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Prevencion de enf cv en la mujer 2011
Prevencion de enf cv en la mujer 2011
Prevencion de enf cv en la mujer 2011
Prevencion de enf cv en la mujer 2011
Prevencion de enf cv en la mujer 2011
Prevencion de enf cv en la mujer 2011
Prevencion de enf cv en la mujer 2011
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Prevencion de enf cv en la mujer 2011

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  • 1. Effectiveness-Based Guidelines for the Prevention of Cardiovascular Disease in Women2011 UpdateAmerican Heart Association, Lori Mosca, Emelia J. Benjamin, Kathy Berra, Judy L. Bezanson, Rowena J. Dolor, Donald M. Lloyd-Jones, L. Kristin Newby, Ileana L. Piña, Véronique L. Roger, Leslee J. Shaw, and Dong Zhao J. Am. Coll. Cardiol. published online Mar 7, 2011; doi:10.1016/j.jacc.2011.02.005 This information is current as of March 13, 2011 The online version of this article, along with updated information and services, is located on the World Wide Web at: http://content.onlinejacc.org/cgi/content/full/j.jacc.2011.02.005v1 Downloaded from content.onlinejacc.org by on March 13, 2011
  • 2. Journal of the American College of Cardiology Vol. 57, No. 12, 2011© 2011 by the American Heart Association, Inc. ISSN 0735-1097/$36.00Published by Elsevier Inc. doi:10.1016/j.jacc.2011.02.005 PRACTICE GUIDELINE 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, MD, MPH, PhD, FAHA, Chair; Emelia J. Benjamin, MD, ScM, FAHA; Kathy Berra, MSN, NP; Judy L. Bezanson, DSN, CNS, RN; Rowena J. Dolor, MD, MHS; Donald M. Lloyd-Jones, MD, ScM; L. Kristin Newby, MD, MHS; Ileana L. Piña, MD, MPH, FAHA; Véronique L. Roger, MD, MPH; Leslee J. Shaw, PhD; Dong Zhao, MD, PhD EXPERT PANEL MEMBERSTheresa M. Beckie, PhD; Cheryl Bushnell, MD, MHS, FAHA; Jeanine D’Armiento, MD, PhD; Penny M. Kris-Etherton, PhD, RD; Jing Fang, MD, MS; Theodore G. Ganiats, MD; Antoinette S. Gomes,MD; Clarisa R. Gracia, MD, MSCE; Constance K. Haan, MD, MS; Elizabeth A. Jackson, MD, MPH; Debra R. Judelson, MD; Ellie Kelepouris, MD, FAHA; Carl J. Lavie, MD; Anne Moore, APRN; Nancy A. Nussmeier, MD, FAHA; Elizabeth Ofili, MD, MPH; Suzanne Oparil, MD, FAHA; Pamela Ouyang, MBBS; Vivian W. Pinn, MD; Katherine Sherif, MD; Sidney C. Smith, Jr, MD, FAHA;George Sopko, MD, MPH; Nisha Chandra-Strobos, MD; Elaine M. Urbina, MD, MS; Viola Vaccarino, MD, PhD, FAHA; Nanette K. Wenger, MD, MACC, MACP, FAHAThe executive writing committee and expert panel members represent the following participating organizations and major cosponsors: the American Heart Association (L.M., E.J.B., K.B., J.L.B., R.J.D., D.M.L-J., L.K.N., I.L.P., V.L.R., L.J.S., D.Z., T.M.B.,C.B., J.D., P.M.K-E., A.S.G., E.K., C.J.L., N.A.N., S.O., P.O., N.C-S., E.M.U., V.V., N.K.W.), Centers for Disease Control andPrevention* (J.F.), American Academy of Family Physicians (T.G.G.), American College of Obstetricians and Gynecologists (C.R.G.), Society of Thoracic Surgeons (C.K.H.), American College of Cardiology (E.A.J.), American Medical Women’s Association (D.R.J.),National Association of Nurse Practitioners in Women’s Health (A.M.), Association of Black Cardiologists (E.O.), National Institutesof Health Office of Research on Women’s Health (V.W.P.), American College of Physicians† (K.S.), World Heart Federation (S.C.S.), and National Heart, Lung, and Blood Institute (G.S.).The following American Heart Association councils were also cosponsors: Council on Arteriosclerosis, Thrombosis and Vascular Biology; Council on Basic Cardiovascular Sciences; Council on Cardiopulmonary, Critical Care, Perioperative and Resuscitation; Council on Cardiovascular Disease in the Young; Council on Cardiovascular Nursing; Council on Cardiovascular Radiology and Intervention; Council on Cardiovascular Surgery and Anesthesia; Council on Clinical Cardiology; Council on Epidemiology and Prevention;Council for High Blood Pressure Research; Council on the Kidney in Cardiovascular Disease; Council on Nutrition, Physical Activity and Metabolism; Council on Peripheral Vascular Disease; Interdisciplinary Council on Functional Genomics and Translational Biology; and Interdisciplinary Council on Quality of Care and Outcomes Research.*The findings and conclusions in this report are those of the authors and do not necessarily represent the official position of the Centers for Disease Controland Prevention. †Representation does not imply endorsement by the American College of Physicians. The American Heart Association makes every effort to avoid any actual or potential conflicts of interest that may arise as a result of an outsiderelationship or a personal, professional, or business interest of a member of the writing panel. Specifically, all members of the writing group are requiredto complete and submit a Disclosure Questionnaire showing all such relationships that might be perceived as real or potential conflicts of interest. This statement was approved by the American Heart Association Science Advisory and Coordinating Committee on January 7, 2011. For copies ofthis document, please contact Elsevier Inc. Reprint Department, fax (212) 633-3820, e-mail reprints@elsevier.com. This article is copublished in Circulation. The online-only Data Supplement is available with this article at http://content.onlinejacc.org/10.1016/j.jacc.2011.02.005. The American College of Cardiology Foundation requests that this document be cited as follows: Mosca L, Benjamin EJ, Berra K, Bezanson JL, DolorRJ, 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 ofcardiovascular disease in women—2011 update: a guideline from the American Heart Association. J Am Coll Cardiol 2011;57:xxx–xxx. Permissions: Multiple copies, modification, alteration, enhancement, and/or distribution of this document are not permitted without the expresspermission of the American College of Cardiology Foundation. Please contact Elsevier’s permission department at healthpermissions@elsevier.com. Downloaded from content.onlinejacc.org by on March 13, 2011
  • 3. 2 Mosca et al. JACC Vol. 57, No. 12, 2011 Guidelines for the Prevention of CVD in Women—2011 Update March 22, 2011:000–000 This report has been endorsed by the American Academy of Physician Assistants; American Association for Clinical Chemistry; American Association of Cardiovascular and Pulmonary Rehabilitation; American College of Chest Physicians; American Diabetes Association; American Society for Preventive Cardiology; American Society of Echocardiography; American Society of Nuclear Cardiology; Association of Women’s Health, Obstetric and Neonatal Nurses; Department of Health and Human Services Office on Women’s Health; Hartford Institute for Geriatric Nursing; HealthyWomen; The Mended Hearts, Inc.; National Black NursesAssociation; The National Coalition for Women with Heart Disease; North American Menopause Society; Preeclampsia Foundation; Preventive Cardiovascular Nurses Association; Society for Vascular Medicine and Biology; Society for Women’s Health Research; Women in Thoracic Surgery; and WomenHeart.S ubstantial progress has been made in the awareness, for 15% to 20% of all ischemic strokes. It has been shown treatment, and prevention of cardiovascular disease that undertreatment with anticoagulants doubles the risk of (CVD) in women since the first women-specific clin- recurrent stroke; therefore, the expert panel voted to includeical recommendations for the prevention of CVD were recommendations for the prevention of stroke among womenpublished by the American Heart Association (AHA) in 1999 with atrial fibrillation (6,9,10).