• Chaim Lotan, Ian T Meredith, Laura Mauri, Minglei Liu, Martin T Rothman, and E-Five Investigators.
• Heart Institute, Hadassah-Hebrew University Medical Center, Jerusalem, Israel. lotan@hadassah.org.il
• JACC Cardiovasc Interv. 2009 Dec 1; 2 (12): 1227-35.

ObjectivesThe 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.BackgroundEarly 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.MethodsThe 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.ResultsOverall 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).ConclusionsThis 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).

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