Randomized comparison of everolimus-eluting and sirolimus-eluting stents in patients treated with percutaneous coronary intervention: the Scandinavian Organization for Randomized Trials with Clinical Outcome IV (SORT OUT IV).
BACKGROUND
Among drug-eluting stents released to date, the sirolimus-eluting stent has demonstrated the least amount of late lumen loss, but its efficacy and safety have not been compared head-to-head with the next-generation everolimus-eluting stent.


RESULTS
The Scandinavian Organization for Randomized Trials with Clinical Outcome IV (SORT OUT IV) trial was a randomized multicenter, single-blind, all-comer, 2-arm, noninferiority trial comparing the everolimus-eluting stent with the sirolimus-eluting stent in patients with coronary artery disease. The primary end point was a composite of safety (cardiac death, myocardial infarction, definite stent thrombosis) and efficacy (target vessel revascularization) parameters. The noninferiority criterion was a risk difference of 0.015. Intention-to-treat analyses were done at 9- and 18-month follow-ups. A total of 1390 patients were assigned to receive the everolimus-eluting stent and 1384 patients to the sirolimus-eluting stent. At the 9-month follow-up, 68 patients (4.9%) treated with the everolimus-eluting stent compared with 72 patients (5.2%) treated with the sirolimus-eluting stent experienced the primary end point (hazard ratio, 0.94; 95% confidence interval, 0.67-1.31; P for noninferiority=0.01). At the 18-month follow-up, this differential remained: 99 patients (7.2%) treated with the everolimus-eluting stent versus 105 (7.6%) treated with the sirolimus-eluting stent (hazard ratio, 0.94; 95% confidence interval, 0.71-1.23). At the 9-month follow-up, the rate of definite stent thrombosis was higher in the sirolimus-eluting group (2 patients [0.1%] versus 9 patients [0.7%]; hazard ratio, 0.22; 95% confidence interval, 0.05-1.02). At the 18-month follow-up, this difference was sustained (3 patients [0.2%] versus 12 patients [0.9%]; hazard ratio, 0.25; 95% confidence interval, 0.07-0.88).


CONCLUSIONS
The everolimus-eluting stent was found to be noninferior to the sirolimus-eluting stent.


BACKGROUND
URL: http://www.clinicaltrials.gov. Unique identifier: NCT00552877.
Department of Cardiology, Odense University Hospital, Denmark. okkels@dadlnet.dk
Lisette Okkels
LO
Jensen
Per
P
Thayssen
Henrik Steen
HS
Hansen
Evald Høj
EH
Christiansen
Hans Henrik
HH
Tilsted
Lars Romer
LR
Krusell
Anton Boel
AB
Villadsen
Anders
A
Junker
Knud Nørregaard
KN
Hansen
Anne
A
Kaltoft
Michael
M
Maeng
Knud Erik
KE
Pedersen
Steen Dalby
SD
Kristensen
Hans Erik
HE
Bøtker
Jan
J
Ravkilde
Richardo
R
Sanchez
Jens
J
Aarøe
Morten
M
Madsen
Henrik Toft
HT
Sørensen
Leif
L
Thuesen
Jens Flensted
JF
Lassen
D000368:Aged; D015906:Angioplasty, Balloon, Coronary / Q000379:methods* / Q000401:mortality; D003324:Coronary Artery Disease / Q000401:mortality / Q000628:therapy*; D023903:Coronary Restenosis / Q000401:mortality / Q000517:prevention & control; D003328:Coronary Thrombosis / Q000401:mortality / Q000517:prevention & control; D054855:Drug-Eluting Stents; D000068338:Everolimus; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007166:Immunosuppressive Agents / Q000008:administration & dosage; D008297:Male; D008875:Middle Aged; D012307:Risk Factors; D020123:Sirolimus / Q000008:administration & dosage* / Q000031:analogs & derivatives*; D016896:Treatment Outcome
D007166:Immunosuppressive Agents; D000068338:Everolimus; D020123:Sirolimus