Current Status of Drug-Eluting vs Bare-Metal Stents: Interpreting the Data
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*Zhong Yuan, Johnson & Johnson 


The understanding of the mechanism of neointimal growth with bare-metal stents has led to the development of drug-eluting stents and revolutionized the therapeutic approach for percutaneous coronary intervention. Because of demonstrated effectiveness in reducing the need for revascularization associated with restenosis in controlled clinical studies, drug-eluting stents were quickly adopted into clinical practice. However, since the time of approval (2003 for the Cypher stent and 2004 for the Taxus stent), some studies raised the concern that drug-eluting stents might be associated with a small increase in risk of late stent thrombosis and led some to question the long-term benefit and risk of such devices. On December 7 and 8, 2006, a meeting of the Circulatory System Devices Advisory Panel of the FDA was convened and subsequently, a series of pooled and meta-analyses were published in the New England Journal of Medicine by various authors, in an attempt to clarify the issues. Interestingly, while those analyses were based on similar, or the same, set of clinical studies, the results could be interpreted differently because different analytical approaches were applied. In this presentation, we review some of those publications and share perspectives about how to interpret the data.