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TAXUS ATLAS 9-Month Results: Evaluation of TAXUS Liberté vs. TAXUS Express Trial. TAXUS ATLAS Trial. Presented at The EuroPCR meeting Paris, France May 2006 Presented by Dr. Mark Turco. TAXUS ATLAS Trial: Background.

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TAXUS ATLAS Trial

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TAXUS ATLAS 9-Month Results: Evaluation of TAXUS Liberté vs. TAXUS Express Trial

TAXUS ATLAS Trial

Presented at

The EuroPCR meeting

Paris, France May 2006

Presented by Dr. Mark Turco


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TAXUS ATLAS Trial: Background

  • The goal of the registry was to evaluate a newer model drug-eluting stent (Taxus Liberté) with historical data from an early generation drug-eluting stent (Taxus Express) among patients with de novo lesions undergoing percutaneous coronary intervention (PCI).

  • Patients underwent PCI and were treated with the Taxus Liberte paclitaxel-eluting stent (N=871).

  • The results were compared to historical control data from the TAXUS IV and TAXUS V trials (N=991), which used the Taxus Express stent.

Presented at EuroPCR May 2006


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TAXUS ATLAS Trial: Study Design

871 patients with coronary heart disease and de novo lesions 10-28 mm long with reference vessel diameter of 2.5-4.0 mm treated with a single stent

Historical control data from TAXUS IV and TAXUS V trials (TAXUS Express stent)

N=991

Treatment with TAXUS Liberté paclitaxel - eluting stentduring PCI

N=871

Historical control data of Angiographic follow up at 9 – months

Angiographic follow up at

9 - months

  • Primary Endpoint: Target vessel revascularization (TVR) at 9 months, evaluated for non-inferiority compared with historical controls from the TAXUS IV and V trials

Presented at EuroPCR May 2006


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TAXUS ATLAS Trial: Baseline Characteristics

Minimum Lumen Diameter

(p = <0.001)

  • Compared with historical controls, patients in the TAXUS ATLAS trial had smaller baseline minimum lumen diameters (0.85mm vs. 0.92mm)

Millimeters

Presented at EuroPCR May 2006


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TAXUS ATLAS Trial: Baseline Characteristics (cont.)

Stenoses and lesions at baseline

Taxus Liberté vs.Taxus Express

  • Patients in the TAXUS ATLAS trial had a larger percent stenosis (69.1% vs. 66.8%, p=<0.001) as well as more type B2/C lesions (75.5% vs. 61.2%, p=<0.001).

  • Multiple stents were implanted in 7.5% of patients in the TAXUS ATLAS trial

  • Bailout was performed less often compared with historical controls (3.1% vs. 6.0%, p=0.04)

p=<0.001

p=<0.001

75.5%

69.1%

66.8%

61.2%

Presented at EuroPCR May 2006


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TAXUS ATLAS Trial: Primary Endpoint

Incidence of Target Vessel Revascularization

(p=0.045 for non-inferiority)

  • The primary endpoint of target vessel revascularization occurred in 8.0% of the TAXUS ATLAS population and 7.1% of historical controls, meeting the non-inferiority criteria (p=0.045).

% Population

Presented at EuroPCR May 2006


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TAXUS ATLAS Trial: Clinical Endpoints

Incidence of stent thrombosis

  • Clinical endpoints were similar between groups, including cardiac death (0.8% vs. 0.7%) and MI (3.7% vs. 3.9%)

  • Stent thrombosis occurred in 0.8% if the TAXUS ATLAS trial and 0.7% of the historical controls

  • In stent late lumen loss also did not differ (0.41mm vs. 0.42mm, p=0.69)

Presented at EuroPCR May 2006


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TAXUS ATLAS Trial: Summary

  • Among patients with de novo lesions undergoing PCI, use of the Taxus Libertéstent paclitaxel-eluting stent was non-inferior when compared with historical controls form the TAXUS IV and TAXUS V trials, which used the Taxus Express stent.

  • When compared to the Taxus Express stent, the Taxus Libertéhas thinner struts which aids in flexibility and a lower profile.

  • The Taxus Libertéstent is currently also involved in trials of direct stenting, small vessels and long lesions

  • Results of the TAXUS ATLAS study should be interpreted with caution as it was a single arm registry study, and the Taxus Liberté stent was not compared to an active control arm but to historical data.

Presented at EuroPCR May 2006


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