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|
| General |
| Study Status |
Completed |
Application Number /
Requirement Number |
P110019 / PAS001 |
| Date Original Protocol Accepted |
10/27/2011
|
| Date Current Protocol Accepted |
10/27/2011
|
| Study Name |
XIENCE PRIME and XIENCE PRIME LL Everolimus Elut
|
| Device Name |
Xience Skypoint Everolimus Eluting Coronary Stent System
|
| General Study Protocol Parameters |
| Study Design |
Prospective Cohort Study
|
| Data Source |
New Data Collection
|
| Comparison Group |
Historical Control
|
| Analysis Type |
Descriptive
|
| Study Population |
Adult: >21
|
| Interim or Final Data Summary |
| Actual Number of Patients Enrolled |
Core Size Registry (CSR) FAS: 401 subjects, ITT: 403 subjects
Long Lesion Registry (LLR) FAS: 104 subjects, ITT: 106 subjects
|
| Actual Number of Sites Enrolled |
62
|
| Patient Follow-up Rate |
CSR FAS: 94% (377/401), ITT: 93.8% (378/403) at 3 years
LLR FAS: 95.2% 99 (104), ITT: 95.3% (101/106) at 3 years
|
| Final Safety Findings |
Core Size Registry (FAS population) endpoint rates observed through 3 years
All Death (Cardiac, vascular, non-cardiovascular) 3.1% (12/390)
TV-MI - Q-wave and non Q-wave per protocol 2.6% (10/390)
per ARC 6.2% (24/390)
Non-target vessel MI (Q-wave, Non Q-wave) per protocol 0.8% (3/390)
per ARC 0.8% (3/390) Clinically indicated-TLR 5.4% (21/390) Clinically indicated Target Vessel Revascularization 9.5% (37/390)
All TLR (Clinically indicated and non-Clinically indicated) 5.6% (22/390) All TVR (Clinically indicated and non-Clinically indicated) 10.0% (39/390) All Coronary Revascularization (TVR and non-TVR) 14.9% (58/390)
Target Lesion failure (cardiac death, target vessel MI and CI-TLR) per protocol 8.5% (33/390)
per ARC 10.8% (42/390) DMR (All death, all MI and all revascularization) per protocol 19.0% (74/390
per ARC 20.5% (80/390)
MACE (Cardiac death, all MI and CI-TLR) per protocol 9.0% (35/390)
per ARC 12.6% (49/390)
Cardiac death or All MI per protocol 3.8% (15/390)
per ARC 8.7% (34/390)
Stent thrombosis, Overall per protocol 1.0% (4/390)
per ARC 0.8% (3/380)
Long Lesion Registry (FAS) endpoint rates observed through 3 years
All Death (Cardiac, vascular, non-cardiovascular) 2.9% (3/104)
TV-MI - Q-wave and non Q-wave per protocol 4.8% (5/104)
per ARC 10.6% (11/104)
Non-target vessel MI (Q-wave, Non Q-wave) per protocol 1.9% (2/104)
per ARC 1.9% (2/104) Clinically indicated-TLR 4.8% (5/104)
Clinically indicated Target Vessel Revascularization 7.7% (8/104) All TLR (Clinically indicated and non-Clinically indicated) 4.8% (5/104) All TVR (Clinically indicated and non-Clinically indicated) 7.7% (8/104) All Coronary Revascularization (TVR and non-TVR) 14.4% (15/104)
Target Lesion failure (cardiac death, target vessel MI and CI-TLR) per protocol 9.6% (10/104)
per ARC 14.4% (15/104)
DMR (All death, all MI and all revascularization) per protocol 20.2% (21/104)
per ARC 25.0% (26/104)
MACE (Cardiac death, all MI and CI-TLR) per protocol 10.6% (11/104)
per ARC 15.4% (16/104)
Cardiac death or All MI- per protocol 5.8% (6/104)
per ARC 11.5% (12/104)
Stent thrombosis, Overall per protocol 0.0% (0/99)
per ARC 0.0% (0/99)
|
| Final Effect Findings |
No separate effectiveness findings were reported.
|
| Study Strengths & Weaknesses |
Strength: The study achieved a follow-up rate greater than 90% at 3 years.
Weakness: No formal statistics were performed to compare the clinical outcomes in SPIRIT PRIME Core Size Registry versus pooled SPIRIT II, III and IV or SPIRIT PRIME Long lesion Registry versus SPIRIT IV overlapping cohort analyses.
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| Recommendations for Labeling Changes |
Labeling change is recommended to reflect the long term data from the post-approval study. The labeling change should include a new section on the label showing a summary of the post- approval study methods (including study objectives, design, population, number of enrolled sites/subjects, key endpoints, follow ¿up visits etc.), results and study strengths and limitations.
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