Drug-Eluting Stents

Abstract

No recent pharmaceutical or medical device has generated as much ongoing and expanding attention as drug-eluting stents (DES). In fact there has been an explosion of published reports on the topic within cardiology, medical, surgical and subspecialty journals. The device industry has repeatedly sent their own summaries of information directly to physicians, while mainstream media has kept the consumer and Wall Street appraised of safety concerns, often with sensational headlines. The Food and Drug Administration has also taken notice by convening a meeting on DES in late 2006. What have we learned through all this dissemination of data? Article p 745 The introduction of DES was greeted with intense enthusiasm in a “perfect storm” sort of way. Device representatives were eager to promote this new product that could dramatically reduce restenosis.1 Patients expected to be treated with this new and “better” technology. Lastly, cardiologists had a potent new tool at their disposal that they increasingly incorporated into practice until it became the default revascularization device instead of bare-metal stents in many parts of the world. This quick and widespread adoption in DES resulted in its frequent use in relatively untested and off-label indications. At the Cleveland Clinic, the use of DES mirrored the community and many interventional practices throughout the world, where the penetration of this device peaked at >90%. While DES use was increasing, McFadden and colleagues sounded an alarm with the publication of a report on 4 patients who experienced late stent thrombosis.2 Although this could have been a chance finding, DES were systematically shown to confer an increased risk of late thrombosis relative to bare-metal stents.3 This safety issue has been confirmed by several independent analyses with patient-level data from the pivotal randomized trials.1,4,5 Stent thrombosis is uncommon, although when it occurs it …