TY - JOUR
T1 - 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)
AU - Godino, Cosmo
AU - Beneduce, Alessandro
AU - Ferrante, Giuseppe
AU - Ielasi, Alfonso
AU - Pivato, Andrea Carlo
AU - Chiarito, Mauro
AU - Cappelletti, Alberto
AU - Perfetti, Giulia
AU - Magni, Valeria
AU - Prati, Eugenio
AU - Falcone, Stefania
AU - Pierri, Adele
AU - De Martini, Stefano
AU - Montorfano, Matteo
AU - Parisi, Rosario
AU - Rutigliano, David
AU - Locuratolo, Nicola
AU - Anzuini, Angelo
AU - Tespilli, Maurizio
AU - Margonato, Alberto
AU - Benassi, Alberto
AU - Briguori, Carlo
AU - Fabbiocchi, Franco
AU - Reimers, Bernhard
AU - Bartorelli, Antonio
AU - Colombo, Antonio
N1 - Copyright © 2017. Published by Elsevier B.V.
PY - 2018/6/1
Y1 - 2018/6/1
N2 - 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.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.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.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.
AB - 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.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.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.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.
KW - Absorbable Implants/trends
KW - Aged
KW - Anti-Bacterial Agents/administration & dosage
KW - Death
KW - Drug-Eluting Stents/trends
KW - Female
KW - Follow-Up Studies
KW - Heart Diseases/diagnosis
KW - Humans
KW - Italy/epidemiology
KW - Male
KW - Middle Aged
KW - Population Surveillance/methods
KW - Registries
KW - Retrospective Studies
KW - Sirolimus/administration & dosage
KW - Time Factors
KW - Treatment Outcome
U2 - 10.1016/j.ijcard.2018.02.014
DO - 10.1016/j.ijcard.2018.02.014
M3 - Article
C2 - 29622449
VL - 260
SP - 36
EP - 41
JO - International Journal of Cardiology
JF - International Journal of Cardiology
SN - 0167-5273
ER -