(1). The myth that heart disease is a “man’s disease” has been Adverse trends in CVD risk factors among women are andebunked; the rate of public awareness of CVD as the leading ongoing concern. After 65 years of age, a higher percentagecause of death among U.S. women has increased from 30% in of women than men have hypertension, and the gap will1997 to 54% in 2009 (2). The age-adjusted death rate likely increase with the continued aging of the femaleresulting from coronary heart disease (CHD) in females, population (6). The prevalence of hypertension in blacks inwhich accounts for about half of all CVD deaths in women, the United States is among the highest in the world, and it iswas 95.7 per 100,000 females in 2007, a third of what it was increasing. From 1988 to 1994 through 1999 to 2002, thein 1980 (3,4). Approximately 50% of this decline in CHD prevalence of hypertension in adults increased from 35.8% todeaths has been attributed to reducing major risk factors and 41.4% among blacks, and it was particularly high amongthe other half to treatment of CHD including secondary black women at 44.0% (11).preventive therapies (4). Major randomized controlled clini- A very ominous trend is the ongoing increase in averagecal trials such as the Women’s Health Initiative have changed body weight, with nearly 2 of every 3 U.S. women Ͼ20 yearsthe practice of CVD prevention in women over the past of age now overweight or obese (6). The rise in obesity is adecade (5). The investment in combating this major public key contributor to the burgeoning epidemic of type 2 diabeteshealth issue for women has been significant, as have the mellitus now seen in Ͼ12 million U.S. women. Furthermore,scientific and medical achievements. the rate of diabetes mellitus is more than double in Hispanic Despite the gains that have been made, considerable women compared with non-Hispanic white women (12.7%challenges remain. In 2007, CVD still caused Ϸ1 death per versus 6.45%, respectively) (6). The increasing prevalence ofminute among women in the United States (6). These repre- diabetes mellitus is concerning for many reasons, especiallysent 421,918 deaths, more women’s lives than were claimed for its association with a greatly increased overall risk ofby cancer, chronic lower respiratory disease, Alzheimer myocardial infarction (MI) and stroke (12).disease, and accidents combined (6). Reversing a trend of the The challenge of CVD in women is not limited to thepast 4 decades, CHD death rates in U.S. women 35 to 54 United States. Recent data document the global scope of theyears of age now actually appear to be increasing, likely problem: Heart disease is the leading cause of death inbecause of the effects of the obesity epidemic (4). CVD rates women in every major developed country and most emergingin the United States are significantly higher for black females economies (13).compared with their white counterparts (286.1/100,000 ver- Given the worldwide health and economic implications ofsus 205.7/100,000). This disparity parallels the substantially CVD in women, there is strong rationale to sustain efforts tolower rate of awareness of heart disease and stroke that has control major CVD risk factors and to apply evidence-basedbeen documented among black versus white women (2,6 – 8). therapies in women.Of concern is that in a recent AHA national survey, only 53% In 2004, the AHA, in collaboration with numerous otherof women said the first thing they would do if they thought organizations, expanded its focus on female-specific clinicalthey were having a heart attack was to call 9-1-1. This recommendations and sponsored the “Evidence-Baseddistressing lack of appreciation by many women for the need Guidelines for Cardiovascular Disease Prevention infor emergency care for acute cardiovascular events is a barrier Women” and updated them in 2007 (14,15). Initially, theto optimal survival among women and underscores the need guidelines challenged the conventional wisdom that womenfor educational campaigns targeted to women (2). should be treated the same as men, primarily related to CVD rates in the United States are significantly higher for concerns about the lack of representation of women inblack females compared with their white counterparts (286.1/ clinical trials. As more women have participated in CVD100,000 versus 205.7/100,000), which parallels the substan- research studies and more gender-specific analyses have beentially lower rate of awareness of heart disease and stroke that published, data have become available to make more defini-has been documented among black versus white women tive recommendations. Evolving science suggests that the(2,6 – 8). Each year, 55,000 more women than men have a overwhelming majority of recommendations to prevent CVDstroke. Atrial fibrillation is independently associated with a 4- are similar for women and men, with few exceptions. Nota-to 5-fold increased risk of ischemic stroke and is responsible bly, aspirin is routinely recommended for the primary pre- Downloaded from content.onlinejacc.org by on March 13, 2011
  • 4. JACC Vol. 57, No. 12, 2011 Mosca et al. 3March 22, 2011:000–000 Guidelines for the Prevention of CVD in Women—2011 Updatevention of MI in men but not women (16,17). However, there Table 1. Class III Interventions (Not Useful/Effective and Mayis a growing appreciation that there may be gender differences Be Harmful) for the Prevention of CVD in Womenin the magnitude of the relative and absolute potential Menopausal therapybenefits and risks of preventive interventions. The panel Hormone therapy and selective estrogen-receptor modulators (SERMs)acknowledged unique opportunities to identify women at risk should not be used for the primary or secondary prevention of CVD(e.g., pregnancy) and addressed concerns that women often (Class III, Level of Evidence A).have more comorbidities and are older than men when they Antioxidant Supplementsexperience CHD. Antioxidant vitamin supplements (e.g., vitamin E, C, and beta carotene) The current guidelines encompass prevention of the scope should not be used for the primary or secondary prevention of CVDof atherosclerotic thrombotic cardiovascular outcomes in (Class III, Level of Evidence A).women. However, it should be noted that the majority of data Folic Acid*used to develop these guidelines is based on trials of CHD Folic Acid, with or without B6 and B12 supplementation, should not be used for the primary or secondary prevention of CVD (Class III, Level ofprevention. Future guidelines should consider recommenda- Evidence A).tions for specific outcomes of particular importance in Aspirin for MI in women <65 years of agewomen, such as stroke. Each year, 55,000 more women die of Routine use of aspirin in healthy women Ͻ65 years of age is notstroke than men, and before 75 years of age. Stroke accounts recommended to prevent MI (Class III, Level of Evidence B).for a higher proportion of CVD events than CHD in females,whereas the ratio is the opposite for males. Women have CVD indicates cardiovascular disease; MI, myocardial infarction. *Folic acid supplementation should be used in the childbearing years tounique risk factors for stroke such as pregnancy and hormone prevent neural tube defects.therapy, have a greater prevalence of hypertension in olderages, a major risk factor for stroke, and may have differentbenefits and risks associated with interventions