Time To Stop “Resolutely Ignoring” Medical Evidence

At the core of health reform is an increased emphasis on evidence-based medicine; a movement toward reimbursement policies and quality ratings that encourage doctors and hospitals to use the most effective and patient-appropriate treatments, backed by clinical data and scientific studies. But when it comes to interventional cardiology—using devices like balloon angioplasty and stents to open blocked arteries—it seems that evidence is still taking a back seat to deeply ingrained practice patterns.

Case in point: Even though many well-designed clinical studies conclude that drug therapy can reduce the risk of heart attack and death in people with stable coronary artery disease just as well as more expensive invasive procedures, many cardiologists continue to use interventions like propping open blocked arteries with costly stents instead of first trying medication. Besides exposing their patients to unneeded risk, just the inappropriate use of so-called “drug-eluting” stents alone increases Medicare expenditures by $1.57 billion each year.

“We’re still not seeing practice trends that are consistent with people following the evidence,” Peter W. Groeneveld, assistant professor of medicine at the University of Pennsylvania School of Medicine tells me. In fact, he continues, it seems that cardiologists are actually “resolutely ignoring the evidence” in favor of performing interventions that they seem to believe are better. Or, as the Los Angeles Times put it recently; “You can lead a cardiologist to water but, apparently, you cannot make him drink.” 

In 2007, results from a large study of patients with stable coronary artery disease (these are people who have not had heart attacks, but have partially blocked arteries) called COURAGE found that patients who received “optimal medical therapy” had the same outcomes in terms of number of subsequent heart attacks and deaths as those who underwent interventions like balloon angioplasty or stent placement to open narrowed coronary arteries. The only benefit of these interventions was more rapid relief from the chest pain and pressure experienced by a minority of patients who reported severe angina before hand.

The COURAGE findings were important because they served to back up a review of 11 other clinical studies that came to the same conclusion; making it clear to doctors that in patients with stable coronary artery disease, trying a course of medication first (at a yearly cost of hundreds of dollars) before resorting to interventions that involve cardiac catheterization and placing drug-eluting stents into arteries (a procedure which can cost up to $48,000) made good sense both in terms of cost and in the quality of care. There is risk inherent in any type of surgery—and in the case of these procedures, called percutaneous cardiac interventions or PCI, patients must take antiplatelet drugs to prevent blood clots, and still face the risk that an opened artery will get blocked again and have to be “restented” after several years.

Recently, William B. Borden, a cardiologist at Weill Cornell Medical College and his colleagues decided to see if the (widely-reported) findings of the COURAGE trial had led to changes in the treatment of stable coronary artery disease in the years following publication. The expectation was that there would be a shift toward making optimal drug therapy the first-line treatment for the majority of these cases.

In fact, the researchers found that many interventional cardiologists seem to be ignoring the evidence. In a new study published last month in the Journal of the American Medical Association, Borden writes that “Among patients with stable CAD [coronary artery disease] undergoing PCI, less than half were receiving OMT [optimal medical therapy] before PCI and approximately two-thirds were receiving OMT at discharge following PCI, with relatively little change in these practice patterns after publication of the COURAGE trial.”

What the study indicates then, is that despite the recommendations of COURAGE and other trials, fewer than half of the patients with stable coronary artery disease are being treated with medication before going straight to PCI. Also worrisome; even after having PCI, a third of those patients are still not receiving the optimal drug therapy—a mix of medications that reduce cholesterol and lower blood pressure as well as daily aspirin to prevent clot reformation.

Borden and his co-authors conclude with two recommendations: 1) that there be better coordination between interventional cardiologists who perform PCI and the internists or other physicians who provide the longer-term care of these heart patients. This coordination is necessary to make sure patients are started on and adhere to drug therapy after they’ve had PCI. 2) The paper also calls for “improving the translation of clinical evidence into practice,” i.e. getting doctors to stop performing PCI on patients with stable CAD who have not yet tried a course of drug therapy to reduce their artery blockages.

