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SIRIUS: A U.S. Multicenter, Randomized, Double-Blind Study of the SIR ol I m US -Eluting Stent in De Novo Native Corona

SIRIUS: A U.S. Multicenter, Randomized, Double-Blind Study of the SIR ol I m US -Eluting Stent in De Novo Native Coronary Lesions. Presented at TCT 2002. SIRIUS: Study Design. n = 1,101 patients. Control Bx VELOCITY TM n = 545. De Novo Coronary Lesions Diameter: 2.5-3.5 mm

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SIRIUS: A U.S. Multicenter, Randomized, Double-Blind Study of the SIR ol I m US -Eluting Stent in De Novo Native Corona

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  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. SIRIUS: Study Design n = 1,101 patients Control Bx VELOCITYTM n = 545 De Novo Coronary Lesions Diameter: 2.5-3.5 mm Length: 15-30 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. SIRIUS: Study Flow All Randomized Patients n = 1,101 De-registered Control Bx VELOCITYTM n = 20 De-registered Sirolimus-eluting Bx VELOCITYTM n = 23 Control Bx VELOCITYTM n = 525 Sirolimus-eluting Bx VELOCITYTM n = 533 Angio FU at 8 Months = 84.7% Clinical FU at 9 Months = 95.8% Angio FU at 8 Months = 85.4% Clinical FU at 9 Months = 95.7% TCT 2002

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

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

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

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

  8. SIRIUS: Diabetic Patient Restenosis Rates at 8 Month Angiographic Follow-up n = 279 Diabetic Patients In-stent Restenosis In-segment Restenosis 65% reduction p < 0.001 83% reduction p < 0.001 Sirolimus Stent Sirolimus Stent Bare 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 Sirolimus Stent Bare 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 76% reduction p < 0.001 95% reduction p < 0.001 Sirolimus Stent Sirolimus Stent Bare 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 Sirolimus Stent Bare 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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