to reduce outcomes benefit but were included in an algorithm forstroke risk compared with men (6). Atrial fibrillation is approaches to the evaluation of women because they mayindependently associated with a 4- to 5-fold increased risk of indirectly impact CVD risk through adherence to preventionischemic stroke and is responsible for 15% to 20% of all therapies or other mechanisms (Figure 1). The expert panelischemic strokes. It has been shown that undertreatment with also recognized that cost-effectiveness, which may differ byanticoagulants doubles the risk of recurrent stroke; therefore, sex, needed to be addressed; thus, a comprehensive review ofthe expert panel voted to include recommendations for the current literature on the topic has been added. The guidelinesprevention of stroke among women with atrial fibrillation continue to prioritize lifestyle approaches to the prevention of(6,9,10). CVD, likely the most cost-effective strategy. The panel also Current systematic and critical review of the literature acknowledged that difficulty in adhering to lifestyle andcontinues to update the guidelines, which have become the medical recommendations limits effectiveness; therefore, newfoundation to inform national educational programs for sections were added on guideline implementation.healthcare professionals and women consumers of healthcare.A major evolution from previous guidelines to the 2011 CVD Risk Assessmentupdate is that effectiveness (benefits and risks observed inclinical practice) of preventive therapies was strongly con- In the 2007 update, a new algorithm for risk classification insidered and recommendations were not limited to evidence women was adopted that stratified women into 3 categories:that documents efficacy (benefits observed in clinical re- “at high risk,” based on the presence of documented CVD,search); hence, in the transformation from “evidence-based” diabetes mellitus, end-stage or chronic kidney disease, orto “effectiveness-based” guidelines for the prevention of 10-year predicted risk for CHD Ͼ20%; “at risk,” given thecardiovascular disease in women, the panel voted to update presence of Ն1 major CVD risk factors, metabolic syndrome,recommendations to those therapies that have been shown to evidence of subclinical vascular disease (e.g., coronary cal-have sufficient evidence of clinical benefit for CVD out- cification), or poor exercise tolerance on treadmill testing;comes. Class III recommendations from prior guidelines that and “at optimal risk” in the setting of a Framingham riskare not recommended for use for the prevention of CVD score Ͻ10%, absence of major CVD risk factors, and(Table 1) were retained as no new evidence has become engagement in a healthy lifestyle. This approach to riskavailable to alter the recommendations. The list of Class III classification in women was based on several observations: 1)recommendations is not exhaustive, and therapies that were The lifetime risk for CVD is high in almost all women andpreviously searched were based on those preventive interven- approaches 1 in 2 on average, so prevention is important in alltions commonly believed to have a potential benefit for the women (18); 2) most clinical trial data used to formulate theprevention of CVD in women despite a lack of definitive recommendations included either women at high risk becauseclinical trial evidence of benefit. Uses of medications for of known CVD or apparently healthy women with a spectrumindications beyond the prevention of ischemic CVD are not of risk, which allowed the scheme to align the guidelines withaddressed in this document. Use of medications for indi- the evidence; and 3) the appreciation of the limitations ofcations beyond the prevention of ischemic CVD is not standard risk stratification schemes such as the Framinghamaddressed in this document and can be found elsewhere risk score is growing. These limitations include the narrow(www.heart.org). Some interventions (e.g., screening for focus on only short-term (10-year) risk and on only MI anddepression) were recognized to lack data on direct CVD CHD death, the lack of inclusion of family history, overesti- Downloaded from content.onlinejacc.org by on March 13, 2011
  • 5. 4 Mosca et al. JACC Vol. 57, No. 12, 2011 Guidelines for the Prevention of CVD in Women—2011 Update March 22, 2011:000–000Figure 1. Flow diagram for CVD preventive care in women. CVD indicates cardiovascular disease; DASH, Dietary Approaches to StopHypertension; CHD, coronary heart disease; LDL-C, low-density lipoprotein cholesterol; HDL-C, high-density lipoprotein cholesterol;and ACS, acute coronary syndrome. Downloaded from content.onlinejacc.org by on March 13, 2011
  • 6. JACC Vol. 57, No. 12, 2011 Mosca et al. 5March 22, 2011:000–000 Guidelines for the Prevention of CVD in Women—2011 Updatemation or underestimation of risk in nonwhite populations, Table 2. Classification of CVD Risk in Womenand the fact that subclinical CVD can have relatively highprevalence among women who are scored as being at low risk Risk Status Criteria(6,19). High risk (Ն1 Clinically manifest CHD high-risk states) Clinically manifest cerebrovascular disease The 2007 panel believed that a Framingham 10-yearpredicted risk for CHD Ͼ20% could be used to identify a Clinically manifest peripheral arterial diseasewoman at high risk but that a lower score was not sufficient Abdominal aortic aneurysmto ensure that an individual woman was at low risk. Thus, the End-stage or chronic kidney diseasealgorithm included consideration of factors beyond the 10- Diabetes mellitusyear predicted risk for CHD used in current National Cho- 10-y Predicted CVD risk Ն10%lesterol Education Panel guidelines of lipid management (20). At risk (Ն1 major Cigarette smokingThe panel emphasized that healthcare professionals should risk factor[s]) SBP Ն120 mm Hg, DBP Ն80 mm Hg, or treatedtake several factors into consideration beyond just the Fra- hypertensionmingham risk score, including medical and lifestyle history, Total cholesterol Ն200 mg/dL, HDL-C Ͻ50 mg/dL,family history of CVD, markers of preclinical disease, and or treated for dyslipidemiaother conditions, as they make decisions about the intensity of Obesity, particularly central adipositypreventive therapy. Poor diet Since the 2007 update, a number of lines of evidence have Physical inactivityemerged to support the risk classification algorithm adopted Family history of premature CVD occurring in first-in 2007. Hsia et al. (21) directly evaluated the algorithm in degree relatives in men Ͻ55 y of age or in161,808 women 50 to 79 years of age who were enrolled in women Ͻ65 y of agethe Women’s Health Initiative and followed up for a mean of Metabolic syndrome7.8 years. When the 2007 update categories were applied, Evidence of advanced subclinical atherosclerosis11% of women were found to be at high risk, 72% were at (e.g., coronary calcification, carotid plaque, or thickened IMT)risk, and 4% were at optimal risk (21). Of note, 13% of Poor exercise capacity on treadmill test and/orwomen could not be classified by the 2007 algorithm because, abnormal heart rate recovery after stoppingalthough they lacked risk factors, they did not adhere to a exercisehealthy lifestyle. Systemic autoimmune collagen-vascular disease Among high-risk, at-risk, optimal risk, and unclassified (e.g., lupus or rheumatoid arthritis)women, the rates of MI, CHD death, or stroke were 19.0%, History of preeclampsia, gestational diabetes, or5.5%, 2.2%, and 