Long-term follow-up of the randomised controlled trial to evaluate the safety and efficacy of the zotarolimus-eluting driver coronary stent in de novo native coronary artery lesions: five year outcomes in the ENDEAVOR II study
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Long-term follow-up of the randomised controlled trial to evaluate the safety and efficacy of the zotarolimus-eluting driver coronary stent in de novo native coronary artery lesions: five year outcomes in the ENDEAVOR II study. / Fajadet, Jean; Wijns, William; Laarman, Gert-Jan; Kuck, Karl-Heinz; Ormiston, John; Baldus, Stephan; Hauptmann, Karl E; Suttorp, Maarten J; Drzewiecki, Janusz; Pieper, Michael; Schultheiss, Heinz-Peter; Mauri, Laura.
in: EUROINTERVENTION, Jahrgang 6, Nr. 5, 11.2010, S. 562-567.Publikationen: SCORING: Beitrag in Fachzeitschrift/Zeitung › SCORING: Zeitschriftenaufsatz › Forschung › Begutachtung
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TY - JOUR
T1 - Long-term follow-up of the randomised controlled trial to evaluate the safety and efficacy of the zotarolimus-eluting driver coronary stent in de novo native coronary artery lesions: five year outcomes in the ENDEAVOR II study
AU - Fajadet, Jean
AU - Wijns, William
AU - Laarman, Gert-Jan
AU - Kuck, Karl-Heinz
AU - Ormiston, John
AU - Baldus, Stephan
AU - Hauptmann, Karl E
AU - Suttorp, Maarten J
AU - Drzewiecki, Janusz
AU - Pieper, Michael
AU - Schultheiss, Heinz-Peter
AU - Mauri, Laura
PY - 2010/11
Y1 - 2010/11
N2 - 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.
AB - 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.
KW - Aged
KW - Angioplasty, Balloon, Coronary
KW - Coronary Artery Disease/therapy
KW - Drug-Eluting Stents/adverse effects
KW - Female
KW - Follow-Up Studies
KW - Humans
KW - Male
KW - Middle Aged
KW - Randomized Controlled Trials as Topic
KW - Sirolimus/administration & dosage
KW - Thrombosis/epidemiology
KW - Treatment Outcome
U2 - 10.4244/EIJV6I5A95
DO - 10.4244/EIJV6I5A95
M3 - SCORING: Journal article
C2 - 21044908
VL - 6
SP - 562
EP - 567
JO - EUROINTERVENTION
JF - EUROINTERVENTION
SN - 1774-024X
IS - 5
ER -