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November 21, 2006 -- 2:45pm ET

Eentsy Weentsy Time Bombs -- or -- The Pen is Mightier Than the Clot
Just when I was thinking that the popular press coverage of the late stent thrombosis issue with drug-eluting stents (DES) had been relatively balanced, along comes this bizarre piece out of NBC News this morning from highly-regarded "chief science and health reporter", Robert Bazell.

MSNBC Time Bombs

There are so many things wrong with this article that it's hard to know where to begin discussing it. So for now I'll just quickly give Mr. Bazell a few suggestions on how to improve his report.

Tip #1: Know Your Audience
When you're writing to people who have weak coronaries, you might not want to lead with:

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

At least not without a roller-coaster warning at the top. I'll wager more stent patients will experience health problems just from reading this sentence than from their drug-eluting stents.

When the news headlines mis-reported the CHARISMA trial back in March, stent patients got very scared and some immediately and incorrectly stopped taking their Plavix and aspirin. As a result, a few of them had heart attacks (Dr. Tim Henry of Abbott Northwestern in Minneapolis related to me at least one of his patients where this occurred -- we're sure there were others.)

It is not a public service to misreport and mischaracterize health issues, especially when the incomplete information might lead patients to panic and harm themselves.

Tip #2: Know Your Facts
The following statements made in this article are totally incorrect (my commentary follows each statement in italics):

"They [drug-eluting stents] may be doing more harm than good."
(Even doctors who are critical of drug-eluting stents agree that late stent thrombosis is a very low frequency problem -- and many interventional cardiologists, like Dr. Jeffrey Moses of Columbia-Presbyterian Medical Center in New York, feel that the lower restenosis rates of DES have prevented heart attacks, as well as repeat interventions, which carry their own complication rates.)

"many top doctors...admit they are in uncharted waters with a frightening problem that was largely unanticipated."
(Concerns about increased risk of stent thrombosis were raised immediately upon approval of the first DES in the fall of 2003 -- studies at that time showed a rate equal to that of bare metal stents.)

"the DES's end up as a piece of metal sticking out in the artery."
(A disturbingly unhealthy visual -- not only incorrect but this would be different than a bare metal stent in what way?)

"The FDA panel may well recommend they not be used at all."
(In the words of Dr. Jeffrey Moses to me earlier today, this article " doing a disservice. To suggest that the FDA is going to withdraw these stents is preposterous! That's not what this panel is about.")

"The origin of this terrifying problem is that medical devices...get tested for a few months in a few hundred or at most a few thousand of people before the FDA approves them."
(The various Cypher and Taxus trials involved thousands of patients over a minimum 12-month period -- the Cypher approval in April 2003 came after two-year followup in the initial RAVEL trial.)

Tip #3: Know Your Controversies
I'm not by any means saying that drug-eluting stents are without flaws and should be given to everyone. Most cardiologists agree that patients who aren't going to be able to maintain the required antiplatelet therapy (Plavix and aspirin for 6 or more months) might be better off with a bare metal stent in certain situations. Even DES evangelists like Dr. Moses have told us they would consider using a bare metal stent in certain straight-forward cases (a single blockage in a very wide artery).

But many U.S. cardiologists take issue with the data presented in the European studies, which they say incorrectly portrayed bare metal stents as having far less clotting issues. The recent TCT meeting reported data that came to different conclusions and also redefined what should be considered a "stent thrombosis" -- the controversy, to some extent, has taken the form of a USA vs. Europe dispute.

Hopefully the FDA open-to-the-public hearings, set for December 7-8, will help clarify some of these issues. We posted a "Patient Advisory" on the issue of late stent thrombosis, most recently revised over a month ago, and see nothing that would change its recommendations (based on those of leading cardiologists).

We agree with Dr. Moses. To use the terms "frightening", "terrifying", "lethal devices" and "time bombs" in an article read by millions of heart patients is irresponsible fear-mongering. Patients are able to discern some of the finer points of these issues, something Angioplasty.Org strives to deliver. In fact, Dr. Sanjay Kaul, author of the American College of Cardiology editorial cited in the MSNBC article, recently complimented Angioplasty.Org:

"...a wonderful website. Very accurate, very balanced, and clearly having the best interest for the patients and for the professional community in mind. I want to commend you for that. Even critics like me enjoy your website!"

Does more need to be done to ensure the safety of these devices? Of course. No one disputes that. And while perspective is necessary, so is caring for the individual patient.

Next year marks the 30th anniversary of the first balloon angioplasty -- a procedure that has revolutionized the treatment of coronary artery disease. And the technology has advanced tremendously. But as Andreas Gruentzig, the inventor of coronary angioplasty, told me back in 1985:

"I am speaking all the time about complications. You may wonder and will say, 'Well he's talking about complications from the beginning to the end. Why is he doing dilatation [angioplasty]?' Well fortunately those complications are rather minor in percentage. And that's the reason I speak up about complications. It is not because it is such a major problem, but it is always my major concern in selecting patients or treating patients."

By the way, the photo (reproduced above) that illustrated the MSNBC story, depicts an open surgical procedure, not an angioplasty....

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