One-year outcome of biolimus eluting stent with biodegradable polymer in all comers: The Italian Nobori Stent Prospective Registry

Cosmo Godino, Dennis Zavalloni Parenti, Damiano Regazzoli, David Rutigliano, Luigi Lucisano, Giacomo Maria Viani, Marco Spartera, Alaide Chieffo, Michael Donahue, Alberto Cappelletti, Nicola Locuratolo, Rosario Parisi, Rossella Fattori, Patrizia Presbitero, Alberto Margonato, Carlo Briguori, Gennaro Sardella, Antonio Colombo

Research output: Contribution to journalArticlepeer-review

Abstract

Methods Unrestricted consecutive high-risk patients treated with BES with biodegradable polymer (Nobori, Terumo, Tokyo, Japan) between February 2008 and July 2012 were prospectively enrolled in an independent multicenter registry and divided in two groups: complex and non complex lesions.

Results 1066 patients (1589 lesions) treated with Nobori BES were analyzed. The majority of patients (57%) were treated for at least one complex lesion and presented a high-risk clinical profile (previous CABG 17.6%, diabetes mellitus 33.1%, chronic kidney disease 14.3%). Angiographic success rate was achieved in 96.2% cases. At 1 year, the primary endpoint, (composite of cardiac death, myocardial infarction, and clinically driven target vessel revascularization), occurred in 39 (4.0%) patients, and was higher in the complex lesions (5.2% vs. 2.5%, P = 0.032). Target lesion failure (TLF, secondary endpoint) occurred in 45 (4.6%) patients, and was more frequent in the complex lesions group (6.2% vs. 2.7%, P = 0.011), mainly due to a higher incidence of any target lesion revascularization (4.8% vs. 2.7%; P = 0.095). Definite and probable stent thrombosis (ST) rate was 0.6% and 0.5% respectively, with no difference between groups.

Conclusions In unrestricted daily practice, BESs were implanted predominantly in high risk patients with complex lesions. Despite this, the Nobori BES was associated with a relatively low rate of primary endpoint and TLF, with a higher risk in patients with complex lesions.

Objectives INSPIRE-1 (Italian Nobori Stent ProspectIve REgistry-1) was designed and conducted to assess clinical performance of Nobori biolimus A9-eluting stent (BES) implantation in an unrestricted "real-world" cohort of patients.

Original languageEnglish
Pages (from-to)11-16
Number of pages6
JournalInternational Journal of Cardiology
Volume177
Issue number1
DOIs
Publication statusPublished - Nov 15 2014

Keywords

  • Biolimus A9-eluting stent
  • Complex lesions
  • High-risk patients
  • Stent thrombosis

ASJC Scopus subject areas

  • Cardiology and Cardiovascular Medicine
  • Medicine(all)

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