Extended Follow-Up Safety and Effectiveness of the Endeavor Zotarolimus-Eluting Stent in Real-World Clinical Practice: Two-Year Follow-Up From the E-Five Registry

Objectives: To present data from the cohort of patients in the all-comers Endeavor zotarolimus-eluting stent (ZES) registry (E-Five) who underwent 2-year follow-up. Background: The Endeavor ZES has been shown to be safe and efficacious for treatment of single, de novo lesions in patients with stable coronary artery disease. E-Five evaluated the ZES in over 8,000 real-world patients, at 188 sites followed to 1 year. A subset of sites continued follow-up through 2 years to evaluate late-term safety and effectiveness of the ZES in this population with diverse clinical and lesion characteristics. Methods: E-Five, a prospective, multicenter, nonrandomized global registry, collected 2-year outcomes for 2,116 patients from 26 centers. Sites were selected for participation based on patient accrual rates and the ability to continue follow-up activities for an additional year. Complete data was available for 2,054 patients. To observe whether or not a sustained benefit was achieved, data for all patients from the selected sites were included in the analysis. Results: The outcomes in the 2-year cohort tracked with the results of randomized controlled trials using the Endeavor ZES. One year results were MACE 7.5%, TLR 4.5%, and ARC definite/probable stent thrombosis 0.6%. Outcomes at 2 years for MACE, TLR, and ARC definite/probable stent thrombosis were 8.5, 5.1, and 0.7%, respectively. Conclusions: Long-term efficacy and safety outcomes were maintained between 1 and 2 years for the 2-year patient cohort, with only a small number of additional MACE, TLR, and very late stent thrombosis events. (C) 2010 Wiley-Liss, Inc.