Slightly more than 3 years ago, in February 2008, the first of what’s been called the “second generation” of drug-eluting coronary stents received FDA approval to enter the U.S. market. At the annual meeting of the American College of Cardiology, held earlier this month, this new generation of coronary stents seemed to fully come of age.
Photo credit: Medtronic
The second generation has had growing pains. The first approved stent from this generation, Medtronic’s Endeavor zotarolimus-eluting stent, produced underwhelming restenosis rates compared with the first-generation drug eluting coronary stents, Cypher and Taxus. This became such a problem for Medtronic that at this year’s ACC meeting they unveiled much of their new data on a follow-up zotarolimus-eluting stent, Resolute, that differs from Endeavor only by a longer period of drug elution, (6 months) a change that seems to have solved the restenosis problem.
Soon after Endeavor appeared came another second-generation stent in 2008, an everolimus-eluting device sold by two different companies under two different names because of a complex ownership history, the Xience V and Promus stents, sold by Abbott and Boston Scientific, respectively. These everolimus-eluting stents have done well, and are now the most widely used drug-eluting coronary stents on the U.S. market.
But now there is more to the new generation, with the Resolute stent moving to likely U.S. approval, and with a follow-up to the Xience V and Promus stents, a platinum-containing stent that is otherwise similar to its everolimus-eluting forebears that may, or may not, have advantages over the Xience V and Promus models. A report at the ACC meeting presented data on more than 700 patients who received the platinum-containing version of the everolimus-eluting stent.
Interventional cardiologist Gregg W. Stone gushed over the roughly 3.5% target lesion failure rate seen in this PLATINUM trial, both in patients who received the new stent as well as in those who received the comparator, Xience V/Promus stents, as well as the 3.7% rate seen in noncomplex patients treated with the Resolute stent.
“I think that this generation of drug-eluting stents is clearly different. They are better than the first generation. We’ve seen tremendous progress made,” Dr. Stone said.
His fellow interventionalist, Martin B. Leon, who reported some of the Resolute results, was equally effusive about all four second-generation stents. “Over many years we have evolved into a state of really excellent PCI outcomes with these new and improved drug-eluting stents. We saw it first with Xience V and Promus, and now with Resolute and the Platinum stents. These results are very hard to beat, and it is difficult to distinguish among these devices” for either safety or efficacy, he said.
Four well-performing, second-generation stents that are difficult to distinguish? The only downside seems to be the inevitable marketing storm, as competing companies try to convince physicians that their second-generation stent stands out from the new-and-improved pack. When marketing mania hits, it will mark these stents as members of a fully mature next generation.
—Mitchel Zoler (on Twitter @mitchelzoler)