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

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, Attila

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

VL - 9

SP - 426

EP - 436

JO - JACC: Cardiovascular Interventions

JF - JACC: Cardiovascular Interventions

SN - 1936-8798

IS - 5

ER -