Drug-eluting stents: Beyond the hyperbole

Drug-eluting stents (DES) promised to reduce the clinical and economic cost of failed bare metal stents (BMS) by locally delivering a therapeutic agent to the injured artery, reducing or eliminating the development of neointimal hyperplasia and reducing the need for repeat interventions to re-open the obstructed artery. Data from initial large-scale, comparable, U.S. pivotal trials of the first two DES to reach the American market, CYPHER from J&J using the drug rapamycin (sirolimus) and TAXUS from Boston Scientific using the drug paclitaxel (taxol), seemed to warrant the enthusiasm. By reducing the failure rate of BMS by about 4-fold, DES have changed clinical practice, reduced the rate of coronary bypass surgery, had a significant economic impact, and triggered extensive research in the areas of stent design, restenosis biology, polymeric drug-delivery and local pharmacology and toxicology.