"My personal and professional journey to prevention took longer than my 3-year cardiology fellowship more than 25 years ago, but it changed the way I practice cardiology. Prevention is the missing component of cardiac care."  Rolando L. deGoma, MD Member Spotlight National Lipid Association Lipid Spin Winter Issue 2010

Offsetting the Cost of Preventive Therapy by Reducing the Human Toll and Reducing the Economic Burden of Preventable Heart Attacks and Strokes

The Economic Burden of Chronic Diseases

It is estimated that 85% of the $2.5 trillion healthcare expenditures are due to chronic diseases. The number one chronic disease in the US like most industrial countries is cardiovascular disease, mainly coronary heart disease and stroke. Both these two conditions are caused by atherosclerosis, a disease caused by cholesterol plaque build-up in the arteries. For decades, the patients with this condition were diagnosed when they presented in the emergency room with acute heart attack or stroke - a late complication of the advanced stage of cholesterol plaque build up. A large cardiovascular health industry has developed and prospered by providing treatment for acute heart attacks and strokes. The diagnosis and treatment of these advanced chronic conditions are expensive and the cost continue to escalate annually. In 2003, the estimated total economic burden of cardiovascular disease was $353 billion and by 2007, just four years later, it rose to $473 billion. How much by 2020? $1 trillion? What will be the impact if healthcare expenditures grow from 1/6 to 1/3 of GNP?

 

American public supports investment in prevention as part of healthcare reform - prevention is the second highest proposal supported, after prohibiting insurance companies from denying coverage because of age, medical history or pre-existing conditions. Click here to read more.

New Treatment vs Old Treatment Approach

Fortunately, there are major scientific advances in our understanding of the underlying process that leads to both heart attack and stroke. Contrary to old thinking - the clogging of arteries is like a kitchen pipe with fatty deposits adhering and accumulating over time on its surface, atherosclerosis is an inflammatory process initiated by oxidized LDL cholesterol. With this old disease model, stenting and bypassing all severely blocked arteries made sense. There was nothing else to do (at that time). This approach generates large revenues and patients seem to do better, at least symptomatically. However, now that we have a greater understanding of the underlying disease process, an entirely different approach is called for.

 

In 1994, the 4S study was published and ushered the beginning of a pro-active preventive approach with lipid therapy using statin. The findings were quite remarkable.

For the first time, a medical therapy compared to placebo was demonstrated to reduce fatal heart attack by 42%, reduce need for future heart bypass surgery by 37%, reduce stroke by 30% and death from any cause by 30%. Stents and heart bypass surgeries help improve symptoms but do not do any of these. The drug was a statin - Zocor, now available in a generic version for just pennies a pill. NNT means the number of patients needed to be treat for 5 years to prevent one serious event. Only 10 patients in this trial! This trial was a secondary prevention trial, meaning that the patients in the trial had diagnosed coronary heart disease. There are a series of large clinical trials that followed with the same results - lowering LDL cholesterol was beneficial in patients with high, average, normal or even low LDL cholesterol.

Does prevention also work for those without known heart disease? Yes, it does. There are several large clinical trials in patients without known heart disease. The most recent was the JUPITER trial in 2008. After less than two years, significant benefits were achieved to the degree that the trial was stopped much earlier than anyone anticipated. There was a 44% combined event reduction compared to placebo.

How does aggressive medical therapy compare to stent therapy in stable patients with advanced but stable disease? COURAGE trial answered that question as shown above.

The above slide points (blue arrows) to all the plaques and the stent in one plaque. One stent only treats one plaque and does nothing to prevent the other plaques from rupturing. Optimal cholesterol treatment treats all the plaques both in the heart and the brain - slowing, even stopping progression or inducing plaque regression plus preventing plaque rupture - the immediate cause of most heart attacks and strokes.

Consequences of Poor Compliance with Preventive Treatment Guidelines

The landmark clinical trials in the last two decades cost many hundreds of millions of dollars. The large volume of very compelling data collected should have transformed our current approach to patients with stable coronary heart disease from more aggressive interventional to more aggressive pro-active preventive approach. High risk patients who will likely develop their first heart attack or stroke within 10 years can be identified and treated effectively to prevent them from happening. But it has not happened yet. We know a lot now but there are still unanswered questions that some physicians are still arguing about - is Apo-B more predictive than non-HDL cholesterol, etc. Physicians like debating everything but these unanswered questions (to everyone's satisfaction) should not stop us from changing our treatment approach. But there is one thing that we all agree about - that there is a widespread treatment gap - a large US population at risk of heart attack and stroke are not receiving recommended NCEP treatment and that this lack of physician compliance has dire consequences as shown below.

