3-Year clinical outcomes in the randomized SORT OUT III superiority trial comparing zotarolimus- and sirolimus-eluting coronary stents.
OBJECTIVE
This study sought to examine the 3-year clinical outcomes in patients treated with the Endeavor (Medtronic, Santa Rosa, California) zotarolimus-eluting stent (ZES) or the Cypher (Cordis, Johnson & Johnson, Warren, New Jersey) sirolimus-eluting stent (SES) in routine clinical practice.


BACKGROUND
The long-term clinical outcome in patients treated with ZES in comparison with SES is unclear.


METHODS
The authors randomized 2,332 patients to ZES (n = 1,162) or SES (n = 1,170) implantation. Endpoints included major adverse cardiac events (MACE), a composite of cardiac death, myocardial infarction, or target vessel revascularization; the individual endpoints of MACE; and definite stent thrombosis.


RESULTS
At 3-year follow-up, the MACE rate was higher in patients treated with ZES than in patients treated with SES (148 [12.9%] vs. 116 [10.1%]; hazard ratio [HR]: 1.33, 95% confidence interval [CI]: 1.04 to 1.69; p = 0.022). Target vessel revascularization was more frequent in the ZES group compared with the SES group (103 [9.1%] vs. 76 [6.7%]; HR: 1.40, 95% CI: 1.04 to 1.89; p = 0.025), whereas the occurrence of myocardial infarction (3.8% vs. 3.3%) and cardiac death (2.8% vs. 2.8%) did not differ significantly. Although the rate of definite stent thrombosis was similar at 3-year follow-up (1.1% vs. 1.4%), very late (12 to 36 months) definite stent thrombosis occurred in 0 (0%) patients in the ZES group versus 12 (1.1%) patients in the SES group (p = 0.0005).


CONCLUSIONS
Although the 3-year MACE rate is higher in patients treated with ZES versus SES, our data highlight a late safety problem concerning definite stent thrombosis with the use of SES. This finding underscores the importance of long-term follow-up in head-to-head comparisons of drug-eluting stents. (Randomized Clinical Comparison of the Endeavor and the Cypher Coronary Stents in Non-selected Angina Pectoris Patients [SORT OUT III]; NCT00660478).
Department of Cardiology, Aarhus University Hospital, Skejby, Aarhus, Denmark. maeng@ki.au.dk
Michael
M
Maeng
Hans-Henrik
HH
Tilsted
Lisette Okkels
LO
Jensen
Anne
A
Kaltoft
Henning
H
Kelbæk
Ulrik
U
Abildgaard
Anton B
AB
Villadsen
Lars Romer
LR
Krusell
Jan
J
Ravkilde
Knud Nørregaard
KN
Hansen
Evald Høj
EH
Christiansen
Jens
J
Aarøe
Jan Skov
JS
Jensen
Steen Dalby
SD
Kristensen
Hans Erik
HE
Bøtker
Morten
M
Madsen
Per
P
Thayssen
Henrik Toft
HT
Sørensen
Leif
L
Thuesen
Jens Flensted
JF
Lassen
D003324:Coronary Artery Disease / Q000188:drug therapy* / Q000601:surgery*; D054855:Drug-Eluting Stents; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D008875:Middle Aged; D020123:Sirolimus / Q000008:administration & dosage* / Q000031:analogs & derivatives*; D013997:Time Factors; D016896:Treatment Outcome
C489443:zotarolimus; D020123:Sirolimus