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

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Presentation on theme: "TAXUS ATLAS Trial Presented at The EuroPCR meeting Paris, France May 2006 Presented by Dr. Mark Turco TAXUS ATLAS 9-Month Results: Evaluation of TAXUS."— Presentation transcript:

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

2 www. Clinical trial results.org 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).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).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.The results were compared to historical control data from the TAXUS IV and TAXUS V trials (N=991), which used the Taxus Express stent. 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).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).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.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 www. Clinical trial results.org TAXUS ATLAS Trial: Study Design  Primary Endpoint: Target vessel revascularization (TVR) at 9 months, evaluated for non-inferiority compared with historical controls from the TAXUS IV and V trials Treatment with TAXUS Liberté paclitaxel - eluting stentduring PCI Treatment with TAXUS Liberté paclitaxel - eluting stent during PCIN=871 N=871 Historical control data from TAXUS IV and TAXUS V trials (TAXUS Express stent) N=991 N=991 871 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 Angiographic follow up at 9 - months Angiographic follow up at 9 - months Historical control data of Angiographic follow up at 9 – months Presented at EuroPCR May 2006

4 www. Clinical trial results.org TAXUS ATLAS Trial: Baseline Characteristics TAXUS ATLAS Trial: Baseline Characteristics Compared with historical controls, patients in the TAXUS ATLAS trial had smaller baseline minimum lumen diameters (0.85mm vs. 0.92mm)Compared with historical controls, patients in the TAXUS ATLAS trial had smaller baseline minimum lumen diameters (0.85mm vs. 0.92mm) Minimum Lumen Diameter (p = <0.001) Millimeters Presented at EuroPCR May 2006

5 www. Clinical trial results.org TAXUS ATLAS Trial: Baseline Characteristics (cont.) Stenoses and lesions at baseline Taxus Liberté vs. Taxus Express p=<0.001 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).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 trialMultiple 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)Bailout was performed less often compared with historical controls (3.1% vs. 6.0%, p=0.04) Presented at EuroPCR May 2006 69.1% 66.8% 75.5% 61.2%

6 www. Clinical trial results.org TAXUS ATLAS Trial: Primary Endpoint TAXUS ATLAS Trial: Primary Endpoint 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).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). Incidence of Target Vessel Revascularization (p=0.045 for non-inferiority) % Population Presented at EuroPCR May 2006

7 www. Clinical trial results.org 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%) 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 controlsStent 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)In stent late lumen loss also did not differ (0.41mm vs. 0.42mm, p=0.69) Presented at EuroPCR May 2006

8 www. Clinical trial results.org 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.Among patients with de novo lesions undergoing PCI, use of the Taxus Liberté stent 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.When compared to the Taxus Express stent, the Taxus Liberté has 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 lesionsThe Taxus Liberté stent 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.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. 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.Among patients with de novo lesions undergoing PCI, use of the Taxus Liberté stent 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.When compared to the Taxus Express stent, the Taxus Liberté has 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 lesionsThe Taxus Liberté stent 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.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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