In 2006, the United States (US) Food and Drug Administration published advisory highlighting concerns for late drug-eluting stent thrombosis; its impact on US bare-metal stent (BMS) utilization is unknown. We examined rates of BMS use among Medicare patients at 946 US hospitals in the CathPCI Registry who underwent percutaneous coronary intervention (PCI) during 3 periods: (1) 2004 to 2006 preadvisory (n = 166,458); (2) 2007 to 2008 postadvisory (n = 216,318); and (3) 2012 to 2014 contemporary (n = 827,948). We examined predicted risks of target vessel revascularization and bleeding among BMS recipients by period. We compared 1-year repeat revascularization and death/myocardial infarction risks among BMS recipients immediately preadvisory and postadvisory. BMS were used in 15.8% of preadvisory, 40.9% of postadvisory, and 20.0% of contemporary PCI procedures. Although 19.5% of preadvisory BMS patients had a predicted target vessel revascularization risk ≥15%/year, this decreased to 16.7% postadvisory (p <0.001), and increased back to 18.7% among contemporary BMS recipients (p <0.001). In contrast, 12.3% of preadvisory BMS recipients had a predicted bleeding risk ≥5%/year, compared with 14.6% postadvisory (p <0.001), and 18.2% in contemporary BMS recipients (p <0.001). Postadvisory BMS recipients had a lower risk of repeat revascularization (12.8% vs 14.6%, adjusted hazard ratio 0.87, 95% CI 0.84 to 0.90) but no difference in the composite risk of death/myocardial infarction (15.9% vs 15.9%, adjusted hazard ratio 0.97, 95% CI 0.93 to 1.00). In conclusion, a surge in BMS use after the advisory was not associated with an increased risk of repeat revascularization or adverse outcomes in BMS-treated patients. One in 5 contemporary PCI procedures still involve BMS implantation.
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