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Www. Clinical trial results.org The C-SIRIUS Study A The Canadian Multi-Center, Randomized, Double-Blind Study of the Sirolimus-Eluting Stent in the Treatment.

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Presentation on theme: "Www. Clinical trial results.org The C-SIRIUS Study A The Canadian Multi-Center, Randomized, Double-Blind Study of the Sirolimus-Eluting Stent in the Treatment."— Presentation transcript:

1 www. Clinical trial results.org 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 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

2 www. Clinical trial results.org 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

3 www. Clinical trial results.org C-SIRIUS: Study Design 100 patients with single de novo lesions in native coronary arteries 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) Uncoated BX Velocity Stent (n=50) Clopidogrel for 2 months Major Adverse Cardiac Events (MACE) (Death / MI / CABG / TLR) 8 Month Angiographic study ACC 2003 Late Breaking Trials

4 www. Clinical trial results.org C-SIRIUS: 8 Month In-stent Angiographic Results Late Loss (mm) Binary Restenosis (%) MLD (mm) p < Bare Stent Bare Stent Sirolimus Coated Sirolimus Coated ACC 2003 Late Breaking Trials p < Bare Stent Bare Stent Sirolimus Coated Sirolimus Coated Bare Stent Bare Stent Sirolimus Coated Sirolimus Coated

5 www. Clinical trial results.org C-SIRIUS: 8 Month In-lesion Angiographic Results Late Loss (mm) Binary Restenosis (%) MLD (mm) p < Bare Stent Bare Stent Sirolimus Coated Sirolimus Coated ACC 2003 Late Breaking Trials p < Bare Stent Bare Stent Sirolimus Coated Sirolimus Coated Bare Stent Bare Stent Sirolimus Coated Sirolimus Coated

6 www. Clinical trial results.org Bare Stent Bare Stent Sirolimus Coated 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 Bare Stent Sirolimus Coated Sirolimus Coated p<0.001 Bare Stent Bare Stent Sirolimus Coated Sirolimus Coated p=NS 1/50 2/50

7 www. Clinical trial results.org 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 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


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