TAXUS ATLAS TrialTAXUS ATLAS TrialTAXUS ATLAS TrialTAXUS ATLAS Trial

Presented atPresented atThe EuroPCR meeting The EuroPCR meeting Paris, France May 2006Paris, France May 2006

Presented by Dr. Mark TurcoPresented by Dr. Mark Turco

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

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

www. Clinical trial results.org

TAXUS ATLAS Trial: BackgroundTAXUS ATLAS Trial: BackgroundTAXUS ATLAS Trial: BackgroundTAXUS ATLAS Trial: Background

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

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

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

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

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

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

Presented at EuroPCR May 2006Presented at EuroPCR May 2006

www. Clinical trial results.org

TAXUS ATLAS Trial: Study DesignTAXUS ATLAS Trial: Study DesignTAXUS ATLAS Trial: Study DesignTAXUS ATLAS Trial: Study Design

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

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

Treatment with TAXUS Treatment with TAXUS Liberté paclitaxel - eluting Liberté paclitaxel - eluting

stentstent during PCIduring PCIN=871N=871

Treatment with TAXUS Treatment with TAXUS Liberté paclitaxel - eluting Liberté paclitaxel - eluting

stentstent during PCIduring PCIN=871N=871

Historical control data from Historical control data from TAXUS IV and TAXUS V trials TAXUS IV and TAXUS V trials

(TAXUS Express stent)(TAXUS Express stent)N=991N=991

Historical control data from Historical control data from TAXUS IV and TAXUS V trials TAXUS IV and TAXUS V trials

(TAXUS Express stent)(TAXUS Express stent)N=991N=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

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 Angiographic follow up at 9 - months9 - months

Angiographic follow up at Angiographic follow up at 9 - months9 - months

Historical control data of Angiographic Historical control data of Angiographic follow up at 9 – months follow up at 9 – months

Historical control data of Angiographic Historical control data of Angiographic follow up at 9 – months follow up at 9 – months

Presented at EuroPCR May 2006Presented at EuroPCR May 2006

www. Clinical trial results.org

TAXUS ATLAS Trial: Baseline CharacteristicsTAXUS ATLAS Trial: Baseline Characteristics TAXUS ATLAS Trial: Baseline CharacteristicsTAXUS ATLAS Trial: Baseline Characteristics

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

0.920.85

0

1

Taxus Liberté Taxus Express

0.920.85

0

1

Taxus Liberté Taxus Express

Minimum Lumen Diameter(p = <0.001)

Mill

imet

ers

Mill

imet

ers

Presented at EuroPCR May 2006Presented at EuroPCR May 2006

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TAXUS ATLAS Trial: Baseline Characteristics (cont.)TAXUS ATLAS Trial: Baseline Characteristics (cont.)TAXUS ATLAS Trial: Baseline Characteristics (cont.)TAXUS ATLAS Trial: Baseline Characteristics (cont.)

Stenoses and lesions at baseline Stenoses and lesions at baseline Taxus LibertTaxus Liberté vs.é vs. Taxus ExpressTaxus Express

0

15

30

45

60

75

% Stenosis Incidence of type B2/Clesions

Liberté Express

0

15

30

45

60

75

% Stenosis Incidence of type B2/Clesions

Liberté Express

p=<0.001p=<0.001p=<0.001p=<0.001

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

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

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

Presented at EuroPCR May 2006Presented at EuroPCR May 2006

69.1%69.1% 66.8%66.8%75.5%75.5%

61.2%61.2%

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TAXUS ATLAS Trial: Primary EndpointTAXUS ATLAS Trial: Primary Endpoint TAXUS ATLAS Trial: Primary EndpointTAXUS ATLAS Trial: Primary Endpoint

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

8.0%7.1%

0.0%

2.0%

4.0%

6.0%

8.0%

Taxus Liberté Taxus Express

8.0%7.1%

0.0%

2.0%

4.0%

6.0%

8.0%

Taxus Liberté Taxus Express

Incidence of Target Vessel Revascularization(p=0.045 for non-inferiority)

% P

opul

atio

n%

Pop

ulat

ion

Presented at EuroPCR May 2006Presented at EuroPCR May 2006

www. Clinical trial results.org

TAXUS ATLAS Trial: Clinical EndpointsTAXUS ATLAS Trial: Clinical EndpointsTAXUS ATLAS Trial: Clinical EndpointsTAXUS ATLAS Trial: Clinical Endpoints

Incidence of stent thrombosisIncidence of stent thrombosis

• Clinical endpoints were Clinical endpoints were similar between groups, similar between groups, including cardiac death including cardiac death (0.8% vs. 0.7%) and MI (0.8% vs. 0.7%) and MI (3.7% vs. 3.9%) (3.7% vs. 3.9%) •Stent thrombosis Stent thrombosis occurred in 0.8% if the occurred in 0.8% if the TAXUS ATLAS trial and TAXUS ATLAS trial and 0.7% of the historical 0.7% of the historical controlscontrols•In stent late lumen loss In stent late lumen loss also did not differ also did not differ (0.41mm vs. 0.42mm, (0.41mm vs. 0.42mm, p=0.69)p=0.69)

Presented at EuroPCR May 2006Presented at EuroPCR May 2006

0.8%0.7%

0.0%

0.2%

0.4%

0.6%

0.8%

ATLAS HistoricalControls

0.8%0.7%

0.0%

0.2%

0.4%

0.6%

0.8%

ATLAS HistoricalControls

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TAXUS ATLAS Trial: SummaryTAXUS ATLAS Trial: SummaryTAXUS ATLAS Trial: SummaryTAXUS ATLAS Trial: Summary

• Among patients with de novo lesions undergoing PCI, use of the Taxus Among patients with de novo lesions undergoing PCI, use of the Taxus

LibertéLiberté stent paclitaxel-eluting stent was non-inferior when compared with stent paclitaxel-eluting stent was non-inferior when compared with historical controls form the TAXUS IV and TAXUS V trials, which used the historical controls form the TAXUS IV and TAXUS V trials, which used the Taxus Express stent. Taxus Express stent.

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

• The Taxus LibertéThe Taxus Liberté stent is currently also involved in trials of direct stenting, stent is currently also involved in trials of direct stenting, small vessels and long lesionssmall vessels and long lesions

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

• Among patients with de novo lesions undergoing PCI, use of the Taxus Among patients with de novo lesions undergoing PCI, use of the Taxus

LibertéLiberté stent paclitaxel-eluting stent was non-inferior when compared with stent paclitaxel-eluting stent was non-inferior when compared with historical controls form the TAXUS IV and TAXUS V trials, which used the historical controls form the TAXUS IV and TAXUS V trials, which used the Taxus Express stent. Taxus Express stent.

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

• The Taxus LibertéThe Taxus Liberté stent is currently also involved in trials of direct stenting, stent is currently also involved in trials of direct stenting, small vessels and long lesionssmall vessels and long lesions

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

Presented at EuroPCR May 2006Presented at EuroPCR May 2006