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.
(c) 2006 Wiley-Liss, Inc.