Cardiovascular Disease Prevention in Women A Paradigm Shift in Risk Assessment from the 2011 Guideline Update

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1 Cardiovascular Disease Prevention in Women A Paradigm Shift in Risk Assessment from the 2011 Guideline Update >10% Risk of CVD / 10 Yrs Pregnancy Complications Low Exercise Tolerance Poor Diet Obesity Lupus Normal BP Normal BMI No Smoking Normal Lipids DASH-Like Diet Exercise 150 Min/Week Karen E. Aspry, M.D., M.S., ABCL, FACC Asst. Professor of Medicine Alpert Medical School Rhode Island Cardiology Center

2 Cardiovascular Disease Mortality in Women and Men in the U.S. Recent Progress Sources: CDC/NCHS, AHA Heart Disease and Stroke Statistics, 2011

3 Cardiovascular Disease Morbidity and Mortality in Women Current and Future Challenges Coronary disease mortality rates have increased among middle aged women, and in-hospital mortality during AMI remains higher in women vs. men < 75 years Stroke prevalence is higher in women, with 55,000 more women experiencing a stroke each year CV risk factors (obesity, hypertension, hyperlipidemia, physical inactivity) are more prevalent in women Awareness of CV risk among women remains low, with only 16% identifying CHD as their # 1 health threat

4 AHA Guidelines for CV Disease Prevention in Women Key Features of the 2011 Update Prevention scope is wider Risk assessment shifts to prediction of global CVD Low risk category is strictly defined High and intermediate risk categories expand Interventions are valued for clinical effectiveness Diversity and disparities are recognized Education and adherence are addressed Cost efficacy is discussed

5 Cardiovascular Risk Assessment and Risk Classification in Women 2011 AHA Guideline Update

6 2011 Guideline Update CHD Risk Scores Underestimate Global CV Risk in Primary Prevention Women Estimated 10 Yr Risk of CHD (via ATP III Risk Score) in a 55 Year Old Female Smoker with Abnormal Blood Lipids and Blood Pressure NATIONAL CHOLESTEROL EDUCATION PROGRAM Third Report of the Expert Panel on Detection, Evaluation and Treatment of High Blood Cholesterol in Adults (Adult Treatment Panel III) www. nhlbi.nih.gov Cavanaugh- Hussey, MW et al. Preventive Medicine 2008:47:619.

7 2011 Guideline Update Use a Global Cardiovascular Risk Score To Predict Risk in Primary Prevention Women Estimated 10 Year Risk of CVD (via updated Framingham Score) in a 55 Year Old Female Smoker with Abnormal Blood Lipids and Blood Pressure 10 Year Risk

8 2011 Guideline Update Use a Global Cardiovascular Risk Score To Predict Risk in Primary Prevention Women Estimated 10 Year Risk of CVD (via the Reynolds Risk Score) in a 55 Year Old Female Smoker with Abnormal Blood Lipids and Blood Pressure Gender O Male Female Age Do you currently smoke? Yes O No 55 Systolic Blood Pressure Total Cholesterol HDL or Good Cholesterol High Sensitivity C-Reactive Protein (hscrp) mmhg mg/dl mg/dl mg/l Did your Mother or Father have a heart attack before age 60? Yes O No 10 Year Risk (age 55) of a heart attack stroke or other heart disease event is 14%

9 Risk Categories and Criteria 2011 CVD Prevention in Women High Risk (any 1) At Risk (any 1) NEW NEW NEW CHD, Cerebrovascular disease, PAD or AAA Diabetes Mellitus ESRD or CKD 10 Yr Predicted CVD Risk > 10% Cigarette Smoking BP > 120 / >80 mmhg, or on treatment Cholesterol > 200 mg/dl or HDL<50 mg/dl, or treated Premature CAD in 1 st degree relative Obesity or Metabolic Syndrome Poor Diet Physical Inactivity Advanced Subclinical Atherosclerosis on Imaging Poor Exercise Tolerance on ETT Pregnancy-Induced HTN, Pre-Eclampsia or DM Collagen Vascular Disease (RA or SLE) Mosca, L. et al. JACC 2011; 57:1404. Ideal CV Health (all) NEW Normal BP, Lipids, FBS, BMI, DASH-Type Diet, Non-Smoker, Exercise min / week

