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| General |
| Study Status |
Completed |
Application Number /
Requirement Number |
P100023 / PAS001 |
| Date Original Protocol Accepted |
04/22/2011
|
| Date Current Protocol Accepted |
04/22/2011
|
| Study Name |
PERSEUS Workhorse and Small Vessel (SV)
|
| Device Name |
ION PACLITAXEL- ELUTING CORONARY STENT SYSTEM (MONORAIL AND OVER-THE-WIRE SYSTEMS)
|
| General Study Protocol Parameters |
| Study Design |
Prospective Cohort Study
|
| Data Source |
New Data Collection
|
| Comparison Group |
Concurrent Control
|
| Analysis Type |
Analytical
|
| Study Population |
Adult: >21
|
| Interim or Final Data Summary |
| Actual Number of Patients Enrolled |
PERSEUS Workhorse: 1,249
PERSEUS Small Vessel: 223
|
| Actual Number of Sites Enrolled |
PERSEUS Workhorse: 90
PERSEUS Small Vessel: 28
|
| Patient Follow-up Rate |
PERSEUS Workhorse: 92% at five years
PERSEUS Small Vessel: 93.7% at five years
|
| 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%)
|
| 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)
|
| 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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