TCT2004年会公布的TAXUS II和TAXUS IV研究2年时试验结果
1,326 patients with single de novo lesions
Lesions 10-28 mm in length, 2.5-3.75 mm in diameter;
Double blind, randomized trial
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
TAXUS II and IV: two-year follow-up
Paclitaxel-eluting stent
Slow-release formulation
n=662
536 patients with single de novo lesions
Lesions <12 mm in length, 3.0-3.5 mm in diameter;
Double blind, randomized trial
Paclitaxel-eluting stent
Slow-release formulation
n=131
Moderate-release formulation
n=135
Bare Stent
n= 270 (combined control)
TAXUS IV Trial
TAXUS II Trial
Presented at TCT 2004
TAXUS II: Late loss at 6 mo. and two yrs.
mm
TCT 2004
p=<0.0001
p =NS
p =NS
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.
TAXUS II: MACE at two years
%
TCT 2004
p=0.0047
p=0.0622
p=0.0006
p=0.0126
p=0.0178
p=0.0178
Target lesion revascularization (TLR) and target vessel revascularization (TVR) remained significantly lower in the TAXUS groups, resulting in lower overall MACE.
TAXUS II: MACE at two years (contin.)
%
TCT 2004
p=NS
p=NS
p=NS
p=NS
Despite reduced TLR and TVR in the TAXUS groups, CABG, MI, and death rates were not statistically different between the TAXUS and control groups.
TAXUS IV: MACE at two years
%
TCT 2004
p=<0.0001
p =<0.0001
p =<0.0001
TAXUS IV showed similar two-year results: TVR, TLR, and overall MACE remained significantly lower in the TAXUS group.
TAXUS IV: MACE at two years (contin.)
%
TCT 2004
p=NS
p =NS
Again, despite reduced overall MACE, rates of death and MI were not significantly different between the two groups.
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)