2.6% per 10 years, respectively (p for trend pregnancy-induced hypertensionϽ0.0001) (20). Although absolute event rates differed among Ideal cardiovascular Total cholesterol Ͻ200 mg/dL (untreated)women of different race/ethnic groups, the 2007 risk classi- health (all of these) BP Ͻ120/Ͻ80 mm Hg (untreated)fication algorithm appropriately ordered event rates in all Fasting blood glucose Ͻ100 mg/dL (untreated)groups, with a 7- to 20-fold difference in event rates between Body mass index Ͻ25 kg/m2optimal-risk and high-risk women. The 2007 update algo- Abstinence from smokingrithm discriminated those who experienced coronary events Physical activity at goal for adults Ͼ20 y of age:with accuracy similar to current National Cholesterol Educa- Ն150 min/wk moderate intensity, Ն75 min/wktion Panel Adult Treatment Panel III risk categories (Ͻ10%, vigorous intensity, or combination10% to 20%, and Ͼ20%) based on Framingham 10-year Healthy (DASH-like) diet (see Appendix)predicted risks (20). CVD indicates cardiovascular disease; CHD, coronary heart disease; SBP, Therefore, the current panel elected to continue this general systolic blood pressure; DBP, diastolic blood pressure; HDL-C; high-densityapproach to risk classification in women for the 2011 guide- lipoprotein cholesterol; IMT, intima-media thickness; BP, blood pressure; andlines with some modifications (Table 2). First, the AHA DASH, Dietary Approaches to Stop Hypertension.recently defined a new concept of “ideal cardiovascularhealth” defined by the absence of clinical CVD and the with an increased risk of CVD in women, have been identi-presence of all ideal levels of total cholesterol (Ͻ200 mg/dL), fied, but their utility for screening and improving clinicalblood pressure (Ͻ120/80 mm Hg), and fasting blood glucose outcomes has not been determined.(Ͻ100 mg/dL), as well as adherence to healthy behaviors, Other modifications to the risk classification algorithmincluding having a lean body mass index (Ͻ25 kg/m2), include acknowledgement of the availability of several 10-abstinence from smoking, participation in physical activity at year risk equations for the prediction of 10-year global CVDrecommended levels, and pursuit of a Dietary Approaches to risk such as the updated Framingham CVD risk profile andStop Hypertension–like eating pattern (22). When achieved the Reynolds risk score for women (23,24). The panelor maintained into middle age, the overall pattern of ideal considered that either of these scores would be appropriatecardiovascular health is associated with greater longevity; for use, particularly given their inclusion of CVD eventsdramatic reductions in short-term, intermediate-term, and beyond just CHD, but did not endorse routine screening withlifetime risks for CVD events; greater quality of life in older high-sensitivity C-reactive protein (hsCRP), which would beages; and lower Medicare costs at older ages (22). It should required for use of the Reynolds risk score, because there arealso be noted that several factors, which have been associated no data to support the association between a reduction in Downloaded from content.onlinejacc.org by on March 13, 2011
  • 7. 6 Mosca et al. JACC Vol. 57, No. 12, 2011 Guidelines for the Prevention of CVD in Women—2011 Update March 22, 2011:000–000hsCRP and improved clinical outcomes. Numerous other suggests that using imaging modalities such as coronarymultivariable risk scores exist and may be clinically useful if calcium scoring and carotid ultrasound to demonstrate thebased on a population and on end points relevant to the presence of advanced atherosclerosis has the greatest utilitypatient in question (25–27). In this context, the current for reclassifying risk in those (including women) predicted toguidelines recommend use of a new cut point for defining be at intermediate risk on the basis of short-term riskhigh risk as Ն10% 10-year risk for all CVD, not just CHD equations such as the Framingham risk score, their value inalone. improving clinical outcomes has not been established (42,43). Recent analyses of clinical trial data suggest that at It should also be noted that several novel risk factors, whichapproximately this threshold statin therapy is associated with have been associated with an increased risk of CVD inhigh cost-effectiveness (and possibly cost savings) in the era women, have been identified, but their utility for screeningof generic statins (28). In addition, the recent Justification for and improving clinical outcomes has not been determined.Use of Statins in Prevention, an Intervention Trial Evaluating Because of its unique cardiovascular and metabolic stress,Rosuvastatin (JUPITER) in primary prevention populations pregnancy provides a unique opportunity to estimate a wom-demonstrated the efficacy of statin medications in lowering an’s lifetime risk. For example, preeclampsia may be an earlyglobal CVD event risk, including among women, although indicator of CVD risk (44,45). A recent large meta-analysisthe absolute benefit was small and the number needed to treat found that women with a history of preeclampsia haveto prevent a major CVD event was greater than in men (29). approximately double the risk for subsequent ischemic heart Several lines of evidence support the focus of women’s disease, stroke, and venous thromboembolic events over the 5guidelines on long-term risk for CVD rather than solely on to 15 years after pregnancy (46). In these patients, the10-year risk for CHD. First, observational and clinical trial physiological “metabolic syndrome of pregnancy” may pro-data indicate that women’s risks for stroke and heart failure voke pregnancy complications. The latter could be consideredthrough middle and older age typically exceed their risk for a “failed stress test,” possibly unmasking early or preexistingCHD, in contrast to the pattern observed in men, for whom endothelial dysfunction and vascular or metabolic diseaseCHD risk increases earliest (30,31). Thus, the focus in the (47). Therefore, appropriate referral postpartum by the obste-current National Cholesterol Education Panel Adult Treat- trician to a primary care physician or cardiologist shouldment Panel III guidelines on 10-year CHD risk may substan- occur so that in the years after pregnancy, risk factors can betially underestimate clinically relevant overall CVD risk and carefully monitored and controlled. Healthcare professionalstherefore tends to preclude the warranted, intensive preven- who meet women for the first time later in their lives shouldtive measures for most high-risk women (32). take a careful and detailed history of pregnancy complica- Indeed, it is difficult for a woman Ͻ75 years of age, even tions with focused questions about a history of gestationalwith several markedly elevated risk factors, to exceed a 10% diabetes mellitus, preeclampsia, preterm birth, or birth of an(let alone a 20%) 10-year predicted risk for CHD with the infant small for gestational age (48 –50).Adult Treatment Panel III risk estimator (33,34). Thus, few Future research should evaluate the potential for exposures,women qualify for aggressive CVD prevention when 10-year events, or interaction with the medical system during periodsrisk is used to determine its need. Fortunately, more recent of potential vulnerability across a woman’s lifespan such asFramingham equations are now available to predict 10- and menarche, pregnancy, and menopause to identify women at30-year risk for all CVD events (including