Five-Year Clinical Follow-Up After Implantation of the Endeavor Zotarolimus-Eluting Stent: ENDEAVOR I, First-in-Human Study Ian T. Meredith, 1 * MBBS, PhD, John Ormiston, 2,3 MB, ChB, Robert Whitbourn, 4 MBBS, I. Patrick Kay, 5 MD, PhD, David Muller, 6 MBBS, MD, and Donald E. Cutlip, 7 MD, on behalf of the ENDEAVOR I Investigators Objective: To evaluate the 5-year clinical outcomes of patients treated with the Endeavor zotarolimus-eluting stent (ZES) in the ENDEAVOR I first-in-human study. Background: ENDEAVOR I was a prospective, nonrandomized, multicenter study of the Endeavor ZES in 100 consecutive patients with symptomatic coronary artery disease (CAD) due to de novo, stenotic lesions in native coronary arteries. Methods: Patients with single or multivessel CAD were eligible to participate, but only one lesion per patient was treated. The lesion had to have 50% stenosis, be 15 mm in length, and located in a vessel with a reference diameter of 3.0–3.5 mm. Major adverse cardiac events (MACE), target lesion revascularization (TLR), target vessel failure (TVF), and stent thrombosis were evaluated 5 years after stent implantation. Results: The cumula- tive incidence of MACE was 2.0% at 1 year, 3.0% at 2 years, 6.1% at 3 years, 7.2% at 4 years, and 7.2% at 5 years. At 5 years, there were seven patients who had eight events; four noncardiac (cancer) deaths, three cases of TLR, of which one presented as a non-Q-wave MI because of a stent thrombosis at 10 days after the index proce- dure. There were no late or very late stent thromboses by any definition. TVF at 5 years was 5.2%. Conclusions: Use of the Endeavor ZES to treat symptomatic CAD due to de novo lesions in native coronary arteries resulted in sustained clinical benefits to 5 years, with low rates of MACE, TLR, TVF, and stent thrombosis. V C 2009 Wiley-Liss, Inc. Key words: coronary artery disease; drug-eluting stents; zotarolimus INTRODUCTION Drug-eluting stents (DES) have been shown to reduce significantly the incidence of restenosis and major adverse coronary events in percutaneous coro- nary interventions when compared with bare metal stents [1–3]. Current DES systems consist of four main components: the underlying stent, the drug-carrier vehi- cle, and the antiproliferative agent to be eluted and the delivery balloon. The success of each type of DES sys- tem is highly dependent on the choice of these compo- nents. The Endeavor stent system (Medtronic Cardio- Vascular, Santa Rosa, California) combines the cobalt- 1 Monash Medical Centre and Monash University, Melbourne, Australia 2 Auckland City Hospital, Auckland, New Zealand 3 Mercy Hospital, Auckland, New Zealand 4 St. Vincent’s Hospital Melbourne, Melbourne, Australia 5 University of Auckland, Auckland, New Zealand 6 St. Vincent’s Hospital Sydney, Sydney, Australia 7 Harvard Clinical Research Institute, Harvard Medical School, Boston, Massachusetts Conflict of interest: Prof. Ian T. Meredith serve as a consultant to Boston Scientific and Medtronic CardioVascular. Dr. Ormiston serves on advisory boards for Abbott Vascular and Boston Scien- tific. Dr. Whitbourn has received research/grant support from Abbott Vascular, Boston Scientific, and Medtronic CardioVascular. Dr. Muller has received research/grant support from Abbott Vascular and Medtronic CardioVascular. Dr. Kay and Dr. Cutlip have no conflicts to report. *Correspondence to: Ian T. Meredith, MBBS, PhD, MonashHEART and Monash University, Monash Medical Centre, 246 Clayton Road, Clayton, Melbourne, Australia. E-mail: ian.meredith@myheart.id.au Received 19 June 2009; Revision accepted 24 June 2009 DOI 10.1002/ccd.22206 Published online 26 October 2009 in Wiley InterScience (www. interscience.wiley.com). V C 2009 Wiley-Liss, Inc. Catheterization and Cardiovascular Interventions 74:989–995 (2009)