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General |
Study Status |
Completed |
Application Number / Requirement Number |
P100023 / PAS001 |
Date Original Protocol Accepted |
04/22/2011
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Date Current Protocol Accepted |
04/22/2011
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Study Name |
PERSEUS Workhorse and Small Vessel (SV)
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Device Name |
ION PACLITAXEL- ELUTING CORONARY STENT SYSTEM (MONORAIL AND OVER-THE-WIRE SYSTEMS)
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Clinical Trial Number(s) |
NCT00484315 NCT00489541
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General Study Protocol Parameters |
Study Design |
Prospective Cohort Study
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Data Source |
New Data Collection
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Comparison Group |
Concurrent Control
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Analysis Type |
Analytical
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Study Population |
Adult: >21
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Interim or Final Data Summary |
Actual Number of Patients Enrolled |
PERSEUS Workhorse: 1,249 PERSEUS Small Vessel: 223
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Actual Number of Sites Enrolled |
PERSEUS Workhorse: 90 PERSEUS Small Vessel: 28
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Patient Follow-up Rate |
PERSEUS Workhorse: 92% at five years PERSEUS Small Vessel: 93.7% at five years
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Final Safety Findings |
PERSEUS Workhorse: Results at five years: -MACE (cardiac death, MI, TVR) TAXUS Express (18.2%) and TAXUS Element (18.6%) -All death TAXUS Express (6.9%) and TAXUS Element (6.8%) -All death and MI TAXUS Express (9.6%) and TAXUS Element (10.6%) -Non-cardiac death TAXUS Express (2.9%) and TAXUS Element (3.3%) -ARC stent thrombosis, definite/probable TAXUS Express (0.7%) and TAXUS Element (1.1%)
At five years, there were no statistically significant differences between the groups in any of the safety outcomes examined.
PERSEUS Small Vessel: Results at five years: -MACE (cardiac death, MI, TVR) TAXUS Element (30.2%) and BMS (41.3%, P<0.05) -All death TAXUS Element (14.9%) and BMS (9.6%) -All death and MI TAXUS Element (15.9%) and BMS (15.2%) -Non-cardiac death TAXUS Element (15.9%) and BMS (15.2%) -ARC stent thrombosis, definite/probable TAXUS Element (0.6%) and BMS (2.1%)
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Final Effect Findings |
PERSEUS Workhorse: Results at five years: -Target lesion failure (TLF) TAXUS Express (13.7%) and TAXUS Element (12.8%) -Target vessel failure (TVF) TAXUS Express (17.9%) and TAXUS Element (17.5%) -Target vessel revascularization (TVR) TAXUS Express (13.3%) and TAXUS Element (13.3%)
There was no statistically significant difference between the groups in any of the effectiveness outcomes examined.
PERSEUS Small Vessel: Results at five years: -Target lesion failure (TLF) TAXUS Element (21.5%) and BMS (35.2%, P<0.05) -Target vessel failure (TVF) TAXUS Element (30.2%) and BMS (39.4%) -Target vessel revascularization (TVR) TAXUS Element (23.6%) and BMS (34.9%, P<0.05)
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Study Strengths & Weaknesses |
The PERSEUS Workhorse study was prospective, randomized, controlled, single-blind, non-inferiority trial with a sample size of 1,262 subjects. The PERSEUS Workhorse study met its performance goals. The PERSEUS Workhorse PAS included only subjects with a study stent implanted (n=1,249) and followed them up to five years. Strengths of this PAS include randomized treatment assignment; a low rate of attrition in both treatment groups, thus minimizing selection bias; and a large sample size. The PERSEUS Small Vessel study was a prospective, single-aim, superiority trial with an historical control. A total of 223 subjects were implanted with the TAXUS Element stent and compared with 125 matched bare metal (BMS) Express stent subjects from the TAXUS V trial. The subjects were followed-up to five years. Strengths of this PAS include a control group; and a low rate of attrition, thus minimizing selection bias.
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Recommendations for Labeling Changes |
A labeling change is recommended to add a summary of the post-approval study results including study strengths and limitations. The updated label will reflect the long-term performance of the device from the pre-market cohorts.
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