1. TAXUS II and IV: two-year follow-up
TAXUS II Trial
TAXUS IV Trial
536 patients with single de novo lesions
Lesions <12 mm in length, mm in diameter;
Double blind, randomized trial
1,326 patients with single de novo lesions
Lesions mm in length, mm in diameter;
Double blind, randomized trial
Paclitaxel-eluting stent
Slow-release formulation
n=131
Moderate-release formulation
n=135
Paclitaxel-eluting stent
Slow-release formulation
n=662
Bare Stent
n= 270 (combined control)
Bare Stent
n= 652
Endpoints (2 year follow-up):
TAXUS II – MACE (97% two-year clinical follow-up)
– Late loss (<40% two-year angiographic follow-up)
TAXUS IV – MACE
– angiographic results not presented
Presented at TCT 2004

2. TAXUS II: Late loss at 6 mo. and two yrs.
Two-year angiographic results were available for < 40% of the original TAXUS cohorts, but those available showed little change in late-loss between six months and two years.
p=<0.0001
p =NS
p =NS mm
TCT 2004

3. TAXUS II: MACE at two years
Target lesion revascularization (TLR) and target vessel revascularization (TVR) remained significantly lower in the TAXUS groups, resulting in lower overall MACE.
p=0.0178
p=0.0178
p=0.0622
p=0.0126 %
p=0.0047
p=0.0006
TCT 2004

4. TAXUS II: MACE at two years (contin.)
Despite reduced TLR and TVR in the TAXUS groups, CABG, MI, and death rates were not statistically different between the TAXUS and control groups.
p=NS
p=NS
p=NS
p=NS %
TCT 2004

5. TAXUS IV: MACE at two years
TAXUS IV showed similar two-year results: TVR, TLR, and overall MACE remained significantly lower in the TAXUS group.
p =<0.0001
p=<0.0001
p =<0.0001 %
TCT 2004

6. TAXUS IV: MACE at two years (contin.)
Again, despite reduced overall MACE, rates of death and MI were not significantly different between the two groups.
p =NS
p=NS %
TCT 2004

7. TAXUS II and IV: two-year follow-up
Among patients with single de novo coronary lesions, treatment with a paclitaxel-eluting stent continued to be associated with a reduction in TLR and TVR at 2 years compared with bare stent
Consistent with the 6 month and 1 year data, TAXUS stents were not associated with a reduction in the clinical endpoints of death or MI at 2 years.
The on-going REALITY trial is a head-to-head trial comparing paclitaxel-eluting stents to sirolimus-eluting stents, which have also been associated with significant reduction in TVR (SIRIUS trial)