8/5/2013. Show Your Heart You Care Guidelines for Prevention of Cardiovascular Disease in Women. Background

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1 Guidelines for Prevention of Cardiovascular Disease in Women Name of Commitment DISCLOSURE STATEMENT Nanette Kass Wenger, M.D. Name of Organization Nanette K. Wenger, MD, MACC, MACP, FAHA Professor of Medicine (Cardiology) Emeritus Emory University School of Medicine Consultant, Emory Heart & Vascular Center Atlanta, Georgia Research Grants/Contracts/Trial Steering Committee/Trial Adjudication Committee/Trial Data Safety and Monitoring Board Consultantship Abbott, Gilead Sciences, Merck, NHLBI, Pfizer Abbott Women s Advisory Board, Amgen, AstraZeneca, Gilead Sciences, Janssen Pharmaceuticals, Merck, Pfizer 1 2 Background Leading cause death US women ½ million CVD deaths annually 250,000 CHD deaths annually CVD Mortality Trends for Males and Females (United States ) Since 1984 women > men CV mortality CV deaths men no change women until 2000 steady women Every minute US woman dies of CV disease Women with CHD 9000 < age 45 have MI each year MI death vs men 2x < age 65 2x mortality CABG vs men 2011 Heart Disease and Stroke Statistics Heart Disease and Stroke Statistics, Circulation 2012:125:e2-e

2 Persisting Magnitude of the Problem More CV deaths among women than cancers, respiratory disease, Alzheimer s disease, accidents combined. CHD death rates in US women years increasing Reversing trend of past 4 decades Likely related to obesity epidemic Leading edge of a brewing storm Black > white women CVD rates Parallels awareness data Recent AHA national survey: only 53% women would call 9ll for symptoms of heart attack Need educational campaigns targeted to women Your Heart: An Owner s Manual Technical specifications parts and features Muscular pump little larger than a clenched fist Weighs less than a pound Beats over 100,000 times daily 2000 gallons of blood daily, nearly 5 quarts of blood each 60,000 miles of arteries, capillaries, veins US warranty (2006) av. 81 years white woman av years black woman read Owners Manual carefully for operating instructions Ford, NEJM 356:2388, 2007 AHA Heart Disease and Stroke Statistics 2011 Update, Dallas, TX, Concepts for Owner: Care and Maintenance Empowering women awareness, education Favorable lifestyle changes can CV risk factors, prevent CV/CHD Continuum of risk Match intensity of intervention to risk Behavioral changes by women, reshaping practice patterns by healthcare providers Dramatically number of women disabled, killed by CHD annually Partnership between women and their healthcare providers Directions for Operation Effectiveness-Based Guidelines for the Prevention of Cardiovascular Disease in Women 2011 Update: A Guideline from the American Heart Association Executive Writing Committee, Lori Mosca, Emelia J. Benjamin, Kathy Berra, Judy L. Bezanson, Rowena J. Dolor, Donald M. Lloyd-Jones, L. Dristin Newby, Ileana L. Pina, Veronique L. Roger, Leslee J. Shaw, Dong Zhao, Theresa M. Beckie, Cheryl Bushnell, Jeanine D Armiento, Penny M. Kris-Etherton, Jing Fang, Theodore G. Ganiats, Antoinette S. Gomes, Clarisa R. Gracia, Constance K. Haan, Elizabeth A. Jackson, Debra R. Judelson, Ellie Kelepouris, Carl J. Lavie, Anne Moore, Nancy A. Nussmeier, Elizabeth Ofili, Suzanne Oparil, Pamela Ouyang, Vivian W. Pinn, Katherine Sherif, Sidney C. Smith, Jr., George Sopko, Nisha Chandra-Strobos, Elaine M. Urbina, Viola Vaccarino, and Nanette K. Wenger. Circulation, 2011;123:

