas bleeding events did not differ between stent groups.
  
  
  CONCLUSIONS
  Among HBR patients with stable or unstable coronary artery disease, E-ZES implantation provides superior efficacy and safety as compared with conventional BMS. (Zotarolimus-Eluting Endeavor Sprint Stent in Uncertain DES Candidates [ZEUS]; NCT01385319).
authors.affiliation: Swiss Cardiovascular Center Bern, Inselspital, Bern University Hospital, Switzerland; Thoraxcenter, Erasmus MC, Rotterdam, the Netherlands.
authors.forename: Sara
authors.initials: S
authors.lastname: Ariotti
authors.affiliation: Thoraxcenter, Erasmus MC, Rotterdam, the Netherlands.
authors.forename: Marianna
authors.initials: M
authors.lastname: Adamo
authors.affiliation: Thoraxcenter, Erasmus MC, Rotterdam, the Netherlands.
authors.forename: Francesco
authors.initials: F
authors.lastname: Costa
authors.affiliation: Cardiology Department, Crete Naval Hospital, Crete, Greece.
authors.forename: Athanasios
authors.initials: A
authors.lastname: Patialiakas
authors.affiliation: Clinica Mediterranea, Napoli, Italy.
authors.forename: Carlo
authors.initials: C
authors.lastname: Briguori
authors.affiliation: Cardiology Center, Szeged, Hungary.
authors.forename: Attila
authors.initials: A
authors.lastname: Thury
authors.affiliation: Interventional Cardiology, San Giovanni Bosco Hospital, Torino, Italy.
authors.forename: Salvatore
authors.initials: S
authors.lastname: Colangelo
authors.affiliation: Cardiovascular Institute, Azienda Ospedaliero-Universitaria di Ferrara, Cona, Ferrara, Italy.
authors.forename: Gianluca
authors.initials: G
authors.lastname: Campo
authors.affiliation: Cardiovascular Institute, Azienda Ospedaliero-Universitaria di Ferrara, Cona, Ferrara, Italy.
authors.forename: Matteo
authors.initials: M
authors.lastname: Tebaldi
authors.affiliation: Cardiology Center, 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, 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: Fondazione IRCCS Policlinico San Matteo, Pavia, Italy.
authors.forename: Marco
authors.initials: M
authors.lastname: Ferlini
authors.affiliation: Virga Jesse Ziekenhuis, Hasselt, Belgium.
authors.forename: Pascal
authors.initials: P
authors.lastname: Vranckx
authors.affiliation: Swiss Cardiovascular Center Bern, Inselspital, Bern University Hospital, Switzerland; Thoraxcenter, Erasmus MC, Rotterdam, the Netherlands. Electronic address: marco.valgimigli@insel.ch.
authors.forename: Marco
authors.initials: M
authors.lastname: Valgimigli
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D002317:Cardiovascular Agents / Q000008:administration & dosage; D003324:Coronary Artery Disease / Q000000981:diagnostic imaging / Q000401:mortality / Q000628:therapy*; D004359:Drug Therapy, Combination; D054855:Drug-Eluting Stents; D005260:Female; D006470:Hemorrhage / Q000139:chemically induced* / Q000401:mortality; D006801:Humans; D008297:Male; D008670:Metals; D009203:Myocardial Infarction / Q000209:etiology; D018579:Patient Selection; D062645:Percutaneous Coronary Intervention / Q000009:adverse effects / Q000295:instrumentation* / Q000401:mortality; D010975:Platelet Aggregation Inhibitors / Q000009:adverse effects*; D011474:Prosthesis Design; D018570:Risk Assessment; D012307:Risk Factors; D016037:Single-Blind Method; D020123:Sirolimus / Q000008:administration & dosage / Q000031:analogs & derivatives; D015607:Stents; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D002317:Cardiovascular Agents; D008670:Metals; D010975:Platelet Aggregation Inhibitors; C489443:zotarolimus; D020123:Sirolimus
keywords: dual antiplatelet therapy; high bleeding risk; zotarolimus-eluting stent(s)