Comparison of zotarolimus-eluting stents with sirolimus- and paclitaxel-eluting stents for coronary revascularization: the ZEST (comparison of the efficacy and safety of zotarolimus-eluting stent with sirolimus-eluting and paclitaxel-eluting stent for coronary lesions) randomized trial.
OBJECTIVE
The aim of this study was to evaluate the relative efficacy and safety of zotarolimus-eluting stents (ZES) in comparison with the established and widely used sirolimus- (SES) and paclitaxel-eluting stents (PES) in routine clinical practice.


BACKGROUND
Whether ZES might provide similar clinical and angiographic outcomes in a broad spectrum of patients compared with SES or PES is undetermined.


METHODS
We performed a single-blind, multicenter, prospectively randomized trial to compare ZES with SES and PES in 2,645 patients undergoing percutaneous coronary intervention. The primary end point was a composite of major adverse cardiac events (MACE) (death, myocardial infarction, and ischemia-driven target vessel revascularization) at 12 months. A noninferiority comparison (ZES vs. SES) and a superiority comparison (ZES vs. PES) were performed for the primary end point.


RESULTS
Baseline clinical and angiographic characteristics were similar in the 3 groups. At 12 months, the ZES group showed noninferior rates of MACE compared with the SES group (10.2% vs. 8.3%, p for noninferiority = 0.01, p for superiority = 0.17) and significantly fewer MACE than the PES group (10.2% vs. 14.1%, p for superiority = 0.01). The incidence of death or myocardial infarction was similar among the groups (ZES vs. SES vs. PES, 5.8% vs. 6.9% vs. 7.6%, respectively, p = 0.31). The incidence of stent thrombosis was significantly lower in the SES group (ZES vs. SES vs. PES, 0.7% vs. 0% vs. 0.8%, respectively, p = 0.02).


CONCLUSIONS
In this large-scale, practical randomized trial, the use of ZES resulted in similar rates of MACE compared with SES and in fewer MACE compared with PES at 12 months. (Comparison of the Efficacy and the Safety of Zotarolimus-Eluting Stent Versus Sirolimus-Eluting Stent and PacliTaxel-Eluting Stent for Coronary Lesions; NCT00418067).
Park
Duk-Woo
DW
Department of Cardiology, Center for Medical Research and Information, University of Ulsan College of Medicine, Asan Medical Center, Seoul, Korea.
Kim
Young-Hak
YH
Yun
Sung-Cheol
SC
Kang
Soo-Jin
SJ
Lee
Seung-Whan
SW
Lee
Cheol-Whan
CW
Park
Seong-Wook
SW
Seong
In-Whan
IW
Lee
Jae-Hwan
JH
Tahk
Seung-Jea
SJ
Jeong
Myung-Ho
MH
Jang
Yangsoo
Y
Cheong
Sang-Sig
SS
Yang
Joo-Young
JY
Lim
Do-Sun
DS
Seung
Ki-Bae
KB
Chae
Jei-Keon
JK
Hur
Seung-Ho
SH
Lee
Sang-Gon
SG
Yoon
Junghan
J
Lee
Nae-Hee
NH
Choi
Young-Jin
YJ
Kim
Hyun-Sook
HS
Kim
Kee-Sik
KS
Kim
Hyo-Soo
HS
Hong
Taeg-Jong
TJ
Park
Hun-Sik
HS
Park
Seung-Jung
SJ
D000368:Aged; D002318:Cardiovascular Diseases / Q000209:etiology / Q000401:mortality; D023903:Coronary Restenosis / Q000209:etiology / Q000401:mortality; D054855:Drug-Eluting Stents / Q000009:adverse effects; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D008875:Middle Aged; D015425:Myocardial Reperfusion / Q000009:adverse effects / Q000295:instrumentation*; D017239:Paclitaxel / Q000008:administration & dosage* / Q000009:adverse effects; D011446:Prospective Studies; D016037:Single-Blind Method; D020123:Sirolimus / Q000008:administration & dosage* / Q000009:adverse effects / Q000031:analogs & derivatives*; D016896:Treatment Outcome
C489443:zotarolimus; D017239:Paclitaxel; D020123:Sirolimus