Expired CME Article

Safety and Efficacy of the Drug-Eluting Stent: A Double-Edged Sword?

Authors: Jack P. Chen, MD, FACC, FSCAI, FCCP

Abstract

Like the introduction of bare metal stents (BMS), that of drug-eluting stents (DES) represented a quantum leap in the interventional cardiology community’s ongoing efforts to conquer restenosis. However, recent concerns over late thrombosis (LT) have tempered the initial enthusiasm. Nonetheless, when compared with BMS, the slightly higher DES-LT is counterbalanced by the device’s markedly lower incidence of restenosis, resulting in net equivalent rates of death, myocardial infarction, and overall major adverse cardiovascular events. This article summarizes for the noncardiology practitioner the benefits and risks of DES, as well as essentials of postprocedural care of the DES patient. We discuss the pathophysiology of stent thrombosis, pivotal DES trials, and adjunct antiplatelet pharmacology. In December 2006, the Food and Drug Administration convened an expert panel to review these devices. Their recommendations, as well as the joint statement from the American College of Cardiology/American Heart Association/Society of Cardiovascular Angiography and Interventions, are outlined.


Key Points


* Drug-eluting stents (DES) are associated with significantly lower restenosis and target lesion/vessel revascularization rates when compared with bare metal stents (BMS).


* Due to inhibition of reendothelialization and prolonged exposure of the metallic stent to flowing blood, DES carry a slightly higher risk of late thrombosis (LT), defined as greater than 1 month after implantation.


* The Food and Drug Administration has determined that the counterbalance of Points 1 and 2 result in no net increase in DES rates of death, myocardial infarction, or overall major adverse cardiovascular mortality, when compared with BMS.


* The FDA strongly recommends dual antiplatelet therapy (DAT) with a thienopyridine and aspirin for a minimum of one year post-DES implantation.


* Patients likely to have premature interruption or discontinuation of DAT for upcoming surgery or compliance issues should be considered for BMS implantation. If such interruption is medically unavoidable, continuation of aspirin while off thienopyridine is strongly recommended.

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