Five-year follow-up after sirolimus-eluting stent implantation results of the SIRIUS (Sirolimus-Eluting Stent in De-Novo Native Coronary Lesions) Trial.
OBJECTIVE
The aim of this study was to examine the 5-year clinical safety and efficacy outcomes in patients enrolled in the SIRIUS (Sirolimus-Eluting Stent in De-Novo Native Coronary Lesions) trial.


BACKGROUND
The SIRIUS trial was a double-blinded randomized study that 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 (n = 1,058) with de novo native coronary artery lesions were randomized to either SES (n = 533) or control BMS (n = 525) and were followed for 5 years.


RESULTS
Between 1 and 5 years, additional clinical events were similarly distributed among the sirolimus and control groups. At 5 years, in sirolimus versus control patients, target lesion revascularization was 9.4% versus 24.2% (p < 0.001) and major adverse cardiovascular events and target vessel failure rates were 20.3% versus 33.5% and 22.5% versus 33.5%, respectively (p < 0.0001 for both). There were no significant differences in death, myocardial infarction, and nontarget lesion revascularization. No significant differences were observed in the cumulative incidence of stent thrombosis for sirolimus versus control patients with either protocol-derived (1.0% vs. 0.8%) or Academic Research Consortium definitions (3.9% vs. 4.2%).


CONCLUSIONS
In patients with noncomplex coronary artery disease, clinical outcomes 5 years after implantation of SES continue to demonstrate significant reduction in the need for repeat revascularization, with similar safety (death and myocardial infarction) compared with BMS, without evidence for either disproportionate late restenosis or late stent thrombosis.
Weisz
Giora
G
Center for Interventional Vascular Therapy, New York-Presbyterian Hospital, Columbia University, and Cardiovascular Research Foundation, New York, USA. gweisz@crf.org
Leon
Martin B
MB
Holmes
David R
DR
Kereiakes
Dean J
DJ
Popma
Jeffrey J
JJ
Teirstein
Paul S
PS
Cohen
Sidney A
SA
Wang
Hong
H
Cutlip
Donald E
DE
Moses
Jeffrey W
JW
D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D016001:Confidence Intervals; D023903:Coronary Restenosis / Q000188:drug therapy* / Q000401:mortality; D004311:Double-Blind Method; D054855:Drug-Eluting Stents; D005260:Female; D006801:Humans; D007166:Immunosuppressive Agents / Q000627:therapeutic use*; D053208:Kaplan-Meier Estimate; D008297:Male; D008875:Middle Aged; D015999:Multivariate Analysis; D016017:Odds Ratio; D012307:Risk Factors; D020123:Sirolimus / Q000627:therapeutic use*; D017741:Survivors; D013997:Time Factors
D007166:Immunosuppressive Agents; D020123:Sirolimus