3 CVD Risk Classification for Women (1) Basis High lifetime CVD risk for women, average 1 in 2 Clinical trial data involve women at high risk or apparently healthy women Limitations of standard risk stratification, e.g. only short-term (10 year) Framingham risk, high prevalence subclinical disease in low risk women Risk status High risk ( 1 high-risk states) >10% 10 year risk for all CVD events women s risk for stroke, HF > CHD At risk ( 1 major RF(s)) Ideal cardiovascular health CVD Risk Classification for Women (2) Classification of CVD Risk in Women Risk Status _Criteria High risk ( 1 Clinically manifest CHD high-risk states) Clinically manifest cerebrovascular disease Clinically manifest peripheral arterial disease Abdominal aortic aneurysm End-stage or chronic kidney disease Diabetes mellitus 10-y Predicted CVD risk 10% Lloyd-Jones, Circulation 113:791, 2006 Lakoski, Arch Intern Med 167:2437, CVD Risk Classification for Women (3) Classification of CVD Risk in Women Risk Status _Criteria At risk ( 1 major risk factor[s]) Cigarette smoking SBP 120 mm Hg,. DBP 80 mm Hg, or treated hypertension Total cholesterol 200 mg/dl, HDL-C < 50 mg/dl, or treated for dyslipidemia Obesity, particularly central adiposity Poor diet Physical inactivity Family history of premature CVD occurring in first-degree relatives in men < 55 y of age or in women < 65 y of age Metabolic syndrome Evidence of advanced subclinical atherosclerosis (eg, coronary calcification, carotid plaque, or thickened IMT) Poor exercise capacity on treadmill test and/or abnormal heart rate recovery after stopping exercise Systemic autoimmune collagen-vascular disease (eg, lupus or rheumatoid arthritis) History of preeclampsia, gestational diabetes, or pregnancy-induced hypertension 11 CVD Risk Classification for Women (4) Classification of CVD Risk in Women Risk Status Criteria Ideal cardiovascular health (all of these) Total cholesterol < 200 mg/dl (untreated) BP < 120/<80 mg Hg (untreated) Fasting blood glucose < 100 mg/dl (untreated) Body mass index < 25 kg/m 2 Abstinence from smoking Physical activity at goal for adults > 20 y of age: 150 min/wk moderate intensity, 75 min/wk vigorous intensity, or combination Healthy (DASH-like) diet 12 3

4 Support for Focus on Long-term Risk for CVD in Women 10-year CHD risk in NCEP ATP III Underestimates overall CVD risk for women Precludes warranted intensive preventive measures for most high-risk women Recent Framingham equations predict 10- and 30-year risk all CVD (CHD, stroke, HF, claudication) In 56% US adults Including 47.5 million women, 64% women aged years 10-year predicted CHD risk <10% Lifetime predicted risk 39% Other Aspects of Risk Assessment in Women Utility for routine screening and improving clinical outcomes for women not established for Novel CVD biomarkers, eg hs CRP, advanced lipid testing Novel imaging technologies, eg coronary calcium scoring? Use to refine risk estimates in intermediate risk patients re need to start drug therapy Women with depression, autoimmune disease, eg. lupus erythematosus, rheumatoid arthritis at risk Screen for CVD risk factors Grundy, Circulation 110:227, 2004 Vasan, Ann Intern Med 142:393, 2005 Marma, Circulation 120:384, 2009 Pencina, Circulation 119:3078, 2009 Marma, Circ CV Qual Outcomes 3:8, Greenland, Circulation 122:e584, 2010 Polonsky, JAMA 303:1610, 2010 Nambi, JACC 55:1600, 2010 Salmon, Am J Med 121(10 suppl 1):S3, Pregnancy Complications and Women s Lifetime CVD Risk Pregnancy a unique cardiovascular, metabolic stress early indicator CVD risk Preeclampsia 2x risk subsequent CHD, stroke, VTE Focused history of pregnancy complications warranted Gestational diabetes Preeclampsia Preterm birth Small for gestational age infant Preventive Approaches: Operating and Maintenance Instructions Lifestyle interventions MAJOR EMPHASIS Major risk factor interventions Preventive drug interventions Wilson, BMJ 326:845, 2003 Ray, Lancet 366:1797, 2005 Bellamy, BMJ 335:974, Mosca, Circulation 2001;123:1243 4

