NIREUS Trial of Medinol’s BioNIR DES Meets Primary Endpoint
May 20, 2016—The NIREUS trial, which is evaluating Medinol’s BioNIR coronary stent system and the company’s eDES elastomeric drug-eluting stent, met its noninferiority primary endpoint of angiographic in-stent late loss at 6 months. The data were unveiled at the EuroPCR 2016 conference held May 17–20 in Paris, France.
According to Medinol, NIREUS is a prospective, multicenter, randomized, noninferiority pivotal study comparing the BioNIR to the Resolute Integrity stent (Medtronic plc). The study enrolled 302 patients (BioNIR, n = 201; Resolute Integrity, n = 101) with coronary artery disease at 31 sites in Europe and Israel and will be used to support Medinol’s submission for European CE Mark approval.
The BioNIR stent also demonstrated exceptionally low late loss compared with Resolute Integrity (0.04 ± 0.31 mm vs 0.03 ± 0.31 mm; P < .0001). Additionally, the BioNIR stent demonstrated a target lesion failure rate at 6 months of 1.5%, compared with 3.0% for Resolute Integrity (P = NS).
The NIREUS Principal Investigator, Pieter C. Smits, MD, commented in the company’s press release, “We are very enthusiastic about the NIREUS results, particularly with the remarkably low in-stent late loss. These uncommonly good clinical results will help increase physician confidence in the long-term benefits of the BioNIR stent for patients."
Dr. Smits continued, “The stent conforms well to the vessel, and provides consistent, smooth scaffolding. This is all very exciting, and we look forward to following these patients to see how these excellent outcomes progress over time.” Dr. Smits is from Maasstad Ziekenhuis in Rotterdam, The Netherlands.
BioNIR’s design is based the company’s NIRxcell stent architecture intended to enhance conformability, scaffolding, and radial strength. The stent is composed of cobalt chromium and elutes ridafarolimus. The BioNIR stent system is an investigational device and is not available for commercial sale, advised the company.