Abstract

Stents that elute antiproliferative drugs prevent restenosis after percutaneous coronary artery revascularization, reducing the need for repeat procedures. Randomized trials in low-risk patients supported initial regulatory approval for drug-eluting stents (DES). In 2006, meta-analyses of long-term outcomes from these trials associated DES use with adverse events, believed to be attributable to late stent thrombosis, occurring more than 9 months after the initial procedure. This article appraises these late adverse effects and illustrates the power and shortcomings of large national registries, focused, well-conducted clinical trials, and meta-analyses of clinical trial data. This timely, robust evidence base reflects an alignment of academic, industry, and public health priorities.

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