Eluvia™ Drug-Eluting Vascular Stent System

Eluvia™ Drug-Eluting Vascular
Stent System

EMINENT Trial
1-Year Results

Medical specialties  /  Vascular Surgery / Drug Eluting Therapies / Eluvia / EMINENT Trial Results
 

Discover our detailed EMINENT Trial Results

 

1-Year Trial Results

EMINENT is the world's largest randomised clinical trial (RCT) comparing Eluvia DES to BMS in the SFA/PPA. In this study Eluvia DES demonstrated a statistically significant superior primary patency and sustained clinical improvement compared to bare metal stent (BMS) at 1 year.

 

EMINENT RCT 1-Year Primary Patency Results1

Eluvia demonstrated superiority over BMS1 with a statistically significant primary patency of 85.4% versus 76.3% and a statistically significant greater rate of sustained clinical improvement without reintervention through 1 year.

EMINENT RCT 1-Year Primary Patency Results

EMINENT RCT 1-Year Primary Patency Results

Eluvia demonstrated sustained clinical improvement

Eluvia demonstrated sustained clinical improvement

*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)
 

EMINENT 1 year subgroup analysis

Eluvia continues to deliver unparalleled results even in complex SFA disease.
It demonstrated consistant primary patency benefit over BMS through 1 year across subgroups.
Eminent trial 1 year
Presented by Pr Yann Goueffic, LINC 2022
Eluvia was superior to BMS even in challenging patients and lesions and it outperformed BMS in CTO lesions

EMINENT Trial Overview

Objective

Evaluate the safety and effectiveness of the Boston Scientific Corporation ELUVIA™ Drug-Eluting Vascular Stent System for treating Superficial Femoral Artery (SFA) and/or Proximal Popliteal Artery (PPA) lesions up to 140 mm in length.

EMINENT Trial Design

RCT (Eluvia DES vs Bare Metal Stent)
  • 2:1 randomised
  • Single-blind
  • Superiority trial
  • Patients: N=775 | Eluvia N=508 vs BMS N=267
  • Primary Endpoint: 12-month primary patency
  • Investigational centers: 58 study centers in 10 European countries

Baseline Characteristics

EMINENT Randomised Controlled Trial Details
EMINENT Trial Eluvia Baseline Characteristics
EMINENT Trial Eluvia 1 Year Safety
* IMPERIAL Trial: Global RCT, Eluvia™ DES vs Cook Medical’s Zilver™ PTX™ Stent. Superiority determined in a post hoc analysis. 12-Month Primary Patency rate of 86.8% in the Eluvia arm vs. 77.5% in the Zilver PTX arm (p-value = 0.0144).
EMINENT Trial: Global RCT, Superiority trial. Eluvia™ Drug-Eluting Stent vs EU Nitinol self (expanding nitinol stent. 12-Month Primary Patency rate of 83.2% in the Eluvia™ arm vs. 74.3% in the BMS arm (p-value = 0.0077)
* IMPERIAL Trial: Global RCT, Eluvia™ DES vs Cook Medical’s Zilver™ PTX™ Stent. Superiority determined in a post hoc analysis. 12-Month Primary Patency rate of 86.8% in the Eluvia arm vs. 77.5% in the Zilver PTX arm (p-value = 0.0144).
EMINENT Trial: Global RCT, Superiority trial. Eluvia™ Drug-Eluting Stent vs EU Nitinol self (expanding nitinol stent. 12-Month Primary Patency rate of 83.2% in the Eluvia™ arm vs. 74.3% in the BMS arm (p-value = 0.0077)
 
Interested to know more?
Access the peer reviewed publication of EMINENT results >
*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. .



Interested to know more about our randomised clinical trials?
Read about IMPERIAL, the world’s first head-to-head Randomised Controlled Trial (RCT) comparing Eluvia™ Drug-Eluting Vascular Stent System to Zilver PTX for SFA/PPA >

 

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