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|
| General |
| Study Status |
Completed |
Application Number /
Requirement Number |
P130021 S014/ PAS001 |
| Study Name |
Continued f/u of premarket cohort
|
| Device Name |
COREVALVE (TM) EVOLUT(TM) R SYSTEM
|
| Clinical Trial Number(s) |
NCT02207569
|
| General Study Protocol Parameters |
| Study Design |
Prospective Cohort Study
|
| Data Source |
Sponsor Registry
|
| Comparison Group |
No Control
|
| Analysis Type |
Descriptive
|
| Study Population |
Adult: At least 22 yrs
|
| Detailed Study Protocol Parameters |
| Study Objectives |
Continued follow-up of all living subjects who were enrolled under the IDE (G140059). The objective of this PAS is to characterize the clinical outcomes annually through 5 years post-procedure.
|
| Study Population |
All living subjects who were enrolled in the IDE
|
| Sample Size |
All living subjects
|
| Key Study Endpoints |
The key safety and effectiveness endpoints include all-cause mortality, all stroke (disabling and non-disabling), life-threatening bleeding, acute kidney injury at stage 2 or 3, coronary artery obstruction requiring
intervention, major vascular complication, valve-related dysfunction requiring repeat procedure, new permanent pacemaker implantation, prosthetic valve endocarditis, prosthetic valve thrombosis, New York Heart Association (NYHA) classification, Kansas City Cardiomyopathy Questionnaire (KCCQ) score, and hemodynamic performance metrics by Doppler echocardiography.
|
| Follow-up Visits and Length of Follow-up |
5 years
|
| Interim or Final Data Summary |
| Actual Number of Patients Enrolled |
351 subjects were enrolled, of which 241 received an attempted implant.
|
| Actual Number of Sites Enrolled |
23
|
| Patient Follow-up Rate |
The follow-up rate through 5 years was approximately 90%.
Compliance with visit assessments (e.g., NYHA Classification, KCCQ) was approximately 67% of subjects who completed the 5Y follow-up visit, and compliance with echocardiographic imaging assessments ranged from 46% to 53% of subjects who attended the final 5-year visit.
|
| Final Safety Findings |
The Kaplan-Meier rates of CEC-adjudicated safety outcomes at 5 years are summarized as follows:
All-cause mortality: 46.9% (27.3% cardiovascular mortality)
All stroke: 14.4% (8.1% disabling stroke)
Vascular complications: 14.5%
Bleeding: 34.6% (15.7% life-threatening or disabling)
Acute kidney injury: 0.8% Stage 2, 0.4% Stage 3
Myocardial infarction: 5.1%
New permanent pacemaker: 27.4%
Valve thrombosis: 0.6%
Valve endocarditis: 1.0%
Valve-related dysfunction requiring repeat procedure: 0.0%
Coronary artery obstruction: 0.4%
|
| Final Effect Findings |
Key effectiveness outcomes are summarized as follows, in subjects who were evaluated for each outcome measure at the 5-year visit (unless otherwise noted):
NYHA Classification: Improvement in NYHA classification was maintained through 5 years. The mean change compared to baseline at 5 years was -1.3 +/-0.8 (n=90), and 76.1% of subjects were Class I/II.
KCCQ: Clinically significant improvement was observed in both overall and clinical summary scores through five years. The change in KCCQ overall summary score at 5 years compared to baseline was 23.6 +/- 28.0 (n=90)
Valve Performance Outcomes:
Mean effective orifice area (EOA) increased from 0.6 +/- 0.2 cm2 at baseline to 1.9 +/- 0.5 cm2 at 30 days. At 5 years, the EOA was 1.8 +/- 0.5 cm2 (n=54)
Overall, mean gradient decreased from 48.2 +/- 13.0 mmHg at baseline to 7.8 +/- 3.1 mmHg at 30 days. At 5 years, the overall mean gradient was 10.0 +/- 8.0 mmHg (n=60).
At 5 years, 100% of subjects with available echocardiographic data (n=60) had mild or less total aortic regurgitation (AR).
At 5 years, 100% of subjects with available echocardiographic data (n=58) had mild or less paravalvular AR.
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| Study Strengths & Weaknesses |
This continued follow-up study provides longer-term data (through 5 years) on the safety and effectiveness of the CoreValve Evolut R valve in patients with severe symptomatic aortic stenosis at high or greater surgical risk. Generally, outcomes suggest that safety and effectiveness is maintained through 5 years post procedure, with meaningful improvement in quality of life outcomes and hemodynamic performance. The lack of completion of some assessments of interest including NYHA Classification, KCCQ, and echocardiographic imaging at the 5-year study visit presents challenges to the interpretability of longer-term effectiveness outcomes. The missing data is in part related to challenges with in-person visits during the COVID-19 pandemic. Additionally, it should be noted that some subjects withdrew or were lost to follow-up in this study. Incomplete follow-up may also lead to biased longer-term results.
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| Recommendations for Labeling Changes |
The labeling is recommended to be updated to reflect the 5 year findings of the study and should be informative to clinicians and patients regarding the longer-term benefit risk profile for the device.
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