Sara Ariotti1, Marianna Adamo2, Francesco Costa2, Athanasios Patialiakas3, Carlo Briguori4, Attila Thury5, Salvatore Colangelo6, Gianluca Campo7, Matteo Tebaldi7, Imre Ungi5, Stefano Tondi8, Marco Roffi9, Alberto Menozzi10, Nicoletta de Cesare11, Roberto Garbo6, Emanuele Meliga12, Luca Testa13, Henrique Mesquita Gabriel14, Marco Ferlini15, Pascal Vranckx16, Marco Valgimigli17. 1. Swiss Cardiovascular Center Bern, Inselspital, Bern University Hospital, Switzerland; Thoraxcenter, Erasmus MC, Rotterdam, the Netherlands. 2. Thoraxcenter, Erasmus MC, Rotterdam, the Netherlands. 3. Cardiology Department, Crete Naval Hospital, Crete, Greece. 4. Clinica Mediterranea, Napoli, Italy. 5. Cardiology Center, Szeged, Hungary. 6. Interventional Cardiology, San Giovanni Bosco Hospital, Torino, Italy. 7. Cardiovascular Institute, Azienda Ospedaliero-Universitaria di Ferrara, Cona, Ferrara, Italy. 8. Azienda Unità Sanitaria Locale di Modena-Ospedale Baggiovara, Italy. 9. Division of Cardiology, University Hospital, Geneva, Switzerland. 10. Interventional Cardiology Unit, Azienda Ospedaliero-Universitaria di Parma, Italy. 11. Policlinico S. Marco, Zingonia (Bergamo), Italy. 12. Azienda Ospedaliera Ordine Mauriziano, Torino, Italy. 13. Interventional Cardiology, Ist. Clinico S. Ambrogio, IRCCS San Donato, Milan, Italy. 14. Hospital de Santa Cruz, Carnaxide, Lisbon, Portugal. 15. Fondazione IRCCS Policlinico San Matteo, Pavia, Italy. 16. Virga Jesse Ziekenhuis, Hasselt, Belgium. 17. Swiss Cardiovascular Center Bern, Inselspital, Bern University Hospital, Switzerland; Thoraxcenter, Erasmus MC, Rotterdam, the Netherlands. Electronic address: marco.valgimigli@insel.ch.
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).
RCT Entities:
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).
Authors: Davide Capodanno; Deepak L Bhatt; C Michael Gibson; Stefan James; Takeshi Kimura; Roxana Mehran; Sunil V Rao; Philippe Gabriel Steg; Philip Urban; Marco Valgimigli; Stephan Windecker; Dominick J Angiolillo Journal: Nat Rev Cardiol Date: 2021-08-23 Impact factor: 32.419