Percutaneous Coronary Intervention in Perspective

Abstract

Since the United States Food and Drug Administration (FDA) approval of drug-eluting stents (DES) in 2003 as a treatment for coronary artery disease (http://www.fda.gov/bbs/topics/NEWS/2003/NEW00896.html), physicians have extended the use of these devices to patient and lesion complexities beyond those studied in pivotal randomized trials that compared their outcomes with bare metal stents. During the early period of enthusiastic adoption of DES, clinical decisions regarding DES implantation often exceeded the supportive evidence for a specific indication and instead were based on extrapolations of DES use in less complex patients, positive reports from subgroup analyses of subsequent trials, and anecdotal experience. Application of DES beyond the studied (and approved) indications, termed “off-label,” represents at least 60% of clinical practice patterns in contemporary percutaneous coronary intervention.1 In parallel with the increasing use of sirolimus- and paclitaxel-eluting stents, there emerged concern that DES may be associated with an increased incidence of late stent thrombosis (ST) and possibly increased rates of myocardial infarction (MI) and death.2–7 Although the pivotal trials evaluating DES were not statistically powered to identify differences in rare adverse events between DES and bare metal stents, the observation that ST, in particular late ST, was often associated with death or MI3,8–13 raised concerns among clinicians and regulators. In many instances, the limited data available obscured the differentiation of “evidence-based” medicine from clinical opinion and raised questions about the risk–benefit equation of DES use. The result was a return to increased use of bare metal stents and a relative decline in DES use from ≈90% of coronary stent revascularization procedures in 2006 to 60% by mid-2007.14 Because of these safety concerns, the FDA convened an expert advisory panel in December 2006 resulting in an updated statement that although the approved DES were associated with a small but measurable increase …