The SIRIUS trial assessed the safety and effectiveness of the sirolimus-eluting Bx VELOCITY stent compared to an uncoated stent in reducing target vessel failure. The trial involved over 1100 patients with de novo coronary lesions treated with either the sirolimus-eluting stent or uncoated stent. At 9 months, the primary endpoint of target vessel failure occurred in significantly fewer patients in the sirolimus-eluting stent group compared to the uncoated stent group. Secondary endpoints including MACE and TLR were also significantly reduced with the sirolimus-eluting stent at 12 months.
6. SIRIUS: Study Design De Novo Coronary Lesions Diameter: 2.5-3.5 mm Length: 15-30 mm Control Bx VELOCITY TM n = 556 CYPHER TM n = 545 n = 1101 patients Angiographic Sub-study: first 850 pts (FU at 8 months) IVUS Substudy: 250 pts at selected sites (FU at 8 months)
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10. SIRIUS: Study Procedure n = 1100 pts Single de novo native coronary lesion Pre-dilation (balloons only) Post-dilation (high pressure balloons) Bx – Sirolimus vs. non-coated
11. SIRIUS: Study Flow All Randomised Patients n = 1101 CYPHER n = 533 Control Bx VELOCITY TM 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% De-registered CYPHER (n=23) De-registered Control Bx VELOCITY TM (n=20)
12. SIRIUS: Patient Demographics 32.9 28.2 Prior MI 23.1 26.3 Prior PCI 22.4 17.7 Current Smoker 67.8 67.6 Hypertension 74.6 72.6 Hyperlipidaemia 28.2 24.6 Diabetes Mellitus 62.4 62.1 Mean age (years) 69.7 72.6 Male Control (%) (n=525) CYPHER (%) (n=533)
13. SIRIUS: Baseline Lesion Characteristics 32.4 30.0 RCA 0.6 0.6 Other 20.6 26.0 C 33.5 32.6 B2 38.1 34.0 B1 7.8 7.4 AHA/ACC A 23.9 25.3 LCx 43.2 44.2 LAD Control (%) (n=525) CYPHER (%) (n=533)
24. CP1104360-1 Freedom from events (%) Post procedure (days) Cypher TLR Control TLR Cypher MACE Control MACE Cypher TVF Control TVF Event-free survival at 1 year for TLR, MACE & TVF