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SIRIUS: A U.S. Multicenter, Randomized, Double-Blind Study of the SIRolImUS-Eluting Stent in De Novo Native Coronary Lesions Presented at TCT 2002.

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Presentation on theme: "SIRIUS: A U.S. Multicenter, Randomized, Double-Blind Study of the SIRolImUS-Eluting Stent in De Novo Native Coronary Lesions Presented at TCT 2002."— Presentation transcript:

1 SIRIUS: A U.S. Multicenter, Randomized, Double-Blind Study of the SIRolImUS-Eluting Stent in De Novo Native Coronary Lesions Presented at TCT 2002

2 De Novo Coronary Lesions
SIRIUS: Study Design n = 1,101 patients Control Bx VELOCITYTM n = 545 De Novo Coronary Lesions Diameter: mm Length: mm Sirolimus-eluting Bx VELOCITYTM n = 556 Primary Endpoint: Target vessel failure (TVF) = cardiac death, MI or TVR (FU at 9 months) Angiographic Substudy: First 850 pts (FU at 8 months) IVUS Substudy: 250 pts at selected sites (FU at 8 months) TCT 2002

3 All Randomized Patients n = 1,101
SIRIUS: Study Flow All Randomized Patients n = 1,101 De-registered Sirolimus-eluting Bx VELOCITYTM n = 23 De-registered Control Bx VELOCITYTM n = 20 Sirolimus-eluting Bx VELOCITYTM n = 533 Control Bx VELOCITYTM n = 525 Angio FU at 8 Months = 85.4% Clinical FU at 9 Months = 95.7% Angio FU at 8 Months = 84.7% Clinical FU at 9 Months = 95.8% TCT 2002

4 SIRIUS: 8 Month Angiographic Follow-up Restenosis Rates
In-stent Restenosis In-segment Restenosis 91% reduction p<0.001 75% reduction p<0.001 Sirolimus Stent Bare Stent Sirolimus Stent Bare Stent TCT 2002

5 SIRIUS: 8 Month Angiographic Follow-up Late Lumen Loss
Proximal Margin p<0.001 In-stent p<0.001 Distal Margin p<0.001 Late Lumen Loss (mm) Sirolimus Stent Bare Stent Sirolimus Stent Bare Stent Sirolimus Stent Bare Stent TCT 2002

6 SIRIUS: Restenosis Events Prevented
Number of In-segment Restenosis Events Prevented per 100 Patients All patients Diabetes Small Vessels Long Lesions LAD TCT 2002

7 SIRIUS: Clinical Events Through 9 Months Target Vessel Failure*
MACE Target Vessel Failure* *Primary clinical endpoint; defined as cardiac death, MI, TVR p<0.001 p<0.001 Sirolimus Stent Bare Stent Sirolimus Stent Bare Stent TCT 2002

8 In-segment Restenosis
SIRIUS: Diabetic Patient Restenosis Rates at 8 Month Angiographic Follow-up n = 279 Diabetic Patients In-stent Restenosis In-segment Restenosis 83% reduction p < 0.001 65% reduction p < 0.001 Sirolimus Stent Bare Stent Sirolimus Stent Bare Stent TCT 2002

9 SIRIUS: Patterns of In-stent Restenosis
n = 159 Patients Baseline Lesion Length (mm) Restenosis Lesion Length (mm) p = NS p < 0.001 Sirolimus Stent Bare Stent Sirolimus Stent Bare Stent TCT 2002

10 SIRIUS: LAD Lesion Restenosis Rates at 8 Month Angiographic Follow-up
n = 462 LAD Lesions In-stent Restenosis In-segment Restenosis 95% reduction p < 0.001 76% reduction p < 0.001 Sirolimus Stent Bare Stent Sirolimus Stent Bare Stent TCT 2002

11 SIRIUS: LAD Lesion Clinical Events Through 9 Months Follow-up
n = 462 LAD Lesions MACE Target Lesion Revascularization p < 0.001 p < 0.001 Sirolimus Stent Bare Stent Sirolimus Stent Bare Stent TCT 2002

12 SIRIUS: Overlapping Stent Subgroup 8 Month Angiographic Follow-up
n = 344 Overlapping Stent Subgroup In-stent Restenosis In-segment Restenosis Late Lumen Loss (mm) p < 0.001 p < 0.001 p < 0.001 Sirolimus Stent Bare Stent Sirolimus Stent Bare Stent Sirolimus Stent Bare Stent TCT 2002

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