Who Should Take Aspirin for Prevention?

The answer is not entirely straightforward.  Aspirin has been shown to reduce the risk of cardiovascular disease, including heart attack and stroke. Aspirin inhibits the function of platelets, the blood cell line responsible for clot formation.  When a heart attack or stroke occur the cholesterol plaque that lines an artery ruptures and platelets aggregate, resulting in a cascade that results in acute occlusion of a blood vessel.  Patients who are treated with aspirin are less likely to clot.  However, the effects of aspirin are not entirely benign. With its platelet inhibition it also confers a higher risk of bleeding—in particular gastrointestinal bleeding and hemorrhagic stroke, which also may be life threatening.

Clinical trials have looked at aspirin intake, cardiovascular outcomes, and bleeding risk. Aspirin for acute cardiovascular events and for “secondary prevention” (prevention after the diagnosis of coronary artery disease or cerebrovascular disease has been established) is undisputed.  Trials suggest that the benefits of therapy outweigh the risks of bleeding. 

However, whether or not aspirin should be prescribed for “primary prevention” (prevention in a person who is disease-free) is more ambiguous.  In 2009 a meta-analysis of existing study data looking at this question was published in Lancet.  The analysis found that aspirin reduced the risk of non-fatal myocardial infarction by one fifth, but that aspirin therapy also significantly increased risk of major gastrointestinal and extracranial bleeding and did not improve overall mortality.  In 2009 the US Preventive Services Task Force (USPSTF) reviewed the existing data and concluded that while aspirin reduces the risk of myocardial infarction in men and ischemic stroke in women, it increases the risk of major extracranial bleeding.  The USPSTF recommended that the decision to use aspirin therapy for the purpose of primary prevention should take into account an individualized assessment of cardiovascular risk and also bleeding risk. Patients with higher cardiovascular risk may benefit most from therapy.  

Patients considering aspirin therapy for primary prevention should assess their cardiovascular risk profile with their personal physician. The Framingham Risk Calculator is a recommended tool for estimating one’s ten year risk of having a major cardiovascular event.   However, Framingham may not be as useful for women as it is for men, and some recommend use of the Reynolds Risk Calculator. The Reynolds Calculator incorporates the inflammatory marker hs-crp into its calculation of ten year risk.

In a similar vein, in 2010 the American Diabetes Association, the American Heart Association, and the American College of Cardiology issued a joint statement revising their recommendations for use of aspirin for thepurpose of primary prevention amongst diabetic patients.  In contrast to old guidelines, the new recommendations do not advise that all diabetics over age 40 receive aspirin therapy.  Rather, they advise aspirin therapy for primary prevention in male diabetics under 50 and female diabetics under 60 only if one additional cardiac risk factor is present (hypertension, high cholesterol, smoking, family history, microalbuminuria) The new recommendation is based in part on a subgroup analyses of diabetic patients in the meta-analysis of the Antithrombotic Trialists’ Collaboration showing  that diabetic patients benefited less from aspirin therapy than non-diabetics. In addition, several smaller studies conducted specifically on diabetics and looking at primary prevention failed to demonstrate a significant benefit of aspirin therapy in those without diagnosed cardiovascular disease.  Further study is ongoing to research the issue of primary prevention of cardiovascular disease with aspirin in diabetic patients.  For now the therapy is recommended for diabetics who are determined to be intermediate to high risk (Framingham risk of 10% or higher).

Who is most likely to suffer a complication related to daily use of aspirin? Risk factors for gastrointestinal bleeding with aspirin therapy have been identified:

• Non-steroid anti-inflammatory (NSAID) use (in particular, high dose NSAID use)
• Chronic steroid use
• Prior history of peptic ulcer disease (PUD)
• Advanced age (>60-65 years old)
• GERD or dyspepsia (less risk than PUD)
• Concomitant use of another anti-coagulant

Treatment with a proton pump inhibitor, or the prostaglandin E analog misoprostol, can reduce one’s risk of gastrointestinal bleeding from NSAIDS.  By contrast, H2 blockers are not effective in this regard.  In addition, using enteric coated aspirin does not reduce its gastrointestinal toxicity.  It is unclear what dose of aspirin is best for primary prevention, but most recommend low dose aspirin (81-162mg), which appears to be equal in efficacy to higher doses (though it has not been demonstrated to be safer).

