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) SIRIUS: Study Procedure n = 1100 pts Single de novo native coronary lesion Pre-dilation (balloons only) Post-dilation (high pressure balloons) Bx – Sirolimus vs. SIRIUS: Exclusion Criteria Recent MI ( Unprotected left main disease Ostial location Total occlusion (TIMI 0 flow) Angiographic evidence of thrombus Calcified lesion which cannot be predilated LV ejection fraction Impaired renal function Pretreatment with devices other than balloon angioplasty Allergy to aspirin or clopidogrel (ticlopidine) Prior or planned intervention within 30 days
SIRIUS: Inclusion Criteria Single de novo coronary lesion Reference vessel > 2.5mm and > 3.5 mm * Lesion length: > 15mm and Diameter Stenosis: > 50% and CCS angina or unstable angina (Braunwald B&C, I-II) or documented silent ischaemia * Visual estimate
Clopidogrel (loading dose, 75mg/day) or Ticlopidine (loading dose, 250mg/2x day) During procedure Heparin (bolus and additional to maintain ACT > 250 secs) IIb/IIIa inhibitors – operator discretion Post-procedure Aspirin (325mg/day) – indefinitely Clopidogrel (75mg/day) or Ticlopidine (250mg/2x day) } > 24hrs } 3 months SIRIUS: Pharmacologic Regimen Pre-procedure Aspirin (325mg) > 24 hrs. 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) IVUS core lab: Peter Fitzgerald, Stanford (Palo Alto) Economic core lab: David Cohen, Beth Israel (Boston) Industry sponsor: Cordis. Angiographic core lab: Jeffrey Popma, Brigham & Women’s Hospital. SIRIUS: Study Design Principal investigators: Martin Leon and Jeffrey Moses, Lenox Hill Study coordination: Richard Kuntz, Brigham & Women’s Hospital. Economic factors – index hospitalisation costs, length of stay, and repeat hospitalisations (for up to 12 months). Device success, lesion success, and procedure success (in-hospital). Angiographic binary restenosis ( 50% DS) at 8 months.
Secondary: MACE at 1, 6, 9, 12m, and annually to 5 years. SIRIUS: Endpoints Primary: 9m Target Vessel Failure (cardiac death, MI, or TVR). SIRIUS: Purpose To assess the safety and effectiveness of the sirolimus-eluting Bx VELOCITY™ in reducing target vessel failure in de novo native coronary artery lesions compared with the uncoated Bx stent.