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Clinical Results

 
A new standard of care in SFA stenting. Eluvia DES has demonstrated superior primary patency at 1-Year against bare metal stents in EMINENT 1 and Zilver PTX in IMPERIAL. 2
 

 

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.

1-Year Primary kaplen meijer Patency estimate

 

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 Trial Eluvia 1 Year Primary Sustained

 

EMINENT Randomized Controlled Trial Details

EMINENT Trial Eluvia Baseline Characteristics
EMINENT Trial Eluvia 1 Year Safety

 

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

 

Chart with Primary Patency Results* 92.1% Eluvia DES 81.8% Zilver PTX

 

IMPERIAL RCT 2-Year Primary Patency Results12

Imperial RCT 2 year results, showing Eluvia with highest primary patency.

 

2-Year Clinically-Driven TLR16

Eluvia DES had statistically significant fewer CD-TLR’s compared to Zilver PTX at 2-Years.

Bar chart showing clinically driven TLR 37% reduction for Eluvia DES

 

IMPERIAL Randomized Controlled Trial Details

Chart showing Eluvia 1-Year primary endpoint patency Eluvia DES 86.8%
Chart with Eluvia DES 1 year (2.1%)  and 2 Year (7.1%) mortality rates
Chart of Eluvia DES baseline characteristics
1. EMINENT Trial: A global randomized controlled multi-center trial with 2:1 randomization of the Eluvia™ Drug-Eluting Stent against commercially-available Self-Expanding Bare Nitinol Stents, single-blind, superiority design; independent core lab adjudication. 1-Year Primary Patency rate of 83.2% in the Eluvia arm vs. 74.3% in the Bare-Metal Stenting arm (p-value = 0.0077).
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 WA, et al; A polymer-coated, paclitaxel-eluting stent (Eluvia) versus a polymer-free, paclitaxel-coated stent (Zilver PTX) for endovascular femoropopliteal intervention (IMPERIAL): a randomized, non-inferiority trial. 1-Year Results. The Lancet. 2018 Oct 27;392(10157):1541-1551. doi: 10.1016/S0140-6736(18)32262-1. Epub 2018 Sep 24. PMID :30262332.
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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