10 2011 Guideline Update Lowering the Threshold for High Risk * Reflects the High Lifetime Incidence of CVD in Middle Age Women With Risk Factors Cumulative Incidence of CVD by Risk Factor (RF) Burden at Age 50 In Women in the Framingham Study (N=4,362) BP >160/100, TC>240, Smoking, or DM BP 140/90-160/100, TC , non-smoker, no DM BP <140/90, TC<200 non-smoker, no DM BP <120/80, TC< 180, non-smoker, no DM 50% 39% 27% Except for those with DM, all would have a <20% 10 Yr Risk of CVD at age % *to >10% / 10 Yrs = >30% / 30 Yrs Attained Age, Years Lloyd-Jones D M et al. Prediction of Lifetime Risk of CVD by Risk Factor Burden at Age 50. Circulation 2006;113:

11 2011 Guideline Update Classification of Pre-Eclampsia as a Risk Factor is Supported by Observational Studies Showing Increased CHD Rates Systematic Review of Pre-Eclampsia and Relative Risk of CHD in 8 Cohort Studies (n=121,487 cases) with Mean FU 11.7 Yrs Study Total # Cases / Women with Pre-Eclampsia Total # Cases / Women With No Pre-Eclampsia Hannaford, / / 14,831 Irgens, / 24, / 602,117 Smith, / 22, / 106,509 Wilson, / 1, / 796 Kestenbaum, /20,552 64/92,902 Funai, / 1, / 35,991 Ray, / 36,982 1,262 / 950,885 Wirkstrom, / 12,533 2,306 / 383,081 Total (95% CI) Heterogeneity Test Test for Overall Effect 614 / 121,487 X 2 =9.6, P 0.21 Z=10.00, P ,483 / 2,187,112 From: Bellamy L et al. BMJ 2007; 335:974.

12 2011 Guideline Update Classification of RA and SLE as Risk Factors is Supported by Observational Studies Showing Increased Relative Risk of MI* Adjusted* Relative Risk of First MI Among Women with Confirmed RA In the Nurses Health Study (N=114,342) Myocardial Infarctions Incidence/100,000 person-years No RA RA P Adjusted RR 1.0 (ref) **Adjusted for Age, DM, Hyperlipidemia, Hypertension, Parental history of MI, Smoking, Physical activity, BMI, use of ASA, steroids, and NSAIDS, and intakes of vitamin E, folate and Omega-3-FAs Solomon, DH et al. Circulation 2003; 107:

13 Interventions for Prevention of CV Disease in Women 2011 AHA Guideline Update

14 Recommendation Classification and Level of Evidence Class I Class IIa Class IIb Class III Benefit >>> Risk Procedure/ Treatment SHOULD be performed/ administered Benefit >> Risk Additional studies with focused objectives needed IT IS REASONABLE to perform procedure/administer treatment Benefit Risk Additional studies with broad objectives needed; Additional registry data would be helpful Procedure/Treatment MAY BE CONSIDERED Risk Benefit No additional studies needed Procedure/Treatment should NOT be performed/administered SINCE IT IS NOT HELPFUL AND MAY BE HARMFUL Level of Evidence (LOE): Level A: Level B: Level C: Multiple randomized clinical trials or meta-analyses provide data Multiple populations evaluated Single randomized trial or nonrandomized studies provide data Limited populations evaluated Consensus of opinion, case studies, or standard of care provide data Very limited populations evaluated

15 Class III Recommendations Treatment Not Useful and May Be Harmful Interventions Menopausal Therapy Hormone Replacement Therapy or SERMs Anti-Oxidant Supplements Vitamin E, Vitamin C, Beta-Carotene Folic Acid Aspirin in At Risk Women Age < 65 Level of Evidence III A III A III A III B JACC 2011; 57:

16 Class I and II Recommendations Treatment Should Be Provided (Class I) or Is Reasonable (Class IIa) or Can Be Considered (IIb) Diet and Lifestyle Interventions Smoking Cessation Counsel and provide nicotine replacement and pharmacotherapy Physical Activity Advise 150 min/week of moderate or 75min/week of vigorous exercise, and muscle strengthening 2 days/week Diet and Supplements Advise a diet rich in fruits, vegetables, whole grains, high fiber foods, and oily fish; low in saturated fat, cholesterol, alcohol, sodium, and sugar; and free of trans-fats Consider Omega-3-Fatty Acid supplementation Weight Maintenance Advise weight loss through exercise, calorie reduction, or behavioral programs to maintain BMI < 25 and waist <35 Cardiac Rehabilitation Advise formal on-site or in-home exercise training after a CHD event or CVA, or with symptomatic PAD or chronic angina Class, LOE II b, B I, A JACC 2011; 57:

