Crying Fire in a Theater or a "Confirmatory Sighting?"

How should the cardiology community respond when informed of an apparent considerable increase in mortality from a procedure when data are derived from the only randomized trial assessing the question, but that trial is small, the analysis post-hoc, and the result somewhat counterintuitive? That is the question raised by the report by Vermeersch et al. (1) in this issue of the Journal in describing an excess risk of late death after sirolimus-eluting stent (SES) placement in patients with diseased saphenous vein grafts (SVG), a group comprising 5 % to 8 % of all patients undergoing percutaneous coronary intervention. The importance of the question is magnified considering the fact that we are speaking of drug-eluting stents (DES), devices implanted in nearly 2 million patients annually worldwide and for which other major safety questions have arisen recently (2-4).