title: One-year outcome of biolimus eluting stent with biodegradable polymer in all comers: the Italian Nobori Stent Prospective Registry.
abstract: OBJECTIVE
  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.
  
  
  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.
authors.affiliation: San Raffaele Scientific Institute, Milan, Italy. Electronic address: cosmogodino@gmail.com.
authors.forename: Cosmo
authors.initials: C
authors.lastname: Godino
authors.affiliation: Humanitas Clinical Institute, Milan, Italy.
authors.forename: Dennis Zavalloni
authors.initials: DZ
authors.lastname: Parenti
authors.affiliation: San Raffaele Scientific Institute, Milan, Italy.
authors.forename: Damiano
authors.initials: D
authors.lastname: Regazzoli
authors.affiliation: Ospedale San Paolo, Bari, Italy.
authors.forename: David
authors.initials: D
authors.lastname: Rutigliano
authors.affiliation: Policlinico Umberto I, "La Sapienza" University of Rome, Italy.
authors.forename: Luigi
authors.initials: L
authors.lastname: Lucisano
authors.affiliation: San Raffaele Scientific Institute, Milan, Italy.
authors.forename: Giacomo Maria
authors.initials: GM
authors.lastname: Viani
authors.affiliation: San Raffaele Scientific Institute, Milan, Italy.
authors.forename: Marco
authors.initials: M
authors.lastname: Spartera
authors.affiliation: San Raffaele Scientific Institute, Milan, Italy.
authors.forename: Alaide
authors.initials: A
authors.lastname: Chieffo
authors.affiliation: Clinica Mediterranea, Naples, Italy.
authors.forename: Michael
authors.initials: M
authors.lastname: Donahue
authors.affiliation: San Raffaele Scientific Institute, Milan, Italy.
authors.forename: Alberto
authors.initials: A
authors.lastname: Cappelletti
authors.affiliation: Ospedale San Paolo, Bari, Italy.
authors.forename: Nicola
authors.initials: N
authors.lastname: Locuratolo
authors.affiliation: Ospedali Riuniti Marche Nord, Pesaro, Italy.
authors.forename: Rosario
authors.initials: R
authors.lastname: Parisi
authors.affiliation: Ospedali Riuniti Marche Nord, Pesaro, Italy.
authors.forename: Rossella
authors.initials: R
authors.lastname: Fattori
authors.affiliation: Humanitas Clinical Institute, Milan, Italy.
authors.forename: Patrizia
authors.initials: P
authors.lastname: Presbitero
authors.affiliation: San Raffaele Scientific Institute, Milan, Italy.
authors.forename: Alberto
authors.initials: A
authors.lastname: Margonato
authors.affiliation: Clinica Mediterranea, Naples, Italy.
authors.forename: Carlo
authors.initials: C
authors.lastname: Briguori
authors.affiliation: Policlinico Umberto I, "La Sapienza" University of Rome, Italy.
authors.forename: Gennaro
authors.initials: G
authors.lastname: Sardella
authors.affiliation: San Raffaele Scientific Institute, Milan, Italy; EMO-GVM Centro Cuore Columbus, Milan, Italy.
authors.forename: Antonio
authors.initials: A
authors.lastname: Colombo
mesh_terms: D020341:Absorbable Implants / Q000639:trends*; D000368:Aged; D015331:Cohort Studies; D054855:Drug-Eluting Stents / Q000639:trends*; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007558:Italy / Q000453:epidemiology; D008297:Male; D008875:Middle Aged; D009203:Myocardial Infarction / Q000453:epidemiology* / Q000601:surgery; D011108:Polymers / Q000008:administration & dosage*; D011446:Prospective Studies; D012042:Registries; D020123:Sirolimus / Q000008:administration & dosage / Q000031:analogs & derivatives*; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D011108:Polymers; C518022:umirolimus; D020123:Sirolimus
keywords: Biolimus A9-eluting stent; Complex lesions; High-risk patients; Stent thrombosis