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U.S. Department of Health and Human Services

Post-Approval Studies (PAS)

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The FDA has the authority to require sponsors to perform a post-approval study (or studies) at the time of approval of a premarket approval (PMA), humanitarian device exemption (HDE), or product development protocol (PDP) application. Post-approval studies can provide patients, health care professionals, the device industry, the FDA and other stakeholders information on the continued safety and effectiveness (or continued probable benefit, in the case of an HDE) approved medical devices. This database allows you to search Post-Approval Study information by applicant or device information.

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XIENCE PRIME and XIENCE PRIME LL Everolimus Elut


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General
Application Number P110019 / PAS001
Current Plan Approved 10/27/2011
Study Name XIENCE PRIME and XIENCE PRIME LL Everolimus Elut
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
Final Study Results
Number of Patients Core Size Registry (CSR) FAS: 401 subjects, ITT: 403 subjects

Long Lesion Registry (LLR) FAS: 104 subjects, ITT: 106 subjects

Number of Sites 62
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

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)



Effect Findings No separate effectiveness findings were reported.
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.

Label 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.


XIENCE PRIME and XIENCE PRIME LL Everolimus Elut Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
one year report 10/31/2012 08/31/2012 On Time
two year report-final report 10/31/2013 05/24/2013 On Time


Contact Us

Julie Unger
Project Manager, Post-Approval Studies Program
Food and Drug Administration
10903 New Hampshire Ave
WO66-4206v Silver Spring, MD
20993-0002

Phone: (301) 796-6134
Fax: (301) 847-8140
julie.unger@fda.hhs.gov

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