Peter Groeneveld would also like to see cardiology practice become more evidence-driven. This month the assistant professor of medicine at the University of Pennsylvania and several colleagues published a new paper, also in JAMA, titled, “Coronary Revascularization Trends in the United States, 2001-2008.”  In their paper, the researchers write that although doctors still perform 1.1 million procedures for opening clogged arteries each year, the rate of coronary artery bypass grafting (CABG) has dropped 38% since 2001 while the rate of PCI and the use of stents to open blocked arteries has remained virtually unchanged.

On the face of it, the finding that the rates of CABG have decreased by more than one-third seems to be good news: avoiding open-heart surgery with its costs and attendant risks sounds beneficial. But the JAMA article suggests that at least some of those patients who might have needed open-heart surgery are instead ending up in the cardiac cath lab getting stents. The problem is that for a lot of these patients, studies find that CABG would actually be the preferred treatment. For example, in a seminal trial called SYNTAX (published in The New England Journal of Medicine in 2009) researchers found that coronary artery bypass grafting is still the best treatment for patients with three or more blocked vessels or for those who have left main coronary artery disease.

Since it’s unlikely that there has been a big decline in patients experiencing these more complicated cardiac problems between 2001 and 2008, Groeneveld says he suspects that CABG is now being underused and it’s likely that in recent years, “patients who would have been optimally treated with CABG surgery were instead treated with PCI."

Why the shift? “The most likely reason is that interventional cardiologists are being more aggressive with their patients and sending fewer of them on to surgeons,” says Groeneveld, adding that “some physicians are resolutely ignoring the evidence” because they are “so enthusiastic about their abilities to do PCI.”

Groeneveld believes that “the vast majority of interventional cardiologists think they are doing their best for their patients.” They are not deliberatly setting out to increase profits by improperly treating certain patients (although clearly some are—see “Stent Scandal: A Shocking Story, But Not News” a HealthBeat post by Maggie that focuses on a "star physician" who was so motivated by profit that he implanted stents in patients who didn’t even need them).  But clearly other imperatives are trumping scientific evidence in driving the decision to use PCI on so many patients. Every year the technology gets more advanced says Groeneveld, and doctors think, “Look at these cool toys I have that are so much better than the ones I had before.” Doctors like to solve problems; they rationalize, “There’s this blockage right in front of me and I want to fix it now.” This urge to “fix a blockage” while the living, breathing patient is already lying on the table having a cardiac catheterization procedure is so ingrained in the physician’s practice that he or she can at that moment easily ignore evidence to the contrary from an arcane and inanimate medical journal.

“Some of these decisions are not even made consciously,” says Groeneveld. Most practitioners think, “My patients are generally different, and I’m better than the average physician.” And why wouldn’t they think that? PCI is often successful; most patients wake up from the experience and say “thank you doctor, you saved my life!” They find it impossible to believe that they could have had this same–or better–result from taking a handful of pills or enduring open-heart surgery.

Groeneveld’s JAMA study uncovered a second trend in the treatment of coronary artery disease that also merits mention. It seems that between 2001 and 2008 more and more hospitals started offering coronary artery bypass surgery as a kind of “flagship” service. But as these additional centers opened, the number of surgeries performed at each one often dropped to fewer than 100 cases per year. This is concerning because studies show that hospitals and surgeons that perform the highest volume of CABG procedures have the best outcomes; i.e. in heart surgery, practice makes perfect.

In the end, the recent spate of articles looking at the relationship between medical evidence and actual practice in cardiology is important in providing insight into how to stem national trends in health care cost growth. Unlike some other high-cost areas of medicine like cancer treatment, for example, there is  a large body of well-accepted studies on the best practices for treating stable coronary artery disease already available. And when it comes to stents, studies have long indicated that inappropriate use is clearly driving up Medicare costs. Rita F. Redberg, a cardiologist at the University of California in San Francisco and editor of the Archives of Internal Medicine writes, "It is estimated that more than 60% of drug-eluting stents are placed for off-label indications, and these patients have higher adverse event rates than on-label usage." A study published earlier this year in Circulation: Cardiovascular Quality and Outcomes found that “it is uncertain that there is any level of severity of angina for which an initial strategy of PCI would meet a societal willingness-to-pay threshold.”

