Tag Archives: Martin B. Leon

Drug-Eluting, Metallic Coronary Stents: Too Good to Get Much Better?

 Drug-eluting coronary stents have progressed substantially since the first models, the sirolimus-eluting Cypher stent and the paclitaxel-eluting Taxus stent, came onto the U.S.market in 2003 and 2004, respectively. As I wrote on this blog a few weeks ago, the second generation drug-eluting stents (DES) that are now either on the market—the everolimus-eluting Xience V/Promus stent—or on the way—the zotarolimus-eluting Resolute stent and the everolimus-eluting Platinum stent—have produced unprecedented levels of efficacy and safety for coronary stents, a true step beyond the first generation. 

Dr. Martin B. Leon/image by Mitchel Zoler

Physicians and patients should feel good about that, and they’ll need to be content with it too because there probably won’t be much further progress in widely available stent technology any time soon, at least according to one of the world’s top stent gurus, Martin B. Leon from Columbia University in New York.

Speaking in reply to a question during a forum on stents and coronary artery bypass surgery earlier this month at the annual meeting of the American Association for Thoracic Surgery, Dr. Leon gave a realistic and perhaps slightly bleak forecast for what the next decade or so holds for new stent technology.

“I think the incremental benefits we’ll get in next generation stents will be minimal. It will be extremely hard to get repeat-revascularization rates much below the 5% we generally see in the first year” with current second-generation DES, and the current low, long-term stent-thrombosis rates will be hard to beat as well. “The amount that would need to be invested to show any improvement will be difficult. I don’t think, with metallic-stent technology, that any future versions will be dramatically different.”

bioabsorbable coronary stent/image courtesy Abbott vascular

And what about bioabsorbable stents, which seem to shape up as the next big thing in coronary stent development? “Absorbable stents have some unique characteristics, but that is a 5-10 year pathway with many speed bumps and curves. Absorbable stents are the next great group to look for, but they will take many years to study adequately,” Dr. Leon warned.

—Mitchel Zoler (on Twitter @mitchelzoler)

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Second-Generation Coronary Stents Come of Age


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.

coronary stent image courtesy of Abbott

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)

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Filed under Cardiovascular Medicine, Drug And Device Safety, IMNG, Internal Medicine, Internal Medicine News