5 Lifestyle Interventions (1) Health Benefits of Smoking Cessation Cigarette Smoking Women should be advised not to smoke and to avoid environmental tobacco smoke. Provide counseling at each encounter, nicotine replacement, and other pharmacotherapy as indicated in conjunction with a behavioral or formal smoking cessation program (Class I; Level of Evidence B). People who quit smoking before age 50 have one half the risk of dying over the next 15 years compared with continuing smokers 1 Smoking cessation improves pulmonary function 20% to 30% within 2 to 3 months 2 After 1 year of smoking abstinence, the risk of coronary heart disease is reduced by 50% 2 Within 5-15 years of smoking cessation, risk of stroke is similar to nonsmokers risk Centers for Disease Control and Prevention. MMWR. 1990;39: Jorenby DE. Circulation. 2001;104:e51-e52. Lifestyle Interventions (2) Physical activity Women should be advised to accumulate at least 150 min/wk of moderate exercise, 75 min/wk of vigorous exercise, or an equivalent combination of moderate- and vigorous-intensity aerobic physical activity. Aerobic activity should be performed in episodes of at least 10 min, preferably spread throughout the week (Class I; Level of Evidence B). Women should also be advised that additional cardiovascular benefits are provided by increasing moderate-intensity aerobic physical activity to 5 h (300 min)/wk, 2 ½ h/wk of vigorous-intensity physical activity, or an equivalent combination of both (Class I; Level of Evidence B). Women should be advised to engage in muscle-strengthening activities that involve all major muscle groups performed on 2 d/wk (Class I; Level of Evidence B). Women who need to lose weight or sustain weight loss should be advised to accumulate a minimum of 60 to 90 min of at least moderate-intensity physical activity (eg, brisk walking) on most, and preferably all, days of the week (Class I; Level of Evidence B). Walking Cuts Women s Heart Disease Risk Nurses Health Study: 72,488 women aged Vigorous exercise and brisk walking reduced the risk of heart attack or death from coronary heart disease by 30-40% Women who were sedentary but later engaged in moderate walking reduced the risk of heart attack and coronary death by 20-30% Walking at slower pace also beneficial Manson JE et al. N Engl J Med. 1999;341:

6 Dietary Intake Lifestyle Interventions (4) Women should be advised to consume a diet rich in fruits and vegetables; to choose whole-grain, high-fiber foods; to consume fish, especially oily fish, at least twice a week; to limit intake of saturated fat, cholesterol, alcohol, sodium, and sugar; and to avoid trans-fatty y acids. See Appendix (Class I; Level of Evidence B). Note: Pregnant women should be counseled to avoid eating fish with the potential for the highest level of mercury contamination (eg, shark, swordfish, king mackerel, or tile fish). Weight maintenance/reduction The 250:250 Rule Exercise an extra 250 calories per day Eat 250 fewer calories per day Equals 500 fewer calories per day 3500 calories per week = 1 lb Women should maintain or lose weight through an appropriate balance of physical activity, caloric intake, and formal behavioral programs when indicated to maintain or achieve an appropriate body weight (eg, BMI <25 kg/m 2 in US women), waist size (eg, < 35 in), or other target metric of obesity (Class I; Level of Evidence B). 21 Major Risk Factor Interventions (1) Major Risk Factor Interventions (2) Blood pressure: pharmacotherapy Blood pressure: optimal level and lifestyle An optimal pressure of <120/80 mmhg should be encouraged through lifestyle approaches such as weight control, increased physical activity, alcohol moderation, sodium restriction, and increased consumption of fruits, vegetables, and low-fat dairy products (Class I; Level of Evidence B). Pharmacotherapy is indicated when blood pressure is 140/90 mm Hg ( 130/80 mm Hg in the setting of chronic kidney disease and diabetes mellitus). Thiazide diuretics should be part of the drug regimen for most patients unless contraindicated or if there are compelling indications for other agents in specific vascular diseases. Initial treatmentt t of high-risk women with acute coronary syndrome or MI should be with β-blockers and/or ACE inhibitors/arbs, with addition of other drugs such as thiazides as needed to achieve goal blood pressure (Class I; Level of Evidence A). Note: ACE inhibitors are contraindicated in pregnancy and ought to be used with caution in women who may become pregnant

7 Classification of Blood Pressure for Adults Major Risk Factor Interventions (3) BP Classification Systolic BP Diastolic BP Normal <120 and <80 Lipid and lipoprotein levels: optimal levels and lifestyle Prehypertension or Stage 1 HTN or The following levels of lipids and lipoproteins in women should be encouraged through lifestyle approaches: LDL-C < 100 mg/dl, HDL-C > 50 mg/dl, triglycerides < 150 mg/dl, and non-hdl-c (total cholesterol minus HDL) < 130 mg/dl (Class I; Level of Evidence B). Stage 2 HTN 160 or more or 100 or more HTN, hypertension JNC-7 Report. JAMA. 2003;289: Major Risk Factor Interventions (4) Major Risk Factor Interventions (6) Lipids: pharmacotherapy for LDL-C lowering, high-risk women LDL-C-lowering drug therapy is recommended simultaneously with lifestyle therapy in women with CHD to achieve an LDL-C < 100 mg/dl (Class I; Level of Evidence A) and is also indicated in women with other atherosclerotic CVD or diabetes mellitus or 10-year absolute risk > 20% (Class I; Level of Evidence B). A reduction to < 70 mg/dl is reasonable in very-high-risk women (eg, those with recent ACS or multiple poorly controlled cardiovascular risk factors) with CHD and may require an LDL-lowering drug combination (Class IIa; Level of Evidence B). Lipids: pharmacotherapy for low HDL-C or elevated non-hdl-c Niacin or fibrate therapy can be useful when HDL-C is low (< 50 mg/dl) or non-hdl-c is elevated (> 130 mg/dl) in high-risk women after LDL-C goal is reached (Class IIb; Level of Evldence B). Diabetes Mellitus Lifestyle and pharmacotherapy can be useful in women with diabetes mellitus to achieve an HbA 1C < 7% if this can be accomplished without significant hypoglycemia (Class IIa; Level of Evidence B)