 

 

If only 60% of eligible patients received appropriate medical therapy in 2000, there would have been 297,470 fewer deaths from heart attacks alone. Deaths from preventable strokes and the number of preventable disabilities were not calculated in this study. Also not included was the cost of the expensive healthcare resources that were consumed by all these major cardiovascular events.

Cardiovascular disease, the most deadly and most expensive public health problem in the US, is also the most preventable. Heart attack is the number 1 and stroke, the number 3 killer of adult Americans, are now considered largely preventable.

Cholesterol plaque takes many years, even decades, to develop before causing a heart attack or stroke. But when a plaque ruptures and clot forms, a life-threatening event unfolds within a few minutes. In one of four, the first sign of heart disease is sudden cardiac death. For the three that survive, their life is changed in many ways. The estimated average life years lost from a heart attack is 15 years (AHA data).

To Prevent or Not To Prevent

Another question that some "experts" are still debating - "Is it better to prevent disease or it is better to wait until later and start treatment when a heart attack or stroke develops?" This question seems a no brainer for physicians in clinical practice. Why invest in research and then withhold newly discovered treatment from the people that will benefit from it? Should there be a study to determine the answer to an unpleasant question that others are also wondering - Is the fact that a large profitable cardiovascular healthcare industry has developed over the last few decades that is geared to treatment of acute heart attack and stokes hinders indirectly (or indirectly) the shift to a more pro-active preventive approach? Is there a pressure to fill the cath lab schedule, to fill CCU beds? Is there an overcapacity problem in this area? Why aren't there more physicians aggressive preventing heart attacks and strokes? How should the financial incentives be realigned so that most heart attacks and strokes are prevented? Do we have the innovations needed to treat the 40 million Americansap at risk to recommended target goals without the vast regional disparities? (Yes, we do.) Certainly, a new business model is needed as well as a new preventive healthcare delivery system. (Yes, there is.) Innovative physicians need to be engaged in the reform movement to reshape healthcare delivery to a large segment of the US population. No one else is more qualified to help fix it than the physicians who deal with the current healthcare system everyday for decades. Legislators just passed the healthcare reform bill but its successful execution will depend on new innovations and the involvement of physicians and others.

Reducing Healthcare Cost by Reducing Consumption of Expensive Healthcare Resources

Screening for breast cancer and osteoporosis has a very high NNT - number needed to screen or/and treat to prevent one breast cancer death or one hip fracture. They are both accepted as standard of care. Treatment of high blood pressure and cholesterol has much lower NNT. Cholesterol treatment for heart and stroke prevention in high risk patients is cost effective. In high risk patients with already established heart disease, the 4S trial NNT is only 10. This means that treating 10 high patients for 5 years with simvastatin will prevent 1 serious event - prevent a heart attack, a stroke or a sudden cardiac death. It does not mean that the 9 that did not have a serious event did not benefit from the therapy - they did. Benefits of treatment increase with duration of treatment. For primary prevention, NNT is higher - 48 for WOSCOPS and 58 for AFCAPS/TexCAPS. The availability of several generic statins significantly lowers the cost of treatment. Cholesterol therapy compares very favorably with mammography (NNT=1,792) and osteoporosis screening and treatment (NNT=1,945).

Jim is in the high risk category - either because he has diagnosed heart disease or without clinical heart disease but with Framingham risk score of over 20%, so called CHD risk equivalent. Preventive lipid treatment significantly reduces his likelihood of a heart attack and even a stroke. Evidence-based preventive therapies progressively reduce his cardiovascular risk and will shift him from very high or high to a lower intermediate risk in a few years. Lower risk means lower event rate. Lower event rate means lower consumption of expensive cardiovascular healthcare resources - fewer hospitalizations, fewer stents, fewer heart bypass surgeries. And in addition, better patient outcomes, fewer deaths, fewer disabilities.

Making Evidence-based Preventive Treatment Available to 40 Million Americans at Risk

One solution is to replicate a best practice prevention clinic model with published performance data in the proposed public health centers. This is new healthcare delivery system for preventive care implementing evidence-based treatment in a manner that overcomes the wide regional treatment disparities that is currently prevalent in the country. It uses innovations in technology that are already available. There are lipid-board certified physicians in every state that can be trained to use this system. A national network of these heart attack and stroke prevention clinics can be established within a reasonable period of time.