Stents, Trials and Studies: What’s in a Word?

What's In a Word?Today the editors of the HEART Group Journals, comprising the Journal of the American College of Cardiology and other participating cardiovascular publications, issued a “Statement on Matching Language to the Type of Evidence Used in Describing Outcomes Data.”

Although the title of the article may be a bit yawn-inducing, the editors deserve a kudo or two for attempting to clarify reporting on medical issues. They are asking medical journalists and investigators to differentiate, for example, among retrospective observational analyses, case-control studies, and randomized controlled trials (RCTs) and to take care when bandying about phrases such as, “the intervention reduces mortality” when, in fact, the study is an observational one and such a conclusion cannot be made. This particular example, cited in the statement, involves reporting results from an observational study that shows fewer deaths in one arm than in another. The correct descriptive statement should be, “the intervention is associated with lower mortality.”

Okay. I hear the hairs splitting, but it’s been my experience that healthcare reporting is a bit like the game “telephone.” A statement or claim is published, it gets repeated and is slightly distorted with each iteration, until a simple observational study in a medical journal that shows an association between that two phenomena suddenly results in a mass media TV headline like “Plavix and Aspirin a Dangerous Combination” or a lede, such as “One in eight U.S. patients who have non-emergency stenting procedures to clear blocked arteries in the heart are likely to see more harm than good from the procedure.”

I have written about “dreadlines” too many times here at Angioplasty.Org. And these distortions have real consequences. The Plavix and aspirin warning was one of many misinterpretations of results from the CHARISMA trial back in 2006. I reported on this phenomenon (“Blame the Messenger: Reporting on Plavix and Aspirin“) but the sad result was that a number of patients who DID read these headlines DID stop taking Plavix and aspirin and DID wind up having a heart attack. I know this from a number of cardiologists who told me of these stories. But, these being observational anecdotal evidence, I can only report that these dreadlines were associated with a increase in myocardial infarctions.

One of the most striking of these in the interventional cardiology field was Robert Bazell’s 2006 NBC Nightly News report about drug-eluting stents being “tiny time bombs in your heart.” While DES stent thrombosis was certainly a major concern at that time and prompted a special two-day FDA panel, the numbers affected were very small in percentage. Yet Bazell’s article was headlined, “Millions face risk from drug-coated stents.” One of those millions was so terrified by NBC’s reporting that he came to the FDA panel (which he learned about through Angioplasty.Org) and testified, specifically calling for better communication of trial results and findings.

So I applaud the word-smithing advocated in today’s statement and urge all who write about medical issues to read it (it’s pretty short). Interestingly, it comes on the heels of the recommendations for changing the words used to describe categories in the Appropriate Use Criteria for Coronary Revascularization (“A Stent By Any Other Name Now Has Other Names!“). Semantics rule the day!

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(A side note on “tiny time bombs”: a few years ago, after a presentation showing extremely low rates of stent thrombosis with the newer second generation drug-eluting stents, I asked Dr. Sigmund Silber if this put to rest the concept of tiny time bombs in patients’ hearts. He said, “Oh no. Millions of patients are walking around with these tiny bombs right now. It’s called coronary artery disease!”)

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(Another side note: the statement from the HEART group, originally under embargo until December 3, was released today because of an embargo break…by the HEART Group — reporters of physicians, heal thyselves!)

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Updated December 4, 2012: Regarding that second side note — the embargo break, for those interested in such matters, was a bit more complicated story. I sensed something more was going on because of the somewhat odd communications I received about this story and the embargo lift from the ACC last Tuesday. So you can read all about on Ivan Oransky’s Embargo Watch. Thanks to Ivan and Dr. Chris Cannon, the story which was already out in Europe could now be told here. ;-)

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Filed under ACC, Appropriate Use Criteria (AUC), Clinical Trials / Studies, Drug-Eluting Stents, FDA, Media Coverage, Patients

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