Clinical Data › Long-Term Evidence

Long-Term Evidence

ELUVIA Drug-Eluting Vascular Stent System

Dr Lookstein comments on paclitaxel

"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 ›

 

2-year results from IMPERIAL, the world’s first head-to-head DES SFA Trial1

Presented at LINC 2020

Eluvia demonstrated the highest primary patency ever reported in an SFA US Pivotal Trial for DES or DCB*

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 Randomization for Zilver PTX RCT. 
** 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 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. 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.

2-Year Results

In IMPERIAL RCT, Eluvia demonstrated a statistically significant reduction in TLR vs. Zilver™ PTX™ at 24 months

Clinically-Driven TLR Rate
Consistently low 2-year clinically-driven TLR in challenging SFA disease
1. Long Lesion TLR is as-treated as presented at FDA Panel 2019. All other TLR data sets adapted from Gray, W. LINC 2020 Presentation, are intention to treat.
 

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* ELUVIA
(n=309)
Zilver PTX
(n=156)
p-value
24-month MAE 14.2% 20.1% 0.1236
All-Cause of Deaths at 1 Month 0.0% 0.0% Undefined
Clinically-driven TLR 12.7% 20.1% 0.0495

* 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.

5-Year Data with Polymer-Based Coronary Paclitaxel Devices

2-year TLR data
comparable all-cause mortality rates
Coronary polymer-based paclitaxel-eluting stents have demonstrated similar all-cause mortality compared to bare metal stents at 5 years.

As a polymer-based drug eluting stent, Eluvia is more like coronary stents, such as Boston Scientific's TAXUS, versus peripheral paclitaxel-coated products. Both Eluvia and TAXUS deliver the same drug and are similar in design intent and mechanism of action; both yielding sustained, targeted paclitaxel delivery.

As published in JACC:CI, TAXUS demonstrated a 9.8% all-cause mortality rate at 5 years, compared to 9.1% in the BMS arm (p-value = 0.53)

image

A 5-year patient-level pooled meta analysis

from randomized, controlled trials, published in JACC:CI, from 2,797 patients (TAXUS DES vs. BMS) showed no difference in mortality

5 year data in PAD patients

(TAXUS DES vs PTA + BMS) showed no difference in mortality in CLI

image

 

 

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