AIMS: We report here the final 5-year follow-up results from the ENDEAVOR II trial, which was the first randomised trial evaluating the Endeavor(tm) zotarolimus-eluting stent (ZES) compared with a bare metal stent (BMS) in patients with single, de novo coronary artery lesions. METHODS AND RESULTS:Eligible patients were randomised 1:1 to receive ZES or BMS and were followed by telephone or clinic visit up to five years. We evaluated TVF and its components (target vessel revascularisation [TVR], Q-wave or non Q-wave myocardial infarction, or cardiac death attributed to the target vessel) at five years. Additionally, we report rates of MACE, TLR, and stent thrombosis (protocol- and ARC-defined) through five years. ENDEAVOR II enrolled 1,197 patients (598 ZES, 599 BMS). At five years of follow-up, the rates of TVF (15.4% vs 24.4%), TVR (10.7% vs 20.1%), MACE (15.4% vs 24.6%), and TLR (7.5% vs 16.3%) remained significantly lower in ZES patients compared with BMS patients. ARC definite and probable very late (>1 year) stent thrombosis remained low (0.2% ZES and 0.3% BMS) through five years. CONCLUSIONS: After five years of follow-up, ZES demonstrated significantly improved clinical outcomes with sustained safety compared with BMS in patients with obstructive coronary artery disease.
RCT Entities:
AIMS: We report here the final 5-year follow-up results from the ENDEAVOR II trial, which was the first randomised trial evaluating the Endeavor(tm) zotarolimus-eluting stent (ZES) compared with a bare metal stent (BMS) in patients with single, de novo coronary artery lesions. METHODS AND RESULTS: Eligible patients were randomised 1:1 to receive ZES or BMS and were followed by telephone or clinic visit up to five years. We evaluated TVF and its components (target vessel revascularisation [TVR], Q-wave or non Q-wave myocardial infarction, or cardiac death attributed to the target vessel) at five years. Additionally, we report rates of MACE, TLR, and stent thrombosis (protocol- and ARC-defined) through five years. ENDEAVOR II enrolled 1,197 patients (598 ZES, 599 BMS). At five years of follow-up, the rates of TVF (15.4% vs 24.4%), TVR (10.7% vs 20.1%), MACE (15.4% vs 24.6%), and TLR (7.5% vs 16.3%) remained significantly lower in ZES patients compared with BMS patients. ARC definite and probable very late (>1 year) stent thrombosis remained low (0.2% ZES and 0.3% BMS) through five years. CONCLUSIONS: After five years of follow-up, ZES demonstrated significantly improved clinical outcomes with sustained safety compared with BMS in patients with obstructive coronary artery disease.
Authors: Pasi Karjalainen; Tuomas O Kiviniemi; Tuomas Lehtinen; Wail Nammas; Antti Ylitalo; Antti Saraste; Jussi Mikkelsson; Mikko Pietila; Fausto Biancari; Juhani K E Airaksinen Journal: Int J Cardiovasc Imaging Date: 2013-08-31 Impact factor: 2.357
Authors: Ahmed N Mahmoud; Nikhil H Shah; Islam Y Elgendy; Nayan Agarwal; Akram Y Elgendy; Amgad Mentias; Amr F Barakat; Dhruv Mahtta; R David Anderson; Anthony A Bavry Journal: Clin Cardiol Date: 2018-01-25 Impact factor: 2.882
Authors: Tobias Härle; Uwe Zeymer; Arne Kristian Schwarz; Claus Lüers; Matthias Hochadel; Harald Darius; Wolfgang Kasper; Karl Eugen Hauptmann; Dietrich Andresen; Albrecht Elsässer Journal: Clin Res Cardiol Date: 2014-01-17 Impact factor: 5.460
Authors: Nicolas W Shammas; Gail A Shammas; Elie Nader; Michael Jerin; Luay Mrad; Peter Marogil; Courtney Henn; Alex Dvorak; Archana Chintalapani; Susan Meriner Journal: Vasc Health Risk Manag Date: 2012-04-11