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.

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