It’s interesting to me that simultaneous with a growing emphasis on incorporating population-based strategies into healthcare delivery we are also becoming increasingly aware of the importance of identifying personalized risk factors in order to best counsel individual patients on medical care and prevention.  Aspirin therapy for primary prevention is an example of how a one-size-fits-all population-based strategy is hard to apply.  We have seen similar recent trends with mammography screening recommendations, using PSA for prostate cancer screening, and will likely soon be hearing more about using a personalized approach to recommending statins for the purpose of primary prevention of cardiovascular disease (given recent associations between statin use and reversible cognitive complaints and diabetes). How population medicine, its associated quality reporting, and pay-for-performance on the one hand, and personalized medicine on the other, are reconciled in medical practice will be a challenge to be dealt on the level of policy, practice, and reimbursement in years to come.

Intuitive Eating and More

Recently Personalized Primary Care Atlanta hosted an evening workshop reviewing some of today’s popular diets.  Nutritionist, David Orozco, RD  presented an overview of popular diets including: Atkins, South Beach, Paleo, Sugar Busters, DASH, Mediterranean, Zone, Weight Watcher’s, and the HCG diet, among others. 

In his talk Mr. Orozco briefly described some key elements of “fad” diets to beware of: 

• A magic bullet (i.e. the hormone HCG, which, when given with a 500 kcal per day diet, results in weight loss)
• Diet phases or stages, such as “Rapid Detox” and “Maintenance” phases
• Celebrity testimonials and endorsements

Medical professionals agree that the DASH diet and the Mediterranean diet have the most scientific evidence to back up their potential benefit in terms of health related outcomes such as hypertension and metabolic syndrome. These two diets are also ranked #1 and #2 respectively by a US News ranking of "Best Diets." WebMD’s diet comparison tool comes very highly recommended if you are sorting through diet options.

However, Mr. Orozco advocates a different approach to dieting: “Intuitive Eating,” or “Mindful Eating.” These concepts involve gaining an understanding of one’s relationship with food and then healing it, such that an individual gains a heightened responsiveness to his or her own body signals.  The premise, a kind of psychotherapeutic approach, is that intuitive eating will result in better food equilibrium and eventual healthy weight maintenance.  I’ll admit that I have not yet read the book, but am eager to do so.

As I listened to the talk, I brought to the table my own perspective—I have never struggled with my weight, I am a relatively compulsive exerciser, and I enjoy cooking and eating out.  Exercise alone has been shown to be an effective technique to help with weight maintenance.  My personal experience (I’ve been about the same weight since age 18) is testimony to this. However, the one time that I did lose 15 pounds, I did it through calorie counting.  Since then (twenty years ago), I’ll admit that I do have a conscious awareness of the caloric value of most food that I ingest.  Do I eat chips, chocolate, an occasional Quarter Pounder and fries? Absolutely; but when the scale tips up five pounds I am quick to take action and cut back.  For dinner tonight—homemade lentil soup with kielbasa, bacon, and carrots, brown rice, green salad with blue cheese, and a glass of Argentine Malbec; for dessert: a sliver of lemon pound cake topped with coconut gelato.

I have found that with my patients who want to achieve more than ten pounds of weight loss, a structured approach is essential—a specific action plan.  Vague plans to cut back and “eat healthier” tend not to be effective. Over the years I have asked my patients who have successfully lost weight what their strategy was.  Though the strategies that my patients describe are as diverse as are the array of diets on the market,  a common thread seems that those who have been successful are able to articulate a clear plan of action that led to the weight loss.

I am an advocated of calorie counting and Weight Watchers (whose point system is essentially like calorie counting).  My viewpoint is that for weight loss, it’s not so much the content of the food that matters, but rather the quantity and caloric value.  However, there is some evidence that low carbohydrate diets may produce more weight loss than very low fat diets (i.e. the Ornish Diet) though this finding has not yet been definitively proven. A pound of fat is equal to 3500 kcal. It’s hard to lose more than a pound of fat every 7 to 10 days, and I don’t recommend it.  I personally consume about 2000-2500 kcal per day (with 30-60 minutes of exercise on most days).

