Abstract

Recent analyses have suggested that implantation of drug-eluting stents (DES) is associated with a higher rate of very late stent thrombosis when compared with bare metal stents. This complication is evident with both sirolimus-eluting stents as well as polymer-based paclitaxel-eluting stents, but the precise magnitude of this risk and whether this applies to all patients or only a subset of those who have received DES is incompletely characterized. This alert is designed to provide the practicing interventional cardiologist with practical advice in light of this new information. It is not the purpose of this document to provide an exhaustive review of the literature on DES and the risk of stent thrombosis; however a brief summary is appropriate. While exact definitions have been variable in different trials, late stent thrombosis generally refers to stent thrombosis occurring at least 1 month following stent implantation, while very late stent thrombosis refers to events occurring more than 12 months following stent placement. Following bare metal stent implantation, stent thrombosis is rare after 2 weeks, and dual antiplatelet therapy (aspirin and a thienopyridine) was typically prescribed for 3–6 weeks. In contrast, sporadic reports of late stent thrombosis in patients receiving DES have occurred over the past few years. These events often (but not always) occurred in the setting of premature discontinuation of dual antiplatelet therapy. In March 2006, the BASKET-LATE trial was reported, describing a significantly greater composite occurrence of cardiac death and non-fatal myocardial infarction in patients treated with DES when compared with bare-metal stents after clopidogrel had been discontinued at 6 months [1]. Other meta-analyses of the existing DES trials also showed an increase in late events in the DES cohort although these analyses were limited by incomplete data in publications, abstracts, and Internet sources [2,3]. In October 2006, an independent patient-level meta analysis of the four pivotal randomized Cypher stent trials and the five pivotal randomized Taxus stent trials was publicly presented. These analyses demonstrated an increased rate of stent thrombosis with both sirolimus-eluting and paclitaxelJ_ID: Z7V Customer A_ID: 06-0418 Cadmus Art: CCI 21093 Date: 5-JANUARY-07 Stage: I Page: 1

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