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. 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.