Through the health reform law, the Secretary of Health and Human Services, along with advisory groups, can create Medicare reimbursement policies that reflect this solid body of evidence and encourage appropriate use of PCI and stents. For patients with stable coronary artery disease, there seems to be little doubt that drug therapy is the preferred first treatment. For those with three or more blocked arteries, the evidence points to coronary bypass surgery as the preferred approach. Penalizing the outliers—providers who consistently use inappropriate treatment—is another way to affect savings.

The idea is not to discourage future technological innovations that lead to better outcomes in terms of preventing heart attacks or death in people with coronary artery disease. But it is vitally important that we bring clinical practice consistently in line with evidence-based medicine. The time is long past when we can just assume that every new device is a better device or that every new surgical intervention is better than an older one. This kind of thinking drives the growth of the for-profit health care industry and may make millionaires out of "cutting-edge" doctors, but in our current era of austerity and cost-cutting it is no longer a tenable approach to cardiac care. 

32 thoughts on “Time To Stop “Resolutely Ignoring” Medical Evidence

  1. Interesting, you would fine Bill Clinton’s cardiologist. I would think you would be more in favor of “shared decision making” than fines and penalties. Fully and completely give them the risks, fully and completely give them the benefits. Let the patient decide. One size fits all edicts and fines is not “patient centered” care. The patient is making no decision in that scenario, it’s already been made before they’ve hit the door. I’d rather not be told that I’m not allowed to have surgery, just as I wouldn’t want to be told that I had to have my chest sawed open because I had 3 vessel disease. That’s a in depth conversation I want to have with my doctor. Maybe that is an opportunity where more coordinated and colaborated care model could be of benefit. But to tie his or her hands behind their back and have them plug me into a table or suffer the consequences. No thanks. Maybe “shared decision making” and “patient centered care” should join “quality” as focus group derived buzzwords with no real meaning in the grand healthcare drinking game, if coercion and force is the ultimate goal.

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  3. Right now, shared decision making goes something like this: the interventional cardiologist says to the patient,”look, the evidence recommends that I put you on meds for x number of months and hopefully your blockage will widen. But, I could use this fantastic new stent to prop open your artery while you’re already on the table and when you wake up you’re going to feel great, no more pain, etc.” Imagine that scenario but with the doctor playing up drug therapy, citing risks of PCI and telling the patient that Medicare won’t cover most of the cost of the intervention. If that’s what you mean by shared decision making or informed consent than I agree with you.

  4. You can’t fight human nature. 48K for a stent versus 84 dollars for an OV. If Medicare wants docs doing fewer stents, pay for them the way they do E&M codes: overhead minus 15%.

  5. Unfortunately, we are rapidly passing the point where “shared decision making” is a rational choice for American health care — largely because American doctors have failed to make it work, but also because so many decisions are made in a context in which rational shared decision making is hard because of emergencies, fear, pain, and guilt.
    Doctors, unfortunately, continue to ignore scientific evidence regarding the effectiveness of treatments from coronary disease management to hypertension to back pain. Whether from ignorance about the science, from being misled by sales efforts, from ego driven beliefs that they are somehow “better” than the science, or — and I like to believe that this is a tiny minority — from greed, American doctors persist in flying in the face of the facts and prescribing expensive management that is ineffective at best and harmful at worst.
    In the face of ever increasing health care costs threatening to bankrupt the government and the country, we are faced with a choice. We can follow the plans already being proposed by some politicians to price large numbers of Americans — low income, working class, and middle class — out of the health care market, or we can change the health care market itself, eliminating waste and inefficiency to lower costs dramatically while actually improving quality of care.
    Patients worldwide are already used to that approach, and their health is better for it. For American patients and doctors the choice is abandoning most Americans or embracing rational care patterns. We — doctors, patients, and politicians — can argue the philosophy, but the facts are clear.

