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| General |
| Study Status |
Completed |
Application Number /
Requirement Number |
P110019 S066/ PAS001 |
| Date Original Protocol Accepted |
10/03/2014
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| Date Current Protocol Accepted |
03/03/2017
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| Study Name |
Extended Followup of the EXPERT CTO Study
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| Device Name |
XIENCE PRIME EVERLIMUS ELUTING CORONARY STENT SYSTEM, XIENCE X PEDITION EVEROLIMUS ELUTING CORONARY STENT SYSTEM
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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 |
Historical Control
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| Analysis Type |
Descriptive
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| Study Population |
Adult: >21
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| Detailed Study Protocol Parameters |
| Study Objectives |
This study is the continued follow-up of the premarket cohort. It is a prospective, multi-center, single-arm study.
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| Study Population |
All patients in whom recanalization and predilatation of CTO are completed and the study stent(s) (XIENCE V and/or XIENCE PRIME) is inserted into the coronary guiding catheter.
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| Sample Size |
A total of 250 patients were enrolled at 20 sites in the United States, with the intention-to-treat population consisting of 222 patients. There are 205 patients available with 1-year follow-up.
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| Key Study Endpoints |
The following outcomes will be reported annually through 5 years:
XRate of Major Adverse Cardiac Events (MACE), defined as a composite of death, Myocardial Infarction (MI), or clinically- driven Target Lesion Revascularization (TLR), and individual MACE components
¿XTarget Lesion Failure (TLF), defined as a composite of cardiac death, target vessel-related MI, and clinically-driven TLR and individual TLF components
¿XTarget Vessel Revascularization (TVR) and clinically-driven TVR
¿XTarget Vessel Failure (TVF), defined as a composite of cardiac death, target vessel-related MI, and clinically-driven TVR
¿XOccurrence of stent fracture at target lesion, as assessed by fluoroscopy in patients undergoing clinically-driven angiographic follow-up at any time during the 5-year study period (the same angiographic core lab will continue to be utilized throughout the five-year follow-up period)
¿XStent thrombosis according to Academic Research Consortium
(ARC) criteria (all, definite, definite/probable, probable, possible): acute, subacute, late, very late and accumulative rates
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| Follow-up Visits and Length of Follow-up |
3 years post-procedure
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| Interim or Final Data Summary |
| Actual Number of Patients Enrolled |
202 subjects available at 1 year for long term follow- up
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| Actual Number of Sites Enrolled |
20
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| Patient Follow-up Rate |
84.7% (171/202) at 4 years
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| Final Safety Findings |
The EXPERT CTO clinical trial met its primary endpoint. The stent related endpoint result of 1- year MACE [composite of death, myocardial infarction (MI) or clinically driven target lesion revascularization (CD-TLR)] rate was significantly lower than the pre-specified performance goal (PG) of 24.4% in both the intent-to-treat (ITT) population (18.5%, 1 sided UCL= 23.4%, p
=0.0248) and the per protocol (PP) population (8.2%, 1 sided UCL = 12.3%, <.0001).
The key secondary endpoints based on the ITT population through four (4) years are as follows: MACE (death, MI or CD-TLR) per ARC 31.6% (62/196)
per protocol 22.4% (44/196)
Target Lesion Failure (cardiac death, Target vessel-MI or CD-TLR) per ARC 24.1% (45/187)
per protocol 17.2% (32/186)
Target Vessel Failure (Cardiac death, Target vessel MI or CD-TVR) per ARC 26.2% (49/187)
per protocol 19.4% (36/186)
Death 10.5% (20/191)
Cardiac Death 5.5% (10/181)
All MI per ARC 20.3% (37/182)
Target Vessel MI (TV-MI) per ARC 15.5% (28/181)
All TLR (target Lesion revascularization) 11.9% (21/177)
CD-TLR 11.3% (20/177)
All TVR (target vessel revascularization), inclusive of target lesion)
13.6% (24/177)
All TVR (non-target lesion) 2.9% (5/172)
Stent Thrombosis (Definite/probable) 1.7% (3/174)
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| Study Strengths & Weaknesses |
Strength: The EXPERT CTO study was a prospective, open-label, multicenter study.
The study achieved a follow-up rate greater than 80% at 4 years. An independent clinical event committee performed adjudication of the safety endpoints including all cases of death, Q-wave myocardial infarction (QMI), non Qwave MI (NQMI), stent thrombosis, target lesion revascularization and target vessel revascularization.
Weakness: There is no formal hypothesis testing for the long term (4 year) study outcomes. The study is limited by the small sample size.
Study Strengths and Limitations: The EXPERT CTO study was a prospective, open-label, multicenter study. All event adjudications were performed by an independent Clinical Event Committee (CEC) with 100% site-reported adjudicable events being source-verified. This study provides important information on clinical outcomes in patients with chronic total occlusions treated with the XIENCE family of stents. The study is limited by being a small study with no head-to-head comparison with other DES platforms. In addition, due to the small population size, subgroup analysis can at best be considered exploratory.
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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 mstudy 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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