24-Month Primary Patency Results

Eluvia demonstrated the highest ever 2-year primary patency1 

 

1. 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 with standard errors. 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.

24 month chart
24-month safety chart

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)

 

* 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 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.
 
Patients treated with Eluvia showed a similar all-cause mortality rate compared to PAD patients analyzed in a large population based study.
2-year All Cause Mortality chart
1. 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.
 

New Eluvia 2-year clinically-driven TLR data show very low revascularization rates with polymer-based delivery.

2-year TLR data

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.

  •  In the MAJESTIC Clinical Trial, Eluvia demonstrated a 3.6% all-cause mortality rate at 3 years, which is in line or lower than with non-coated devices*
  • 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)

* Innova Bare Metal Stent (SuperNOVA Trial) 3-year All-Cause Mortality: 7.9%

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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