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Clinical Results

 
A new standard of care in SFA stenting. Eluvia DES demonstrated superiority at 1-Year in two Randomized Control Trials - bare metal stents in EMINENT1 and Zilver PTX in IMPERIAL2.
 

 

EMINENT Randomized Clinical Trial Results1

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.

Watch Prof. Y. Goueffic (Vascular Surgeon, France) presents the 12-Month results of the EMINENT RCT.
Watch Prof. Y. Goueffic (Vascular Surgeon, France) presents the 12-Month results of the EMINENT RCT. 

 

Eminent RCT 1-Year Primary Patency Results1

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
*Kaplan-Meijer 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.
**Log rand p-value compares the entire K-M curves from time point zero to day 390 (full 1-Year follow-up window)

 

ELUVIA DEMONSTRATED SUSTAINED CLINICAL IMPROVEMENT1

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
*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.
 **Log-rank p-value compares the entire K-M curves from time point zero to day 390 (full 1-year follow-up window)
***In EMINENT, primary sustained clinical improvement was defined as an improvement (decrease) by at least 1 Rutherford category, without TLR.
1. EMINENT Clinical Trial 1-Year results presented by Professor Yann Goueffic, MD. VIVA 2021
2. 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 randomised, 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. .

 

IMPERIAL Randomized Controlled Trial Results1,2

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-Year3.

 

IMPERIAL 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.

Chart with Primary Patency Results* 92.1% Eluvia DES 81.8% Zilver PTX
* 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.
** Log-rank p-value compares the entire K-M curves from time zero to full 1-Year follow-up window.

 

IMPERIAL RCT 2-Year Primary Patency Results*

Imperial RCT 2 year results, showing Eluvia with highest primary patency.
* Intention to treat. 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. ** In IMPERIAL RCT, Eluvia K-M Primary Patency was 83.0% vs. 77.1% for Zilver PTX at 2-Years, p=0.1008.
*** Vermassen, F. VIVA Late-Breaking Clinical Trials June 2020.

 

2-Year Clinically-Driven TLR4

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. 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.
2. Kaplan-Meier Primary Patency Estimate through 1-Year (including follow-up window) was statistically significant with a p-value of 0.0094.
3. 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.
4. Long Lesion TLR data is as-treated as presented at FDA panel 2019. All other data sets are intention to treat, adapted from Gary, W. LINC 2020 presentation.
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