Tag Archives: coronary 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

Let’s Hear It for the Heart Team

A relatively new, somewhat revolutionary concept appears to be quickly crystallizing for cardiac disease management: the Heart Team. Simply put, the heart team is a collaboration of interventionalist cardiologists and cardiac surgeons (and maybe non-interventionalist cardiologists too) at a single center who work together to combine their endovascular and open-surgical skills in a collaborative and complementary way to give patients optimized treatment that thoughtfully combines the best of both approaches.

The heart team concept has even given birth to a related, new phrase: the hybrid cardiac suite, which is the ultimate collaborative site, a room that accommodates both endovascular and open-surgical procedures under one roof.

Peaceable Kingdom By Edward Hicks/courtesy Wikimedia Commons

It sounds great and makes a lot of sense, but until very recently seemed to be the stuff of dreams, as endovascularists and surgeons traditionally acted as worst enemies, jealously guarding their turf and touting their approach as best.

Those days now may be coming to an end. Get ready to root on the heart team.

When I covered the annual meeting of the American Association for Thoracic Surgery in Philadelphia earlier this month, it seemed like I kept bumping into the heart team idea. There was a report from the PARTNER study, which compared endovascular aortic valve repair to open-surgical repair, and relied on heart teams to run the show. PARTNER, a U.S.study, is also credited with providing fertile ground for the heart team idea to take root in America.

In Europe, the heart team concept got jump-started by the European-based SYNTAX trial, which compared coronary stenting and coronary bypass and relied on a heart team at each participating European center to run the trial. The SYNTAX spirit of cooperation led the major European cardiology and thoracic surgery societies, the European Society of Cardiology and the European Association for Cardio-Thoracic Surgery to last year co-write a new set of guidelines for managing coronary revascularization, and endorsement of heart teams is a key feature of those guidelines. These days, in routine practice at the Thoraxcenter inRotterdam for example, a heart team meets every morning to discuss the pending coronary cases and how they’ll be managed, said heart surgeon A. Pieter Kappetein at the meeting.

Heart teams also got mentioned at the meeting as the new way that patients with ruptured aortic aneurysms are getting managed at selected U.S. sites, as endovascularists and surgeons quickly decide on the best way to treat an emergency aneurysm rupture.

Will U.S.guidelines soon appear that follow the European lead and give a formal nod to heart teams? Yes, said John D. Puskas, chief of cardiac surgery at Emory in Atlanta and a member of the joint American College of Cardiology and Society for Thoracic Surgeons guidelines-writing group that will soon issue their recommendations. “The new guidelines are embargoed, but all of the cardiologists and surgeons who wrote the U.S. guidelines read the European guidelines with interest with respect to the heart team,” he told me.

Will the concept catch on for U.S.practice, after so many years of catheterist-surgeon animosity? Dr. Puskas said yes to that too, citing the changing character of U.S.medical practice as a major factor easing the transition.

“Cardiologists and surgeons are being bought by networks and are becoming salaried. That will lower the barriers that have led to competition. I think we’ll see better collaboration in our specialties than ever before. It gets down to patient-centered decision making.”

—Mitchel Zoler (on Twitter @mitchelzoler)

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Filed under Cardiovascular Medicine, Drug And Device Safety, Health Policy, IMNG, Internal Medicine, Internal Medicine News, Practice Trends, Surgery, Thoracic Surgery

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

Which Would You Rather Risk: Stroke or MI?

It sounds like the ultimate trick question, where the correct answer is, of course, C: none of the above.

image courtesy Flickr user chase baltz

But the choice between stroke, myocardial infarction (MI), or another cardiovascular end point, such as need for revascularization, is something now faced by patients confronted by at least a couple of somewhat different clinical situations where treatment of their vascular disease could be done by either endovascular stenting or open surgery. (Sometimes the third option is medical management and no surgery, but these are cases too advanced for medicine alone to work).

One of these situations is severe carotid artery stenosis (especially when the patient already had a stroke or transient ischemic attack).  Last year, results from CREST, the largest randomized study to compare the two main treatment options for these patients, cartoid artery stenting or open surgery by endarterectomy, showed that overall the two treatments led to similar 4-year outcomes based on the cumulative rate of death, stroke, or MI. But more detailed results, hinted at in last year’s report and then expanded on earlier this month at the International Stroke Conference, showed that the choice is a lot more nuanced, and in many ways boils down to what a patient would rather risk, having a MI or stroke. Carotid-artery stenting produced more strokes, especially in women and older patients (65 or older). Carotid endarterectomy produced more MIs, especially in men.

The gut reaction has generally been to regard strokes as a worse outcome, but now other new data from CREST, also reported at the stroke conference, prove it’s true. Dr. Joshua M. Stolker reported on the health-status outcomes from CREST. In part, this showed that CREST patients who had a stroke following their intervention had significant decrements in seven of eight quality-of-life measures on the Short Form-36, compared to a decrement in just one SF-36 measure among the patients who had a MI. Patients with major strokes had decrements in all eight subdomains, but even patients with minor strokes had significant decrements in three or four subdomains, so even a minor stroke was quantitatively worse for patients, on average, than a MI.

The analysis “confirmed what a lot of us already suspected,” Dr. Stolker said when he gave his report.

The stroke or MI choice seen in CREST was reminiscent of the results seen in 2009 from the SYNTAX trial, the most recent study to compared coronary artery bypass surgery with coronary stenting. Interesting, in SYNTAX the adverse event profile was somewhat flipped. In this case it was the CABG patients who underwent open surgery who had a significantly increased rate of stroke during follow-up compared with stented patients. The excess risk faced by patients treated with the endovascular intervention was an increased rate of a need for revascularization therapy down the road.

As far as I know, no follow-up study examined the health impact of the strokes that occurred in SYNTAX and the impact of revascularization, but it’s hard to imagine that the result would be different from what was found in CREST. A stroke is a stroke, and a nasty outcome for patients regardless of their medical history.

—Mitchel Zoler (on Twitter @mitchelzoler)

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