Yesterday’s edition of USA Today carried an article by Peter Eisler titled, “Six common surgeries often done unnecessarily” — and, you guessed it, angioplasty and stents were at the top of the list of “six common surgeries that carry significant risks of being done without medical necessity, according to federal data and independent studies.”
I was a bit taken aback because I was not aware of any new study, federal or independent, that concluded stents were being vastly over-used. And it turns out that there wasn’t one.
Instead this very brief piece seemed to be based on two older studies: a 2005 Consumer Reports article which in turn was based on a somewhat distorted interpretation of the COURAGE study (now a decade old and somewhat modified by newer studies, like FAME and FAME 2), and a very important analysis of the NCDR PCI database by Dr. Paul Chan et al, which appeared in the July 2011 issue of the Journal of the American Medical Association under the title, “Appropriateness of Percutaneous Coronary Intervention.”
What amazed me was how this article in USA Today could do such a disservice to the field of interventional cardiology in a mere 99 words.
Putting aside the initial semantic error of angioplasty NOT being surgery performed by surgeons (it’s a procedure performed by interventional cardiologists), the first claim is that, “In cases where patients were not suffering acute heart attack symptoms, 12% of all angioplasty procedures were found to lack medical necessity.”
Not exactly. It’s a complicated topic, mainly because of the terminology that was used back in 2011, classifications which have since been changed “to lessen confusion in the lay press and media.“ Those were Dr. Paul Chan’s words. I wrote about these changes back in November (“A Stent By Any Other Name Now Has Other Names!“) but the confusion seems to have survived.
First, some perspective: of all the half-million angioplasties looked at in the JAMA study over the period of 2009-2010, 71% were done in acute patients. These were patients having, or about to have, a heart attack. Angioplasty and stenting is considered the gold standard for treating and stopping a heart attack from progressing. These interventional procedures have revolutionized the treatment of heart attacks, saved countless lives, and reduced the debilitating after-effects of a heart attack.
This is a fact I always like to start with, because this very important perspective too often gets buried: the vast majority of angioplasties are done in patients experiencing an acute event — there is virtually no controversy about appropriateness in these cases.
So now we’re talking about the 29% of angioplasties that are non-urgent, elective, performed mainly for relief of angina and other symptoms. Of these half were judged “appropriate” — and by “appropriate”, the authors mean there have been sufficient studies to show definite benefit for these patients. Another 38% were judged “uncertain”, a term that is now changed to “may be appropriate”; and 12% were labeled “inappropriate”, a term now changed to “rarely appropriate.” An important point about the last two terms. These labels do not mean unnecessary. They do mean that there is a range of clinical evidence about these types of patients, ranging from possibly beneficial to probably not.
It’s also possible that a doctor may be treating the type of patient not sufficiently studied in clinical trials of stents. For example, octogenarians are systematically excluded from most clinical PCI trials, so there is little or no hard evidence that angioplasty provides benefit to this population. Yet doctors treat these elderly patients on a daily basis and angioplasty has provided many of these patients with significant benefit. Do you know an 80-year-old who has gotten an angioplasty. Would you call that inappropriate or unnecessary?
Looked at another way, only 4% of all angioplasties in this study were classified as “rarely appropriate.” Not too bad really. Not a reason to view the entire field of interventional cardiology with great suspicion.
Oh yeah, did I mention that my concerns about how the press may misinterpret these classifications and data were shared by Dr. Paul Chan, the author of the study? Read my interview with him to get more of his viewpoint. In the interview, Dr. Chan, who is not an interventional cardiologist, also gives praise to the stent doctors:
“This sub-specialty of cardiology should really be applauded in taking the leadership in looking at these hard questions…. Whether it’s ICDs or angioplasty or stress testing. It really starts the conversation of how to improve quality…and that is a remarkable effort, knowing that sometimes it may lead to some revenue decreases for members of the field itself.”
Finally, the USA Today article ends with a scare: “[Angioplasty] has risks, including, in two to six percent of patients, heart attack, stroke or death.” Not sure where this assertion comes from, but the most current data I’ve seen shows that 30-day mortality for all PCI procedures (where death is a result of the PCI) is about 0.8% — remember that’s all angioplasties, including emergencies, heart attacks, etc. The risk of stroke at 30 days, even less at 0.3%. The stats for myocardial infarction 48-hours after PCI do run around 4.2%, but these are not necessarily “big” heart attacks, causing damage, and most are due to stent thrombosis, where blood clots inside the stent — an occurrence that may be happening less often as better antiplatelet drugs are put into practice.
So does this mean you should ignore these cautions about unnecessary procedures? Of course not. Any patient who is having such a procedure should question the cardiologist, to make sure they understand precisely why the procedure is being recommended, what the potential benefits and risks are, and to participate in this decision.
But as far as this article claiming that stents are “often unnecessary,” I’d just say that this was an article appearing in “USA Yesterday.”