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Sustained increased risk of adverse cardiac events over 5 years after implantation of gold‐coated coronary stents
Author(s) -
Pache Jürgen,
Dibra Alban,
Schaut Christian,
Schühlen Helmut,
Dirschinger Josef,
Mehilli Julinda,
Kastrati Adnan,
Schömig Albert
Publication year - 2006
Publication title -
catheterization and cardiovascular interventions
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.988
H-Index - 116
eISSN - 1522-726X
pISSN - 1522-1946
DOI - 10.1002/ccd.20814
Subject(s) - medicine , hazard ratio , myocardial infarction , stent , clinical endpoint , restenosis , cardiology , confidence interval , gold standard (test) , incidence (geometry) , surgery , cumulative incidence , revascularization , randomized controlled trial , cohort , physics , optics
Objective: To study the 5‐year outcome of patients treated with gold‐coated stent placement. Background: We have previously shown in the setting of a randomized trial that gold‐coated stents are associated with worse mid‐term outcome, mainly because of an increased risk of restenosis, compared to uncoated stents. The long‐term outcome and, in particular, mortality risk after implantation of gold‐coated stents are not known. Methods: A total of 731 patients with symptoms or signs of ischemia received randomly either a gold‐coated ( n = 367) or an uncoated steel stent ( n = 364) of identical design. Patients were clinically followed‐up at 1 and 5 years. The primary endpoint of the study was the composite of major cardiac events (death, myocardial infarction, or target vessel revascularization (TVR)). The incidence of death was a secondary endpoint. Results: Five‐year follow‐up was available in 97.5% of the patients. The composite of death, myocardial infarction, or TVR occurred in 51% of the patients treated with gold‐coated stents and 40% of the patients treated with uncoated stents ( P = 0.005). Of note, there was a marked increase in the absolute difference in mortality between patients in the gold‐coated and uncoated stent groups, from 1.6% at 1 year to 4.9% after 5‐year follow‐up ( P = 0.09). A multivariate analysis showed that gold‐coated stent implantation was independently associated with 5‐year mortality (hazard ratio, 1.46; 95% confidence interval, 1.02–2.09; P = 0.04). Conclusions: Gold‐coated stents are associated with a sustained increased overall risk for major cardiac events, and notably, they may increase the long‐term mortality risk. © 2006 Wiley‐Liss, Inc.