Tag Archives: drug-eluting stent

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

Fan Bids Cypher, the Sirolimus-Eluting Coronary Stent, Adieu

Cypher will soon morph into cipher, and it’s not just about the why, but also the whence and the what once was and the what came next.

Cypher is, of course, the sirolimus drug-eluting stent (DES), the first, the original coronary DES, the one that burst onto the scene a decade ago and launched a new era in interventional cardiology. And soon it will be no more.

Dodo bird; courtesy Line 1; Wikimedia Commons

Earlier this week, Cypher’s manufacturer, Johnson & Johnson, announced that it would pull the stent off the market by the end of this year.   J&J cited “evolving market dynamics.” What they meant to say was that Cypher’s time has come and gone. I’ve recently written on this blog on how the second-generation coronary DES have set new efficacy standards for the field. Cypher had become a 10-year old dinosaur. Presumably the announced demise of the other first-generation DES, the paclitaxol-eluting Taxus stent, made by Boston Scientific, is just around the corner.

But I write not so much to bury Cypher as to celebrate it. In a dusty corner of my laptop, in a yellowed folder labeled ESC Stockholm 9/2001, sits the story I wrote almost a decade ago when French cardiologist  Marie-Claude Morice reported at the annual Congress of the European Society of Cardiology the primary, 7-month results from the first randomized, head-to-head comparison of a DES, Cypher, with a bare metal stent. The results from that 238-patient study showed a zero restenosis rate for the 120 patients who each received a single Cypher DES compared with a 26% restenosis rate in the control patients who received a bare metal stent. It was an electric moment.

“This is the start of a new era in treating coronary disease,”  I quoted Dr. Morice as saying. “We’ve never seen results like this before in interventional cardiology,” gushed Willem J. Van der Giessen, a cardiologist at the Thoraxcenter in Rotterdam, The Netherlands.

Like most heady, early days, reality soon arrived.  The more innocent era a decade ago was before most people thought about late stent thrombosis, before the idea of dual antiplatelet therapy existed. But few advances in medicine come without costs, and the truth is that DES were a sea change for cardiology and for medicine and Cypher was there first. And now it’s obsolete, which is good. That means there’s something better.

Here’s to you, Cypher.

—Mitchel Zoler (on Twitter@mitchelzoler)

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Filed under Cardiovascular Medicine, IMNG, Internal Medicine, Internal Medicine News, Practice Trends

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