CHD, stroke, heart risk and to determine the effectiveness of diagnostic andfailure, and claudication) (34 –36). preventive interventions during these critical times. A focus on long-term CVD risk, not solely on 10-year Other factors that are more prevalent among women and/orCHD risk, is also supported by recent data indicating that may make special contributions to CVD risk in women need56% of American adults (87 million people), including 47.5 further clarification in the context of defining effective inter-million women overall and 64% of women 60 to 79 years of ventions to improve CVD outcomes, as well as functionalage, have a 10-year predicted risk for CHD of Ͻ10% but a outcomes and adherence to therapy. These include depressionpredicted lifetime risk for CVD of Ն39% (37). and other psychosocial risk factors, as well as autoimmune The role that novel CVD risk biomarkers (e.g., hsCRP or diseases. Systemic lupus erythematosus and rheumatoid ar-advanced lipid testing) and imaging technologies (e.g., coro- thritis may be unrecognized risk factors in women and havenary calcium scoring assessment) should play in risk assess- been associated with a significantly increased relative risk forment and in delineation of appropriate preventive interven- CVD (51). Women with such conditions but without clini-tions is not yet well defined. It should be noted that JUPITER cally evident CVD should be considered at risk and screeneddid not test a strategy of routine screening with hsCRP to for CVD risk factors, whereas women with prior CVD eventsdetermine benefit of statin therapy because those with lower should be screened for these conditions to allow appropriatehsCRP levels were not studied (29). These approaches should secondary CVD prevention efforts and to allow the autoim-not be used for routine screening of all women. Instead, the mune condition to be addressed.AHA and other national groups have recommended that theuse of these novel modalities should be reserved for refining Diversity, Disparities, andrisk estimates in intermediate-risk patients when there is Population Representationuncertainty about the need to start drug therapy (38 – 41).Further research is needed on added benefits, risks, and costs The changing demographics of the United States, and indeedassociated with such strategies. Although recent evidence the world, necessitate that healthcare professionals consider Downloaded from content.onlinejacc.org by on March 13, 2011
  • 8. JACC Vol. 57, No. 12, 2011 Mosca et al. 7March 22, 2011:000–000 Guidelines for the Prevention of CVD in Women—2011 Updatethe diversity of the patients that they encounter. Diversity with stresses of immigration, lower socioeconomic status,may denote a variety of factors to each member of a and inadequate access to healthcare. Despite these adversi-healthcare team. In addition to the well-recognized classifi- ties, Hispanics, with a burden of cardiovascular risk factorscations of race/geographic origin and ethnic origin, other similar to that of non-Hispanic whites, have a lower mortal-facets of diversity need to be considered such as age, ity. This observation has been called the “Hispanic paradox”language, culture, literacy, disability, frailty, socioeconomic as confirmed in recent data released by the National Centerstatus, occupational status, and religious affiliation, among for Health Statistics, which finds Hispanic life expectancy toothers. A better understanding of these aspects of diversity be 80 years compared with 77.5 years for non-Hispanicmay help to reduce disparities in healthcare delivery. The whites and 72.3 years for non-Hispanic blacks (60,61).Institute of Medicine defines disparity as a difference in Although deaths from heart disease have decreased in alltreatment provided to members of ethnic or racial groups that groups, Hispanics have the lowest percentage of cardiovas-is not justified by health condition differences or treatment cular deaths (21.7%) compared with non-Hispanics (26.3%)preferences. The Institute of Medicine report also states that (62). The life expectancy for Hispanic women was the highestthese disparities exist even when controlling for insurance for all groups at 83.1 years compared with 80.4 years forstatus, socioeconomic status, and comorbidities (52). Dispar- non-Hispanic white women, 76.2 years for non-Hispanicities in cardiovascular health continue to be a serious public black women, 77.9 years for Hispanic men, and 75.6 years forhealth issue in the United States. Despite the remarkable non-Hispanic white men. The lowest life expectancy was fordeclines in cardiovascular mortality observed nationally over non-Hispanic black men at 69.2 years (63).the past few decades, many population subgroups defined by In addition to racial and ethnic diversity, the healthcarerace, ethnicity, gender, socioeconomic status, educational professional should be familiar with the patient’s socioeco-level, or geography, still show striking disparities in cardio- nomic status, which may make attaining healthy lifestyles andvascular health. The pervasive nature of these disparities and using medications more difficult. In this context, recommen-compelling evidence of the adverse impact they have on dations that are more appropriate to the life circumstances ofclinical outcomes and quality of life in black and Hispanic the patient may have to be adapted. Age should also bewomen need to be recognized by clinicians. The root causes considered in the context of diversity because in the lifeof disparities include variations and lack of understanding of continuum of women, application of the guidelines may needhealth beliefs, cultural values and preferences, and patients’ adaptation to stages such as pregnancy or the frailty of theinability to communicate symptoms in a language other than elderly. Thus, the recognition of all aspects of diversity andtheir own, among other factors (53–55). During the past the delivery of culturally sensitive care must guide cliniciansdecade, the clinical research focus on innovative methods to to apply these guidelines broadly to match the diversityeliminate healthcare disparities has demonstrated some prom- of women patients they treat, avoiding disparity of careise in multiteam culturally tailored interventions such as those (64 – 66).with nurse-led case managers and community health workers.Cultural competence, therefore, has emerged as a process that International Issuesunites the assessment and recognition of cultural differences,cultural knowledge, and cultural skills (56). Culturally sensi- The international applicability of these guidelines is a criticaltive care includes the adaptation of healthcare delivery to issue because CVD has become a global pandemic amongmeet the needs of a diverse patient population. Thus, diver- women. Approximately 81% of all CVD deaths in womensity, as defined above, in the context of healthcare, is occur in low- and middle-income countries with limitedconcerned with delivering equitable care for all individuals capacity for guidelines development (67). International appli-(57–59). cability can be defined as the desirability and capacity to Although guidelines may be applied across all groups, it is adopt the recommendations proposed in this guidelines doc-important to remember the higher prevalence of risk factors ument “as is” or after appropriate adaptation by medicalin certain racial/ethnic groups such as hypertension among societies, clinicians, and patients in other countries.black women or diabetes mellitus in women of Hispanic The World Health Organization and other internationaldescent (6). Notably, the highest coronary heart death rates organizations have proposed measures for evaluating theand the highest overall CVD morbidity and mortality occur in international applicability of a guidelines document (68 –72).black women. Furthermore, the mortality from coronary In the Global Program on Evidence for Health Policy.artery disease for black women is similar to that of white men Guidelines for WHO Guidelines, 4 criteria were proposed for(6). These disparities in the occurrence of CVD and estab- assessing the international applicability of guidelines: 1)lished risk factors underscore the need for heightened pre- efficacy and safety, 2) cost-effectiveness, 3) affordability, andventive efforts in subpopulations of women. 