4.5 Article

Coronary Stenting With the Genous™ Bio-Engineered R Stent™ in Elderly Patients-12-Month Outcomes From the e-HEALING Registry

Journal

CIRCULATION JOURNAL
Volume 75, Issue 11, Pages 2590-2597

Publisher

JAPANESE CIRCULATION SOC
DOI: 10.1253/circj.CJ-11-0509

Keywords

e-HEALING; Elderly; Genous (TM) EPC capturing R stent (TM); 12-month outcomes

Funding

  1. OrbusNeich Medical BV
  2. OrbusNeich Medical BV, The Netherlands

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Background: We evaluated the Genous (TM) Bio-engineered R stent (TM) 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 cardiac 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. (Circ J 2011; 75: 2590-2597)

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