  6. The answer seems pretty clear; stop paying for therapies that have marginal or no benefit! If the science all shows that stents are no better than medication, then stenting becomes a cost to the patient or a writeoff for the hospital. Since it is not the poor patients responsibility to decide if a stent is needed when his cardiologist is telling him he needs one, you would need to bring the economic pain down on the provider (hospital and cardiologist). Once hospitals start having to eat the cost, you will see them tighten up on the indications for this procedure. Keep rewarding them for inappropriate stenting and you will continue to get more inappropriate stents!
    The big problem I see is there are a lot of cardiologists who have spent several years of trainng to do these procedures who are now seeing the indications for their major revenue generating procedure drying up. Just as they are ready to cash in on all that training and educational expense, their chosen profession is looking a whole lot less lucrative. This is a very good senario for getting overuse and extension of indications for cath procedures and stenting. Don’t expect to see this change till Medicare and other insurers tighten up the indications for stent placement. Makes a good case for why we need comparitive effectiveness research funded by an impartial party (not the stent manufacturers).

  7. Naomi,
    This is a great summary of the current evidence and the failure of profit-driven medicine to follow the best medical advice. Thanks for putting this together.
    I think the point of the article is that Medicare shouldn’t pay for expensive and ineffective treatment, not that you will be prohibited from deciding that you want to have expensive and ineffective treatment… you can still do that… you just have to find someone else to pay for it.

  8. Like PatS, I’d like to believe that the problem is mostly that cardiologists genuinely believe they are offering better care. The problem is that fee-for-service introduces a difficult variable, which is personal gain for the doctor.
    I wonder if there are any studies about this from salaried practices, such as Mayo or Kaiser? Although that would not be perfect, it might offer some control of the personal gain factor.
    I also agree that doctors do what they are trained to do, what they even enjoy doing. So suddenly finding that PCA and stents don’t help can be quite a threat to one’s self image, if not an entire career. Better to put your fingers in your ear and hum “la, la, la — I can’t hear you.”

  9. Naomi,
    How do you know what the shared decision conversation sounds like? Are you in the room?

  10. I think the decision whether or not to implant a cardiac stent is one of the more difficult in healthcare. In my own case, after angiography in 1999, I needed a quintuple CABG. Despite maximum medical management and perfect compliance, I needed a stent in 2005. When the doctor located the source of my discomfort during the 2nd angiogram in 2005, he was able to insert the stent in 10-15 minutes. After a night in the hospital, I went home the next day to celebrate Thanksgiving.
    Doctors tell me that it’s not so cut and dried to determine whether a stent is appropriate in a particular case or not. Where is the blockage? How significant is it? Is there more than one? Even if the doctor thinks that inserting a stent won’t extend life beyond what medical management would have, relief from angina and other discomfort is a clear and tangible benefit for the patient.
    By contrast, the choice between physical therapy and back surgery or hip replacement is a much different matter. It’s easy for an insurer to insist on pre-certification or to try PT first before approving surgery. With respect to shared decision making, patients have time to think about it, read the brochures, watch the video, and talk with friends and family members. Even cancer treatment options lend themselves to shared decision making reasonably well, again because there is time to make an informed choice. A decision to insert a stent, by contrast, usually needs to be made on the spot while the angiography is in progress. Between the immediacy of the situation and the life threatening nature of heart disease, patients are more likely to want to defer to their doctor’s judgment. Just because the patient hasn’t suffered a heart attack yet doesn’t mean he won’t have one soon. It’s not an easy call and not comparable to shared decision making involving many, if not most, other medical conditions.

  11. I have a close friend who had a stent placed not too long ago. He was advised by his regular internist that he did not need the stent and that medical therapy would be effective for him. He then went doctor shopping and found a cardiologist who was willing and eager to place a stent, and had the procedure. He is very happy with the results, and tends to discount the impact of his maximal medical therapy on his condition and to believe his life was saved by the stent.
    He is actually angry at the doctor who advised medical therapy, and switched doctors to get away from him.
    This is all too typical. Many patients are enamored with the drama of stents, surgery, and other high tech intervention (as well as with high tech imaging,) and feel that the procedures offer a chance to be “fixed.” They are not happy with the idea of being told they have a chronic condition that will require treatment for the rest of their lives — even though the chronic condition continues after the intervention and they receive the same treatment as if they had not had it.
    Except for a few people who have had serious complications, I have never talked with a patient who had stent placement or CAB who was not very happy with the experience. That is especially true of stenting, where the only real inconvenience is a sore groin for a week or so. I have no doubt that most patients in the several large studies that showed lack of advantage for stenting compared with medical treatment alone would feel the same way.
    As long as doctors continue to offer scientifically questionable care and advise patients to get it, the idea of “shared decision making” in this context is unlikely to be useful, and the US can no longer afford it. Insurance should pay for scientifically proven management, and fliers into unproven management should pay their own way. Otherwise, the price will be paid by large numbers of people who will be unable to afford most health care of any kind, much less unproven care. The proposal passed by the House envisions seniors paying 65% of their health care costs out of pocket, well beyond the means of most retired people, and also would end many programs for poor women and children. That is the way we must go if we decide we must offer the option of expensive inappropriate care in the name of shared decision making.
    BTW, I have also encountered many patients who have had spine or joint surgery that is questionable, cancer patients receiving unproven or ineffective treatment, as well as people who take expensive proprietary medication when much cheaper generics are as good or better, all of whom are equally pleased with their treatment, and equally sure it was exactly what they needed, so the idea that cardiac care has some special status is less true than you would think.

