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| General |
| Study Status |
Completed |
Application Number /
Requirement Number |
P110010 S001/ PAS001 |
| Date Original Protocol Accepted |
06/01/2012
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| Date Current Protocol Accepted |
08/24/2012
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| Study Name |
PROMUS Element Plus US PAS
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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 |
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 |
Analytical
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| Study Population |
Transit. Adolescent A (distinctively) : 18-21 yrs,
Adult: >21
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| Detailed Study Protocol Parameters |
| Study Objectives |
Prospective, open-label, multi-center registry study
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| Study Population |
PLATINUM-like patients, including at least 200 patients treated with PROMUS Element Plus long lesion stents 32/38 mm lengths (2.50-4.0mm diameters).
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| Sample Size |
2,689 consecutive, consented patients from up to 65 sites in order to attain 906 PLATINUM like patients from the US PAS (33.7% of the enrolled patients)
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| Key Study Endpoints |
Primary: Cardiac death or myocardial infarction rate through 12 months post stent implantation among all PLATINUM-like patients
Secondary: Stent thrombosis rate, longitudinal stent deformation, and PROMUS Element plus related MACE, cardiac death/MI, TVF, TVR, cardiac death, and MI.
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| Follow-up Visits and Length of Follow-up |
5 years
30- days, 180-days, and annually through 5 years post intervention
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| Interim or Final Data Summary |
| Actual Number of Patients Enrolled |
Three hundred and forty-three (343) subjects were enrolled including platinum-like patients (n=13) and non-platinum like patients (n=328)
Two patients with unknown reference vessel diameter were not included in either group but included in the overall Long Lesion population.
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| Actual Number of Sites Enrolled |
Fifty-three (53) sites
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| Patient Follow-up Rate |
84% (246/293) at 5 years
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| Final Safety Findings |
Final safety and effectiveness findings (key endpoints) through 5 years:
All Subjects
Stent thrombosis (ST) rate, using ARC definition (definite/probable) in the overall patient population was 3.6% (11/304). Stent thrombosis (ARC definition, definite/probable) related to PROMUS Element plus rate was 2.6% (8/304).
The overall rate of longitudinal stent deformation was 0.15% (1/670).
The overall major adverse cardiac event (MACE, composite of cardiac death, myocardial infarction or MI, and target vessel revascularization or TVR) rate was 29.6% (90/304). PROMUS Element Plus-related MACE rate was 24.7% (75/304).
The overall cardiac death or MI rate was 12.8% (39/304). PROMUS Element Plus-related cardiac death or MI rate was 10.5% (32/304).
The overall target vessel failure (TVF) rate was 28.6% (87/304). PROMUS Element Plus-related TVF rate was 24.7% (75/304).
TThe overall cardiac death rate was 9.2% (28/304). PROMUS Element Plus-related cardiac death rate was 8.9% (27/304).
The overall MI rate was 5.6% (17/304). PROMUS Element Plus-related MI rate was 3.3% (10/304).
All death rate was 16.4% (50/304). Non-cardiac death rate was 7.2% (22/304)
All death or MI rate was 20.1% (61/304).
Subgroup Outcomes: Platinum-like and Non-Platinum like Patient Populations
Stent thrombosis (ARC, Definite/Probable) rate in PLATINUM-like patients was 0.0% (0/12) and in non-PLATINUM-like patients was 3.8% (11/290).
MACE rate related to PROMUS element Plus in PLATINUM-like patients was 33.3% (4/12) and in non-PLATINUM-like patients was 24.5% (71/290).
Cardiac death or MI rate related to PROMUS element Plus in PLATINUM-like patients was 8.3% (1/12) and in non-PLATINUM-like patients was 10.7% (31/290).
TVR rate related to PROMUS element Plus in PLATINUM-like patients was 33.3% (4/12),he overall TVR rate was 21.7% (66/304). PROMUS Element Plus-related TVR rate was 17.8% (54/304).
and in non-PLATINUM-like patients was 17.2% (50/290).
TVF rate related to PROMUS element Plus in PLATINUM-like patients was 33.3% (4/12), and in non-PLATINUM-like patients was 24.5% (71/290).
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| Study Strengths & Weaknesses |
Strengths: The PROMUS Element Plus US post-approval Long Lesion study was a prospective, open-label, multi-center study that evaluated outcomes data of patients treated with at least one PROMUS Element Plus stent length 32 or 28 mm (excluding sizes 2.25 x 32 mm) in routine practice. Patients were consecutively enrolled, and the target enrollment of 200 patients was exceeded. The follow-up rate achieved through 5- years was 84%.
Weakness: Compared to non-platinum like patient population, the sample size of platinum-like patient population (n=13) was too small to make any meaningful comparison of the safety and effectiveness outcomes between the two subgroups.
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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
endpoint, follow-up visits etc.), final results, study strengths and limitations of the PAS.
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