Ten-year clinical outcomes after sirolimus-eluting stent implantation: Impact of an in-stent restenosis target lesion

Am Heart J. 2016 May:175:47-55. doi: 10.1016/j.ahj.2016.02.005. Epub 2016 Feb 17.

Abstract

Little is known about the long-term outcomes after first-generation sirolimus-eluting stent (SES) implantation. We aimed to investigate the clinical outcomes up to 10 years after SES implantation.

Methods: The study population comprised 342 patients (504 lesions) who underwent SES implantation between January 2002 and December 2004. The median duration of follow-up was 3816 days (interquartile range [Q1-Q3], 3,705-3,883 days).

Results: The cumulative event rate of definite stent thrombosis was 3.9%. The cumulative rate of target lesion revascularization (TLR) at 1, 5, and 10 years was 8.7%, 18.8%, and 31.1%, respectively, and the annual rate of TLR was 3.1%. Clinically driven TLR occurred at relatively constant rate during 10 years (2.0% per year). In a multivariate analysis, higher body mass index, hemodialysis, in-stent restenosis (ISR) target lesion, and total stent length >30 mm were independent risk factors of TLR within 5 years. An independent risk factor of TLR beyond 5 years was ISR target lesion.

Conclusions: Late TLR after SES implantation is a long-term hazard, lasting up to 10 years. The ISR target lesion is a risk factor of TLR during 10 years.

MeSH terms

  • Aged
  • Aged, 80 and over
  • Coronary Restenosis* / diagnosis
  • Coronary Restenosis* / epidemiology
  • Coronary Restenosis* / etiology
  • Drug-Eluting Stents / adverse effects*
  • Female
  • Follow-Up Studies
  • Humans
  • Immunosuppressive Agents / administration & dosage
  • Immunosuppressive Agents / adverse effects
  • Japan / epidemiology
  • Long Term Adverse Effects* / diagnosis
  • Long Term Adverse Effects* / epidemiology
  • Long Term Adverse Effects* / etiology
  • Male
  • Middle Aged
  • Myocardial Infarction* / diagnosis
  • Myocardial Infarction* / epidemiology
  • Myocardial Infarction* / surgery
  • Percutaneous Coronary Intervention* / instrumentation
  • Percutaneous Coronary Intervention* / methods
  • Registries
  • Retrospective Studies
  • Risk Factors
  • Sirolimus* / administration & dosage
  • Sirolimus* / adverse effects

Substances

  • Immunosuppressive Agents
  • Sirolimus