  12. I would like to know where the money to fund the study actually came from. All I can find is “partially” from Veterans Affairs. (& where did VA get the money from?)I know many people who benefited from stents, have had reactions to medications and also lost their entire sternum because of infection after a CABG. Every media treatment of every area of healthcare is so full of spin you can hardly stand up. I’m no cardiologist, but I’m also not foolish enough to believe every medical “study” that hits the news. These so called facts may be bought and paid for like so many others before.

  13. Isn’t a big part of the problem that we pay too much for stents, even when they ARE indicated?
    This is the inevitable result of CMS’s unethical rubber-stamping of the recommendations from the AMA’s corrupt RUC.
    We pay for stents: we get lots of stents
    We don’t pay for talk and shared decision making: we don’t get much talk.
    We get what we pay for.

  14. Mark-
    I’d go one further, give me my own money and let me make my own decisions.
    Insisting on PT is not shared decision making. That’s an edict. That’s a mandate. From experience, I can tell you is all it does is hardens a patients view against it. If I brought PT up through a discussion as an option, rather than told a patient “No, PT is your only option according to your insurance. Good Luck with that.”, my compliance and buy in is much better in the former scenario. I see no reason why a fully informed stable patient can’t be given all options, all risks, and make their own decision in a coronary scenario. Maybe a nonintervential cardiologist as a gatekeeper model, could provide such a scenario, but it’s not unreasonable.

  15. Hey Change is tough- especially change that lowers one’s income!
    We need capitated care to end this fee for service nightmare of excess.
    And we need a new generation of doctors who don’t expect to become wealthy by practicing the once noble profession of Medicine.
    Dr. Rick Lippin

  16. Naomi-
    Groeneveld’s statement that CABG is underutilized is not damning at all. If anything it is reassuring. Anyone who takes care of patients should want them to be underutilized. Sawing open the sternum, harvesting arteries, clamping the aorta, bypassing the heart, stopping the heart, restarting the heart and wiring the sternum shut SHOULD be underutilized. The much, much less invasive procedure SHOULD be overutilized. Now comparing PCI with drug treatment and finding ways to push drug treatment, can I get behind that? Absolutely. But pushing for more CABG compared to PCI, the two procedures aren’t even in the same ballpark in regards to risk, pain and cost.

  17. Pat,
    Thanks for confirming what I have long thought. “Patient centered care” and “shared decision making” are nothing more than focus group derived buzzwords, that people like Donald Berwick and health care reformers have no real plan of implementing. They make for a catchy speech though. You can probably add “eliminating waste” and “improving quality”, too. Everyone drink!

  18. Jenga —
    There is a big difference between shared decision making and shared waste.
    To revisit past posts, it is easiest to understand what is going on if you just substitute the words “rhinoceros horn powder” for “coronary stent placement.” It is silly to insist that doctors and patients have the right to have insurance or Medicare coverage for treatments that science demonstrates are ineffective or harmful if the doctor and patient agree to the treatment.
    Shared decision making is appropriate, but it must be confined to the realm of valid science. Doctors and patients don’t have some right to insist that the entire scientific base of medicine be discarded if the idea is appealing to them.

