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TAXUS ATLAS Trial

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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  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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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