Here are some of my own weight loss tips: 

• Eat smaller portions, but don’t skip meals
• Count and record your calories for at least 1-2 weeks when you begin to diet
• Don’t reduce your caloric intake by more than 500 kcal per day below baseline intake (it’s too hard to maintain)
• Don’t drink diet drinks and don’t drink any beverage all day long (including water)
• Do have coffee or tea following a meal if you are not quite satisfied
• Do enjoy a mealtime ritual at least once a day-- set the table and play some music while you dine, enjoy your oatmeal and coffee while reading the paper
• Don’t snack more than once per day
• Do allow yourself to feel hunger for a couple of hours before you eat
• Limit refined carbohydrates and add healthy fats, but forget margarine, it’s no substitute for butter
• Don’t eliminate your favorite food, save it as a treat a day or two per week
• Treat yourself to meals out, but split your portion with a companion or eat an appetizer instead of an entree
• Exercise 3-4 times per week, but keep in mind that adding exercise alone rarely works to achieve more than 5 to 10 pounds of weight loss 
• Don’t chastise yourself if you are unable to exercise, most of weight loss comes through alterations in one’s diet not through exercise
• Cook at least three times per week using whole food ingredients and cook enough for two meals so that you can have leftovers
• Pack your lunch and bring it to work

Once your desired weight loss is reached, this is where intuitive or mindful eating becomes important—retraining oneself toward a healthier relationship with food.  Weight maintenance is the hard part. Some of you may have read a recent New York Times Magazine cover article entitled “The Fat Trap” by weekly health columnist and author of the NYT "Well" blog Tara Parker-Pope.  Ms. Parker-Pope makes the case that powerful metabolic and hormonal factors make it very difficult to maintain weight loss.  I personally find Ms. Parker-Pope’s viewpoint overly nihilistic, though she brings to light interesting information.  A petitioned response to Ms. Parker-Pope’s piece, authored Gary Taubes and Peter Attia, MD, argues that Ms. Parker-Pope’s article neglected the important effect of insulin resistance on obesity.  The authors maintain that restriction of refined carbohydrates, as opposed to overall caloric restriction, can allow overweight patients to successfully bypass some of the metabolic impediments to weight loss by reducing insulin resistance, while all the while suppressing hunger through increased protein and fat consumption.  Indeed there is some medical evidence to support low carbohydrate diets.

In my own practice I have seen numerous patients lose weight successfully.  The metabolic effects on cholesterol, blood sugar and blood pressure are typically profound.  Remember, if you are overweight or obese, weight loss in itself is as important of a goal as is healthy eating.

How did you lose weight? Were you able to maintain it? What do you think of the intuitive eating concept? I welcome you to share your own lessons and help others. 

*To learn more about intuitive eating contact David Orozco RD of T+D Wellness in Atlanta at 404-228-9704.

When is unneeded care criminal?

Co-Authored by Juliet K. Mavromatis, MD, FACP, Personalized Primary Care Atlanta and Kreton Mavromatis, MD, Assistant Professor of Medicine, Emory University, Director of the Cardiac Catheterization Laboratory, Atlanta VA Medical Center

Recent media coverage has sensationalized the criminal investigation of several cardiologists for the possibility of performing fraudulent cardiac procedures.  Is this a case of individuals with unethical conduct? Or, does it point toward a more systemic problem in medical care, where Medicare dollars are wasted on unneeded care? As reported in Heartwire on July 27, 2011:

"A federal jury convicted McLean, 59, on six charges of healthcare fraud relating to insurance claims he'd filed for stents deemed to have been placed unnecessarily, as well as for ordering unnecessary tests and making false entries in patient medical records…evidence brought forward suggested that McLean had performed cardiac catheterizations and implanted unnecessary cardiac stents in more than 100 patients.  He then falsely recorded in the patients' medical records the existence or extent of coronary artery blockage, known as lesions, observed during the procedures in order to justify the stent and the submission of claims to healthcare benefit programs, including Medicare and Medicaid."

In a separate case the Senate Finance Committee investigated Dr. Mark Midei, an interventional cardiologist practicing in Towson Maryland, for the possibility of performing unnecessary stents and also for his relationship with Abbott Laboratories, the company that manufactures the stents that he used.
A prominent cardiologist commented in the New York Times report: 

“What was going on in Baltimore is going on right now in every city in America,” saying that he routinely treats patients who have been given multiple unneeded stents. “We’re spending a fortune as a country on procedures that people don’t need.”

Coronary artery disease affects a large proportion of people in Western civilization. The disease manifests as blockages in coronary arteries limiting blood flow to heart muscle, causing heart pain, heart  attacks, heart failure and/or sudden death. Heart disease kills 1 out of every 6 Americans. Coronary artery stents are metal mesh tubes that can be placed in blocked coronary arteries completely reopening them and improving blood flow to the heart muscle.   Many studies (PAMI, TACTICS-TIMI 18, etc.) have shown that when used appropriately, stents can be life-saving and improve quality of life by relieving heart pains (angina) and preventing heart attacks.

