Critical review and evidence implications of paclitaxel drug-eluting balloons and stents in peripheral artery disease.

A recent meta-analysis identified increased 2- to 5-year mortality associated with paclitaxel-eluting balloons and stents when they are used to treat peripheral artery disease. The history of the development of paclitaxel, its mechanism of action, and its use in the coronary and peripheral circulation are reviewed in this special communication. In addition, inferences are made to place these findings in perspective and to explain them in light of presently available information, and proposals regarding end points and open access to data are put forth to minimize risk of such developments in the future.