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
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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 -