A Decade of Drug-Eluting Technology in Peripheral Arterial Disease: Blurred by Dissembling Evidence

Excerpt

In 2005 the results of the Sirocco II trial, comparing the safety and efficacy of the sirolimus-eluting stents and bare nitinol stents in the superficial femoral artery were published [1]. In this study, finally, no statistically significant differences in any of the outcomes could be shown. Since then there has been a complete revolution in drug-eluting technologies for peripheral vessels. There have been fierce debates about coatings, types of drugs, release profiles, and doses. The introduction of the drug-eluting balloons provoked a new debate about not leaving something behind. Unfortunately, the majority of the literature is about these technical details and safety and there are only a few randomized trials available for clinical analysis. Although the results of all these new devices have been presented as very successful or at least very promising, there were also a few critical voices at the background [2]. These voices however have not had much attention, moreover they were seen as silly twaddle or flawed arguments. …