4) population benefits (68). The Appraisal of Guidelines Ethnic categorization often fails to recognize cultural Research and Evaluation project, an international collabora-differences such as within Hispanics. Although the broad term tion, also designed an instrument to appraise clinical guide-is “Latino” or “Hispanic,” the actual definition includes lines (69). The indicators for applicability assessment includepeople of Cuban, Mexican, Puerto Rican, or South or Central potential organizational barriers in applying the guidelines,American origin. These cultures have distinct backgrounds, cost implications of applying the recommendations, and thehealth behaviors, and beliefs, but they are often grouped presence of key review criteria for monitoring and audittogether. Hispanics living in the United States may be faced purposes (70). Methods and tools are available for interna- Downloaded from content.onlinejacc.org by on March 13, 2011
  • 9. 8 Mosca et al. JACC Vol. 57, No. 12, 2011 Guidelines for the Prevention of CVD in Women—2011 Update March 22, 2011:000–000tional users to determine whether recommendations provided tions and outcomes between studies and other methodologicalin guidelines are suitable for local applications or whether limitations (84,85). The preponderance of evidence suggestssome modifications are needed before application of guide- that unidimensional interventions such as brief initial patientlines (70 –75). education and traditional patient reminders are generally International applicability is an important feature of the ineffective (84,85). The most robust interventions are multi-updated women’s guidelines because almost all of the rec- faceted, are interactive, and incorporate decision systems andommendations can be used in most countries or regions, feedback (84,85).either directly or with slight modifications. The descriptions An intervention increasingly advocated improving guide-of the recommendations are easy to comprehend and apply in lines adherence is “pay for performance.” Performance mea-clinical practice. Risk classification is practical and should be sures are available for primary prevention of CVD, and thefeasible for clinicians and patients worldwide. Additionally, literature suggests some improvement in healthcare profes-generic drugs are available for most of the therapies recom- sional adherence to healthcare quality measures when pay-mended in this guidelines document. Some modifications, for-performance policies are implemented (86,87). Unfortu-however, may be required, depending on the specific de- nately, however, because of reliance on patient outcomes,mands of the countries or regions such as the definition of such policies may also result in unintended detrimentalgeneralized overweight obesity and central obesity. consequences such as reduced access to care for sicker It is noteworthy that some of the recommendations in the patients (87). Similar to the literature supporting guidelinesguidelines for CVD prevention in women are based on adherence in general, much more research is needed on beststudies with relatively small sample sizes of women, which is practices, benefits, and hidden costs of pay-for-performanceparticularly problematic when considering women with dif- initiatives, including whether performance measures some-ferent cultural and racial-ethnic backgrounds. Thus, the con- times increase disparities in care.clusions of meta-analyses based on these studies may not be Improvement in adherence to CHD guideline has beengeneralizable to women worldwide. documented in centers implementing the Get With The Guidelines program of the AHA (88). Of note, disparities inHealthcare Professional Implementation MI guidelines adherence by gender, age, ethnicity, and race appeared to narrow over time in hospitals instituting thisAchievement of both the desired degree and persistence of program (88,89). The AHA is now initiating a Get With TheCVD preventive care has been disappointing in both women Guidelines–Outpatient program, and the American College ofand men. Although improving, the level of public awareness Cardiology has embraced quality improvement activities inand rates of treatment and control of lipids, hypertension, and implementation of CVD prevention guidelines.diabetes mellitus remain suboptimal (76 –78). For instance, The evidence base for practical methods for improvingϷ50% of Americans with hypertension are not treated to guideline adherence by effectively addressing substantivegoal. Furthermore, ethnic/racial disparities in the manage- patient, clinician, and system-level barriers is generally lack-ment of hypertension, lipids, and diabetes mellitus persist (76). ing; however, there is some cause for optimism. There is By establishing scientific levels of evidence and desired increasing patient and clinician knowledge of the importancetreatment strategies, guidelines are fundamental to improving of CHD in women, and there have been improvements inCVD preventive care. However, multiple patient, clinician, CVD risk factor awareness, treatment, and control (89).and systemic barriers limit adherence to CVD prevention Achieving the goal of improving cardiovascular healthguidelines for women (79,80). A meta-analysis of Ͼ100 while reducing death and disability from CVD and stroke inmedical adherence studies shows that women are as likely to women will require concerted efforts toward further researchbe nonadherent to medical therapies as men (81). It is ironic and the dissemination and implementation of lifestyle andthat the level of scientific evidence incorporated in most treatment interventions. In the interim, quality improvementguidelines is much more robust than the research available for efforts can focus on incorporating multidimensional, interac-practical implementation and maintenance of adherence to tive systems to increase accountability among payers, health-those guidelines. Multiple barriers hinder adoption of guide- care professionals, and patients for cardiovascular preventivelines, including lack of access to primary care services and care in women (90).lack of knowledge and skill in guideline implementation onthe part of internists, family practitioners, and gynecologists Patient and Public Education(82,83). For instance, in a study of impediments to CVDprevention, one half of obstetrician-gynecologists and one In 2000, it was estimated that only 7% of people with CHDthird of internists surveyed were unaware that tobacco use is adhered to prescribed treatments for CVD lifestyle riskthe leading cause of MIs in younger women (84). factors (91). Studies evaluating adherence to medical thera- The physicians who reported time as a barrier were less pies for CVD prevention also show similarly low rates oflikely to discuss smoking cessation with their women patients persistence. In addition, it is estimated that people with(83). Impediments to implementation of guidelines include chronic illnesses may see up to 16 different physicianstime pressures, lack of organizational support, and patient annually, making adherence reinforcement even more chal-resistance to behavioral change (84,85). Conclusions about lenging for patients and healthcare professionals (92,93).the best methods for implementation of CVD prevention have Thirty percent to 70% of all hospital admissions forbeen difficult to reach because of heterogeneity in interven- medication-related illness are attributed to poor adherence, Downloaded from content.onlinejacc.org by on March 13, 2011
