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Safety and Effectiveness of the Endeavor Zotarolimus-Eluting Stent in Real-World Clinical Practice

12-Month Data From the E-Five Registry

Chaim Lotan, MD^_*,_*, Ian T. Meredith, MBBS, PhD, Laura Mauri, MD, MSc, Minglei Liu, PhD, Martin T. Rothman, MB, ChB^|| for the E-Five Investigators

^_* Heart Institute, Hadassah-Hebrew University Medical Center, Jerusalem, Israel
Monash Heart Medical Centre, Melbourne, Australia
Brigham and Women's Hospital and Harvard Clinical Research Institute, Boston, Massachusetts
Medtronic CardioVascular, Santa Rosa, California
^|| The London Chest Hospital, Barts, and The London NHS Trust, London, United Kingdom

^_* Reprint requests and correspondence: Dr. Chaim Lotan, Director of Heart Institute, Hadassah-Hebrew University Medical Centre, Jerusalem, Kiryat Hadassah, P.O. Box 12000, 91120 Jerusalem, Israel (Email: lotan{at}hadassah.org.il).

Objectives: The E-Five registry was designed to evaluate the safety and effectiveness of the Endeavor zotarolimus-eluting stent (ZES) (Medtronic CardioVascular, Santa Rosa, California) for the treatment of coronary artery stenosis across a wide range of patients treated in real-world clinical practice settings.

Background: Early clinical trials with the Endeavor ZES have demonstrated low rates of target lesion revascularization with a favorable safety profile including low late stent thrombosis with up to 4 years of follow-up. A clinical registry was designed to complement controlled trial data by examining a large patient population, including high-risk patient subsets.

Methods: The E-Five registry is a prospective, nonrandomized, multicenter global registry conducted at 188 centers worldwide. Adult patients (n = 8,314) with coronary artery disease who underwent single-vessel or multivessel percutaneous coronary intervention were enrolled. The primary end point was the rate of major adverse cardiac events (MACE) at 12 months. A secondary analysis stratified patients by standard versus extended-use clinical and lesion characteristics.

Results: Overall 12-month outcome rates were MACE 7.5%; cardiac death 1.7%; myocardial infarction (all) 1.6%; target lesion revascularization 4.5%; and stent thrombosis (Academic Research Consortium definite and probable) 1.1%. The 12-month MACE rates were 4.3% and 8.6% for standard- and extended-use patients, respectively (p < 0.001).

Conclusions: This large, international multicenter registry provides important information regarding the long-term safety and efficacy of the Endeavor ZES across standard and extended-use patients in the real-world setting. Rates of MACE and measures of safety including cardiac death, myocardial infarction, and stent thrombosis were low and consistent with pooled results of clinical trials. (E-Five Registry: A World-Wide Registry With The Endeavor Zotarolimus Eluting Coronary Stent [eFive Registry]; NCT00623441)

Key Words: coronary artery lesion • drug-eluting stent • multicenter registry • restenosis • stent thrombosis

Abbreviations and Acronyms   ARC = Academic Research Consortium   BMS = bare-metal stent(s)   CEC = clinical events committee   CK-MB = creatine kinase-myocardial band   DES = drug-eluting stent(s)   MACE = major adverse cardiac events   MI = myocardial infarction   PCI = percutaneous coronary intervention   PES = paclitaxel-eluting stent(s)   SES = sirolimus-eluting stent(s)   TLR = target lesion revascularization   TVF = target vessel failure   TVR = target vessel revascularization   ZES = zotarolimus-eluting stent(s)

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