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Clinical Results
EMINENT Randomized Controlled Trial Results3
EMINENT is the largest Randomized Controlled Trial (2:1) comparing Eluvia™ Drug-Eluting Vascular Stent System to self-expanding bare metal stents (BMS) for SFA/PPA; EU multi-center; superiority trial; core lab adjudicated.
EMINENT RCT 1-Year Primary Patency Results
Eluvia demonstrated superiority over BMS1 with a statistically significant primary patency of 85.4% versus 76.3% through 1-Year.
EMINENT RCT 1-Year Primary Sustained Clinical Improvement6
Eluvia demonstrated a statistically significant greater rate of sustained clinical improvement without reintervention over BMS through 1-Year.
EMINENT Randomized Controlled Trial Details
| Baseline Characteristics | Eluvia DES (n=508) |
Control (n=267) |
p-value |
|---|---|---|---|
| Age (Years) | 68.9 ± 8.7 | 68.9 ± 9.1 | 0.9739 |
| Male Gender | 71.5% | 67.4% | 0.2431 |
| Diabetes Mellitus (medically-treated) | 31.9% | 32.6% | 0.8440 |
| History of Smoking (current/previous) | 36.0% / 39.6% | 36.0% / 41.6% | 0.9849 / 0.5884 |
| Percent Stenosis (%) | 86.6 ± 15.2 | 85.5 ± 15.3 | 0.3629 |
| Total Occlusions | 42.3% | 39.9% | 0.5372 |
| Total Stented Length (mm) | 105.8 ± 48.4 | 109.2 ± 49.8 | 0.3858 |
| Target Lesion Length (mm) | 75.6 ± 50.3 | 72.2 ± 47.0 | 0.3815 |
| Moderately Calcified | 21.6% | 26.0% | 0.1849 |
| Severely Calcified | 30.3% | 31.1% | 0.8122 |
| 1-Year Safety Results | Eluvia DES (n=492) |
BMS (n=273) |
p-value |
|---|---|---|---|
| All Death, Major Amputation, TLR | 11.8% (56/474) | 11.8% (31/263) | 0.9912 |
| All-Cause Death at 1-Year | 2.7% (13/474) | 1.1% (3/263) | 0.1528 |
| Target Limb Major Amputation | 0.2% (1/474) | 0.0% (0/263) | 1.0000 |
| Clinically-Driven Target Lesion Revascularization | 8.4% (40/474) | 10.6% (28/263) | 0.3212 |
IMPERIAL Randomized Controlled Trial Results7,8
Eluvia DES demonstrated statistically significant difference in primary patency versus Zilver PTX and achieved the highest primary patency reported in any SFA DE Pivotal Trial at 1-Year.9
IMPERIAL RCT 1-Year Primary Patency Results10
IMPERIAL RCT 2-Year Primary Patency Results12
2-Year Clinically-Driven TLR16
Eluvia DES had statistically significant fewer CD-TLRs compared to Zilver PTX at 2-Years.
IMPERIAL Randomized Controlled Trial Details
| 2-Year Primary Endpoints | Eluvia DES (n=309) |
Zilver PTX (n=156) |
p-value |
|---|---|---|---|
| Primary Patency | 83.0% | 77.1% | 0.1008 |
| Major Adverse Events | 14.2% | 20.1% | 0.1236 |
| Mortality Rates | Eluvia DES | Zilver PTX | p-value |
|---|---|---|---|
| 1-Year All-Cause Mortality | 2.1% | 4.0% | 0.23 |
| 2-Year All-Cause Mortality | 7.1% (21/295) |
8.3% (12/145) |
0.6649 |
| Baseline Characteristics | Eluvia DES (n=309) |
Zilver PTX (n=156) |
|---|---|---|
| Age (Years) | 68.5 ± 9.5 | 67.8 ± 9.4 |
| Male Gender | 66.0% | 66.7% |
| Diabetes Mellitus | 41.7% | 43.6% |
| History of Smoking | 86.1% | 84.0% |
| Target Lesion Length (mm) | 86.5 ± 36.9 | 81.8 ± 37.3 |
| Severely Calcified | 40.1% | 32.3% |
| Total Occlusions | 31.2% | 30.3% |
| Extending into Distal SFA | 66.3% | 65.4% |
2. IMPERIAL Trial: A global randomized controlled multi-center trial with 2:1 randomization of the Eluvia™ Drug-Eluting Stent against Cook Medical’s Zilver™ PTX™ Stent, single-blind, non-inferiority design; independent core lab adjudication. Superiority determined in a post hoc analysis that was specified prior to unblinding. 1-Year Primary Patency rate of 86.8% in the Eluvia arm vs. 77.5% in the Zilver PTX arm (p-value = 0.0144).
3. EMINENT RCT 1-Year results presented by Yann Gouëffic, MD. VIVA 2021
4. Kaplan-Meier Estimate: Primary patency defined as core-lab assessed duplex ultrasound peak systolic velocity ratio (PSVR) ≤ 2.4 at 1-year in the absence of clinically-driven TLR or bypass of the target lesion.
5. Log-rank p-value compares the entire K-M curves from time point zero to day 395 (full 1-year follow-up window)
6. In EMINENT, primary sustained clinical improvement was defined as an improvement (decrease) by at least 1 Rutherford category, without TLR.
7. Gray W. 2-year Outcomes from the IMPERIAL Randomized Head to Head Study of Eluvia DES and Zilver PTX; LINC 2020, Leipzig Jan 28,2020.
8. Kaplan-Meier Primary Patency Estimate through 1-Year (including follow-up window) was statistically significant with a p-value of 0.0094.
9. Based on 1-Year Kaplan-Meier estimates reported for IMPERIAL, RANGER II SFA, IN.PACT SFA, ILLUMENATE, LEVANT II and Primary Randomization for Zilver PTX RCT.
10. Kaplan Meier Estimate; Primary patency as determined by duplex ultrasound (DUS) Peak Systolic Velocity Ratio (PSVR) is ≤ 2.4 at the 1-Year follow-up visit, in the absence of clinically-driven TLR or bypass of the target lesion.
11. Log-rank p-value compares the entire K-M curves from time zero to full 1-Year follow-up window.
12. Intention to treat. Adapted from Iida, O VIVA 2019 Presentation. Kaplan-Meier estimate utilizing time-to-event of clinically-driven TLR up to 730 days and Duplex Ultrasound data at 2-Years. Primary patency defined as duplex ultrasound PSVR ≤2.4, in the absence of clinically-driven target lesion revascularization or bypass of the target lesion, as assessed by the DUS core lab.
13. In IMPERIAL RCT, Eluvia K-M Primary Patency was 83.0% vs. 77.1% for Zilver PTX at 2-Years, p=0.1008.
14. Vermassen, F. VIVA Late-Breaking Clinical Trials June 2020.
15. Iida, O. IMPERIAL Head to Head Randomized Study of Eluvia and Zilver PTX. Two-Year Outcomes & Japanese Patients. JET 2020.
16. Intention to treat. Iida O, VIVA 2019. RCT, randomized controlled trial; TLR, target lesion revascularization.
17. Gray, W. 2 year Outcomes from the IMPERIAL Randomized Head to Head Study of Eluvia DES and Zilver PTX. LINC 2020.
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