[Increased rate of stent thrombosis with DES]

The success story of drug-eluting stents (DES) with which the "last" problem of coronary stenting seemed to be solved and which led to an unprecedented enthusiasm with which cardiologists embraced this new treatment modality of coronary artery disease was recently challenged by the detection of late stent thromboses leading to myocardial infarction and death many months or even years after stent implantation. The BAsel Stent Kosten Effektivitaets Trial (BASKET) and especially the observational BASKET-LAte Thrombotic Events (BASKET-LATE) follow-up study demonstrated that late clinical events related to late DES thrombosis is a real and worrisome complication of DES. In the meantime, these findings have been confirmed by large registry data and meta-analyses of late followups of prospective trials. This has led to vivid discussions and an urgently organized Food and Drug Administration (FDA) panel meeting which cautioned the use of DES particularly in "off-label" use but warned also to put the risks of late events after DES implantation in relation to the early important benefit of these stents indicating that there is no hint for an excess mortality with DES. The FDA suggested that 12 months of dual antiplatelet therapy should be given to all patients treated with DES as long as they are not at increased risk of bleeding. Further studies are needed to identify patients at risk for late stent thrombosis and patient subgroups with a particularly high benefit after implantation of DES. In addition, new second-generation DES with a decreased risk for late stent thrombosis have to be developed.