Tag Archives: Promus

Everlolimus-Eluting Coronary Stents Notch a Major Thrombosis Victory

What a difference a few years, and a new generation, has meant for the fortunes of drug-eluting coronary stents.

In the late summer of 2006, at that year’s meeting of the European Society of Cardiology, the specter of stent thrombosis first rose around the drug eluting coronary stents of that era, the sirolimus- and paclitaxel-eluting devices. The concern led to an abrupt plunge in the use of drug-eluting stents, routine use of more prolonged dual antiplatelet therapy with aspirin and clopidogrel, and eventually the development and marketing of second-generation stents, which used new drugs—everolimus and zotarolimus—and new polymers to bind the drugs to the stent.

Over the past couple of years, the second generation has given drug-eluting stents a renewed, more robust profile. And now, a new meta-analysis published online in The Lancet brings the best news so far for the new generation: the cobalt-chromium everloimus-eluting stent–marketed as both Xience V and Promus—fared significantly better than bare metal stents in their rates of stent thrombosis both 1 and 2 years after placement, and the cobalt-chromium everolimus-eluting stent also significantly surpassed all of its competition, both first- and other second-generation coronary stents.

image courtesy Abbott Vascular

image courtesy Abbott Vascular

The Lancet article that described the meta-analysis, which included 49 trials with more than 50,000 patients, called the finding “a paradigm shift,” something that, if confirmed in a prospective trial, “would have profound clinical implications.” A drug-eluting coronary stent that’s actually substantially safer than a bare-metal stent for the important safety endpoint of stent thrombosis. Who would have thought it possible just a few years ago?

The editorial accompanying the new analysis, by New Zealand cardiologists John Ormiston and Mark Webster, cautions that as a meta-analysis the finding can strictly be regarded as only hypothesis generating, but they also note that a head-to-head randomized comparison of the cobalt-chromium everolimus-eluting stent and a bare-metal stent for this endpoint is unlikely to ever happen. They also said that while the new finding was “unexpected,” the cobalt-chromium everolimus-eluting stent must now be “regarded as the standard against which future design improvements [in stent technology] are compared.” The “firestorm” about stent safety, first set ablaze 5.5 years ago at the ESC  “is now barely smoldering,” they concluded.

The authors of the meta-analysis said that the suggestion that this everolimus-eluting stent could actually best bare-metal stents for stent thrombosis first became plausible at last August’s ESC, in results from the EXAMINATION study, which compared the two stent types in about 1,500 acute myocardial infarction patients. The meta-analysis pooled results from two head-to-head comparisons of the cobalt-chromium everolimus-eluting stent against a bare-metal stent in a total of about 3,800 patients (including the EXAMINATION population), and found that the everolimus-eluting device cut the 1-year thrombosis rate by 86% and the 2-year rate by 65% compared with bare-metal stents. The cobalt-chromium everolimus-eluting model also significantly surpassed every other first- and second-generation drug-eluting stent for their 1-year rate of definite stent thrombosis.

Hypothesis generating or not, it’s a result that cardiologists will find hard to ignore.

—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