How many grails do we need?

Abstract

In a classic mixed metaphor of Greek and more recent continental lore, restenosis has been called the Achilles’ heel of interventional cardiology and the solution to restenosis has been called the holy grail. Restenosis itself has been the target of a multiplicity of initiatives, starting with trials of established drugs in the early 1980s, then moving more broadly to trials of many newer and different classes of drugs, and then finally to the application of a large number of widgets and gadgets. After initial promising animal trials and often small positive pilot human clinical experiences, larger scale randomized clinical trials were mounted only to fail the test of scientific trial design, the problems seemingly unmanageable.1 See p 2168 The combination of drugs and devices in a single (albeit expensive) package has revolutionized the field. There are now abundant data from large scale well-designed clinical trials and even larger “real world” registries that have documented definitively that restenosis, although not completely abrogated, is dramatically improved with clinical restenosis rates in the lower to mid single digit range.2,3 This formed the basis for the exceedingly rapid implementation of a specific drug-eluting stent code in the United States. The earliest and by far most robust data set is centered around sirolimus-eluting stents, which have been documented to be very safe and extremely effective in randomized blinded multicenter trials of selected patients, as well as in broader “real world” consecutive patient series.2, 4–9 More recently, paclitaxel-eluting stents have been approved,10 and they also …