Opinion: Some Common Stents

Below, a guest post by Dr. Nortin M. Hadler, MD MACP MACR FACOEM
Professor of Medicine and Microbiology/Immunology, School of Medicine University of North Carolina at Chapel Hill and Attending Rheumatologist, UNC Hospitals

The 5-year mortality for a well man after his first heart attack has dropped from 50% to 5% in one generation. The line of people who are taking credit for this happy turn of events is very long. At the head of the line stand the cardiovascular surgeons and interventional cardiologists. They bask in the praise of the media and of their celebrity patients who consider them saviors. If you have survived one of these modern medical miracles unscathed, you feel blessed to live in such a medically advantaged community. If symptoms return, it seems so reasonable to return to this technological fountain. If you survived scathed or ultimately succumb, it means that even modern medical miracles were no match for the magnitude of your affliction.

This is the social construction that every American has been taught and nearly every American has accepted. I have been decrying this sophism in lectures and in print throughout all the decades it took for it to become common wisdom. I started out relying on principles first, but as the technology evolved, so did the clinical science testing its efficacy. There is no doubt in my mind that interventional cardiology and cardiovascular surgery for coronary artery disease has written the bleakest chapter in the entire history of western medicine. Today I am bolstered by an informative science.

Systematic studies have failed to demonstrate that doing violence to coronary arteries advantages the patient more than pills and other medical therapies. No patient is rewarded in terms of longevity, incidence of heart attacks, or likelihood of chest pain for having submitted to these expensive technical and technological feats, and many suffer harm in the course of the procedure. Here are my picks as the best evidence of the lot:

•    In the RITA-2 trial, 1000 carefully selected patients with angina in 1997 were randomized to angioplasty or medical therapy. The consequences were last reported in 2003. Those initially randomized to non-invasive treatment did as well as those who underwent angioplasty.

•    Angioplasty was invented by Matthias E. Pfisterer, a Swiss cardiologist. Subsequently, Pfisterer and his Swiss co-investigators randomized elderly patients with angina to optimized medical therapy or early invasive therapy with angioplasty (with or without stenting) or bypass graft surgery and followed them for 4 years. There was no advantage to the early invasive strategy in terms of death or myocardial infarction.

•    The COURAGE trial is particularly damning; no one with stable angina should be told that angioplasty, with or without stenting, prevents a heart attack or stroke, or prolongs life.

•    In the multi-center OAT trial, funded by the National Institutes of Health, 2000 patients were recruited within a month of their heart attack because they had persistent blockage of the relevant coronary artery and heart damage. All received optimal medical care; half were randomized to also undergo angioplasty and stent placement. Over the next 4 years, there was no difference between the two groups in terms of recurrent heart attack, death, or heart failure. If anything, those with the stents fared less well.

•    In BARI-2D, the comparison is with high risk patients with Type 2 diabetes. Still, there is no advantage to prompt revascularization over medical therapy for coronary artery disease.

So why is it that over a million such invasive procedures are performed in the U.S. each year, indemnified by all private insurers, by Medicaid programs, and by Medicare? If angioplasty was a pharmaceutical, do you think the FDA could find a way to license it when the critical data prerequisite to licensing a drug was a series of negative randomized controlled trials? But procedures are not subjected to licensing, and devices such as stents are held to a much lower standard; they must be safe in the short term but there need not be a demonstration of efficacy. Hence, the FDA is not standing between Americans and the invasive cardiology and cardiovascular surgery community. Since the coronary artery plaque removal enterprise is the recipient of a sizable portion of the “health care dollar”, it has the fiscal wherewithal to make certain that it is favored in the media, in Congress, and generally in the mind of the public. A few of the leading medical journalists, such as John Carey, have had the editorial support to display the relevant science as early as 2005, but such efforts are overwhelmed by the miasma of marketing.

How about the doctors who do this violence to our coronary arteries? Some, as discussed in the accompanying essay by Maggie Mahar, have bent their moral compass to an unconscionable if not illegal degree. Most are not misanthropes. The “thought leaders” are well aware of the science. But most can overcome my kind of compunctions with 3 rationales:

•    One I call the “folly of peer review.” These interventional cardiologists and cardiovascular surgeons are prominent in their communities where their incomes, if nothing else, command respect. It is human nature for such people to come together bursting with pride that “my stent is bigger than your stent”. It is not human nature to applaud the “peer” who questions whether the stenting should have been done in the first place. The folly of peer review is not exclusive to my guild; it operates widely including on Wall Street when wizards were bundling bigger junk-mortgages.

•    Another rationale is science based. All randomized controlled trials specify the population that is recruited, including criteria such as age, coincidental diseases, prior cardiac history, current symptoms, and the like. It is easy for an interventionalist to tell a patient that he or she is different from the subjects in the studies and that “In my experience this works for patients like you.” For all I know, the interventionalist is correct – but believing so is a matter of faith in the face of the precedent that medical therapy works better in all other circumstances. For me, creating a theory that is self-serving is the essence of quackery. Any such theory should be subjected to testing before it can or should be offered based “on my experience.”

•    If you go to an American emergency room with chest pain, everything will be done to get you to the cardiac catheterization laboratory as quickly as possible and on to angioplasty (± stent) or bypass grafting if the eyes of the beholding interventionalist are convinced it’s feasible. They are in such a hurry because it’s so difficult to demonstrate you are better off with the procedure(s) if there is any delay. Since it is believed that the procedures are inherently sensible, it follows that they should be done as quickly as possible with little if any time to make an informed medical decision. This race from the door to the catheterization suite is lucrative but driven by metaphysics and not by data. In some studies you are better off if your local hospital lacks a cardiac catheterization laboratory thus sparing you from this vortex.

