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September 3, 2007 -- 3:38PM EDT

"England swings like a pendulum do"
The pendulum here is not the one that Roger Miller sang about in 1966, but rather, if you don't mind a major gear-shift, the one that Dr. Kirk Garratt of Lenox Hill Heart and Vascular Institute discussed with me recently -- namely the use of drug-eluting stents vs. bare metal stents. (I'll explain what England has to do with it later on, as well as gear-shifts.) Dr. Garratt told me that he felt the pendulum had swung too far in the direction away from drug-eluting stents (DES).

In 2004, DES were the darling of interventional cardiologists: these new devices were going to change the way interventions were done because they overcame the bug-a-boo of restenosis. DES became one of the fastest adoptions of a new technology ever and in the U.S. virtually replaced the older bare metal stent overnight.

Swing pendulum swing!

Everything was going along fine until the small but potentially catastrophic incidence of late stent thrombosis came to the forefront, most publicly one year ago at the European Congress of Cardiology. Was it a big problem? There was much heated debate, scary headlines and the convening of a 2-day FDA stent safety panel in December. At that panel, Dr. Lars Wallentin presented the SCAAR registry data from Sweden which concluded a 0.5%-1% increased risk of death or heart attack from drug-eluting stents per year, starting after 6 months.

Swing back pendulum! In just 6 months, the stent device industry experienced a thrombosis of their own: drug-eluting stent use in the U.S. had dropped from 90% to 70%. (In Sweden, DES use hovers around 20%.)

Now, yesterday in fact, longer follow-up and greater numbers have significantly revised the latest SCAAR registry data -- new conclusions have just been presented at this year's ESC and guess what? No discernible difference between DES and bare metal has been found in terms of higher risk of death and MI! The disparity seen at 1-year disappeared after 3 and 4 years, as the patients with bare metal stents caught up, and as cardiologists, concerned over stent thrombosis, began selecting patients more carefully and prescribing antiplatelet therapy for a longer duration.

(This trend of catch-up and evening out, by the way, was one which was vociferously advocated by Marty Leon and Gregg Stone at last year's TCT meeting. They were right.)

Various studies have also been presented showing long-term safety for the Taxus and Cypher stents. And Medtronic's Endeavor and Abbott's Xience second generation DES are expected to hit the U.S. market in the next year.

Stand clear. Pendulum about to swing back.

While many may seem astonished at the 360 that's occurred, the reasons are not that complicated and were totally predictable. In fact we at Angioplasty.Org have been writing about these factors for the past year. Immediately after last year's ESC, in the midst of the scare dreadlines from the press and the antidotal "they're okay, really" messages from the device industry, we posted a "Stent Advisory for Patients" to help our very concerned readers understand and make intelligent decisions.

In our exclusive interview with Dr. Antonio Colombo, he compared drug-eluting stents to a high performance race car:

It’s like if you were driving a faster car. If you know what you’re doing, it’s fine. But it’s more prone to make a mistake if you’re not very careful.

We would add that you also need to know where you can drive it safely, how long the trip is going to take, and make sure to check the oil regularly.

Cutting to the chase, DES work great, but they require at least a year or two of dual antiplatelet therapy (clopidogrel and aspirin) to prevent thrombosis. This is not a plus for patients who need or are likely to need surgery in that year. Also not a plus for patients who are at high risk for bleeding. Or for patients who might be allergic to the stent, the polymer, the drug, or Plavix.

Similarly, cardiologists need to take care in placing the stents accurately and expanding them fully -- something Dr. Colombo and others discuss at length and why they use Intravascular Ultrasound (IVUS) to guide them in these decisions.

Finally, there are patient populations who don't really see a large benefits from DES: those with large diameter arteries, for example.

In contrast, narrow arteries, bifurcation lesions, diabetics -- those at higher risk for restenosis, can benefit widely from the use of drug-eluting stent technology, since these devices can reduce the repeat procedures that have been necessary in the past, eliminating the risks inherent in any additional medical procedures and, saving the cost of repeat procedures.

Which brings me to England. The National Institute for Health and Clinical Excellence (NICE -- or as British cardiologists are now calling it, not-NICE) has recommended that the British Health Service cease reimbursing the use of DES because they are not cost-effective. Comments from the public on this proposal just closed last week and the decision as to whether to follow NICE's guidelines is imminent. Given the somewhat different news coming out of the ESC, perhaps England will also swing like the pendulum do, and deep-six this recommendation -- something strongly urged by cardiologists not only in Britain, but all around the world.

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