TY - JOUR
T1 - One-year outcome of biolimus eluting stent with biodegradable polymer in all comers
T2 - The Italian Nobori Stent Prospective Registry
AU - Godino, Cosmo
AU - Parenti, Dennis Zavalloni
AU - Regazzoli, Damiano
AU - Rutigliano, David
AU - Lucisano, Luigi
AU - Viani, Giacomo Maria
AU - Spartera, Marco
AU - Chieffo, Alaide
AU - Donahue, Michael
AU - Cappelletti, Alberto
AU - Locuratolo, Nicola
AU - Parisi, Rosario
AU - Fattori, Rossella
AU - Presbitero, Patrizia
AU - Margonato, Alberto
AU - Briguori, Carlo
AU - Sardella, Gennaro
AU - Colombo, Antonio
PY - 2014/11/15
Y1 - 2014/11/15
N2 - 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.
AB - 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.
KW - Biolimus A9-eluting stent
KW - Complex lesions
KW - High-risk patients
KW - Stent thrombosis
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U2 - 10.1016/j.ijcard.2014.09.019
DO - 10.1016/j.ijcard.2014.09.019
M3 - Article
C2 - 25499324
AN - SCOPUS:84909942738
VL - 177
SP - 11
EP - 16
JO - International Journal of Cardiology
JF - International Journal of Cardiology
SN - 0167-5273
IS - 1
ER -