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February 16, 2010 -- 10:55pm EST

Stents Downgraded by Wall Street Journal: If Only It Were That Simple
coronary stentA broad-based critique, claiming overuse of heart stents and angioplasty, was published as a major feature in Thursday's Wall Street Journal. Clocking in at just under 2,000 words, Keith J. Winstein's article, "A Simple Health-Care Fix Fizzles Out", time-travels back three years to look at the COURAGE trial and how it has affected (or not) the treatment of patients with "stable coronary artery disease". (For a refresher on COURAGE, read Angioplasty.Org's 2007 report).

The main thesis of Winstein's piece is that the use of stents, after an initial drop of 13% right after COURAGE was published, is now back to pre-COURAGE levels. With the subtitle, "Why Health Policies Can Fail to Keep Up With Key Medical Findings", the WSJ article questions this rebound in stent use, which it characterizes as a "lucrative treatment" that can be "ineffective" and "unnecessary", and discusses the resistance to the COURAGE results from both the interventional cardiology community and the medical device manufacturers. (Gee...and I always thought the WSJ was a "friend" to business and industry.) The article also discusses how reimbursement policies currently favor stenting over medical therapy.

WSJ Simplifies Study Results by Ignoring Key Issues
Although the impact of the article may have been lessened somewhat when Bill Clinton was treated successfully with two stents only hours after the WSJ hit the street, there's no question that the COURAGE study (along with other similar trials, such as the recent BARI 2D) raises important issues, but the WSJ piece leaves out some important points and, well, here's a sample of the opening graphs:

It sounds like such a simple concept: Study different medical treatments and figure out which delivers the best results at the cheapest cost, giving patients the most effective care.... Yet, an examination of one of the best-known examples of a comparative-effectiveness analysis shows how complicated such a seemingly straightforward idea can get. The study, known as "Courage" (sic)...shook the world of cardiology. It found that the most common heart surgery—a $15,000 procedure that unclogs arteries using a small scaffold or stent—usually yields no additional benefit when used with a cocktail of generic drugs in patients suffering from chronic chest pain

The words that jump out at me are "simple" and "straightforward" -- because the diagnosis and treatment of coronary artery disease are neither. It may be comforting to view medicine through the eyes of an engineer or programmer, where you define a problem, create a fix, test it and implement it. But figuring out how to diagnose and treat a specific patient involves juggling multiple moving targets while keeping on top of the latest research, findings and available tools: it's what good doctors do.

Also Winstein's choice of the phrase "no additional benefit" is not accurate. The COURAGE study concluded that the addition of stenting "did not reduce the risk of death, myocardial infarction, or other major cardiovascular events." In fact, the Quality of Life portion of COURAGE showed that patients who received stents felt better (less pain) than the patients on OMT. That would definitely be a "benefit".

So here are a few facts and findings that may mess up this "simple concept" and show it to be a bit less than straightforward:

Comparison About More Than Just Drugs vs. Stents
COURAGE was not simply about "generic drug cocktails" vs. stents; it was about Optimal Medical Therapy (OMT) alone vs. OMT with the addition of stents. OMT is defined as a combination of "intensive medical therapy, a reduction of risk factors, and lifestyle intervention (diet, regular exercise, and smoking cessation)." Patients on OMT took 8-10 or more pills daily. They also were counseled about lifestyle changes, given support to lose weight, to exercise, to stop smoking -- none of these changes, as many of us know, are easy to accomplish; These patients got a type of personalized care that unfortunately is not readily available to many. In the "real world" studies have shown 40-50% compliance with diet, exercise, etc. -- in COURAGE compliance was boosted to 80-90% -- but can this be extrapolated to real-life? If insurers actually paid for these types of full-blown support services for weight-loss, exercise and smoking cessation (and they should!) -- what would that additional cost be for all "stable" heart patients?

