Circulation publishes lengthy correction of MIST paper Reply

Circulation has posted a lengthy correction of the highly controversial MIST trial, which was designed to test percutaneous closure of PFOs to reduce migraines. We won’t go into details here– just the thought of returning to this story brings on a migraine– but you can read lots of background material, starting with this heartwire story.

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Are low-carb, high fat diets “fads”? 4

Should low-carb, high fat diets be considered “fad diets”? A Comment by Mann and Nye published in the Lancet simply assumes that these diets don’t have any scientific credibility, but we’ve seen a number of important studies in major publications, including recent trials in the NEJM by Shai et al and in JAMA, by Gardner et al, to suggest that these diets are very far from being dismissed as mere fads. In fact, there’s plenty of evidence to suggest that they should be taken very seriously indeed. (In fact, as any expert will reluctantly concede, there’s almost no good randomized, controlled data to conclusively demonstrate that any diet is better than any other.)
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FDA official reviews his own prasugrel review in NEJM 3

Now that prasugrel has finally been approved, EF Unger, one of its chief reviewers at the FDA, is providing insight into the FDA thought process in a perspective in the New England Journal of Medicine. Along the lines of the old TV ad for EF Hutton, when EF Unger speaks, people interested in prasugrel listen. As Unger writes, the “FDA grappled with a number of complex issues during the review process.” Discussing the TRITON-TIMI 38 trial, Unger says that:
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ESC: bivalirudin and otamixaban in ACS Reply

Two new ACS trials with the agents bivalirudin and otamixaban were presented today at the ESC and published simultaneously in the Lancet.

In the first trial, one year followup from the HORIZONS-AMI trial, Roxana Mehran and colleagues reported a reduction in the rate of net adverse clinical events and major bleeding in STEMI patients undergoing PCI who received bivalirudin compared to those who received heparin plus a glycoprotein IIb/IIIa inhibitor.
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RE-LY at ESC: dabigatran in, warfarin (finally) on the way out? 3

Is the long, unhappy reign of warfarin possibly drawing to a close? The RE-LY trial may have finally identified a candidate, dabigatran, an oral direct thrombin inhibitor that could one day replace warfarin. Unlike warfarin, dabigatran does not require dose adjustments or anticoagulation monitoring.

RE-LY randomized 18,113 AF patients to either one of two fixed doses of dabigatran (110mg or 150 mg twice daily) or warfarin. The results of RE-LY were presented this morning at the ESC and published simultaneously in the New England Journal of Medicine. The RE-LY investigators concluded that “compared with warfarin, the 110-mg dose of dabigatran was associated with similar rates of stroke and systemic embolism and lower rates of major hemorrhage; the 150-mg dose of dabigatran was associated with lower rates of stroke and systemic embolism but with a similar rate of major hemorrhage.”

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ARBITER-6 scheduled as AHA Late-Breaker, Kastelein to be discussant 1

ARBITER-6 is scheduled to be presented as a late-breaking clinical trial on Monday, November 16 at 11:07 AM. The discussant for the trial will be John Kastelein. Several knowledgeable observers have pointed out that, as the principal investigator of the highly controversial ENHANCE trial, and as a lecturer and consultant for numerous companies, including Merck and Schering Plough, which has a drug directly involved in the trial, Kastelein is an unusual and potentially controversial choice for the discussant.

Update: Readers may be interested to learn that Kastelein is the co-author of an article, “Surrogate markers in clinical trials– Challenges and opportunities,” in the September 2009 atherosclerosis.
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Topol and Teirstein argue about stents on NPR’s All Things Considered 3

To illuminate the topic of how difficult it is “to get doctors to quit ordering unnecessary procedures and tests,” NPR’s radio news show All Things Considered set up a discussion between Eric Topol and Paul Teirstein.

Reporter Chana Joffe-Walt used the two Scripps Health interventional cardiologists– “same specialty, same city, same hospital, very different points of view”– to demonstrate that “what seems unnecessary to some doctors is standard procedure for others.”
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Sensitive troponin assays enter the fray Reply

Two large new studies have demonstrated that newer, more sensitive troponin assays may improve the early diagnosis of acute MI. The major limitation of current troponin assays is that the tests are less sensitive in the early hours of ischemia. The two studies, along with an accomapnying editorial by David Morrow, are published in the New England Journal of Medicine.
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Editorial: Prescription for medical education: sunshine 5

Note to readers: The following editorial by CardioBrief‘s Larry Husten appears simultaneously in a slightly different form on KevinMD.Com. CardioBrief thanks Dr. Kevin Pho for the opportunity to bring this piece before a much wider audience.

A recent hearing of the Senate Aging Committee on continuing medical education (CME) should scare anyone who might need to see a doctor in the next few years. But you don’t need to be a Washington policy wonk to discover that there’s a huge problem with CME.

Just walk into the lobby of any major downtown hotel when a large medical conference is in town and you will see big cardboard posters advertising “satellite” symposia (“satellite” because they orbit but are not an official part of the main conference). Unless you are a doctor the title of the sessions won’t mean anything to you, and the big, boldface names of doctors featured prominently on the posters will be unfamiliar.
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