The C-SIRIUS Study
A The Canadian Multi-Center, Randomized, Double-Blind
Study of the Sirolimus-Eluting Stent in the
Treatment of Patients with De Novo
Coronary Artery Lesions
Erick Schampaert,
Eric A. Cohen, Francois Reeves, Laurence M. Title,
M. Dean Traboulsi, Richard R. Mildenberger,
Dominic Raco, Sylvain Plante, Jeffrey Popma
Presented at ACC 2003 Late Breaking Clinical Trials
C-SIRIUS: Background
Sirolimus (Rapamune? - Wyeth Ayerst) is a naturally occurring macrocyclic antibiotic
It is a potent immunosuppressive agent inducing late G1 cell cycle arrest
ACC 2003 Late Breaking Trials
C-SIRIUS: Study Design
100 patients with single de novo lesions in native coronary arteries 15-32 mm in length and 2.5 to 3.0 mm in diameter, randomized trial in Canada to
BX Velocity Stent Coated with Sirolimus (n=50)
Uncoated BX Velocity Stent
(n=50)
Clopidogrel for 2 months
Clopidogrel for 2 months
+
+
Major Adverse Cardiac Events (MACE) (Death / MI / CABG / TLR)
8 Month Angiographic study
ACC 2003 Late Breaking Trials
C-SIRIUS: 8 Month In-stent Angiographic Results
Late Loss (mm)
Binary Restenosis (%)
MLD (mm)
p < 0.001
Bare
Stent
Sirolimus
Coated
ACC 2003 Late Breaking Trials
p < 0.001
p < 0.001
Bare
Stent
Sirolimus
Coated
Bare
Stent
Sirolimus
Coated
C-SIRIUS: 8 Month In-lesion Angiographic Results
Late Loss (mm)
Binary Restenosis (%)
MLD (mm)
p < 0.001
Bare
Stent
Sirolimus
Coated
ACC 2003 Late Breaking Trials
p < 0.001
p < 0.001
Bare
Stent
Sirolimus
Coated
Bare
Stent
Sirolimus
Coated
Bare
Stent
Sirolimus
Coated
p<0.001
MACE*
TLR
Non-Q-Wave MI
C-SIRIUS: 9 Month Clinical Event Results
MACE = Death/MI/Emergent CABG/TLR
Bare
Stent
Sirolimus
Coated
p<0.001
Bare
Stent
Sirolimus
Coated
p=NS
1/50
2/50
C-SIRIUS: Conclusions
Treatment of a single de novo lesion with a sirolimus-eluting stent was associated with larger MLDs and a reduction in binary restenosis on 8 month angiographic follow-up
The angiographic results were similar to those in RAVEL but in longer lesions (12-32 mm) with smaller reference diameters (mean 2.6 mm)
MACE by 9 months was reduced in sirolimus-eluting stent arm but was driven entirely by target lesion revascularization (no deaths or Q-wave MIs in either arm)
Patients will be followed for clinical events for 5 years
ACC 2003 Late Breaking Trials