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)
Cited by (0)
A complete list of the E-Five Investigators is provided in the Online Appendix.
This registry is funded by the Medtronic Bakken Research Center, Medtronic CardioVascular, Inc. Dr. Lotan has served as a speaker and advisory board member for Cordis Corporation Medtronic, Inc., and has served as a consultant to Angio Score Ltd. Dr. Meredith has served as an advisory board member for Boston Scientific and Medtronic, Inc. Dr. Mauri has served as a consultant to Cordis and Medtronic, Inc. Dr. Liu is an employee of Medtronic CardioVascular. Dr. Rothman has served as a consultant to Cordis Corporation, Abbott Vascular, Medtronic, Inc., and Lombard Medical Technologies PLC, and has received research/grant support from Abbott Vascular, Boston Scientific, CardioBridge GmbH, Cordis Corporation, and Medtronic, Inc. Data management was performed by Medtronic CardioVascular.
