1. Safety and effectiveness of the Endeavor zotarolimus-eluting stent in real-world clinical practice: 12-month data from the E-Five registry.
- Author
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Lotan C, Meredith IT, Mauri L, Liu M, and Rothman MT
- Subjects
- Aged, Angioplasty, Balloon, Coronary adverse effects, Angioplasty, Balloon, Coronary mortality, Australia, Coronary Stenosis mortality, Europe, Female, Humans, Israel, Kaplan-Meier Estimate, Male, Middle Aged, Myocardial Infarction etiology, Platelet Aggregation Inhibitors therapeutic use, Prospective Studies, Prosthesis Design, Registries, Risk Assessment, Sirolimus administration & dosage, South America, Thrombosis etiology, Time Factors, Treatment Outcome, United States, Angioplasty, Balloon, Coronary instrumentation, Cardiovascular Agents administration & dosage, Coronary Stenosis therapy, Sirolimus analogs & derivatives
- Abstract
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).
- Published
- 2009
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