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April-September 2007 Archives: September 3, 2007 -- 3:38PM EDT "England swings like a pendulum do" 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:
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. « permalink » « send comment » « back to top » June 8, 2007 -- 7:14PM EDT Consumer Retorts CR also thinks that multislice CT angiography is "seldom worthwhile"; their number one recommendation: "In general, don't bother with CT angiography." You might think that this recommendation might slightly upset the 3,400 members of the Society of Cardiovascular Computed Tomography (SCCT) -- and it did. The CR piece was published online last week, but had been published in print back in March -- and the SCCT leadership wrote a strongly worded critique, taking Consumer Reports to task for maligning this new and valuable test. For example, CR mistook a CT angiogram for a Calcium Scoring test. Well this new online version corrected that one error, but left in a slew of others. You can read all about it in today's feature on Angioplasty.Org. « permalink » « send comment » « back to top » April 19, 2007 -- 12:26pm EDT Banned in Boston This action was taken in response to Leon's alleged breaking of the press embargo around the COURAGE trial, which was scheduled to be presented on Tuesday morning, March 27, at this year's American College of Cardiology annual meeting in New Orleans -- and simultaneously published online by the New England Journal. The five-year COURAGE trial studied whether angioplasty/stents added to medical therapy provided any additional benefit in reducing death and heart attack in stable patients. In the weeks leading up to the ACC, the trial had been the subject of much press hype and statements from non-interventional cardiologists that, if the results showed no benefit for stents over drug therapy, it would "shake the foundations of interventional cardiology" -- a throwing down of the gauntlet to stent-evangelists like Marty Leon, one of the builders of that foundation. As for the embargo, the Thursday before the ACC began, the NEJM gave the results of the COURAGE trial to all health reporters, this one included, so that we could prepare our stories. We were allowed to reveal those results to anyone we interviewed for an article. We just weren't supposed to publish or discuss the results in public until Tuesday morning. Fast forward to Sunday night the 25th at the Hilton New Orleans Riverside hotel. The first two days of ACC presentations and PowerPoints were now over and many interventionalists were attending a free reception (food with open bar) and an evening "satellite symposium" about drug-eluting stents, sponsored by Boston Scientific. The final speaker was Marty Leon. As Keith Winstein reported two hours later in the Wall Street Journal's Health Blog:
Boom. The Battle of New Orleans had begun. Or was it just "Marty Gras"? In any case, the whiff of grapeshot wafted across Convention Center Boulevard. Monday morning's WSJ ran a more detailed story. The embargo was broken. ACC and NEJM leadership was furious. They hastily scheduled a press conference and made the following statement:
Boom. Boom. Dr. William Boden, lead author of the COURAGE trial, was very disappointed at having to scurry around and not present the results of his five-year's worth of arduous study at the appointed time and place. Now, not quite four weeks later, the New England Journal of Medicine has levied its penalty -- the ACC has yet to announce what, if any, sanctions it will take. As for Dr. Leon, he has denied breaking the embargo, saying that his comments had been misunderstood, taken out of context by a journalist, that he didn't reveal any results, that he was talking to a room of cardiologists and did not know who was in the audience. And as for Keith Winstein, the Wall Street Journal reporter, the NEJM stated that it did not have a problem with his article, because he was only reporting on the embargo break. Winstein reported to us receiving a similar sentiment from Steve Nissen, president of the ACC. This incident, however, has a bit more back story -- which I'll be discussing in short order. « permalink » « send comment » « back to top » April 7, 2007 -- 6:36pm EDT New York Times: Angioplasty AND Drugs Are
Important Instead of pumping a false comparison about how "drugs are better than stents", or vice-versa, Kolata's piece is not only totally accurate, but a much-needed correction, showing both the importance of compliance with prescribed heart medications, and how angioplasty can literally stop a heart attack in its tracks and save a life. One of our fears at Angioplasty.Org, one shared by most interventional cardiologists I've spoken to in the last week, is that the onslaught of anti-stent press would send a message to the public that angioplasty doesn't work. Forbes magazine even ran a headline, "Stent Shocker: They Don't Stop Heart Attacks" -- total crap! They do! And Ms. Kolata's article describes just how they do in a very compelling story. BOTH drug and stents are important therapies. The real problem is that they are unfortunately not being delivered to a majority of the people who need them most -- which is the subject of our latest analysis of the COURAGE trial results. |