Rationale and design of a randomized clinical comparison of everolimus-eluting (Xience v/Promus) and sirolimus-eluting (cypher select+) coronary stents in unselected patients with coronary heart disease.
BACKGROUND
The sirolimus-eluting stent has demonstrated the least amount of late lumen loss among previously released drug-eluting stents, but its safety and efficacy has not been compared head-to-head with the everolimus-eluting stent.


METHODS
The Scandinavian Organization for Randomized Trials with Clinical Outcome (SORT OUT) IV trial was designed as a prospective, multi-center, open-label, all-comer, two-arm, randomized, non-inferiority study comparing the everolimus-eluting stent with the sirolimus-eluting stent in the treatment of atherosclerotic coronary artery lesions. Based on a non-inferiority design, power calculations estimated a needed enrolment of 2,678 patients. The primary endpoint is a composite of cardiac death, myocardial infarction, and stent thrombosis or target vessel revascularization after 9 months. Data on clinical events and mortality for all randomized patients will be obtained from national databases at 9 months. No clinical follow-up examination is scheduled.


CONCLUSIONS
The SORT OUT IV trial will directly compare clinically relevant differences in efficacy and safety in two drug-eluting stents: a first-generation sirolimus-eluting stent versus a second-generation everolimus-eluting stent. The study makes use of clinical endpoints routinely collected in computerized healthcare registries, allowing complete follow-up of a large, well-defined population without scheduled angiographic examinations.
Jensen
Lisette Okkels
LO
Department of Cardiology, Odense University Hospital, Odense, Denmark. okkels@dadlnet.dk
Thayssen
Per
P
Tilsted
Hans Henrik
HH
Ravkilde
Jan
J
Junker
Anders
A
Hansen
Henrik Steen
HS
Hansen
Knud Nørregaard
KN
Pedersen
Knud Erik
KE
Sørensen
Henrik Toft
HT
Thuesen
Leif
L
Lassen
Jens Flensted
JF
D015906:Angioplasty, Balloon, Coronary; D003327:Coronary Disease / Q000628:therapy*; D054855:Drug-Eluting Stents; D000068338:Everolimus; D005500:Follow-Up Studies; D006801:Humans; D007166:Immunosuppressive Agents / Q000008:administration & dosage; D012107:Research Design; D018401:Sample Size; D020123:Sirolimus / Q000008:administration & dosage* / Q000031:analogs & derivatives*
D007166:Immunosuppressive Agents; D000068338:Everolimus; D020123:Sirolimus