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November 12, 2007 -- 12:50pm EST About Those Stents: Tiny Time Bombs in
Your Heart...or Not? I reported on the misinformed flame-stoking press coverage at the time, and specifically the news report that started off:
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:
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:
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!") « permalink » « send comment » « back to top »
November 8, 2007 -- 11:14 EST Headline Writers
Play "Telephone" It's the game of "Telephone" -- you whisper a message in the next person's ear and by the end of the line...well, you get the idea. That's exactly what happened to the study which I discussed in Tuesday's post. The CorE 64 trial, presented at the AHA this week, proved the extremely high accuracy of Multislice CT in ruling out coronary artery disease. To be sexy, AP dubbed it a "Super X-Ray". But in the story was a completely inaccurate line that the CT radiation dose was 10 times higher than a standard angiogram. I disputed this in my post, and yesterday an expert in the field, Dr. Michael Poon, President of the Society for Cardiovascular CT, confirmed to me that major studies have shown the radiation dose from CT to be 1-2 times that of a standard angiogram, and certainly the same as, if not less than, the dose from a nuclear stress test. But facts shouldn't get in the way of selling papers (or, in the case of Fox News, selling...um, what is it that they're selling anyway?) So what started out on Monday as the scientific presentation of a very successful randomized clinical trial of Multislice CT, turned within 24 hours into the totally fear-mongering headline above -- which is great on Halloween, but not so much when people's healthcare is concerned. « permalink » « send comment » « back to top »
November 6, 2007 -- 9:48 EST The Super X-Ray So it was with amazement that, when I logged onto the news yesterday, I saw headlines everywhere proclaiming a medical breakthrough: the "Super X-Ray". We had just posted an article about the results of the CorE 64 study, presented at the annual American Heart Association Scientific Sessions in Orlando by the investigators at Johns Hopkins. The goal was to compare the diagnostic accuracy of 64-slice CT angiography with the current "gold standard" of invasive cardiac catheterization in the detection of coronary artery disease. The results were excellent -- you can read more about the study in our article, "64-Slice CT Heart Scan Gets High Marks As Test for Blocked Arteries." It quickly became clear that all the articles about the "Super X-Ray" were in fact about the CorE 64 study. In fact, most of the articles were feeds from the AP article by Marilynn Marchione. I've discussed with cardiologists from the Society of Cardiovascular Computed Tomography the fact that this technology, which has been around for a few years now, needed a name. Sometimes it's called Multislice CT (CT stands for "computed tomography") or Multidetector CT or Cardiac CT or CT Angiography, CTA and so on. And there are generations from 16-slice to the current 64-slice and coming soon at your neighborhood imaging center, the 256-slice scanner. But now the retail press has taken care of that: presenting the "Super X-Ray". I'll take two, please. By the way, I'll be writing more on this subject -- because there are some serious inaccuracies in the AP article, for example, stating that Multislice CT scans "deliver 10 times more radiation to the patient than a standard angiogram". (Who wouldn't glow after one of those?) There are a number of studies that show the range of radiation doses to be anywhere from the same to about twice as much, depending on who does the study, what equipment is used and whether newer techniques such as gating and phasing are used (significantly reducing the radiation dose). Even at its high end, the radiation exposure from CTA is similar or less than what the patient gets in a typical nuclear stress test -- a widely-used test that many imaging specialists feel will be replaced by CTA. For more, and more accurate information and interviews with experts about this and other imaging technologies, visit Angioplasty.Org's Imaging Center. « permalink » « send comment » « back to top »
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. « permalink » « send comment » « back to top »
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On
Halloween night, Turner Classic Movies ran a Karloff-a-thon and
I got to see a favorite sci-fi flick from my nerdy 8th grade years: "