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)

Cosmo Godino, Alessandro Beneduce, Giuseppe Ferrante, Alfonso Ielasi, Andrea Carlo Pivato, Mauro Chiarito, Alberto Cappelletti, Giulia Perfetti, Valeria Magni, Eugenio Prati, Stefania Falcone, Adele Pierri, Stefano De Martini, Matteo Montorfano, Rosario Parisi, David Rutigliano, Nicola Locuratolo, Angelo Anzuini, Maurizio Tespilli, Alberto MargonatoAlberto Benassi, Carlo Briguori, Franco Fabbiocchi, Bernhard Reimers, Antonio Bartorelli, Antonio Colombo

Research output: Contribution to journalArticlepeer-review

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.

Original languageEnglish
Pages (from-to)36-41
Number of pages6
JournalInternational Journal of Cardiology
Volume260
DOIs
Publication statusPublished - Jun 1 2018

Keywords

  • Absorbable Implants/trends
  • Aged
  • Anti-Bacterial Agents/administration & dosage
  • Death
  • Drug-Eluting Stents/trends
  • Female
  • Follow-Up Studies
  • Heart Diseases/diagnosis
  • Humans
  • Italy/epidemiology
  • Male
  • Middle Aged
  • Population Surveillance/methods
  • Registries
  • Retrospective Studies
  • Sirolimus/administration & dosage
  • Time Factors
  • Treatment Outcome

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