17 Class I and II Recommendations Treatment Should Be Provided (Class I) or Is Reasonable (Class IIa) or Can Be Considered (IIb) Major Risk Factor Interventions Blood Pressure Control to <120/80mmHg Advise DASH-diet and lifestyle interventions in all Advise drugs if BP >140/90 (>130/80 with DM or CKD) Lipid Control to LDL<100, TG <150, HDL >50 and Non-HDL to <130mg/dl Advise diet and lifestyle interventions in all Drugs useful to achieve LDL <100 with CHD Drugs useful to achieve LDL <100 with DM, PVD or Risk >20% Niacin/fibrates useful if HDL<50 or non-hdl>130 in high risk Drugs useful if LDL >130 and Risk is 10-20% Drugs useful if LDL >160 even if Risk is <10% Drugs useful if LDL >190 regardless of risk level Drugs can be considered if age >60, LDL<130 and hscrp>2 Blood Glucose Control in Diabetics Advise diet with or without drugs to achieve HgbA 1C <7%? High Risk At Risk Class, LOE I, A I, A IIb, B IIb, B IIa, B

18 Class I and II Recommendations Treatment Should Be Provided (Class I) or Is Reasonable (Class IIa) or Can Be Considered (IIb) Preventive Drug Interventions Aspirin Should be used in all women with CHD, unless contraindicated Is reasonable in women with DM, unless contraindicated Can be useful in women > 65 years, if BP is controlled May be reasonable for women <65 years for CVA prevention Should be used in women with AF unable to take anti-coagulants Anti-Coagulant Therapy for Atrial Fibrillation Should be used in women with AF, stroke risk and low bleeding risk Beta Blockers Should be used for up to 3 years post ACS with normal LVEF Should be used indefinitely with LV failure May be considered in other women with CHD or vascular disease ACE Inhibitors or ARBS Should be used if MI, CHF, LVEF<40%, or DM, unless contraindicated Aldosterone Antagonists Should be used post MI with heart failure, unless contraindicated Class, LOE I, A IIa, B IIa, B IIb, B I, A I, A I, A IIb, C I, A 1, B

19 Algorithm for CVD Prevention In Women per the 2011 Guideline Update Risk Assessment CV Symptoms and Depression Screening Medical, Pregnancy and Family History PE including BMI and Waist Size Labs including FBS and Lipids CVD Risk Scoring if no CHD, PAD or DM History of Arial Fibrillation? Implement ASA or Anti-Coagulant Therapy Implement Diet and Lifestyle Interventions (Class I) For All Smoking Cessation DASH-type Diet Physical Activity Weight Control Yes Recent CV Event? Yes Refer to Cardiac Rehab Yes High Risk? CHD, CVA, PAD or AAA DM or CKD >10% Predicted Risk of CVD in 10 Yrs Yes Implement Class I Risk Factor and Drug Recommendations ASA Beta Blocker ACEI or ARB LDL control to <100 No At Risk? Any 1 Risk Factor From Table Yes Implement Class I Risk Factor Recommendations BP control LDL control to goal Modified from: JACC 2011; 57: Consider Class II Recommendations LDL control to <70 Drugs to target non-hdl + HDL Omega-3 fatty acids Consider Class II Recommendations ASA Therapy for non-hdl + HDL (in selected women)

20 Closing the Prevention Gap in Practice Maintain Cost Efficacy Diet and lifestyle changes, aspirin, anti-hypertensive therapies and generic statins are cost effective in high risk women Make Systems Changes to Implement Guidelines Develop interventions that are multifaceted, interactive, and incorporate decision support and regular feedback Consider quality reporting to improve performance Educate Patients to Promote Adherence Recognize low health literacy, cognitive impairment, psychiatric illness, and caregiver roles as barriers in women Use education, counseling, motivational interviewing, self monitoring, group visits, and computerized reminders Require Delivery System Re-Design Recognize Diversity and Disparities Recognize cultural, socioeconomic and age diversity of women and deliver culturally sensitive care

21 Summary CV disease mortality in women has decreased in the last decade but challenges remain Higher mortality during acute CHD events, higher stroke rates, a higher burden of CV risk factors, and lower awareness of CV risk mandate more aggressive prevention efforts in women The 2011 update shifts to global CV risk assessment, redefines optimal risk, lowers the threshold for high risk, and adds gender specific risk factors Prevention efforts are likely to be more successful if they incorporate elements of the Chronic Care Model, including team approaches, decision support, patient education, and regular feedback; recognize and respect patient diversity, and maintain cost efficacy

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