Increased risk of restenosis after placement of gold-coated stents: results of a randomized trial comparing gold-coated with uncoated steel stents in patients with coronary artery disease.
BACKGROUND
Gold is a highly biocompatible material. Experimental evidence suggests that coating the stent with a gold layer may have a beneficial influence. In this randomized trial, we assessed whether gold-coated stents were associated with a better clinical and angiographic outcome after coronary placement.


RESULTS
Patients with symptomatic coronary artery disease were randomly assigned to receive either a gold-coated Inflow stent (n = 367) or an uncoated Inflow stainless steel stent (n = 364) of identical design. Follow-up angiography was routinely performed at 6 months. The primary end point of the study was the occurrence of any adverse clinical event (death, myocardial infarction, or target-vessel revascularization) during the first year after stenting. At 30 days, there was no significant difference in the combined incidence of adverse events, with 7.9% in the gold-stent group versus 5.8% in the steel-stent group (P = 0.25). The incidence of angiographic restenosis (> or =50% diameter stenosis) was 49.7% in the gold-stent group and 38.1% in the steel-stent group (P = 0.003). One-year survival free of myocardial infarction was 88.6% in the gold-stent group and 91.8% in the steel-stent group (P = 0.14). One-year event-free survival was significantly less favorable in the gold-stent group (62.9% versus 73.9% in the steel-stent group; P = 0.001).


CONCLUSIONS
Coating steel stents with gold had no significant influence on the thrombotic events observed during the first 30 days after the intervention. However, gold-coated stents were associated with a considerable increase in the risk of restenosis over the first year after stenting.
Kastrati
A
A
Deutsches Herzzentrum and 1 Medizinische Klinik rechts der Isar der Technischen Universität, Munich, Germany. kastrati@dhm.mhn.de
Schömig
A
A
Dirschinger
J
J
Mehilli
J
J
von Welser
N
N
Pache
J
J
Schühlen
H
H
Schilling
T
T
Schmitt
C
C
Neumann
F J
FJ
D000368:Aged; D001672:Biocompatible Materials; D017023:Coronary Angiography; D003327:Coronary Disease / Q000628:therapy*; D018572:Disease-Free Survival; D005260:Female; D005500:Follow-Up Studies; D006046:Gold; D006801:Humans; D008297:Male; D008875:Middle Aged; D012008:Recurrence; D013232:Steel; D015607:Stents
D001672:Biocompatible Materials; D013232:Steel; D006046:Gold