TAXUS ATLAS - TAXUS ATLAS

May 17, 2005
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Date Presented:
01/01/2006
Date Published:
01/01/2007
Date Updated:
05/17/2005
Original Posted Date:
05/17/2005
References

Description:

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

Study Design

Study Design:

Patients Enrolled: 871
Mean Follow Up: 9 months
Mean Patient Age: Mean age 61.9 years
Female: 30

Patient Populations:

Single de novo lesions 10-28 mm long with reference vessel diameter of 2.5-4.0 mm in a native artery treated with a single stent.

Exclusions:

Acute (<72 h) myocardial infarction (MI), left main disease, ostial or bifurcation lesions, total occlusion or thrombus, calcification, or tortuosity.

Primary Endpoints:

Target vessel revascularization at 9 months, evaluated for noninferiority compared with historical controls from the TAXUS IV and V trials

Drug/Procedures Used:

Patients underwent PCI and were treated with the Taxus Liberte paclitaxel-eluting stent (N = 871). Results were compared to historical control data from the TAXUS IV and TAXUS V trials (N = 991), which used the Taxus Express stent.

Principal Findings:

Compared with historical controls, patients in the TAXUS ATLAS trial had smaller baseline minimum lumen diameters (0.85 mm vs. 0.92 mm, p < 0.001), larger percent stenosis (69.1% vs. 66.8%, p < 0.001), and more type B2/C lesions (75.5% vs. 61.2%, p < 0.001). Multiple stents were implanted in 7.5% of patients in the present trial. Bailout was performed less often compared with historical controls (3.1% vs. 6.0%, p = 0.004).

The primary endpoint of target vessel revascularization occurred in 8.0% of the TAXUS ATLAS population and 7.1% of historical controls, meeting the noninferiority criteria (p = 0.045). Other clinical endpoints were also similar between groups, including cardiac death (0.8% vs. 0.9%) and MI (3.7% vs. 3.9%). Stent thrombosis occurred in 0.8% of the TAXUS ATLAS trial and 0.7% of the historical controls by 9 months. In-stent late lumen loss also did not differ (0.41 mm vs. 0.42 mm, p = 0.69).

Interpretation:

Among patients with de novo lesions undergoing PCI, use of the Taxus Liberte paclitaxel-eluting stent was noninferior compared with historical controls from the TAXUS IV and TAXUS V trials, which used the Taxus Express stent.

Compared with the Taxus Express stent, the Taxus Liberte stent has thinner struts and is designed to provide more flexibility and a lower profile. The Taxus Liberte stent is currently also being evaluated in trials of direct stenting, small vessels, and long lesions. Results of the present study should be interpreted with caution, as it was a single-arm registry study, and the Taxus Liberte stent was not compared to an active control arm, but to historical data.

References:

Turco MA, et al. Polymer-Based, Paclitaxel-Eluting TAXUS Liberté Stent in De Novo Lesions. J Am Coll Cardiol 2007;49:1676-83.

Presented by Dr. Mark Turco at the EuroPCR meeting, May 2006, Paris, France.

Keywords: Paclitaxel, Registries, Coronary Artery Disease, Thrombosis, Drug-Eluting Stents, Constriction, Pathologic, Percutaneous Coronary Intervention


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