  19. There’s a big difference between “rhino horn powder” and PCI. If you are suggesting PCI has no valid science behind it, I just have to laugh. What if someone has 3 vessel disease, is fully informed about risks and benefits and wants the less invasive and less costly PCI over a CABG, are you going to force them to have their chest sawed open because it hits the data points on a graph? Patients have a right to be in charge of their own bodies. That’s what I thought was the supposed beauty behind shared decision making, that they might not chose the most invasive and expensive procedure. But like I said, shared decision making is just a fairy tale that reformers tell us. They don’t really mean it. What they really, really want is edicts, penalties and ultimately control.

  20. Please note that the COURAGE study applies to patients with STABLE coronary disease, not unstable disease. It also did not show that stenting was ineffective. Rather it showed that stenting is no more effective than medical therapy in terms of preventing heart attacks and deaths. There should be some individual selection. I have one elderly friend who was fine with restricting his activity and using meds for his coronary artery disease. Another individual, whose greatest enjoyment in life is to hike in the woods with his dog, might need otherwise. The biggest downside to stents, especially drug-eluting ones, other than the expense, is the need for plavix for up to a year. Bad news if you have a gi bleed or need surgery.
    An unanswered question is why a little piece of metal should cost such an incredible amount.

  21. I recently read that only 3 types of cancer have been proven to increase survival rates and yet we bombard anyone with any type of cancer with chemo. Few people even know they should question this treatment. Patients need to know that sometimes NO scientific for their treatment exists.

  22. There are special situations in which evidence shows that stent placement is indicated, especially MI in progress and unstable angina, and I do not suggest that PCI is not indicated and should not be used in those settings. However, the vast majority of PCI in this country are performed in settings in which the four major controlled studies (OAT, COURAGE, BARI 2D, and RITA-2) showed failure to match or exceed the results of medical therapy alone. This includes results involving lifestyle and activity issues, since the evidence that PCI improves ability to tolerate exercise or other activities over time in most coronary artery disease settings except as a placebo effect is weak, and even trade groups admit that PCI aiming to effect lifestyle and activity issues is indicated only after failure of a significant trial of medical therapy. In addition, there are risks, infrequent but real, besides the risk of long term anticoagulation – risks that include death, massive MI, induction of congestive failure and crippling disability, and so on. The New York Times recently ran a report of a woman who, because of being a well respected hospital employee where she was being treated, had a case of musculo-skeletal chest pain cascade into a heart transplant following a series of “favors” (arrived at by shared decision making) by doctors who knew her and performed a series of studies and treatments that went disastrously wrong.
    This means that when you advocate use of shared decision making in this setting, what you are suggesting is that doctors and patients be allowed to work together to choose to spend billions (about $70 billion a year in this case) of dollars on management for which there is no scientific rationale for use over medical therapy alone – therapy that the patient will get IN ADDITION to the interventional therapy anyhow.
    And yes, that does place the doctors and the patients in the same category as rhinoceros horn powder – both are therapies that some patients and some practitioners may want to use and may believe in, but for which there is no scientific rationale for choosing. Rhino horn powder actually does work, it just doesn’t work better than placebo. The problem that we American doctors have is that it is very hard for us to accept that many of the things we do and are so dear to both our self-image and our wallets often are not justified medically and scientifically. We have passed the point in our economic history where we, as a nation, can afford to continue to indulge this type of waste simply because some people prefer it.
    Regulation of this sort does not really represent a departure from the existing standards in the US. Medical care is already heavily regulated at many levels, doctors are enjoined from using all sorts of management that they may believe work perfectly well and are forced to make other choices, and third party payers already refuse to pay for many management approaches. What this does threaten is forcing rational regulation on areas of management that play a major role in the financial environment of medicine and reducing large income streams for doctors, hospitals, and drug and equipment vendors – controls on the “rainmakers” and threats to what are really whole industries. Huge amounts of money are spent on several important categories of management that have failed to show value that significantly exceeds or even matches much less expensive choices, and diversion of those income streams would have major effects on the health care economy — positive for the nation, but negative for many stakeholders.
    There is a lot of resistance to this kind of thing, some of which we have seen on these pages, since it threatens the way that doctors and others have learned to think and behave in the US and their traditional power and autonomy. Most other countries have learned that they cannot continue to allow that power and autonomy to continue unchecked if they wish to continue to offer health care to most citizens, and, fortunately, have found that health care results are as good or better when controls are introduced and applied.
    I don’t know if we can do that in the US – the resistance expressed here is mild compared with the amount of organized political and PR resistance we can expect. I do know that if we don’t regulate health care spending on the basis of comparative effectiveness we will have to reduce health spending in other ways, most of which would mean that large segments of the population, including most middle class retirees and even most middle class workers and their families, would be excluded from health care on the basis of cost. Perhaps you think that for philosophic or personal reasons that is acceptable and even preferable. I don’t.

