Incidence of adverse cardiac events 5 years after polymer-free sirolimus eluting stent implantation: Results from the prospective Bad Berka Yukon Choice™ registry

Catheter Cardiovasc Interv. 2014 Dec 1;84(7):1080-6. doi: 10.1002/ccd.25272. Epub 2013 Nov 12.

Abstract

Objectives: Drug-eluting stents (DES) constitute a major achievement in preventing re-stenosis, concerns remain regarding the increased inflammatory responses associated with the polymers used. This analysis focuses on outcomes in patients receiving the polymer-free sirolimus-eluting stent system YUKON-Choice (Yukon-DES, Translumina, Germany).

Methods: From 01/2006-09/2008 all patients receiving Yukon-DES (≥2.5 mm diameter) were prospectively enrolled in our registry. The primary endpoint was long-term major adverse cardiac events (MACE).

Results: 701 patients were included in our registry. Mean age was 65.7 ± 10 years (73% male gender, 35.5% diabetes, and 32.2% acute coronary syndrome). 76% of the lesions were of Type B2/C. Lesion length was 24.6 ± 5.2 mm and mean stent diameter was 2.8 ± 0.4 mm. A total of 511 pts (72%) underwent 6-months angiographic follow-up, target vessel revascularization was noted in 23.5%. At 5 years clinical outcomes were: cardiac death 5.8%; myocardial infarction 3.4%; and TVR 24.6%. The incidence of MACE differed significantly between "on-label" and "off-label" indications (14.8% vs. 40.8% MACE; P < 0.001). Incidence of definitive/probable stent thrombosis (ST) was 1.14% (8/701); very late (>1 year) ST occurred in 0.29%.

Conclusion: Our data suggests that the implantation of the sirolimus-coated polymer-free YUKON-DES is safe and feasible with a very low incidence of ST in this real world patient cohort with high percentage of diabetes and small vessels.

Keywords: 5-year results; Yukon choice; outcome; sirolimus eluting stent.

Publication types

  • Observational Study
  • Randomized Controlled Trial

MeSH terms

  • Aged
  • Coronary Angiography
  • Coronary Artery Disease / surgery*
  • Coronary Restenosis / diagnostic imaging
  • Coronary Restenosis / epidemiology*
  • Drug-Eluting Stents*
  • Female
  • Follow-Up Studies
  • Germany / epidemiology
  • Humans
  • Incidence
  • Male
  • Polymers
  • Prospective Studies
  • Registries*
  • Sirolimus / pharmacology*
  • Survival Rate / trends
  • Time Factors

Substances

  • Polymers
  • Sirolimus