The Drug-Eluting Stent Saga

Abstract

Drug-eluting stents (DES) represent a breakthrough technology owing to their potent reduction of restenosis, which is a nuisance in the quality of life of affected patients, a rare cause of myocardial infarction (MI), and the principal shortcoming of stents compared with coronary artery bypass surgery. First-generation DES with controlled release of sirolimus or paclitaxel from durable polymers reduce the need of target lesion revascularization by 50 to 70% compared with bare metal stents, requiring treatment of only 8 patients (number needed to treat 6 to 10) to prevent 1 revascularization event.1 The benefit, albeit attenuated, persists in studies without protocol-mandated angiographic follow-up,2 is particularly pronounced in diabetic patients,3 and endures during long-term follow-up extending to 5 years.1 The safety of first-generation DES has been scrutinized in unprecedented depth and comprehensiveness after insinuation of impaired clinical outcome. Even though mortality and MI were found to be similar or even lower with the use of first-generation DES in randomized trials, meta-analyses, and large-scale registries,4 very late stent thrombosis (ie, sudden thrombotic occlusion of the device >1 year after implantation) emerged as a distinct entity complicating their use.5 Article p 680 Later-generation DES have been developed with the objective to improve clinical outcomes by providing better deliverability and optimized long-term biocompatibility of polymer coatings and by introducing new antiproliferative drugs. One of these new DES is the everolimus-eluting stent (Abbott Vascular, Santa Clara, Calif), recently approved by the US Food and Drug Administration for percutaneous coronary interventions.6,7 The underlying stent platform is the Multilink Vision stent made of L-605 cobalt chromium alloy with an open cell nonlinear link design and the lowest strut thickness (81 μm) currently available with DES. Everolimus is a sirolimus derivative in which the hydroxyl at position C40 of sirolimus has been …