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The C-SIRIUS Study

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,

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The C-SIRIUS Study

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  1. 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

  2. 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. 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 Uncoated BX Velocity Stent (n=50) BX Velocity Stent Coated with Sirolimus (n=50) + + Clopidogrel for 2 months Clopidogrel for 2 months 8 Month Angiographic study Major Adverse Cardiac Events (MACE) (Death / MI / CABG / TLR) ACC 2003 Late Breaking Trials

  4. C-SIRIUS: 8 Month In-stent Angiographic Results p < 0.001 p < 0.001 p < 0.001 MLD (mm) Late Loss (mm) Binary Restenosis (%) Bare Stent Sirolimus Coated Bare Stent Sirolimus Coated Bare Stent Sirolimus Coated ACC 2003 Late Breaking Trials

  5. C-SIRIUS: 8 Month In-lesion Angiographic Results p < 0.001 p < 0.001 p < 0.001 Binary Restenosis (%) Late Loss (mm) MLD (mm) Bare Stent Sirolimus Coated Bare Stent Sirolimus Coated Bare Stent Sirolimus Coated ACC 2003 Late Breaking Trials

  6. C-SIRIUS: 9 Month Clinical Event Results TLR MACE* Non-Q-Wave MI p<0.001 p=NS p<0.001 2/50 1/50 Sirolimus Coated Sirolimus Coated Sirolimus Coated Bare Stent Bare Stent Bare Stent MACE = Death/MI/Emergent CABG/TLR

  7. 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

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