Drug-eluting stents: What is the balance of risks and benefits?
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Corresponding author Antonio Colombo, MD San Raffaele Scientific Institute, Via Olgettina 60, 20132 Milan, Italy. E-mail: [email protected] Current Cardiovascular Risk Reports 2007, 1:279–283 Current Medicine Group LLC ISSN 1932-9520 Copyright © 2007 by Current Medicine Group LLC
Restenosis following bare metal stent (BMS) implantation has been the Achilles heel of percutaneous coronary intervention. When randomized trials showed dramatic reductions in restenosis and target-lesion revascularization in favor of drug-eluting stents (DES), they were widely embraced and soon used in 80% of percutaneous coronary interventions in the United States and some European centers. Consequently, the indications for stenting were pushed into uncharted territories. DES confirmed significant improvements in short- and mid-term outcomes as compared with BMS in real world registries. As the penetration of DES continued into patient and lesion subsets not formally tested in randomized trials, an entity characterized by sudden occlusion of the DES with an associated acute clinical syndrome was occasionally detected. The term late stent thrombosis was introduced to define this relatively new phenomenon, sometimes described with BMS as well. The absolute risk of stent thrombosis appears to be less than 2% throughout the first 3 years after stent implantation. DES thrombosis has provided a moment for pause to reconsider how to best use these new devices and what to expect from future ones.
Introduction Restenosis following bare metal stent (BMS) implantation has been the Achilles heel of percutaneous coronary intervention, occurring in 20% to 40% of the cases at 6 months [1,2]. The concept of drug-eluting stents (DES) that could inhibit neointimal hyperplasia has emerged, and DES have represented one of the fastest growing fields in interventional cardiology within the past years. When randomized trials showed dramatic reductions in restenosis and target-lesion revascularization in favor of DES [3–6], they were widely embraced and soon used in over
80% of percutaneous coronary interventions in the United States and in some European centers [7,8]. Consequently, the indications for stenting were pushed in patients and lesions not evaluated in the major randomized trials, which led to the approval of DES. Implantation of DES in these lesions defined as off-label usage comprises up to 70% of the procedures in major European and United States centers. In these subsets, DES confirmed significant improvements in short- and mid-term outcomes, as compared with BMS [9–12]. As the length of follow-up extended and the implantation of DES was performed in patients and lesions at higher risk and with more complexity, an entity characterized by sudden occlusion of the DES with an associated acute clinical syndrome was occasionally detected. In some of the early reports, a temporal association between late discontinuation of antiplatelet therapy and thrombosis was observed. The term late stent thrombosis was introduced to define this relatively new ph
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