Five-year clinical follow-up after implantation of the endeavor zotarolimus-eluting stent: ENDEAVOR I, first-in-human study

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 cumulative 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 procedure. 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. © 2009 Wiley‐Liss, Inc.