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

Ian Meredith, Martin Rothman, Andrejs Erglis, Keyur Parikh, Chaim Lotan

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10 Citations (Scopus)

Abstract

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.
Original languageEnglish
Pages (from-to)993 - 1000
Number of pages8
JournalCatheterization and Cardiovascular Interventions
Volume77
Issue number7
DOIs
Publication statusPublished - 2011

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