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General |
Study Status |
Completed |
Application Number / Requirement Number |
P060008 / PAS001 |
Date Original Protocol Accepted |
10/10/2008
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Date Current Protocol Accepted |
10/10/2008
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Study Name |
Outcomes TAXUS ATLAS
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Device Name |
TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM (MONORAIL AND OVER-THE-WIRE)
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General Study Protocol Parameters |
Study Design |
Prospective Cohort Study
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Data Source |
Sponsor Registry
|
Comparison Group |
Concurrent Control
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Analysis Type |
Analytical
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Study Population |
Transit. Adolescent B (as adults) : 18-21 yrs,
Adult: >21
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Interim or Final Data Summary |
Interim Results |
The MACE (cardiac death, MI, and TVR) rate at 4 years post stent implantation was comparable between the TAXUS ATLAS Group and the Control Group (22.5% versus 23.8%, P=0.5015). There was no statistically significant difference in MI, cardiac death, TVR, TLR, stent thrombosis and death rates between the two groups. The principal safety and efficacy outcomes just noted in the interval from 3 to 4 years post stent implantation were comparable as well. Despite greater lesion complexity in the TAXUS ATLAS Group, the 4 year post implantation data presented by the sponsor demonstrate that the TAXUS Liberté stent is comparable to the TAXUS Express stent with respect to MACE (including individual MACE components cardiac death, MI, and TVR), TLR, and TVF. There are no new safety or effectiveness concerns raised by this data.
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Actual Number of Patients Enrolled |
867
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Actual Number of Sites Enrolled |
60
|
Patient Follow-up Rate |
91.7%
|
Final Safety Findings |
The MACE (cardiac death, MI, and TVR) rate at 5 years post stent implantation was comparable between the TAXUS ATLAS Group and the Control Group (26.2% versus 27.1%, P=0.7026). There was no statistically significant difference in MI, cardiac death, TVR, TLR, overall stent thrombosis and death rates between the two groups. The 1461-1855 day stent thrombosis rate was 2.4% in the TAXUS ATLAS group and 0% in the control group. This, with a 5-year stent thrombosis rate of 2.3% in the TAXUS ATLAS group and 2% in the control group.
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Final Effect Findings |
See above
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Study Strengths & Weaknesses |
Despite greater lesion complexity in the TAXUS ATLAS Group, the 5 year post implantation data presented by the sponsor demonstrate that the TAXUS Liberté stent is comparable to the TAXUS Express stent with respect to MACE (including individual MACE components cardiac death, MI, and TVR), TLR, and TVF.
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Recommendations for Labeling Changes |
The 1461-1855 day stent thrombosis rate was 2.4% in the TAXUS ATLAS group and 0% in the control group. This, with a 5-year stent thrombosis rate of 2.3% in the TAXUS ATLAS group and 2% in the control group is higher than would be expected and was updated in a labeling change.
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