  • 10. JACC Vol. 57, No. 12, 2011 Mosca et al. 9March 22, 2011:000–000 Guidelines for the Prevention of CVD in Women—2011 Updateresulting in billions of dollars in additional healthcare costs chair, the executive writing committee members with specificannually. Addressing adherence to recommendations in guide- expertise (methods and cost-effectiveness, risk assessment,lines is of utmost importance (94,95). Effective implementation healthcare professional implementation, patient and con-of national guidelines for the primary prevention of CVD will sumer education, diversity and population representation, andrequire a team-based approach to education that includes the international issues), and expert panel members to review thepatient, the family, and key healthcare professionals (93). literature for updates to the recommendation topic areas. The The Joint Commission emphasizes the importance of leadership of each AHA scientific council was asked topatient education that is directed at improving patient out- nominate a recognized expert in CVD prevention who hadcomes, including quality of life (96). National guidelines for particular knowledge about women.the primary prevention of CVD rely on patient education to Major professional or government organizations with asupport the importance of lifestyle change and medication mission consistent with CVD prevention were solicited toadherence to reduce acute MI and stroke (32,97). Providing serve as cosponsors and were asked to nominate 1 represen-successful patient education is challenging for clinicians tative with full voting rights to serve on the expert panel.because of many factors, including limited time for healthcare Each executive writing committee and expert panel membervisits, patients with complex comorbidities, lack of staff for completed a conflict of interest statement and was asked toteaching and follow-up, lack of training in counseling patients abstain from discussion or voting on any recommendationsabout behavior change, and lack of reimbursement for pre- deemed to be a potential conflict of interest. Panelists alsovention in general and patient education in particular (98). suggested diverse professional and community organizationsPatient-related nonadherence is common and is most preva- to endorse the final document after its approval by the AHAlent in several circumstances, including low socioeconomic Science Advisory and Coordinating Committee and cospon-status, low literacy level, depression and other psychiatric soring organizations.illnesses, older age, poor hearing or vision, poor cognitivefunction, and lack of fluency in English, as well as in certain Selection of Topics and Systematic Searchcultures and religions in which confidence in and cooperation The expert panel reviewed the list of recommendations in thewith Western medicine may be limited. 2007 guidelines and suggested additional topics to be Understanding effective educational theories/practices can searched to determine if they warranted discussion or aimprove the ability of clinicians to effect behavior change and clinical recommendation. The search terms for the systematicadherence to therapies. Well-recognized approaches include search were similar to those conducted in 2007 and previ-behaviorally based individual counseling, “motivational in- ously described (14,15). The databases searched for thisterviewing,” “self-efficacy,” and “stages of readiness for update were PubMed, Embase, and Cochrane. The timeframechange” (99 –101). Self-monitoring (e.g., food records, blood for the updated search was January 2006 through Januarypressure/blood glucose logs), group sessions/shared medical 2010. Briefly, studies were included if they were randomizedvisits (e.g., for newly diagnosed diabetes mellitus), computer- clinical trials or large prospective cohort studies (Ͼ1,000assisted reminders, and other electronic communication to subjects) of CVD risk–reducing interventions, meta-analysessupport behavioral change have been shown to improve both that used a quantitative systematic review process, or surro- gate end-point studies with at least 10 cases of major clinicallifestyle and medication adherence (102–106). Involving the CVD end points reported. The systematic search was con-patient and the patient’s family in setting appropriate short-term achievable goals with frequent follow-up will alsoenhance success. Table 3. Classification and Levels of Evidence These guidelines call for a renewed focus on healtheducation, including systematic follow-up to assess effective- Classificationness of medical and lifestyle therapies. Assessment of barriers and Level of Evidence Strength of Recommendationto adherence and interventions to address them must be Classificationintegrated into clinical practice, and barriers specific for Class I Intervention is useful and effectivewomen must be considered. Barriers hindering adherence to Class IIa Weight of evidence/opinion is in favor ofCVD prevention recommendations are common among usefulness/efficacywomen and include family and caretaking responsibilities, Class IIb Usefulness/efficacy is less well established by evidence/stress, sleep deprivation, fatigue, and lack of personal time. opinionEducational efforts are critically important, because increased Class III Procedure/test not helpful or treatment has no provenawareness of personal cardiovascular risk factors has been benefitassociated with improved health and lifestyles for women and Procedure/test excess cost without benefit or harmful ortheir family members (107). treatment harmful to patients Level ofMethods evidence A Sufficient evidence from multiple randomized trials B Limited evidence from single randomized trial or otherSelection of Expert Panel nonrandomized studiesThe AHA Manuscript Oversight Committee commissioned C Based on expert opinion, case studies, or standard of carethe update of the guidelines and approved the writing group Downloaded from content.onlinejacc.org by on March 13, 2011
