The stent

Well, it’s finally here. Just a few weeks ago (April 24th to be exact), the United States Food and Drug Administration approved the first drug-eluting stent (DES) for marketing. After years of anticipation, we now have an awaited technology in our hands; at least some of us do, pending widespread availability of sufficient inventory. Clearly, the scientific data regarding the efficacy of DES are impressive. A look back over the years indicates that DES are a significant advance in the treatment of restenosis. Early balloon angioplasty resulted in restenosis rates of 31–37% [1,2,3]. [For the purposes of these comparisons, I have chosen early, single vessel, angiographically-controlled trials of each device.] Later introduction of “new devices” (directional atherectomy for example) saw the restenosis rate fall slightly to 31% [4,5], but expanded the lesions we could approach. Subsequently, widespread introduction of stenting (even first generation low pressure devices) lowered it further (22– 31%) [6,7]. We also changed our focus from angiographic restenosis to target lesion revascularization (TLR), a more appropriate indication of clinical efficacy. Introduction of high-pressure stenting (prompted by IVUS) and application of non-angiographic guiding technologies was another step forward, with restenosis rates between 10 and 24% [8,9]. Now DES enter with restenosis rates of 9% [10]. Table 1 displays these and other pertinent data regarding device costs. I have graphed this progression and its associated cost in an admittedly non-rigorous way, but I believe a fairly accurate one (Fig 1). I have corrected the device costs for inflation and expressed them in 2002 US dollars. As you can see, for a progressive improvement in restenosis, DES come at a price increase which appears in line with prior advances. One could argue that the development costs or the complexity of these new stents does not warrant such an increase, but I believe that once a competitive device hits the market, traditional market forces will mediate the cost issues. In the meantime, although formal cost-effectiveness evaluations of the SIRIUS trial data [11] suggest that “society” is willing to pay the additional cost to achieve lower TLR rates, it is widely expected that significant hospital losses will occur. There is no mechanism for redistributing the societal gains