Are Drug-Eluting Stents Cost-Effective?

Abstract

Since their commercial introduction in 2003, drug-eluting stents (DES) have rapidly altered the management of coronary artery disease. Before their development, the percutaneous management of coronary artery disease was performed predominantly by implantation of bare metal stents (BMS) made of either surgical stainless steel or metal alloys. Although such stents represented a considerable advance over balloon angioplasty alone, they remained limited by restenosis resulting from neointimal proliferation. As a result, ≈15% to 20% of patients treated with BMS required ≥1 repeat revascularization procedure within the 6 to 12 months after stent implantation.1 Despite numerous attempts at systemic pharmacotherapy, device modification, and even use of ionizing radiation, the rate of restenosis after BMS implantation remained largely unaffected. Response by Eisenberg p 1744 Over the past 5 years, effective DES have become the first device to substantially reduce the incidence of restenosis after stent implantation. By delivering high concentrations of either antiproliferative or immunomodulatory compounds directly to the site of arterial injury and by controlling this delivery through polymer-based drug release, both sirolimus- and paclitaxel-eluting stents have safely and effectively inhibited the proliferative process that results in in-stent restenosis. In pivotal clinical trials, both sirolimus- and paclitaxel-eluting stents have reduced rates of angiographic restenosis by 70% to 90% compared with conventional BMS designs, with parallel reductions in the need for clinically driven target vessel revascularization (TVR).2–4 As a result, in April 2003, DES were approved for use in clinical practice in the United States. Within 9 months of their introduction, DES made up 35% of all stent implantations in the United States,5 and their use has increased rapidly since that time. At our own institution, DES comprised >85% of all stents implanted during the past year, and national estimates are that >90% of all percutaneous coronary intervention (PCI) procedures …