1/3rd of Patients Given "Drugs Only" Switched to Stents
While it is true that there were no statistically significant differences between the two groups in terms of death and heart attack, fully 1/3 of the patients who started with medical therapy crossed-over to stenting, mainly for symptom relief (the BARI 2D trial experienced a similar cross-over rate of over 40%). In other words, someone thought stenting was beneficial!

Study included only Bare Metal Stents
Drug-eluting stents were not even approved until the final 6 months of COURAGE, so less than 3% of patients received them; 97% received the older bare metal variety. Drug-eluting stents significantly reduce restenosis (reblocking of the artery). Studies have shown that about 1/3 of the time, restenosis manifests as a heart attack. So would the results of COURAGE have favored stenting if drug-eluting stents were used?

Very Limited Patient Selection -- 90% of Candidates Rejected
90% of the patients initially screened for COURAGE were not enrolled in the trial (i.e. they did not fit the study's definitions of "stable angina"). A 90% exclusion rate is fairly high and critics of COURAGE point to this to show that the patient population was not what cardiologists encounter in their day-to-day practice.

Pre-Testing No Simple Solution Either
The WSJ article also makes a case for more pre-testing of patients before a stent is decided upon. According to the AHA/ACC/SCAI Guidelines, this is the way it's s'posed to be. But studies have shown that up to 50% of patients getting a diagnostic angiogram have not had a nuclear stress test. There are reasons. Because of previous diagnostics and/or clear symptoms, there may be no question that the patient has coronary artery disease (Bill Clinton did not need to undergo a stress test last week). Another confounder is that nuclear stress tests show a relatively large number of false positives or equivocal results, so those patients are sent to the cath lab for a diagnostic angiogram -- yet 37% of patients who get diagnostic caths show no coronary artery disease. And the scenario of someone dying of a heart attack the day after a negative stress test is oft-quoted (the tragic case of Tim Russert, for example). Moreover, many imaging experts believe that Cardiac CT is a better, more accurate test for the presence of coronary artery disease -- yet its use is being restricted by insurers and Medicare as being overused (not true) and unsafe (also not true -- properly done, the radiation from a Cardiac CT scan is less than that from a standard nuclear stress test). The testing/decision tree for patients with chest pain definitely needs updating.

Guidelines Plus Individualized Medicine -- More Effective than One Size Fits All!
Certainly, some sort of decision-making, and discussion with the patient, before choosing stenting as the treatment is essential. And treatment with medical therapy and lifestyle change should be the first line. These are the guidelines agreed upon by the professional cardiology societies.

What we really need is better patient and professional education, and a system that supports patient self-care, which might increase implementation of these guidelines. But making that happen is a hard sell -- probably because it doesn't immediately make or save anyone money (take it from those of us in the education business!).

The take-away from COURAGE is that, in this very specific low risk patient population, stenting can be safely deferred, to see if OMT can provide a less invasive, less costly benefit.

The downside for patients, however, is if insurers take some of these concepts and use them to deny care. In an interesting experiment, Blue Cross/Blue Shield in some parts of New York is requiring "stable patients" to do 12 weeks of medical therapy before they will cover a stent procedure. I only wonder if the type of COURAGE-level support will be there for them. I also wonder how the type of patient that would be in the COURAGE cross-over-to-stenting group will fare. Will they have to suffer angina for weeks before their procedure can be covered by insurance?

Finally, there is a strong movement in medicine today towards individualized treatment. As more is learned of genetic markers, cytochromes, etc. it may be that "one size fits all" treatment will disappear. This concept has been discussed at length by many cardiologists, most directly by Dr. Eric Topol regarding optimal duration of antiplatelet therapy. (Read his exclusive interview on Angioplasty.Org)

So the fear of using results from a study of a very particular hand-picked although large patient population to mandate (and possibly limit) care for a broad population of heart patients, is a bit disconcerting.

Remember too that in all of this, we are only discussing those patients with "chronic stable angina", a condition which itself many have trouble defining. Not in dispute are patients with more serious coronary artery disease, especially those in the midst of a heart attack. They are, without any question, best served by reopening the arteries, whether via bypass surgery or angioplasty.

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