One-year clinical outcome of biodegradable polymer sirolimus-eluting stent in diabetic patients: Insight from the ULISSE registry (ULtimaster Italian multicenter all comerS Stent rEgistry): Catheterization and Cardiovascular Interventions

A. Beneduce, G. Ferrante, A. Ielasi, C.A. Pivato, M. Chiarito, A. Cappelletti, L. Baldetti, V. Magni, E. Prati, S. Falcone, A. Pierri, S. De Martini, M. Montorfano, R. Parisi, D. Rutigliano, N. Locuratolo, A. Anzuini, M. Tespili, A. Margonato, A. BenassiC. Briguori, B. Reimers, F. Fabbiocchi, A. Bartorelli, A. Colombo, C. Godino

Research output: Contribution to journalArticlepeer-review

Abstract

Background: The ULISSE registry evaluated the real-world performance of the Ultimaster® biodegradable polymer sirolimus-eluting stent (BP-SES) in a multicenter-independent cohort of patients undergoing percutaneous coronary intervention, including a large proportion of diabetes mellitus (DM) patients. Methods: In this subgroup analysis, 1,660 consecutive patients, 2,422 lesions, treated with BP-SES enrolled in the ULISSE registry were divided in two groups: DM (485 patients, 728 lesions) and non-DM (1,175 patients, 1,694 lesions). Primary endpoint was target lesion failure (TLF), a composite endpoint of cardiac-death, target-vessel myocardial infarction (TV-MI), and clinically driven target lesion revascularization (TLR) at 1-year. Secondary endpoint was TLR at 1-year. Results: At 1-year follow-up TLF occurred in 5% overall patients and was significantly higher in DM patients (8 vs. 3.7%; p =.001), due to more cardiac deaths (3.4 vs. 1.1%; p =.002). TLR occurred in 3.2% overall patients, and it was not significantly higher in DM compared to non-DM patients (4.4 vs. 2.8%; p =.114). The incidence of stent thrombosis was low and similar between groups (0.4 vs. 0.9%; p =.526). Insulin-treated DM (ITDM) patients showed higher rate of TLF as compared to non-ITDM patients (13 vs. 6.5%; p =.041), but similar rate of TLR (6 vs. 4%; p =.405). After adjustment for relevant comorbidities, DM was not significantly associated with TLF or cardiac death in patients undergoing BP-SES implantation. Conclusions: This study is the first all-comers evaluation of BP-SES in DM patients. Our findings show that DM patients, mostly those with ITDM, still represent a vulnerable population and experience significantly higher rate of TLF. Overall BP-SES efficacy is considerable, although not statistically significant higher rate of TLR is still present in DM compared to non-DM patients. © 2019 Wiley Periodicals, Inc.
Original languageEnglish
Pages (from-to)255-265
Number of pages11
JournalCatheter. Cardiovasc. Interventions
Volume96
Issue number2
DOIs
Publication statusPublished - 2020

Keywords

  • biodegradable polymer sirolimus-eluting stent
  • diabetes mellitus
  • percutaneous coronary intervention
  • insulin
  • cardiovascular agent
  • rapamycin
  • aged
  • Article
  • cardiovascular parameters
  • clinical effectiveness
  • clinical outcome
  • cohort analysis
  • comorbidity
  • controlled study
  • female
  • follow up
  • heart death
  • heart infarction
  • heart left ventricle ejection fraction
  • human
  • incidence
  • major adverse cardiac event
  • major clinical study
  • male
  • multicenter study
  • observational study
  • stent thrombosis
  • target lesion failure
  • target lesion revascularization
  • target vessel myocardial infarction
  • therapy effect
  • adverse event
  • biodegradable implant
  • clinical trial
  • coronary artery disease
  • devices
  • diagnostic imaging
  • drug eluting stent
  • Italy
  • middle aged
  • mortality
  • prospective study
  • prosthesis design
  • register
  • risk assessment
  • risk factor
  • time factor
  • treatment outcome
  • Absorbable Implants
  • Aged
  • Cardiovascular Agents
  • Coronary Artery Disease
  • Diabetes Mellitus
  • Drug-Eluting Stents
  • Female
  • Humans
  • Male
  • Middle Aged
  • Percutaneous Coronary Intervention
  • Prospective Studies
  • Prosthesis Design
  • Registries
  • Risk Assessment
  • Risk Factors
  • Sirolimus
  • Time Factors
  • Treatment Outcome

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