Increased mortality after implantation of first generation drug-eluting stents: seeing the smoke, where is the fire?

During the World Congress of Cardiology 2006 in Barcelona, concerns regarding the long-term safety of drug-eluting stents (DES) have been voiced based on meta-analyses including numbers large enough to relate statistical significance to low incidence events such as late-stent thrombosis and mortality in percutaneous coronary intervention (PCI) patients. Since then, these potential safety issues have commanded widespread attention from the medical community, health care providers, regulatory bodies, the press, and the public. Interpretation of compiled data sets, formally as meta-analyses or pooled with any statistical methods, is fraught with complexities, in particular in trying to understand relevance to daily clinical practice. Across variations in study inclusion criteria, adjunctive therapies and endpoint definitions, DES studies are notable for such complexity. Nonetheless, it is essential that large and relevant data are published and the two analyses of mortality outcome in patients receiving DES reported back-to-back in this issue of the Journal bear consideration in the larger question of long-term DES safety.