TAXUS ATLAS: Evaluation of the TAXUS Liberté vs TAXUS Express -- 9-Month Clinical Events
TAXUS ATLAS: Evaluation of the TAXUS Liberté vs TAXUS Express -- 9-Month Clinical Events
"This study will help pave the road for the next generation of drug-eluting stents. The goal of the present study was to show that there are no performance differences between these 2 stents, and that goal was achieved."
Presenter: Mark A. Turco, MD (Washington Adventist Hospital, Takoma Park, Maryland), on behalf of the TAXUS ATLAS Investigators
The market-approved TAXUS Express paclitaxel-eluting polymer-coated stent (Boston Scientific Corporation, Natick, Massachusetts) has been shown to be effective for the treatment of simple to complex lesions, including de novo lesions, long lesions, lesions in small vessels, and, most recently, in-stent restenosis as studied in the series of TAXUS trials.
The TAXUS Liberté represents the "next generation" drug-eluting stent system. The device has thinner struts and continuous cell architecture; provides greater flexibility and lower profile; and offers better side-branch access.
The TAXUS ATLAS trial was designed to demonstrate that the TAXUS Liberté is noninferior in efficacy to the TAXUS Express control stent system.
Study Design
The TAXUS ATLAS is a multicenter, single-arm study that enrolled 871 patients at 61 global sites.
Inclusion Criteria
Primary Endpoint: Noninferiority of 9-month target vessel revascularization (TVR)
The trial compared outcomes of patients treated with the TAXUS Liberté stent (n = 871) with those of a case-matched control group of patients from the TAXUS IV and V trials treated with the TAXUS Express stent (n = 991).
Results
Quantitative and qualitative angiographic characteristics showed that patients treated with the TAXUS Liberté had longer lesions and more tortuosity, calcification, branch vessel disease, and B2/C type lesions than did control patients (Table). The groups were well matched for other baseline characteristics.
Table. TAXUS ATLAS: Angiographic Characteristics
*P < .001; P = .0011; P = .0012
DS = direct stenting; MLD = minimum lumen diameter; RVD = reference vessel diameter
Use of the TAXUS Liberté device was associated with improved procedural performance. Procedural time, number of post-dilations, ratio of stent length to lesion length, as well as the need for bailout glycoprotein IIb/IIIa inhibitor use were all significantly lower in the TAXUS Liberté-treated group.
At 9-month follow-up, the primary noninferiority endpoint was met -- by intention-to-treat analysis, there was no difference in the rate of TVR between the control and TAXUS Liberté groups (7.1% vs 8.0%, respectively; P = .48). The individual endpoints of the study were also similar (Figure). In addition, the rates of stent thrombosis were low and did not differ between the 2 groups (0.7% and 0.8%).
Figure. TAXUS ATLAS: events at 9-month follow-up.
MACE = major adverse cardiac events; MI = myocardial infarction; TLR = target lesion revascularization; TVR = target vessel revascularization Conclusions
This study will help pave the road for the next generation of drug-eluting stents. The goal of the present study was to show that there are no performance differences between these 2 stents, and that goal was achieved.
As noted by investigators, the TAXUS ATLAS program will continue to evaluate use of the TAXUS Liberté stent in direct stenting and for the treatment of small vessels and long lesions.
The research in this article was supported by Boston Scientific Corporation.
"This study will help pave the road for the next generation of drug-eluting stents. The goal of the present study was to show that there are no performance differences between these 2 stents, and that goal was achieved."
Presenter: Mark A. Turco, MD (Washington Adventist Hospital, Takoma Park, Maryland), on behalf of the TAXUS ATLAS Investigators
The market-approved TAXUS Express paclitaxel-eluting polymer-coated stent (Boston Scientific Corporation, Natick, Massachusetts) has been shown to be effective for the treatment of simple to complex lesions, including de novo lesions, long lesions, lesions in small vessels, and, most recently, in-stent restenosis as studied in the series of TAXUS trials.
The TAXUS Liberté represents the "next generation" drug-eluting stent system. The device has thinner struts and continuous cell architecture; provides greater flexibility and lower profile; and offers better side-branch access.
The TAXUS ATLAS trial was designed to demonstrate that the TAXUS Liberté is noninferior in efficacy to the TAXUS Express control stent system.
Study Design
The TAXUS ATLAS is a multicenter, single-arm study that enrolled 871 patients at 61 global sites.
Inclusion Criteria
De novo lesions, 10-28 mm in length
Reference vessel diameter 2.5-4.0 mm
Treated with a single stent
Primary Endpoint: Noninferiority of 9-month target vessel revascularization (TVR)
The trial compared outcomes of patients treated with the TAXUS Liberté stent (n = 871) with those of a case-matched control group of patients from the TAXUS IV and V trials treated with the TAXUS Express stent (n = 991).
Results
Quantitative and qualitative angiographic characteristics showed that patients treated with the TAXUS Liberté had longer lesions and more tortuosity, calcification, branch vessel disease, and B2/C type lesions than did control patients (Table). The groups were well matched for other baseline characteristics.
Table. TAXUS ATLAS: Angiographic Characteristics
| Parameter | Control (n = 991) |
TAXUS Liberté
(n = 871) |
|---|---|---|
| RVD (mm) | 2.79 ± 0.49 | 2.75 ± 0.50 |
| MLD (mm) | 0.92 ± 0.34* | 0.85 ± 0.36 |
| % DS | 66.8 ± 10.8 | 69.1 ± 11.8* |
| Lesion length (mm) | 13.60 ± 6.11 | 14.76 ± 6.61* |
| Angulation (degree) | 25.9 ± 18.4 | 33.8 ± 17.8* |
| Tortuosity (%) | 8.4 | 13.1 |
| Calcification (%) | 23.1 | 29.8 |
| Branch vessel disease (%) | 5.0 | 10.9* |
| B2/C lesions (%) | 61.2 | 75.5* |
*P < .001; P = .0011; P = .0012
DS = direct stenting; MLD = minimum lumen diameter; RVD = reference vessel diameter
Use of the TAXUS Liberté device was associated with improved procedural performance. Procedural time, number of post-dilations, ratio of stent length to lesion length, as well as the need for bailout glycoprotein IIb/IIIa inhibitor use were all significantly lower in the TAXUS Liberté-treated group.
At 9-month follow-up, the primary noninferiority endpoint was met -- by intention-to-treat analysis, there was no difference in the rate of TVR between the control and TAXUS Liberté groups (7.1% vs 8.0%, respectively; P = .48). The individual endpoints of the study were also similar (Figure). In addition, the rates of stent thrombosis were low and did not differ between the 2 groups (0.7% and 0.8%).
MACE = major adverse cardiac events; MI = myocardial infarction; TLR = target lesion revascularization; TVR = target vessel revascularization Conclusions
The primary endpoint of the study was met -- the TAXUS Liberté is as safe and effective as the TAXUS Express stent system.
Despite the presence of more complex lesions in the TAXUS Liberté-treated group, this stent demonstrated improved performance and comparable clinical and angiographic outcomes to those of the TAXUS Express-treated group.
This study will help pave the road for the next generation of drug-eluting stents. The goal of the present study was to show that there are no performance differences between these 2 stents, and that goal was achieved.
As noted by investigators, the TAXUS ATLAS program will continue to evaluate use of the TAXUS Liberté stent in direct stenting and for the treatment of small vessels and long lesions.
The research in this article was supported by Boston Scientific Corporation.