Sustained increased risk of adverse cardiac events over 5 years after implantation of gold-coated coronary stents.
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.
Pache
Jürgen
J
Deutsches Herzzentrum, Lazarettstr. 36, 80636 München, Germany. pache@dhm.mhn.de
Dibra
Alban
A
Schaut
Christian
C
Schühlen
Helmut
H
Dirschinger
Josef
J
Mehilli
Julinda
J
Kastrati
Adnan
A
Schömig
Albert
A
D000368:Aged; D019917:Blood Vessel Prosthesis Implantation; D002317:Cardiovascular Agents / Q000009:adverse effects* / Q000627:therapeutic use; D020099:Coated Materials, Biocompatible / Q000009:adverse effects* / Q000627:therapeutic use; D017023:Coronary Angiography; D023903:Coronary Restenosis / Q000453:epidemiology / Q000209:etiology; D023921:Coronary Stenosis / Q000000981:diagnostic imaging / Q000453:epidemiology / Q000401:mortality / Q000601:surgery*; D005260:Female; D005500:Follow-Up Studies; D005858:Germany / Q000453:epidemiology; D006046:Gold / Q000009:adverse effects* / Q000627:therapeutic use; D006801:Humans; D053208:Kaplan-Meier Estimate; D008297:Male; D008875:Middle Aged; D015999:Multivariate Analysis; D009203:Myocardial Infarction / Q000453:epidemiology / Q000209:etiology; D011237:Predictive Value of Tests; D012307:Risk Factors; D015607:Stents / Q000145:classification; D016019:Survival Analysis; D013997:Time Factors; D016896:Treatment Outcome
D002317:Cardiovascular Agents; D020099:Coated Materials, Biocompatible; D006046:Gold