A randomized comparison of the Endeavor zotarolimus-eluting stent versus the TAXUS paclitaxel-eluting stent in de novo native coronary lesions 12-month outcomes from the ENDEAVOR IV trial.
OBJECTIVE
The ENDEAVOR IV (Randomized Comparison of Zotarolimus-Eluting and Paclitaxel-Eluting Stents in Patients with Coronary Artery Disease) trial evaluated the safety and efficacy of the zotarolimus-eluting stent (ZES) compared with the paclitaxel-eluting stent (PES).


BACKGROUND
First-generation drug-eluting stents have reduced angiographic and clinical restenosis, but long-term safety remains controversial. A second-generation drug-eluting stent, which delivers zotarolimus, a potent antiproliferative agent, via a biocompatible phosphorylcholine polymer on a cobalt alloy thin-strut stent has shown promising experimental and early clinical results.


METHODS
This is a prospective, randomized (1:1), single-blind, controlled trial comparing outcomes of patients with single de novo coronary lesions treated with ZES or PES. The primary end point was noninferiority of 9-month target vessel failure defined as cardiac death, myocardial infarction, or target vessel revascularization.


RESULTS
Among a total of 1,548 patients assigned to ZES (n = 773) or PES (n = 775), at 9 months, ZES was noninferior to PES with rates of target vessel failure 6.6% versus 7.1%, respectively (p(noninferiority) < or = 0.001). There were fewer periprocedural myocardial infarctions with ZES (0.5% vs. 2.2%; p = 0.007), whereas at 12 months, there were no significant differences between groups in rates of cardiac death, myocardial infarction, target vessel revascularization, or stent thrombosis. Although incidence of 8-month binary angiographic in-segment restenosis was higher in patients treated with ZES versus PES (15.3% vs. 10.4%; p = 0.284), rates of 12-month target lesion revascularization were similar (4.5% vs. 3.2%; p = 0.228), especially in patients without planned angiographic follow-up (3.6% vs. 3.2%; p = 0.756).


CONCLUSIONS
These findings demonstrate that ZES has similar clinical safety and efficacy compared with PES in simple and medium complexity single de novo coronary lesions. (ENDEAVOR IV Clinical Trial; NCT00217269).
Columbia University Medical Center and the Cardiovascular Research Foundation, New York, New York, USA. mleon@crf.org
Martin B
MB
Leon
Laura
L
Mauri
Jeffrey J
JJ
Popma
Donald E
DE
Cutlip
Eugenia
E
Nikolsky
Charles
C
O'Shaughnessy
Paul A
PA
Overlie
Brent T
BT
McLaurin
Stuart L
SL
Solomon
John S
JS
Douglas
Michael W
MW
Ball
Ronald P
RP
Caputo
Ash
A
Jain
Thaddeus R
TR
Tolleson
Bernard M
BM
Reen
Ajay J
AJ
Kirtane
Peter J
PJ
Fitzgerald
Kweli
K
Thompson
David E
DE
Kandzari
D000368:Aged; D003324:Coronary Artery Disease / Q000188:drug therapy*; D054855:Drug-Eluting Stents; D005260:Female; D006801:Humans; D007166:Immunosuppressive Agents / Q000008:administration & dosage*; D008297:Male; D008875:Middle Aged; D017239:Paclitaxel / Q000008:administration & dosage*; D016037:Single-Blind Method; D020123:Sirolimus / Q000008:administration & dosage / Q000031:analogs & derivatives*; D016896:Treatment Outcome
D007166:Immunosuppressive Agents; C489443:zotarolimus; D017239:Paclitaxel; D020123:Sirolimus