Speaking of scientific testing, I find it striking that interventional cardiology and cardiovascular surgery offers no advantage over medical therapy in terms of symptoms for all the many clinical subsets that have been studied. Dramatic “interventions” tend to have an enormous placebo effect because the providers exude enthusiasm, the recipients drip preconceptions of benefit, and the result is colored by the need for justification by both parties.

I would have thought that the only way to test the efficacy of interventional procedures for chest pain was by randomizing volunteers to the procedure or to a sham procedure. A sham surgery trial was done many years ago for an early version of coronary artery bypass surgery for severe angina with a negative result; all patients were anaesthetized and all had a skin incision but only half had the actual bypass performed. The likelihood of improvement was the same whether or not the bypass was performed. In all the trials listed above, despite placebo bias, invasiveness does no better than medical therapy in saving lives or sparing heart attacks for every form of coronary artery disease that has been studied. I will assume that holds for every form of coronary artery disease that has yet to be studied until a well designed randomized controlled trial convinces me otherwise. I have been pleading for years for the FDA to pummel the world of devices and techniques with similar sentiments.

Dr. Hadler is  the author of
The Last Well Person. How to stay well despite the health care system

Worried Sick. A prescription for health in an overtreated America

Stabbed in the Back. Confronting back pain in an overtreated society

Address: Department of Medicine
              Division of Rheumatology
              3300 Thurston Building CB#7280
              University of North Carolina
              Chapel Hill, NC 27599-7280
              Tel: 919-966-0566        FAX: 919-966-1739

              Email: nmh@med.unc.edu


6 thoughts on “Opinion: Some Common Stents

  1. This is an insightful and–I believe–accurate commentary. Having practiced, and taught internal medicine for over 40 years, I’ve been impressed with the advances in medical care and the rapid embracing of those treatments that appear to be “quick fixes” to a health problem AND that have commercial value.
    I think there may be another factor at work as well: namely what I call our “automotive world view” . That is, we tend to think of our bodies as mechanical devices–and hence we look most kindly on treatments that involve a mechanical approach, namely surgical procedures.
    Whatever the reason, our society has adopted a general overestimation of the benefits of surgical (and I include interventional cardiology in that group) approaches and an underestimation of their risks, and we are paying the price in many ways.

  2. Obviously I agree with this and Maggie’s post on the same subject, as well as Dr. Wachter’s comments that Maggie quotes.
    Americans, as Keith says, are obsessed with the notion that they can be “fixed.” Procedure after procedure and test after test are sold as a high tech “get out of jail free” cards, allowing people to feel they can easily and quickly return to “normal” and not have to think of themselves — correctly — as people with chronic medical conditions that require constant effort to manage, including giving up some of their favorite bad habits.
    As a footnote, it is very interesting to see that another topic that Dr. Hadler felt was worthy of a whole book was the back pain industry — probably the other huge offender in ineffective treatment and wasted dollars. Both of these areas of medicine not only waste money and risk patients with ineffective treatments, but also generate a huge amount of additional waste on spending for diagnostic testing in support of the industries, testing that would be largely unnecessary if treatments were mainly medical treatment and rehab instead of dramatic interventions.

  3. One of the first randomized trials of stents was published in the New England Journal of Medicine in early 1997. It compared stents to simple angioplasty. It found that patients with stents had fewer repeat angioplasties during the first six months bu there was no difference after 8 months. This was promoted by J&J as proving that stents had value. I spoke to one of the investigators and pointed out to him that everyone in the study had a follow-up angiogram at six months. Before that angiogram, patients underwent a repeat angiogram and possible angioplasty only if they were symptomatic. Because this was not a blinded study, doctors and patients knew whether they received a stent. I told him it seemed likely to me that patients who did not receive the new innovative therapy and their doctors were more likely to detect symptoms and treat symptoms as possibly cardiac meriting an early angiogram than patients who received stents. Once everyone received their six month follow-up angiogram, doctors and patients evaluated their symptoms in the context of their follow-up angiogram findings and the difference between stents and angioplasty disappeared. He agreed with me that it was a real possibility but didn’t think it was practical to do a blinded study and since he liked the idea behind stents and the results of animal studies he believed the study showed that stents were helpful even if it could not be “proven”. None of this, of course, was said in the journal article and accompaning editorial.

  4. Mar–
    You write: “He agreed with me that it was a real possibility but didn’t think it was practical to do a blinded study and since he liked the idea behind stents and the results of animal studies he believed the study showed that stents were helpful even if it could not be “proven”
    Exactly. That says it all.
    He “liked the idea of stents” even if the concept couldn’t be “proven”
    So much for science

  5. One of the things about angioplasty and stents that blows my mind are the risks people take getting them in facilities that do not have quick access to bypass surgery on the off chance the procedure tears a coronary artery.
    I remember as an ER nurse how we would fight to get a patient to the cath lab within 30 minutes. The cardiologists would send us before and after pictures of coronary arteries to show us how good we were in getting the patient to the OR. Felt pretty good at the time.
    Now I wonder how many patients’ health I put at risk participating in this sham.