Eluvia™ Drug-Eluting Vascular Stent System
Eluvia™ Drug-Eluting Vascular Stent System

IMPERIAL Trial Results

 

Discover our detailed IMPERIAL Trial Results



1-Year Trial Results

In this 1-Year Trial, Eluvia DES demonstrated a statistically significant difference in primary patency and half the TLR rate vs. Zilver PTX at 12 months.
(12-month results from IMPERIAL, the world's first head-to-head DES SFA Trial1 - Presented at LINC 2020)

Kaplan-Meier Primary Patency Rate: 12-Month Results chart

CLINICAL-DRIVEN TLR RATE

In IMPERIAL RCT and as reported in The Lancet, 1-year ITT, CEC adjudicated mortality rates were 2.1% (6/292) for Eluvia and 4.0% (6/150) for Zilver PTX (p=0.23).
*Kaplan Meier Estimate; Primary patency as determined by duplex ultrasound (DUS) Peak Systolic Velocity Ratio (PSVR) is ≤ 2.4 at the 12-month follow-up visit, in the absence of clinically-driven TLR or bypass of the target lesion.
** Gray, WA TCT 2018.
† Log-rank p-value compares the entire K-M curves from time zero to full one year follow-up window.
1. IMPERIAL Trial: A global randomised controlled multi-center trial with 2:1 randomisation 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. 12-Month Primary Patency rate of 86.8% in the Eluvia arm vs. 77.5% in the Zilver PTX arm (p-value = 0.0144).

 

Better patient outcomes with Eluvia at a lower cost
based on comparison with Zilver PTX treatment

improve financial health.
  • Boston Scientific’s ELUVIA Drug-Eluting Stent and Coronary Paclitaxel-Eluting Stent Clinical Experience.
    Available at: https://www.fda.gov/media/128145/download [Accessed July 4 2019]Kbr/> Gray WA et al. Lancet. 2018 Oct 27;392(10157):1541-1551
    2-Year Results from IMPERIAL Trail; Presented at LINC 2020
Increase Operational Efficiencies
  • Boston Scientific’s ELUVIA Drug-Eluting Stent and Coronary Paclitaxel-Eluting Stent Clinical Experience.
    Available at: https://www.fda.gov/media/128145/download [Accessed July 4 2019]Kbr/> Gray WA et al. Lancet. 2018 Oct 27;392(10157):1541-1551
    2-Year Results from IMPERIAL Trail; Presented at LINC 2020

2-Year Trial Results

In this 2-Year Trial, Eluvia DES demonstrated the highest primary patency ever reported in an SFA US Pivotal Trial for DES or DCB1.

  1. Highest-two year primary patency based on 24-month Kaplan-Meier estimates reported for IMPERIAL, IN.PACT SFA, ILLUMENATE, LEVANT II and Primary Randomisation for Zilver PTX RCT.
 
Hear Dr. Robert Lookstein's Commentary on Eluvia's 2-Year Data.

"We were hoping that we would see a device that would allow us to tell our patients that we would have mid-80% patency at 24 month follow-up."

Hear Dr. Robert Lookstein's Commentary on Eluvia's 2-Year Data

Robert Lookstein, MD
Mount Sinai Medical Center
New York, NY

 

2-Year Durable and Consistent Results in Complex Lesions

2-Year Durable and Consistent Results in Complex Lesions.

* Highest-two year primary patency based on 24-month Kaplan-Meier estimates reported for IMPERIAL, IN.PACT SFA, ILLUMENATE, LEVANT II and Primary Randomisation for Zilver PTX RCT. Results from different clinical investigations are not directly comparable. Information provided for educational purposes only.
** Intention to treat. Kaplan-Meier estimate utilizing time-to-event of clinically-driven TLR up to 730 days and Duplex Ultrasound data at 24 months. 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.

  1. IMPERIAL Trial: A global randomised controlled multi-center trial with 2:1 randomisation 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. 12-Month Primary Patency rate of 86.8% in the Eluvia arm vs. 77.5% in the Zilver PTX arm (p-value = 0.0144).
  2. In IMPERIAL RCT, Eluvia K-M Primary Patency was 83% vs. 77.1% for Zilver PTX at 24 months, p=0.1008.
  3. Vermassen, F. VIVA Late-Breaking Clinical Trials June 2020.
  4. 70% of IMPERIAL Long Lesion Sub-study lesions were Severe/Moderate Calcium.
 

2-Year Results

In IMPERIAL RCT, Eluvia demonstrated a statistically significant reduction in TLR vs. ZilverTM PTXTM at 24 months

CLINICALLY-DRIVEN TLR RATE

CONSISTENTLY LOW 2-YEAR CD-TLR IN CHALLENGING SFA DISEASE

 
Target Lesion Revascularization (TLR) at 2 Years.

Boston Scientific’s ELUVIA Drug-Eluting Stent and Coronary Paclitaxel-Eluting Stent Clinical Experience.
Available at: https://www.fda.gov/media/128145/download [Accessed July 4 2019]Kbr/> Gray WA et al. Lancet. 2018 Oct 27;392(10157):1541-1551
2-Year Results from IMPERIAL Trail; Presented at LINC 2020

24-Month Safety Results*

  • 85.8% of Eluvia patients were free from Major Adverse Events at 24 months (vs. 79.9% of Zilver PTX patients)
  • All-cause mortality for Eluvia was 7.1% (21/295) vs. 8.3% (12/145) for Zilver PTX (p=0.6649)
24-month Safety Results
*Intention to treat. Clinical Events Committee-adjudicated adverse events included major adverse events (MAE), all deaths, and stent thrombosis. MAEs defined as all causes of death through 1 month, target limb major amputation through 24 months, and target lesion revascularization through 24 months.
 

2-Year All-Cause Mortality Rate for Eluvia

All cause mortality for Eluvia was within range expected for symptomatic peripheral arterial disease*

Imperial RCT

Intention to treat. Adapted from Iida, O, VIVA 2019 Presentation.
*Amputation Rates, Mortality, and Pre-operative Comorbidities in Patients Revascularised for Intermittent Claudication or Critical Limb Ischaemia: A Population Based Study Baubeta Fridh, E. et al. European Journal of Vascular and Endovascular Surgery , Volume 54 , Issue 4 , 480 – 486.



IMPERIAL 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.

IMPERIAL Trial Design

Global multi-center, 2:1 randomisation against Cook Medical’s Zilver™ PTX™ Stent, controlled, single-blind, non-inferiority trial; core lab adjudicated
  • 465 (RCT) patients across 64 sites
  • 5-year follow-up
  • Degree of stenosis ≥ 70% (visual angiographic assessment)
  • Vessel diameter ≥ 4 mm and ≤ 6 mm
  • Total lesion length ≥ 30 mm and ≤ 140 mm

Baseline Characteristics

Baseline Characteristics
Baseline Characteristics
 
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