Randomized comparison of Zotarolimus-Eluting Endeavor Sprint versus bare-metal stent implantation in uncertain drug-eluting stent candidates: Rationale, design, and characterization of the patient population for the Zotarolimus-eluting Endeavor Sprint stent in Uncertain DES Candidates study

• Published in: The American heart journal 2013-11, Vol.166 (5), p.831-838
• Main Authors: Valgimigli, Marco, MD, PhD, Patialiakas, Athanasios, MD, Thury, Attila, MD, PhD, Colangelo, Salvatore, MD, Campo, Gianluca, MD, Tebaldi, Matteo, MD, Ungi, Imre, MD, PhD, Tondi, Stefano, MD, Roffi, Marco, MD, Menozzi, Alberto, MD, PhD, de Cesare, Nicoletta, MD, Garbo, Roberto, MD, Meliga, Emanuele, MD, Testa, Luca, MD, PhD, Gabriel, Henrique M., MD, Airoldi, Flavio, MD, Ferlini, Marco, MD, Liistro, Francesco, MD, Dellavalle, Antonio, MD, Vranckx, Pascal, MD, Briguori, Carlo, MD, PhD
• Format: Article
• Language: English
• Subjects: Anticoagulants; Cardiovascular; Clinical trials; Drug therapy; Drug-Eluting Stents; Female; Follow-Up Studies; Humans; Hungary; Italy; Male; Metals; Middle Aged; Myocardial Infarction - complications; Myocardial Infarction - therapy; Nonsteroidal anti-inflammatory drugs; Platelet Aggregation Inhibitors - administration & dosage; Platelet Aggregation Inhibitors - adverse effects; Portugal; Research Design; Risk Assessment; Sirolimus - administration & dosage; Sirolimus - adverse effects; Sirolimus - analogs & derivatives; Stents; Switzerland; Thrombosis; Thrombosis - drug therapy; Time Factors; Treatment Outcome; Uncertainty
• ISSN: 0002-8703; 1097-6744
• DOI: 10.1016/j.ahj.2013.07.033

Background The use of drug-eluting stent (DES) instead of bare-metal stent (BMS) in patients at high stent thrombosis or bleeding risk as well as in those at low restenosis risk (ie, uncertain DES candidates) remains a matter of debate. Zotarolimus-Eluting Endeavor Sprint stent (E-ZES) (Santa Rosa, CA) is a hydrophilic polymer-based second-generation device with unique drug fast-release profile, which may allow for a shorter dual antiplatelet therapy (DAPT) duration without safety concerns. Hypothesis The primary objective is to assess whether E-ZES implantation followed by a shorter than currently recommended course of DAPT will decrease the incidence of 12-month major adverse cardiovascular events as compared with BMS in undefined DES recipients. Actual duration of DAPT regimen will be dictated by patients' characteristics and not by stent type and, as such, can be as short as 30 days after intervention in both stent groups. Study Design The ZEUS study is an open-label randomized clinical trial conducted at 20 clinical sites in Italy, Switzerland, Portugal, and Hungary. With 1,600 individuals, this study will have 85% power to detect a 33% difference in the primary end point consisting of the composite of death, nonfatal myocardial infarction, or target vessel revascularization. Summary The ZEUS trial aims to assess whether the use of E-ZES, followed by a DAPT duration regimen based on patients' characteristics and not by stent type, is superior to conventional BMS implantation in undefined DES recipients who qualify for the presence of high thrombosis, bleeding, or low restenosis risk criteria.