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 > or = 50% stenosis, be < or = 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.
Meredith
Ian T
IT
Monash Medical Centre and Monash University, 246 Clayton Road, Clayton, Melbourne, Australia. ian.meredith@myheart.id.au
Ormiston
John
J
Whitbourn
Robert
R
Kay
I Patrick
IP
Muller
David
D
Cutlip
Donald E
DE
D000328:Adult; D000368:Aged; D015906:Angioplasty, Balloon, Coronary / Q000009:adverse effects / Q000295:instrumentation* / Q000401:mortality; D001315:Australia; D002317:Cardiovascular Agents / Q000008:administration & dosage*; D017023:Coronary Angiography; D023921:Coronary Stenosis / Q000000981:diagnostic imaging / Q000401:mortality / Q000628:therapy*; D054855:Drug-Eluting Stents; D005260:Female; D006801:Humans; D008297:Male; D008404:Massachusetts; D008875:Middle Aged; D009203:Myocardial Infarction / Q000209:etiology; D009520:New Zealand; D011446:Prospective Studies; D011474:Prosthesis Design; D012720:Severity of Illness Index; D020123:Sirolimus / Q000008:administration & dosage / Q000031:analogs & derivatives*; D013927:Thrombosis / Q000209:etiology; D013997:Time Factors; D016896:Treatment Outcome
D002317:Cardiovascular Agents; C489443:zotarolimus; D020123:Sirolimus