  23. Medical therapy is not Placebo. It’s a control arm. By your train of thought you are also comparing “rhino horn powder” to medical therapy as well. It is a nice rhetorical slight of hand. There is no study comparing PCI to placebo and likely none to come if you want IRB approval and subject patients to sham procedure. I stand by my statement, “shared decision making”, “patient centered care” are just empty words to try and make physicians and patients feel warm and fuzzy about the coming changes in our system. This article and responses are the clearest indication I’ve seen so far.

  24. Maybe Jenga would feel better with the phrase:
    Informed patient choice from an acceptable and evidence-proven menu of options!

  25. Jenga —
    As I am sure you know there are well defined statistical standards for placebo effect in surgery to attempt to account for the well known and proven placebo effect of surgical procedures on results that have a subjective component and other soft end points. These were established in days of yore, when not telling a patient that an attempted surgical procedure had failed was considered acceptable, at least in the context of experimental studies. The exercise and activity effects of PCI do not exceed those standards. In addition, they fade fairly rapidly over time, another common sign that placebo effect is operating. The failure of PCI to match or exceed hard end points is of course very well established.
    It is clear that we are going to disagree, based on your apparent misperception that shared decision making allows doctors freedom to do and bill for anything they want as long as they can convince the patient.
    As NG notes, there has always been an understanding that that applied only within the bounds of proven relative effectiveness. In this respect it is not significantly different from existing standards, except that application of the standards is now being proposed for several of the most common and most financially significant procedures, a critical issue since they are such huge foci of waste at a time when waste in the hundreds of billions of dollars per year is no longer an option.
    If you choose to see that as a betrayal that is your choice. In reality it is just the application of common sense.

  26. Jenga,
    Several readers have posted their response to your take on shared decision making and patient-centered care and it’s clear you don’t agree with them or with me. These are both very positive ideas in health care–involving the patient and his or her individual priorities (age,overall health,level of activity,extent of disease–as well as personal factors and beliefs) in making decision about treatment. I’m sure you can agree (and you’ve stated several times in this thread)that one-size-fits all medicine is not doing any one good. No one has said that PCI should never be performed and stents are completely useless. But as Pat S. has reiterated, study after study has shown that in most people with stable coronary artery disease medical therapy is just as good and should be the first line of treatment. If you choose not to tell patients this information and instead go straight to PCI you are practicing poor quality care and even putting your patient in harm’s way.
    Rhino powder may not be a great analogy but what about radical masectomy vs. lumpectomy for certain types of breast tumors. For years surgeons ignored evidence that survival and recurrence rates were the same for both procedures (and led women to believe otherwise)and subjected them to the more radical surgery and far more serious side-effects because it was a practice they believed superior and were used to performing. It wasn’t until patient rights groups made this an issue of informed decision making (or patient-centered care, whatever…)that radical mastectomy stopped being routinely performed for all tumors.

  27. A great many comments of force and emotion.
    As an orthopedic surgeon who recently had a pci for unstable angina with a large occlusion of my LAD adjacent to the main coronary, I empathize with all of the difficult decision making. In my case, I trusted my cardiologist, but was happy that my friend the cardiac surgeon was on standby….As a surgeon, a robotic transfer of the internal mammary seemed a more efficient and better.
    Since then I have followed the scientific evidence base. Confusing. My chest pain may or may not be better. My wife is not a widow.
    From an orthopedic standpoint the degree of difficulty in defining what is the best “evidenced based” decisions are equally difficult. Some decisions are based on surgical skills and experience, which my outweigh the evidence. Oft, the evidence is found to be scanty or wrong.
    How does a physician work closely with a patient in an informed decision making interview in the most ethical and patient centric manner?
    these buzzwords may be searching for meaning. Hopefully not coercive. I speculate often that the ACO’s and insurance based decision making protocols are simply economically based and not based on patient needs and physician abilities.

