1 / 12

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

hazel
Download Presentation

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

An Image/Link below is provided (as is) to download presentation Download Policy: Content on the Website is provided to you AS IS for your information and personal use and may not be sold / licensed / shared on other websites without getting consent from its author. Content is provided to you AS IS for your information and personal use only. Download presentation by click this link. While downloading, if for some reason you are not able to download a presentation, the publisher may have deleted the file from their server. During download, if you can't get a presentation, the file might be deleted by the publisher.

E N D

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. 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

More Related