However, in 2007 the COURAGE  trial was published demonstrating that in some patients with coronary artery disease, there was no mortality or heart attack benefit associated with an initial treatment strategy of using stents, compared  with medication treatment.  The trial also found evidence that a strategy of using medications alone could potentially save money. In considering these results, several caveats must be kept in mind: patients included in the study were very select (< 1 in 15 patients considered were actually studied); they tended to have mild disease (78% had either no or only slight symptoms; patients with recent heart attacks were excluded);  ~1/3 of patients initially treated with medications alone eventually required stents for their blockages anyway.  In addition, patients who underwent initial treatment with stents had a quicker improvement in quality of life as compared to patients who initially were treated with medications alone. Nonetheless, this single study suggested that the need for coronary stenting is unnecessary in at least some patients with coronary artery disease, and that trying medication therapy alone in those patients is reasonable. There is ongoing investigation designed to confirm or refute the observations of the COURAGE trial.

In a New York Times editorial entitled Cut Medicare, Help Patients authors Ezekiel Emanuel and Jeffrey Liebman discuss the use of cardiac stents for treatment of symptomatic coronary artery disease suggesting that many stents are unneeded.

“Every year more than 1 million cardiac stents are placed in patients to open blocked arteries… many patients who receive stents paid for by Medicare are either experiencing no pain or have not tried medication first.”

In a review of national registry data published this year in JAMA by Chan et al. it was concluded that by current criteria 1 to 11.6 percent of stents placed may have been “inappropriate” based in part on the results of the COURAGE study.  

It is important to distinguish between “unneeded care” due to fraud and “unneeded care” due to less expensive but similarly effective alternatives. Fraud implies dishonest intent. Unneeded care due to fraud is universally considered to be wrong. In contrast, calling care unneeded because there are less expensive and similarly effective alternatives is subject to a broad range of opinion. In an article that I read recently Dr. Maneesh Patel  (Duke Clinical Research Institute, Durham, NC) made the important point:

"the majority of what we do in medicine is based on evidence that would fall into the category of 'uncertain' "—for example, guideline recommendations with level of evidence B or C.“

The Maryland cardiologists are accused fraud, or falsely recording the presence of significant coronary artery disease, and billing health insurance for placing stents in such patients. This is very different than choosing to treat significant coronary artery disease with a stent when medical therapy alone may also be a reasonable strategy in preventing death or myocardial infarction (heart attack).  

Here’s an example:  a 50 year old man was found to have calcifications in his coronary arteries on a chest CT done for follow up of cancer (presumed cured). On questioning, the patient, who has high blood pressure, high cholesterol, and a family history of heart disease, noticed some shortness of breath with exertion, potentially due to obstructive coronary artery disease.  An exercise treadmill test was ordered and was positive after ten minutes.  An exercise echocardiogram was ordered and showed a possible small area of reduced blood flow after ten minutes.  A cardiac catheterization was ordered and an 80 percent blockage of one artery was found. A stent was placed and the patient was started on blood thinners.  The patient also had 30 to 50 percent blockages in other locations and was advised to take more cholesterol and blood pressure medication.

Which of the tests/treatments in this case were unnecessary? If the coronary blockage was 40 percent and not 80 percent, the stenting here would be universally considered to be unnecessary. (Furthermore, if the physician knowingly reported this 40 percent blockage as 80 percent, stented it, and billed for it, then it would constitute fraud). If the coronary artery blockage was truly 80 percent then according to the results of the COURAGE trial, first trying medical therapy alone could be as effective as immediately using stents for the purposes of minimizing the cardiovascular mortality in this patient (but perhaps not from the point of view of immediately relieving his symptoms).  In this situation, the immediate stent placement could also be considered “unnecessary.”

With a proposal to add “cost-conscious care and stewardship of resources” as one of the ACGME’s core competencies for medical trainees, and with Medicare aggressively tightening its belt in order to remain fiscally solvent, determining “unnecessary care” will depend on developing a consensus on the value of life, suffering, and the validity of extrapolating scientific data analysis to a multitude of individual specific patient situations.   As health professionals and policy makers appropriately engage in this discussion about what represents effective care that health insurance should pay for, they should be careful not to equate outliers, such as doctors facing criminal charges for fraud, with accepted variation in standard practice that might encompasses care that some deem “unneeded.”  Equating unneeded care with dishonest intent is bound to elicit a highly emotional response from most doctors, who are deeply committed to their professional obligation to do what they believe is best for their patients.