Coronary stenting with the Genous™ Bio-Engineered R Stent™ in elderly patients

Circ J. 2011;75(11):2590-7. doi: 10.1253/circj.cj-11-0509. Epub 2011 Sep 14.

Abstract

Background: We evaluated the Genous™ Bio-engineered R stent™ in elderly patients undergoing non-urgent percutaneous coronary intervention. The elderly have an increased risk of (temporary) discontinuation of clopidogrel, which is associated with a higher risk of developing stent thrombosis (ST).

Methods and results: In the e-HEALING registry, 2,651 patients were <65, 1,403 were 65-74 and 869 were ≥ 75 years old. The 12-month primary outcome was target vessel failure (TVF), defined as target vessel-related car-diac death or myocardial infarction and target vessel revascularization. Secondary outcomes included target lesion revascularization (TLR) and ST. Cumulative event rates were estimated with the Kaplan-Meier method and compared with a log-rank test. TVF occurred significantly more often in elderly patients compared with younger patients (7.0% in patients aged < 65, 8.8% in patients aged 65-74 and 11.7% in patients aged ≥ 75 years, P<0.001). There was a trend to higher TLR with increasing age (log-rank P=0.06) and no difference in ST.

Conclusions: The 1-year results of the Genous stent in a population of elderly patients show a significantly higher TVF rate compared with younger patients, mainly driven by a higher mortality. Although there was a trend to higher TLR rates with increasing age, there was no difference in ST. This attests to the safety of this therapy for the elderly, in whom there could be concerns with administering long-term dual antiplatelet therapy.

Publication types

  • Clinical Trial
  • Multicenter Study
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Age Factors
  • Aged
  • Angioplasty, Balloon, Coronary
  • Blood Vessel Prosthesis / adverse effects*
  • Clopidogrel
  • Death
  • Female
  • Humans
  • Male
  • Myocardial Infarction* / etiology
  • Myocardial Infarction* / mortality
  • Platelet Aggregation Inhibitors / administration & dosage
  • Product Surveillance, Postmarketing*
  • Registries*
  • Risk Factors
  • Stents / adverse effects*
  • Thrombosis* / etiology
  • Thrombosis* / mortality
  • Thrombosis* / prevention & control
  • Ticlopidine / administration & dosage
  • Ticlopidine / analogs & derivatives

Substances

  • Platelet Aggregation Inhibitors
  • Clopidogrel
  • Ticlopidine