Drug-eluting stents: What is the balance of risks and benefits?

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.