Comparison of zotarolimus-eluting and everolimus-eluting coronary stents.
BACKGROUND
New-generation coronary stents that release zotarolimus or everolimus have been shown to reduce the risk of restenosis. However, it is unclear whether there are differences in efficacy and safety between the two types of stents on the basis of prospectively adjudicated end points endorsed by the Food and Drug Administration.


METHODS
In this multicenter, noninferiority trial with minimal exclusion criteria, we randomly assigned 2292 patients to undergo treatment with coronary stents releasing either zotarolimus or everolimus. Twenty percent of patients were randomly selected for repeat angiography at 13 months. The primary end point was target-lesion failure, defined as a composite of death from cardiac causes, any myocardial infarction (not clearly attributable to a nontarget vessel), or clinically indicated target-lesion revascularization within 12 months. The secondary angiographic end point was the extent of in-stent stenosis at 13 months.


RESULTS
At least one off-label criterion for stent placement was present in 66% of patients. The zotarolimus-eluting stent was noninferior to the everolimus-eluting stent with respect to the primary end point, which occurred in 8.2% and 8.3% of patients, respectively (P<0.001 for noninferiority). There were no significant between-group differences in the rate of death from cardiac causes, any myocardial infarction, or revascularization. The rate of stent thrombosis was 2.3% in the zotarolimus-stent group and 1.5% in the everolimus-stent group (P=0.17). The zotarolimus-eluting stent was also noninferior regarding the degree (+/-SD) of in-stent stenosis (21.65+/-14.42% for zotarolimus vs. 19.76+/-14.64% for everolimus, P=0.04 for noninferiority). In-stent late lumen loss was 0.27+/-0.43 mm in the zotarolimus-stent group versus 0.19+/-0.40 mm in the everolimus-stent group (P=0.08). There were no significant between-group differences in the rate of adverse events.


CONCLUSIONS
At 13 months, the new-generation zotarolimus-eluting stent was found to be noninferior to the everolimus-eluting stent in a population of patients who had minimal exclusion criteria. (ClinicalTrials.gov number, NCT00617084.)
Serruys
Patrick W
PW
Department of Cardiology, Erasmus Medical Center, Molewaterplein 40, Ba-583, 3015 GD Rotterdam, The Netherlands. p.w.j.c.serruys@erasmusmc.nl
Silber
Sigmund
S
Garg
Scot
S
van Geuns
Robert Jan
RJ
Richardt
Gert
G
Buszman
Pawel E
PE
Kelbaek
Henning
H
van Boven
Adrianus Johannes
AJ
Hofma
Sjoerd H
SH
Linke
Axel
A
Klauss
Volker
V
Wijns
William
W
Macaya
Carlos
C
Garot
Philippe
P
DiMario
Carlo
C
Manoharan
Ganesh
G
Kornowski
Ran
R
Ischinger
Thomas
T
Bartorelli
Antonio
A
Ronden
Jacintha
J
Bressers
Marco
M
Gobbens
Pierre
P
Negoita
Manuela
M
van Leeuwen
Frank
F
Windecker
Stephan
S
D000368:Aged; D017023:Coronary Angiography; D003327:Coronary Disease / Q000401:mortality / Q000628:therapy*; D023903:Coronary Restenosis; D054855:Drug-Eluting Stents / Q000009:adverse effects; D000068338:Everolimus; D005260:Female; D006801:Humans; D057194:Intention to Treat Analysis; D053208:Kaplan-Meier Estimate; D008297:Male; D008875:Middle Aged; D009203:Myocardial Infarction / Q000453:epidemiology / Q000628:therapy*; D011474:Prosthesis Design; D019233:Retreatment; D020123:Sirolimus / Q000008:administration & dosage / Q000031:analogs & derivatives*; D017211:Treatment Failure
D000068338:Everolimus; C489443:zotarolimus; D020123:Sirolimus