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November 12, 2007 -- 12:50pm EST

About Those Stents: Tiny Time Bombs in Your Heart...or Not?
This morning's New York Times announces that the drug-eluting stent has been pardoned and taken off Death Row. In an article, titled "A Heart Stent Gets a Reprieve From Doctors", Barnaby Feder discusses the recent flurry of data that seems to be reversing the year-old panic that drug-eluting stents (DES) were "tiny time bombs in your heart". This phenomenon was dubbed the "firestorm of the ESC" because the first major presentations, pointing out a higher-than-reported incidence of potentially fatal late stent thrombosis in DES, were made at the 2006 European Society of Cardiology (ESC) meeting last September.

I reported on the misinformed flame-stoking press coverage at the time, and specifically the news report that started off:

"Millions of Americans could be walking around with tiny time bombs in their hearts."

In my blog entry of exactly one year ago, titled "Eentsy Weentsy Time Bombs -- or -- The Pen is Mightier Than the Clot", I critiqued that report and took its author to task for scaring the hell out of patients with incorrect information.

This morning's NYT references the same report, attributing it to "a cable news network". In point of fact the author, Robert Bazell, is the Emmy and Peabody awarding-winning chief science and health correspondent for NBC, and his report appeared on the NBC Nightly News with Brian Williams. Bazell continued his thrust a month later in his broadcast about the FDA stent safety panel:

"Many cardiologists have gotten carried away with the new technology with results that could be very dangerous for some patients."

Or..."Watch out for that cowboy in your heart!"

The point being that much of the negative and incorrect news coverage appeared in the broadcast and mainstream media and had a very big impact.

As I look back and read my report from November 21, 2006, as well as the various DES articles we posted on Angioplasty.Org, in light of the new data presented at this year's ESC, TCT and AHA meetings, I have to say nothing in my mind has changed. These stents work well, there is a very small, but serious complication involved, strict adherence to dual antiplatelet therapy is critical, patient selection is extremely important (don't use DES in patients who won't be able to comply with the Plavix/aspirin combo and consider using a bare metal stent in situations that have a low risk for restenosis), and statistically speaking, the small increase in complications from DES will be offset by the increased restenosis seen in bare metal stents (studies have shown that restenosis presents as a heart attack about 1/3 of the time).

All this was known a year ago, the new registries and studies have confirmed this knowledge.

So nothing has changed...except, oh yeah, the sales of drug-eluting stents have slumped, down over a billion dollars worldwide, and DES usage in the U.S. has dropped from 90+% to low 60% range. Boston Scientific and Cordis are laying people off and the field has been in turmoil.

Except that now multiple studies, including the oft-quoted SCAAR Registry from Sweden, are revising the view that DES are dangerous. It's a billion-dollar Emily Latella gag.

So to me, the very interesting question was one raised by Rotterdam-based Dr. Patrick Serruys, during a panel at the TCT last month. In referring to the 2006 ESC presentations, he asked:

"How could such a small group of studies by a small group of people have such a big effect on the entire field of interventional cardiology?"

I have an answer. Tune in tomorrow....

(By the way, after I sat through almost a dozen studies presented at TCT, all showing no difference in heart attack or death between drug-eluting stents and bare metal stents, I asked the panel, "So would you conclude that there's no ticking time bomb inside patients' hearts?" And distinguished cardiologist, Dr. Sigmund Silber of Munich, replied, "No. Millions of patients are walking around with a ticking time bomb in their hearts -- it's called coronary artery disease!")

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