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| General |
| Study Status |
Completed |
Application Number /
Requirement Number |
P110010 / PAS002 |
| Date Original Protocol Accepted |
11/22/2011
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| Date Current Protocol Accepted |
05/11/2012
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| Study Name |
Continued F/u of Premarket Cohort
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| Device Name |
PROMUS ELEMENT PLUS EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM
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| General Study Protocol Parameters |
| Study Design |
Randomized Clinical Trial
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| Data Source |
New Data Collection
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| Comparison Group |
Concurrent & Historical 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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| Detailed Study Protocol Parameters |
| Study Objectives |
Workhorse (WH) Trial is a prospective, randomized, controlled, single blind, multicenter, non-inferiority trial
Small Vessel (SV) is a prospective, single-arm, multi-center sub-study
Human Pharmacokinetics (PK) is a prospective, single-arm, multi-center, international, observational sub-study
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| Study Population |
Continued follow-up of the premarket cohorts:
WH - Subjects with a maximum of 2 de novo lesions ≤ 24 mm in length in native coronary arteries ≥2.50 mm to ≤4.25 mm. PROMUS Element (test) vs. PROMUS (control)
SV - Subjects with a single target lesion ≤28 mm in length in a native coronary artery ≥2.25 mm to <2.50 mm. PROMUS Element (test) vs. TAXUS Express (historical control)
PK - Subjects with a maximum of 2 de novo lesions ≤24 mm in length in native coronary arteries ≥2.50 mm to ≤4.25 mm
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| Sample Size |
WH 1,532
SV 94
PK 20-30
Approximately 85 sites in the US, 50 in Europe, 15 in the IC region, and 10 in Japan
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| Key Study Endpoints |
WH target lesion failure (TLF), MI, or death at 12 months
SV - TLF at 12 months
PK - whole blood everolimus levels as delivered by the PROMUS Element stent.
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| Follow-up Visits and Length of Follow-up |
Through 5 years post-procedure
12 months, 18 months, 2 years, 3 years, 4 years, and 5 years after the index procedure
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| Interim or Final Data Summary |
| Actual Number of Patients Enrolled |
-WH Randomized Clinical Trial: 1530
-SV Subtrial: 94
-PK Subtrial: 22
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| Actual Number of Sites Enrolled |
Actual number of study sites enrolled
-Workhorse (WH) Randomized Clinical Trial: 132
-Small Vessel (SV) Subtrial: 23
-Pharmacokinetics (PK) Subtrial: 5
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| Patient Follow-up Rate |
-WH Randomized Clinical Trial: 94%
-SV Subtrial: 93.3%
-PK Subtrial: 100%
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| Final Safety Findings |
-WH Randomized Clinical Trial: At the 5 year follow-up both the PROMUS Element and PROMUS/Xience V stent had good safety rates with no significant difference between the groups in long term clinical outcomes. The PROMUS Element continued to trend toward numerically lower event rates for cardiac death (2.6% and 3.5% respectively). The cardiac death or myocardial infarction (MI) rate at five years for the PROMUS Element and the PROMUS Xience V were 6.2% and 5.7%, respectively. Academic Research Consortium (ARC)-defined (definite/probable) stent thrombosis (ST) at five years was similar among both groups (0.8% and 0.7% respectively).
-SV Subtrial: The cardiac death or MI rate at five years for the PROMUS Element small vessel was 7.0%. No ST events were observed in the study.
-PK Subtrial: There was no death, MI or ST observed during the length of the study.
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| Final Effect Findings |
-WH Randomized Clinical Trial: the 12-month target lesion failure (TLF) primary endpoint was met, indicating non-inferiority of the PROMUS Element stent (3.4% [25/731]) versus the PROMUS/XIENCE V stent 2.9% [21/714], p=0.0013). At the 5 year follow-up, both the PROMUS Element and PROMUS/Xience V stent had low rates of revascularization with no significant difference between the groups in long term clinical outcomes.
-SV Subtrial: The 12-month TLF primary endpoint was met. The TLF rate at 12 months was 2.4% (2/84) with an upper 1-sided 95% confidence interval of 7.31% which is less than the pre-specified performance goal of 21.1% (p<0.0001).
-PK Subtrial: There were no target vessel revascularizations reported.
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| Study Strengths & Weaknesses |
-WH Randomized Clinical Trial: This was a large (>1,500 subjects) randomized clinical trial with a low rate of attrition; therefore, confounding and selection bias were minimized. This study met its primary endpoint and provides longer-term (5-year) performance data for the PROMUS Element Everolimus-Eluting Coronary Stent System.
-Both SV and PK subtrials provide longer-term (5-year) performance for the device although they have small sample sizes.
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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 (5-year) performance of the device.
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