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December 7, 2011 -- 2:15pm EST

A Stent By Any Other Name

Stent and Rose
Forgive the perverse Shakespearean pun in the title but, as the Bard wrote: "What's in a name? That which we call a rose by any other name would smell as sweet." My topic is pretty much the polar opposite of roses, but the whole concept of labels and what we call things has become increasingly important. It's one that I touched on in my post over last weekend about the impending CMS audits of stent procedures: namely, that the "official" terms used to describe treatment of a blocked artery are flawed when it comes to proper use of the English language.
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The official "Appropriate Use Guidelines" place stent and angioplasty procedures into three categories: Appropriate, Uncertain and Inappropriate. Any patient, potential patient or, for that matter, anyone not steeped in the minutiae of interventional cardiology, would look at those terms and assume that any doctor putting a metal coil into someone's heart when the procedure was labeled "uncertain" or "inappropriate" should be fined or fired or both.

Except they would be wrong. These terms specifically relate to the "level of evidence" in the official guidelines, evidence that has been adjudicated by a large committee that looked at clinical trials and studies and came up with categories and subcategories like Ia (the highest) and IIIb or IIc, etc. etc.

But, if you are a patient and your particular clinical situation was not included in a large randomized clinical trial (and many are not), then your doctor's decision to treat would most likely fall into the "uncertain" or possibly the "inappropriate" category, even though his or her best medical judgement is that a procedure would benefit you.

In other words these terms relate only to how they have been tested in large clinical trials -- i.e. there is clear evidence supporting the use of this particular procedure in this particular situation.

Unfortunately, many clinical trials exclude large numbers of patients, often those who are the sickest, specifically because their inclusion will "muddy the waters" so to speak and confound any clear scientific results. For example, the oft-touted COURAGE trial, the one that showed no additional benefit for stenting over optimal medical therapy in stable patients, excluded 90% of the patients who were screened, because they did not fit the study's definition of stable angina.

Yes, that's 90%! Only one out of ten patients screened for COURAGE was included in the actual study.

I'm not saying that categorizing procedures in terms of levels of evidence is wrong -- there have to be definitions against which medical practice can measure and judge itself. But it's just that guidelines, as I've written before, are NOT rules or laws. They're just there to "guide" judgement. If you are a cardiologist and you have a patient whose condition falls outside the guidelines' medians, then you have to exercise your best clinical decision-making -- yet the procedure you perform, if it is labeled by some type of panel, might be called "uncertain" or "inappropriate". This does not mean "wrong" or "dangerous" or "harmful". It just means there's equivocal or no evidence in published studies for this situation. As FaceBookers would say: "It's Complicated" -- and it is -- for more on these issues regarding Approrpiateness Criteria, read my interview with Dr. Paul S. Chan.

But back to my point about words. Cardiologists may have ongoing debates about these issues in journals, at national meetings, etc. but when guidelines or reports on "Appropriate Use of PCI" are issued, these reports are picked up by the public, the media and the evening news, and the precise words and labels used become important, and their intent changes from the strict narrow scientific definitions to broad-based meanings with all sorts of implied understanding (or mis-understanding) among the general population...and these labels usually appear in the headlines (or dreadlines, as I am wont to call them).

A prime example are the following dreadlines that appeared right after the July publication of Paul Chan's study in JAMA, which showed that only 4% of PCI procedures were inappropriate:

"Heart Procedure to Clear Arteries May Be Misused 12% of Time, Study Finds" -- Bloomberg News

"Angioplasty unnecessary in some cases, study finds" -- CNN

"Study Finds Too Many Elective Stent Procedures" -- MedPageToday

"Many US heart stents inappropriate: study" -- Reuters

So my recommendation is that a committee be organized to rework the terminology used in the guidelines -- a kind of guidelines for the guidelines committee. And this committee should be tasked with the goal of creating better labels and ways to communicate the safety and efficacy of these procedures to the public, as well as to the profession, payers and politicians. And, I would highly recommend that such a committee consist not just of doctors and scientists, but of members who are, in effect, wordsmiths: writers, journalists...perhaps even bards....

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