(Circulation. 2000;101:2478.)
© 2000 American Heart Association, Inc.
Clinical Investigation and Reports |
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
From Deutsches Herzzentrum and 1 Medizinische Klinik rechts der Isar der Technischen Universität, Munich, Germany.
Correspondence to Dr Adnan Kastrati, Deutsches Herzzentrum, Lazarettstraße 36, 80636 München, Germany. E-mail kastrati{at}dhm.mhn.de
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.
Methods and 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 (
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.
Key Words: stents • thrombosis • restenosis • trials
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