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EMINENT clinical trial results

EMINENT1 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 BMS2 with a statistically significant primary patency of 85.4% versus 76.3% through 1-Year.

1-Year Kaplan-Meier primary patency estimate

1-Year Primary Kaplen Meijer Patency estimate

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 395 (full 1-year follow-up window).

EMINENT RCT 1-year primary sustained clinical improvement

Eluvia demonstrated a statistically significant greater rate of sustained clinical improvement without reintervention over BMS through 1-Year.3

EMINENT Trial Eluvia 1 Year Primary Sustained

EMINENT randomized controlled trial details

 Eluvia DES
All Death, Major Amputation, TLR11.8% (56/474)11.8% (31/263)0.9912
All-Cause Death at 1-Year2.7% (13/474)1.1% (3/263)0.1528
Target Limb Major Amputation0.2% (1/474)0.0% (0/263)1.0000
Clinically-Driven Target Lesion Revascularization8.4% (40/474)10.6% (28/263)0.3212
 Eluvia DES
Age (Years)68.9 ± 8.7 68.9 ± 9.10.9739
Male Gender71.5%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 ± 15.285.5 ± 15.30.3629
Total Occlusions42.3%39.9%0.5372
Total Stented Length (mm)105.8 ± 48.4109.2 ± 49.80.3858
Target Lesion Length (mm)75.6 ± 50.372.2 ± 47.00.3815
Moderately Calcified21.6%26.0%0.1849
Severely Calcified30.3%31.1%0.8122

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1. EMINENT RCT 1-Year results presented by Yann Gouëffic, MD. VIVA 2021

2. 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. Primary Endpoint: 1-Year Binary Primary Patency rate of 83.2% in the Eluvia arm vs. 74.3% in the Bare-Metal Stenting arm (p-value = 0.0077).

3. In EMINENT, primary sustained clinical improvement was defined as an improvement (decrease) by at least 1 Rutherford category, without TLR.