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TAXUS II and IV: two-year follow-up. TAXUS IV Trial. TAXUS II Trial. 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. 536 patients with single de novo lesions Lesions < 12 mm in length, 3.0-3.5 mm in diameter;

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TAXUS II and IV: two-year follow-up

TAXUS IV Trial

TAXUS II Trial

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

536 patients with single de novo lesions

Lesions <12 mmin length, 3.0-3.5 mm in diameter;

Double blind, randomized trial

  • Paclitaxel-eluting stent

  • Slow-release formulation

  • n=662

  • Paclitaxel-eluting stent

  • Slow-release formulation

  • n=131

  • Moderate-release formulation

  • n=135

  • Bare Stent

  • n= 652

  • Bare Stent

  • n= 270 (combined control)

  • 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


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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


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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


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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


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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


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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


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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)


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