  28. Richard Scott —
    Excellent comments. I certainly agree that management decisions need to be based on studies that are large, well conducted, and can be replicated. By now it is quite clear that stent angioplasty has received that evaluation, and that cases like yours with unstable angina are appropriate candidates for PCI, while patients with completed MI, stable angina, or without symptoms of coronary disease are not appropriate candidates without a sufficient trial of medical therapy. There are several other areas of medicine where there is similar evidence, although there are many areas where more evidence needs to be gathered.
    I would caution against the argument that individual physicians are exempt from scientific guidelines based on a higher level of skill and experience. This is a common perception and is at the root of a lot of incorrect decisions. Given the fact that almost no physicians have large controlled studies measuring their own performance, they need to assume that the evidence does, in fact, apply to them too.
    I know the feeling however. In my own career I have had ample evidence, based on fairly large data bases, that in some areas of care my own performance was well above average. However, I long ago decided that I could not in conscience claim that my performance justified ignoring science in favor of the feeling that I was better than the doctors involved in the studies.
    Good luck to you in managing your heart disease.

  29. Naomi-
    I couldn’t agree more about the fully informed patient and have stated that several times. That’s why I said maybe a gatekeeper model with a nonintervential cardiologist is in order.
    Naomi and Pat-
    Where my disagreement is, is equating PCI with placebo, which has never been the case. It has been shown in a few studies to be no better than medical therapy for stable CAD, that is what we know. To say it is no better than placebo is false and has not been tested in that way, nor will it. NG is exactly right. That IS what I would prefer, assuming the patient would actually get to choose. My point is if we are going to give the patient no choice, let’s call a spade a spade and drop the monikers “shared decision making” and “patient centered care” from the reform vocabulary.

  30. Jenga —
    Re-read my post. I did not say that PCI was placebo, I said that the apparent effect on exercise and activity had to be evaluated as a possible placebo effect, since that is not a hard end point and is influenced by subjective patient attitudes and confidence. The numbers reported for that effect as well as the loss of the effect over time suggest that there may be a placebo effect operating.
    All surgery has some degree of placebo effect, as do almost all other treatments. That is why hard end points are so important, and why the results of the large randomized studies are so important.
    BTW, there are not a “few studies” that question the effectiveness of PCI in patients with completed MI, with stable angina, and with positive angiography but no symptoms or findings. In those cases every large study that has had randomized PCI and medical treatment alone arms has shown medical treatment alone to have the same or superior results and to be safer. The studies have evaluated just about every possible set of circumstances, and the results are always the same.
    Randomized studies do show a positive impact for PCI in acute MI in progress and in unstable angina, and those two areas should, at this point, continue to be managed with PCI when possible.
    As Naomi said originally, it is “time to stop resolutely ignoring the medical evidence.”

  31. When you say substitute “rhino horn powder” for “PCI”, it’s pretty clear when you are getting at. That it’s useless or in other words “placebo”, which isn’t the case as you stated. My suggestion for this would be to align incentives, save money, and generate instant buy in with the medical community, all with minimal direct cost. One word- safeharbor. Provide safe harbor to those following evidence based guidelines and you will transform the system quicker and more efficiently than anything stated in the article.

  32. I agree with Jenga about the need for safe harbor protection from lawsuits for doctors who follow evidence based guidelines where they exist.
    If the standard of care in a community or region is to provide stents to relieve chest pain for patients with stable angina, it seems hard for a single doctor or small group of doctors to practice more conservatively, especially if patients want a quick fix. If the patient doesn’t get the stent and suffers a heart attack later, the doctor fears being sued. Even if the interventional cardiologist is salaried and doesn’t benefit financially from performing more stent procedures rather than fewer, the standard of care, driven by a combination of patient expectations and the litigation environment, pushes in the direction of stenting. If we want doctors to practice more conservatively, at least in this instance where the procedure is expensive, we need to at least protect them against litigation from patient lawsuits.