Data Driven Evidence-Based Medicine Improves on Framingham

Data Driven Evidence-Based Medicine Improves on Framingham


The most recent American Heart Association data states that 4 out 5 strokes and 50% of fatal heart attacks are asymptomatic.1 However, if identified early, most CVD and acute and morbid cardiac events can be prevented. Unfortunately, while the tools and methods to identify early-stage arterial and cardiac disease exist, most physicians – and the vast majority of primary care physicians – have not incorporated them into their clinical practice.


For a generation now, risk factor prevention has been at the heart of cardiovascular event management and cardiometabolic disease prevention. However, while risk factors are useful at the population level, they are of limited utility when assessing a specific patient. Put simply: risk factors are not disease.


Consider that 99% of men between the ages of 35 and 74 years have at least one risk factor for CVD2. In that context, what value are risk factors in defining risk for a particular patient? Would you act on a test that has a specificity near 0? How would you advise or treat your patients based on risk factors?


For decades, Framingham has been the most widely referenced system for stratifying and scoring risk and driving treatment decisions. While increasingly viewed as outdated, its concepts still influence much of the clinical decision-making in the modern practice, placing emphasis on a limited set of six risk factors:


Age      Gender   Total Cholesterol   HDL Cholesterol     Systolic BP   Smoking


It excludes other important risk factors, like family history, diet and exercise patterns, and TG levels. In addition, Framingham also does not predict “soft” events like angina or revascularization. Most critically, it has no ability to assess asymptomatic atherosclerosis, but rather waits until patients are symptomatic to start treatment. Early atherosclerotic disease is the earliest detectable stage of CVD and the critical junction between risk factors and clinical disease. It is reversible, and therefore needs to be identified early enough to delay or avert the onset of cardiovascular morbid events:


  • Autopsy studies report that 45%-77% of men in their 20s showed signs of atherosclerosis.3

  • The first indicator of CAD in up to 50% of individuals is the acute event, which is often fatal.4

  • As noted above, 4 out 5 strokes and half of fatal heart attacks are asymptomatic.


Around other diseases, the medical community has abandoned risk factor assessment and prevention as the primary means of identifying and tracking actual disease: Mammography, Colonoscopy, and Prostate Antibody are all illustrative examples proactive disease identification replacing reactive disease management as standard practice and common clinical sense.


The same approach is needed (and has been validated) in cardiac event prevention. If we wait until BP and cholesterol levels reach guideline-mandated levels, many patients will already have had their acute or morbid event, and many more will have received pharmacologic intervention unnecessarily. Instead, the actual disease needs to be assessed so that the actual need for intervention can be determined, and the most appropriate intervention delivered.


When we consider that CVD and acute and morbid cardiac events can be prevented but not cured, it is clear that prevention is needed in the primary care setting. Moreover, insurance companies and the Affordable Care Act have recognized this, and have implemented incentives for primary care physicians in order to improve patient outcomes and avoid high dollar costs.


Heartwise: Evidence-based Preventative Wellness and Diagnostics for Primary Care


Through better tools deployed in the context of an evidence-based protocol, Heartwise gives physicians the ability to identify and track arterial and cardiac disease that will eventually make people sick and lead to morbid events. This is the definition of Preventative Care. And the very definition of Primary Care.


The protocol combines a select set of diagnostic assessments that, together, establish the presence of disease and/or risk: vascular evaluation, cardiac evaluation, and assessment of modifiable disease contributors (such as pulmonary function, fasting lipids, etc.).


Delivered as an entirely turnkey program within a practice, the Heartwise assessment protocol is based on decades of University of Minnesota and Harvard Medical research that is proven to identify early cardiac and metabolic disease, stratify existing disease and guide appropriate intervention. The protocol drives greater insight into the cardiovascular and cardiometabolic health of each patient, and proprietary software algorithms produce definitive 6 and 10 year risk scores for heart attack, stroke and other cardiac events. These scores not only help physicians provide highly targeted treatment plans, but also improve patient compliance through tangible and concrete risk scoring.


What is the clinical impact? In a study5 of 666 consecutive women stratified as “low risk” by Framingham, 436 of whom were untreated, using this protocol:


  • Nearly 2/3rds (268, 61.5%) were determined to be of intermediate to high risk

  • More than 1 in 2 (232, 53.2%) had abnormal vascular or cardiac evaluations

  • Nearly 1 in 3 (134, 30.7%) had elevated modifiable disease contributors

  • Additionally, the remaining 230 patients stratified as low-risk by Framingham were treated, when approximately 1 in 3 of those patients were actually low risk; a high percentage of them were treated unnecessarily.


In practice, for physicians, the clinical impact manifests in three profound ways:


1) The physician now has the data about the presence and severity of disease and can be proactive rather than reactive in managing each individual patient’s health,


2) The physician can tailor treatment with greater accuracy and confidence, and


3) Both the physician and patient emerge with better data, goals and tools to partner in truly affecting behavior – to a level not seen in typical primary care environments.


Heartwise provides exactly this for their physician partners, resulting in proven outcomes with tens of thousands of patients to date.


As healthcare costs continue to surge and payers look to save money through prevention of poor outcomes and costly events, it is the primary care physician who can have the greatest impact on their patients’ health, outcomes and costs. When done the right way – with the right set of tools and outcomes, and established economic incentives for the physician – prevention in the primary care setting really can work.





1. American Heart Association (current website).

2. Vasan RS, Sullivan LM, Wilson PW, et al. Relative importance of borderline and elevated levels of coronary heart disease risk factors. Ann Intern Med 2005;142:393– 402.

3. Joseph A, et al. J Am Coll Cardiol. 1993;22;459-467.

4. Naghavi M, et al. Am J Cardiol. 2006;98:2H-15H.

5. Shahawy, M. From Cardiovascular Risk factors to cardiovascular risk markers. 38th Ann Mtg of the Egypt Soc of Card, Oct 2011.