TAXUS IV Trial Slow-rate release polymer-based paclitaxel-eluting stent compared with bare stent in patients with single de novo coronary lesions Presented at TCT 2003

TAXUS IV Trial 1,326 patients with single de novo lesions Lesions 10-28 mm in length and 2.5-3.75 mm in diameter; Double blind, randomized trial Paclitaxel-eluting stent Slow-release formulation n=662 Bare Stent n= 652 Endpoints (follow-up 1 year): Primary – Ischemic driven target vessel revascularization, adjudicated by CEC Secondary – MACE at 30 days and 1 year, defined as cardiac death, MI, or TVR; angiographic restenosis at 9 months; IVUS at 9 months TCT 2003

Target lesion revascularization TAXUS IV Trial Target vessel revascularization p<0.0001 Target lesion revascularization p<0.0001 TCT 2003

TAXUS IV Trial Mortality at 1 year MACE at 1 year p=NS p=0.0002 TCT 2003

TAXUS IV Trial Late lumen loss (mm) at 9 months Diameter stenosis p<0.0001 Diameter stenosis at 9 months p<0.0001 Binary restenosis at 9 months p<0.0001 TCT 2003

TAXUS IV Trial Among patients with single de novo coronary lesions, treatment with the slow-rate release polymer-based paclitaxel-eluting stent was associated with a reduction in the primary endpoint of target lesion revascularization at 1 year compared with bare stent Results of the present trial are consistent with results from the SIRIUS trial, which compared sirolimus-eluting stents with bare stents and also showed a significant reduction in TVR with the drug-eluting stent Neither trial has shown a reduction in the clinical endpoints of death or MI The on-going REALITY trial is comparing the two drug-eluting stents in a head-to-head trial