1. 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

2. TAXUS IV Trial 1,326 patients with single de novo lesions
Lesions mm in length and 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

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

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

5. 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

6. 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