Is Bare-Metal Stent Implantation Still Justifiable in High Bleeding Risk Patients Undergoing Percutaneous Coronary Intervention? A Pre-Specified Analysis from the ZEUS Trial

Sara Ariotti, Marianna Adamo, Francesco Costa, Athanasios Patialiakas, Carlo Briguori, A. Thury, Salvatore Colangelo, Gianluca Campo, Matteo Tebaldi, Imre Ungi, Stefano Tondi, Marco Roffi, Alberto Menozzi, Nicoletta De Cesare, Roberto Garbo, Emanuele Meliga, Luca Testa, Henrique Mesquita Gabriel, Marco Ferlini, Pascal VranckxMarco Valgimigli

Research output: Contribution to journalArticle

55 Citations (Scopus)

Abstract

Objectives 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).

Original languageEnglish
Pages (from-to)426-436
Number of pages11
JournalJACC: Cardiovascular Interventions
Volume9
Issue number5
DOIs
Publication statusPublished - Mar 14 2016

Fingerprint

Percutaneous Coronary Intervention
Stents
Metals
Hemorrhage
Coronary Artery Disease
Myocardial Infarction
Safety
Anticoagulants
Anemia
Thrombosis
Therapeutics
Confidence Intervals
Mortality

Keywords

  • dual antiplatelet therapy
  • high bleeding risk
  • zotarolimus-eluting stent(s)

ASJC Scopus subject areas

  • Cardiology and Cardiovascular Medicine

Cite this

Is Bare-Metal Stent Implantation Still Justifiable in High Bleeding Risk Patients Undergoing Percutaneous Coronary Intervention? A Pre-Specified Analysis from the ZEUS Trial. / Ariotti, Sara; Adamo, Marianna; Costa, Francesco; Patialiakas, Athanasios; Briguori, Carlo; Thury, A.; Colangelo, Salvatore; Campo, Gianluca; Tebaldi, Matteo; Ungi, Imre; Tondi, Stefano; Roffi, Marco; Menozzi, Alberto; De Cesare, Nicoletta; Garbo, Roberto; Meliga, Emanuele; Testa, Luca; Gabriel, Henrique Mesquita; Ferlini, Marco; Vranckx, Pascal; Valgimigli, Marco.

In: JACC: Cardiovascular Interventions, Vol. 9, No. 5, 14.03.2016, p. 426-436.

Research output: Contribution to journalArticle

Ariotti, S, Adamo, M, Costa, F, Patialiakas, A, Briguori, C, Thury, A, Colangelo, S, Campo, G, Tebaldi, M, Ungi, I, Tondi, S, Roffi, M, Menozzi, A, De Cesare, N, Garbo, R, Meliga, E, Testa, L, Gabriel, HM, Ferlini, M, Vranckx, P & Valgimigli, M 2016, 'Is Bare-Metal Stent Implantation Still Justifiable in High Bleeding Risk Patients Undergoing Percutaneous Coronary Intervention? A Pre-Specified Analysis from the ZEUS Trial', JACC: Cardiovascular Interventions, vol. 9, no. 5, pp. 426-436. https://doi.org/10.1016/j.jcin.2015.11.015
Ariotti, Sara ; Adamo, Marianna ; Costa, Francesco ; Patialiakas, Athanasios ; Briguori, Carlo ; Thury, A. ; Colangelo, Salvatore ; Campo, Gianluca ; Tebaldi, Matteo ; Ungi, Imre ; Tondi, Stefano ; Roffi, Marco ; Menozzi, Alberto ; De Cesare, Nicoletta ; Garbo, Roberto ; Meliga, Emanuele ; Testa, Luca ; Gabriel, Henrique Mesquita ; Ferlini, Marco ; Vranckx, Pascal ; Valgimigli, Marco. / Is Bare-Metal Stent Implantation Still Justifiable in High Bleeding Risk Patients Undergoing Percutaneous Coronary Intervention? A Pre-Specified Analysis from the ZEUS Trial. In: JACC: Cardiovascular Interventions. 2016 ; Vol. 9, No. 5. pp. 426-436.
@article{98a3f48477cf4bd182e5322ffc2134b4,
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 = "Objectives 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).",
keywords = "dual antiplatelet therapy, high bleeding risk, zotarolimus-eluting stent(s)",
author = "Sara Ariotti and Marianna Adamo and Francesco Costa and Athanasios Patialiakas and Carlo Briguori and A. Thury and Salvatore Colangelo and Gianluca Campo and Matteo Tebaldi and Imre Ungi and Stefano Tondi and Marco Roffi and Alberto Menozzi and {De Cesare}, Nicoletta and Roberto Garbo and Emanuele Meliga and Luca Testa and Gabriel, {Henrique Mesquita} and Marco Ferlini and Pascal Vranckx and Marco Valgimigli",
year = "2016",
month = "3",
day = "14",
doi = "10.1016/j.jcin.2015.11.015",
language = "English",
volume = "9",
pages = "426--436",
journal = "JACC: Cardiovascular Interventions",
issn = "1936-8798",
publisher = "Elsevier Inc.",
number = "5",

}

TY - JOUR

T1 - Is Bare-Metal Stent Implantation Still Justifiable in High Bleeding Risk Patients Undergoing Percutaneous Coronary Intervention? A Pre-Specified Analysis from the ZEUS Trial

AU - Ariotti, Sara

AU - Adamo, Marianna

AU - Costa, Francesco

AU - Patialiakas, Athanasios

AU - Briguori, Carlo

AU - Thury, A.

AU - Colangelo, Salvatore

AU - Campo, Gianluca

AU - Tebaldi, Matteo

AU - Ungi, Imre

AU - Tondi, Stefano

AU - Roffi, Marco

AU - Menozzi, Alberto

AU - De Cesare, Nicoletta

AU - Garbo, Roberto

AU - Meliga, Emanuele

AU - Testa, Luca

AU - Gabriel, Henrique Mesquita

AU - Ferlini, Marco

AU - Vranckx, Pascal

AU - Valgimigli, Marco

PY - 2016/3/14

Y1 - 2016/3/14

N2 - Objectives 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).

AB - Objectives 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).

KW - dual antiplatelet therapy

KW - high bleeding risk

KW - zotarolimus-eluting stent(s)

UR - http://www.scopus.com/inward/record.url?scp=84959863935&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=84959863935&partnerID=8YFLogxK

U2 - 10.1016/j.jcin.2015.11.015

DO - 10.1016/j.jcin.2015.11.015

M3 - Article

C2 - 26965932

AN - SCOPUS:84959863935

VL - 9

SP - 426

EP - 436

JO - JACC: Cardiovascular Interventions

JF - JACC: Cardiovascular Interventions

SN - 1936-8798

IS - 5

ER -