AHA’s New Guidelines on CVD Prevention in Women Can Result in Massive Overtreatment and Undue “High Risk” Labeling of Many Healthy Women

HOUSTON, February 22, 2011 – The 2011 guidelines from the American Heart Association for the prevention of cardiovascular disease (CVD) in women1 have raised serious issues that should be promptly addressed. The previous 2004 and 2007 guidelines used the definition of High Risk based on hard coronary heart disease (CHD) endpoints, i.e., 10-year risk of myocardial infarction or coronary death 20%. The 2011 updated guideline lowers this threshold to 10% and, furthermore, changes the endpoint from “hard CHD” to the much more common endpoint “all CVD,” including hard CHD, coronary insufficiency, angina, stroke, transient ischemic attack, heart failure and claudication.

The SHAPE Task Force welcomes the much needed update of existing guidelines for risk assessment of asymptomatic at-risk individuals. However, we have serious concerns about the new AHA women’s guideline1 since an arbitrary change in the definition of High Risk is likely to result in massive overtreatment and undue “High Risk” labeling of many otherwise healthy women. For example, a 65 year old non-smoking, non-diabetic, non-hypertensive woman with total cholesterol of 200 mg/dl and HDL of 49 mg/dl who lives an active life style would now be classified as High Risk. In contrast, the same individual would be defined as Low Risk by the 2010 ACCF/AHA2 and NCEP Guidelines. More importantly, the new guidelines do not take into account the fact that such an individual’s risk could be better refined by screening for subclinical atherosclerosis.

SHAPE recommends that the new AHA women’s guideline1 be amended to prevent undesired consequences. To improve individual risk assessment in this population, the guideline should include noninvasive detection of subclinical atherosclerosis, through coronary artery calcium scoring or measurement of carotid plaque and intima-media thickness (IMT). Such an amendment would be in line with the 2010 ACCF/AHA guidelines (for assessment of cardiovascular risk in asymptomatic adults) in which testing for subclinical atherosclerosis (coronary artery calcium scoring and carotid plaque/IMT) received a strong evidence based (level IIa) recommendation.2,3

The new AHA women’s guideline criticizes the absence of outcome studies for risk assessment based on testing for subclinical atherosclerosis. However, it fails to acknowledge that the approach for risk assessment which uses Framingham Risk Score and NCEP guidelines has also never been demonstrated improve outcomes in clinical trials.

In conclusion, given the large, consistent and growing body of evidence showing that testing for subclinical atherosclerosis is a more accurate method of predicting atherosclerotic cardiovascular events than testing only for traditional risk factors of atherosclerosis, the SHAPE Task Force respectfully urges the responsible authorities at the American Heart Association to address the following question:

Is it reasonable, cost-effective and ethically acceptable to arbitrarily label millions of women as being “High Risk” for atherosclerotic cardiovascular events without testing them for subclinical atherosclerosis?

References:

1- Mosca L, Benjamin EJ, Berra K, Bezanson JL, Dolor RJ, Lloyd-Jones DM, Newby LK, Piña IL, Roger VL, Shaw LJ, Zhao D, Beckie TM, Bushnell C, D’Armiento J, Kris-Etherton PM, Fang J, Ganiats TG, Gomes AS, Gracia CR, Haan CK, Jackson EA, Judelson DR, Kelepouris E, Lavie CJ, Moore A, Nussmeier NA, Ofili E, Oparil S, Ouyang P, Pinn VW, Sherif K, Smith SC Jr, Sopko G, Chandra-Strobos N, Urbina EM, Vaccarino V, Wenger NK. Effectiveness-Based Guidelines for the Prevention of Cardiovascular Disease in Women–2011 Update: A Guideline from the American Heart Association. Circulation. 2011 Feb 16.

2- Greenland P, Alpert JS, Beller GA, Benjamin EJ, Budoff MJ, Fayad ZA, et al. 2010 ACCF/AHA Guideline for assessment of cardiovascular risk in asymptomatic adults. A report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines. J Am Coll Cardiol 2010;56:e50–103.

3- Taylor AJ, Cerqueira M, Hodgson JM, Mark D, Min J, O’Gara P, Rubin GD, Kramer CM, Taylor AJ, Berman D, Brown A, Chaudhry FA, Cury RC, Desai MY, Einstein AJ, Gomes AS, Harrington R, Hoffmann U, Khare R, Lesser J, McGann C, Rosenberg A, Schwartz R, Shelton M, Smetana GW, Smith SC Jr, Wolk MJ, Allen JM, Bailey S, Douglas PS, Hendel RC, Kramer CM, Min J, Patel MR, Shaw L, Stainback RF. ACCF/SCCT/ACR/AHA/ASE/ASNC/SCAI/SCMR 2010 Appropriate Use Criteria for Cardiac Computed Tomography. J Am Coll Cardiol 2010; 56: 1864 – 94.