Two-year outcomes after sirolimus-eluting stent implantation: results from the Sirolimus-Eluting Stent in de Novo Native Coronary Lesions (SIRIUS) trial.
OBJECTIVE
The purpose of this study was to examine the two-year clinical outcomes in patients enrolled in the Sirolimus-Eluting Stent in De Novo Native Coronary Lesions (SIRIUS) study.


BACKGROUND
The SIRIUS study was a double-blinded randomized study which demonstrated that sirolimus-eluting stents (SES) significantly improved angiographic results (at 8 months) and clinical outcomes (at 9 and 12 months) compared with bare-metal stents (BMS).


METHODS
Patients with de novo native coronary artery lesions randomized to either SES (533 patients) or control BMS (525 patients) were followed for two years.


RESULTS
Between one and two years, there were infrequent additional clinical events that were equally distributed between the sirolimus and control groups. After two years, target lesion revascularization was 5.8% and 21.3% in SES and control patients, respectively (p < 0.001), and major adverse cardiovascular events and target vessel failure rates were 10.1% versus 24.4% and 12.0% versus 26.7%, respectively (p < 0.0001 for both). There were no differences in death, myocardial infarction, and stent thrombosis between the two groups.


CONCLUSIONS
Clinical outcomes two years after implantation of SES continue to demonstrate significant reduction in the need for repeat target lesion (and vessel) revascularization compared with BMS without evidence for either disproportionate late restenosis or late stent thrombosis.
Weisz
Giora
G
Cardiovascular Research Foundation and Columbia University Medical Center, New York, New York 10032, USA.
Leon
Martin B
MB
Holmes
David R
DR
Kereiakes
Dean J
DJ
Clark
Mel R
MR
Cohen
Barry M
BM
Ellis
Stephen G
SG
Coleman
Patrick
P
Hill
Carolyn
C
Shi
Chunxue
C
Cutlip
Donald E
DE
Kuntz
Richard E
RE
Moses
Jeffrey W
JW
D017023:Coronary Angiography; D003327:Coronary Disease / Q000000981:diagnostic imaging / Q000628:therapy*; D004311:Double-Blind Method; D005500:Follow-Up Studies; D006801:Humans; D015994:Incidence; D015337:Multicenter Studies as Topic; D016032:Randomized Controlled Trials as Topic; D020123:Sirolimus / Q000008:administration & dosage* / Q000627:therapeutic use; D015607:Stents / Q000009:adverse effects; D013927:Thrombosis / Q000453:epidemiology / Q000209:etiology; D016896:Treatment Outcome
D020123:Sirolimus