A prospective randomised trial comparing the novel ridaforolimus-eluting BioNIR stent to the zotarolimus-eluting Resolute stent: Six-month angiographic and one-year clinical results of the NIREUS trial

Valeria Paradies, Ori Ben-Yehuda, Michael Jonas, Shmuel Banai, Andres Iñiguez, Gidon Y. Perlman, David E. Kandzari, Gregg W. Stone, Pieter C. Smits*

*Corresponding author for this work

Research output: Contribution to journalArticlepeer-review

Abstract

Aims: The aim of this study was to evaluate the efficacy and safety of the BioNIR stent compared with the Resolute Integrity stent for the treatment of coronary artery disease. Methods and results: This first-in-human, multicentre, single-blind randomised non-inferiority trial was performed in Europe and Israel. Patients with stable coronary artery disease or acute coronary syndromes were randomly assigned to treatment with BioNIR or Resolute Integrity stents in a 2:1 fashion. The primary endpoint was angiographic in-stent late lumen loss (LLL) at six months. Three hundred and two patients were randomised, of whom 261 (86.0%) underwent six-month angiographic follow-up. The BioNIR stent was non-inferior to the Resolute Integrity stent for the primary endpoint of in-stent LLL at six months (0.04±0.30 mm vs. 0.03±0.31 mm, respectively, pnoninferiority<0.0001). At 12-month follow-up, target lesion failure occurred in 3.4% in the BioNIR group and 5.9% in the Resolute Integrity group (p=0.22). Rates of MACE were similar between the BioNIR and Resolute Integrity groups (4.3% vs. 5.9%, respectively, p=0.45). Conclusions: The BioNIR stent was non-inferior to the Resolute Integrity stent for the primary endpoint of angiographic in-stent LLL at six months. Clinical outcomes at one year were comparable between the two groups.

Original languageEnglish
Pages (from-to)86-93
Number of pages8
JournalEuroIntervention
Volume14
Issue number1
DOIs
StatePublished - May 2018
Externally publishedYes

Funding

FundersFunder number
Medinol Ltd
Medinol Ltd.
Tel Aviv, Israel
Cardiovascular Research Foundation

    Keywords

    • Coronary artery disease
    • Drug-eluting stent
    • QCA

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