8 io Risk Rati Framingham Heart Study 30-Year Follow-up of CVD Events in Patients with Diabetes Ages Men Women 0 Total CVD CHD Cardiac Failure P<.001 for all values. Intermittent Claudication Stroke Lifestyle Changes: They Work! Diabetes Prevention Program (DPP) Diet and exercise effectively delayed diabetes in a diverse American population of overweight people with IGT: Physical activity for 30 minutes per day and weight loss of 5-7% of body weight: Reduced their risk of getting Type 2 Diabetes by 58% Diabetes Prevention Program Research Group. N Engl J Med. 2002;346(6): Wilson PWF, Kannel WB. In: Ruderman N et al, eds. Hyperglycemia, Diabetes and Vascular Disease Preventive Drug Interventions (1) Aspirin and Women Aspirin: high-risk women Aspirin therapy ( mg/d) should be used in women with CHD unless contraindicated (Class I; Level of Evidence A). Aspirin therapy ( mg/dl) is reasonable in women with diabetes mellitus unless contraindicated (Class IIa; Level of Evidence B). If a high-risk woman has an indication but is intolerant of aspirin therapy, clopidogrel should be substituted (Class I; Level of Evidence B). Women s Health Study: 39,876 healthy low risk women age 45 or older randomized to receive 100 mg aspirin ALTERNATE DAYS or placebo; monitored for 10 years No decrease in the risk of cancer No decrease in the risk of cardiovascular events Decreased risk if >65 years PRIMARY prevention but no benefit even in those > 10% risk Decreased risk of stroke by 17% 24% decrease in ischemic stroke Nonsignificant increase in hemorrhagic stroke Increased risk of GI bleeding 31 Ridker P et al. N Engl J Med. 2005;352:

9 Low-Dose Aspirin for Primary Prevention of CVD in Women Application Clear gender difference men benefit for MI, not stroke for primary prevention Low-dose aspirin prevents stroke (not MI) with potential for GI bleeding in women at low risk for CVD Low-dose aspirin prevents stroke, MI or CV death in women > 65 y but with increased risk for bleeding - individualize Class III Interventions: Not Useful/Effective and May Be Harmful for CVD Prevention in Women (1) Menopausal therapy Hormone therapy and selective estrogen-receptor modulators (SERMs) should not be used for the primary or secondary prevention of CVD (Class III; Level of Evidence A). Antioxidant Supplements Antioxidant vitamin supplements (eg, vitamin E, C, and beta carotene) should not be used for the primary or secondary prevention of CVD (Class III; Level of Evidence A). Ridker P, et al. N Engl J Med. 2005;352: Increased Risk Heart attack 29% Breast cancer 26% Blood clots 2X Strokes 41% Dementia Ovarian Cancer WHI Results Decreased Risk Estrogen plus progestin - July 2002 Estrogen alone March 2004 Hip fractures 34% Colorectal cancer 37% Cancer of uterine lining No Effect Quality of life Class III Interventions: Not Useful/Effective and May Be Harmful for CVD Prevention in Women (2) Folic Acid Folic Acid, with or without B6 and B12 supplementation, should not be used for the primary or secondary prevention of CVD (Class III; Level of Evidence A). Strokes Probable dementia or memory loss Hip fractures WHI, Women s Health Initiative National Institutes of Health study shows a trend toward increase in risk Stefanick ML, Writing Group for WHI Investigators. JAMA. 2002;288: Breast cancer Heart disease Aspirin for MI in women < 65 years of age Routine use of aspirin in healthy women < 65 years of age is not recommended to prevent MI (Class III; Level of Evidence B). 36 9

10 Owner s Manual: Checkups and Maintenance (1) Owner s Manual: Checkups and Maintenance (2)

2/5/2013. Show Your Heart You Care Guidelines for Prevention of Cardiovascular Disease in Women. DISCLOSURE STATEMENT Nanette Kass Wenger, M.D.

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