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.

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) / C. Godino, A. Beneduce, G. Ferrante, A. Ielasi, A.C. Pivato, M. Chiarito, A. Cappelletti, G. Perfetti, V. Magni, E. Prati, S. Falcone, A. Pierri, S. De Martini, M. Montorfano, R. Parisi, D. Rutigliano, N. Locuratolo, A. Anzuini, M. Tespilli, A. Margonato, A. Benassi, C. Briguori, F. Fabbiocchi, B. Reimers, A. Bartorelli, A. Colombo. - In: INTERNATIONAL JOURNAL OF CARDIOLOGY. - ISSN 0167-5273. - 260(2018), pp. 36-41.

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)

A. Bartorelli;
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. 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.
Biodegradable polymer sirolimus-eluting stent; Complex lesions; High-risk patients; Percutaneous coronary intervention; Stent thrombosis; Absorbable Implants; Aged; Anti-Bacterial Agents; Death; Drug-Eluting Stents; Female; Follow-Up Studies; Heart Diseases; Humans; Italy; Male; Middle Aged; Retrospective Studies; Sirolimus; Time Factors; Treatment Outcome; Population Surveillance; Registries; Cardiology and Cardiovascular Medicine
Settore MED/11 - Malattie dell'Apparato Cardiovascolare
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Utilizza questo identificativo per citare o creare un link a questo documento: http://hdl.handle.net/2434/633968
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