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One-year clinical outcome of biodegradable polymer sirolimus-eluting stent in all-comers population. Insight from the ULISSE registry (ULtimaster Italian multicenter all comerS Stent rEgistry).

Authors :
Godino C
Beneduce A
Ferrante G
Ielasi A
Pivato CA
Chiarito M
Cappelletti A
Perfetti G
Magni V
Prati E
Falcone S
Pierri A
De Martini S
Montorfano M
Parisi R
Rutigliano D
Locuratolo N
Anzuini A
Tespilli M
Margonato A
Benassi A
Briguori C
Fabbiocchi F
Reimers B
Bartorelli A
Colombo A
Source :
International journal of cardiology [Int J Cardiol] 2018 Jun 01; Vol. 260, pp. 36-41.
Publication Year :
2018

Abstract

Background: This study was designed to confirm in a large population of unselected patients the promising results of Ultimaster® biodegradable polymer sirolimus-eluting stent (BP-SES) already shown in previous trial.<br />Methods: ULISSE is an observational, multicenter, national registry evaluating all patients undergoing PCI with the Ultimaster® BP-SES. Incidence of 1-year TLF (cardiac death or target vessel MI or clinically indicated TLR) was the primary endpoint. Pre-specified subgroup analysis was performed for diabetic patients and for those with lesion longer than 25 mm, bifurcation and CTO lesions.<br />Results: 1660 patients were enrolled in 9 Italian cardiology centers, 82% were males, mean age of 68 ± 10 years, and 29% were diabetics. Overall 2422 lesions were treated, 65% type B2/C lesions, 7% CTOs, 17% bifurcations and 38% long lesions. The incidence of 1-year TLF was 5%, with 3.2% of clinically indicated TLR. TLF occurred in 8% of the patients with diabetes mellitus, and 7% in bifurcation, 6.7% in CTO and 6.2% in long lesions. Definite overall ST was 0.9%, and 1.2% in patients treated for type B2/C lesions. Multivariate logistic regression analysis identified stenting on unprotected LMT (OR = 4.80), stenting on ISR lesion (OR = 3.19) and need for rotational atherectomy (OR = 6.24) as the strongest independent predictors of TLF.<br />Conclusions: The results of this national all-comers registry show that the Ultimaster® BP-SES real-world performance was comparable with that observed in the clinical trial, with low rate of primary endpoint and TLR. Long term follow-up will be necessary to prove the theoretical advantage of the BP-SES over time.<br /> (Copyright © 2017. Published by Elsevier B.V.)

Details

Language :
English
ISSN :
1874-1754
Volume :
260
Database :
MEDLINE
Journal :
International journal of cardiology
Publication Type :
Academic Journal
Accession number :
29622449
Full Text :
https://doi.org/10.1016/j.ijcard.2018.02.014