  • 11. 10 Mosca et al. JACC Vol. 57, No. 12, 2011 Guidelines for the Prevention of CVD in Women—2011 Update March 22, 2011:000–000Table 4. Guidelines for the Prevention of CVD in WomenLifestyle Interventions 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 program or formal smoking cessation program (Class I; Level of Evidence B). 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 1/2 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 Ն2 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 (e.g., brisk walking) on most, and preferably all, days of the week (Class I; Level of Evidence B). Cardiac rehabilitation A comprehensive CVD risk-reduction regimen such as cardiovascular or stroke rehabilitation or a physician-guided home- or community-based exercise training program should be recommended to women with a recent acute coronary syndrome or coronary revascularization, new-onset or chronic angina, recent cerebrovascular event, peripheral arterial disease (Class I; Level of Evidence A) or current/prior symptoms of heart failure and an LVEF Յ35% (Class I; Level of Evidence B). Dietary intake 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 avoid trans-fatty 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 (e.g., shark, swordfish, king mackerel, or tile fish). Weight maintenance/reduction 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 (e.g., BMI Ͻ25 kg/m2 in U.S. women), waist size (e.g., Ͻ35 in), or other target metric of obesity. (Class I; Level of Evidence B). Omega-3 fatty acids Consumption of omega-3 fatty acids in the form of fish or in capsule form (e.g., EPA 1800 mg/d) may be considered in women with hypercholesterolemia and/or hypertriglyceridemia for primary and secondary prevention (Class IIb; Level of Evidence B). Note: Fish oil dietary supplements may have widely variable amounts of EPA and DHA (likely the only active ingredients).Major risk factor interventions Blood pressure: optimal level and lifestyle An optimal blood pressure of Ͻ120/80 mm Hg 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). Blood pressure: pharmacotherapy Pharmacotherapy is indicated when blood pressure is Ն140/90 mm Hg (Ն130/80 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 treatment of high-risk women with acute coronary syndrome or MI should be with ␤-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. Lipid and lipoprotein levels: optimal levels and lifestyle The following levels of lipids and lipoproteins in women should be encouraged through lifestyle approaches: LDL-C Ͻ100 mg/dL, HDL-C Ͼ50 mg/dL, triglycerides Ͻ150 mg/dL, and non–HDL-C (total cholesterol minus HDL) Ͻ130 mg/dL (Class I; Level of Evidence B). 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 Ͻ100 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 Ͼ20% (Class I; Level of Evidence B). A reduction to Ͻ70 mg/dL is reasonable in very-high-risk women (e.g., 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). (Continued) Downloaded from content.onlinejacc.org by on March 13, 2011
  • 12. JACC Vol. 57, No. 12, 2011 Mosca et al. 11March 22, 2011:000–000 Guidelines for the Prevention of CVD in Women—2011 UpdateTable 4. Continued Lipids: pharmacotherapy for LDL-C lowering, other at-risk women LDL-C–lowering with lifestyle therapy is useful if LDL-C level is Ն130 mg/dL, there are multiple risk factors, and the 10-y absolute CHD risk is 10% to 20% (Class I; Level of Evidence B). LDL-C lowering is useful with lifestyle therapy if LDL-C level is Ն160 mg/dL and multiple risk factors even if 10-y absolute CHD risk is Ͻ10% (Class I; Level of Evidence B). LDL-C lowering with lifestyle therapy is useful if LDL 190 mg/dL regardless of the presence or absence of other risk factors or CVD (Class I; Level of Evidence B). In women Ͼ60 y of age and with an estimated CHD risk Ͼ10%, statins could be considered if hsCRP is Ͼ2 mg/dL after lifestyle modification and no acute inflammatory process is present (Class IIb; 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 (Ͻ50 mg/dL) or non–HDL-C is elevated (Ͼ130 mg/dL) in high-risk women after LDL-C goal is reached (Class IIb; Level of Evidence B). Diabetes mellitus Lifestyle and pharmacotherapy can be useful in women with diabetes mellitus to achieve an HbA1C Ͻ7% if this can be accomplished without significant hypoglycemia (Class IIa; Level of Evidence B).Preventive drug interventions Aspirin: high-risk women Aspirin therapy (75–325 mg/d) should be used in women with CHD unless contraindicated (Class I; Level of Evidence A). Aspirin therapy (75–325 mg/d) 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). Aspirin: other at-risk or healthy women Aspirin therapy can be useful in women Ն65 y of age (81 mg daily or 100 mg every other day) if blood pressure is controlled and benefit for ischemic stroke and MI prevention is likely to outweigh risk of gastrointestinal bleeding and hemorrhagic stroke (Class IIa; Level of Evidence B) and may be reasonable for women Ͻ65 y of age for ischemic stroke prevention (Class IIb; Level of Evidence B). Aspirin: atrial fibrillation Aspirin 75–325 mg should be used in women with chronic or paroxysmal atrial fibrillation with a contraindication to warfarin or at low risk of stroke (Ͻ1%/y or CHADS2 score of Ͻ2) (Class I; Level of Evidence A). Warfarin: atrial fibrillation For women with chronic or paroxysmal atrial fibrillation, warfarin should be used to maintain the INR at 2.0 to 3.0 unless they are considered to be at low risk for stroke (Ͻ1%/y or high risk of bleeding) (Class I; Level of Evidence A). Dabigatran: atrial fibrillation Dabigatran is useful as an alternative to warfarin for the prevention of stroke and systemic thromboembolism in patients with paroxysmal to permanent AF and risk factors for stroke or systemic embolization who do not have a prosthetic heart valve or hemodynamically significant valve disease, severe renal failure (creatinine clearance 15 mL/min), or advanced liver disease (impaired baseline clotting function) (Class I; Level of Evidence B). ␤-Blockers ␤-Blockers should be used for up to 12 mo (Class I; Level of Evidence A) or up to 3 y (Class I; Level of Evidence B) in all women after MI or ACS with normal left ventricular function unless contraindicated. Long-term ␤-blocker therapy should be used indefinitely for women with left ventricular failure unless contraindications are present (Class I; Level of Evidence A). Long-term ␤-blocker therapy may be considered in other women with coronary or vascular disease and normal left ventricular function (Class IIb; Level of Evidence C). ACE inhibitors/ARBs ACE inhibitors should be used (unless contraindicated) in women after MI and in those with clinical evidence of heart failure, LVEF Յ40%, or diabetes mellitus (Class I; Level of Evidence A). In women after MI and in those with clinical evidence of heart failure, an LVEF Յ40%, or diabetes mellitus who are intolerant of ACE inhibitors, ARBs should be used instead (Class I; Level of Evidence B). Note: ACE inhibitors are contraindicated in pregnancy and ought to be used with caution in women who may become pregnant. Aldosterone blockade Use of aldosterone blockade (e.g., spirololactone) after MI is indicated in women who do not have significant hypotension, renal dysfunction, or hyperkalemia who are already receiving therapeutic doses of an ACE inhibitor and ␤-blocker and have LVEF Յ40% with symptomatic heart failure (Class I; Level of Evidence B). LVEF indicates left ventricular ejection fraction; BMI, body mass index; EPA, eicosapentaenoic acid; DHA, docosahexaenoic acid; ACE, angiotensin-convertingenzyme; ARB, angiotensin receptor blocker; LDL-C, low-density lipoprotein cholesterol; HDL-C, high-density lipoprotein cholesterol; CHD, coronary heart disease; CVD,cardiovascular disease; ACS, acute coronary syndrome; hsCRP, high-sensitivity C-reactive protein; HbA1C, hemoglobin A1C; MI, myocardial infarction; CHADS2,Congestive Heart Failure, Hypertension, Age, Diabetes, Prior Stroke; and INR, international normalized ratio. Downloaded from content.onlinejacc.org by on March 13, 2011
  • 13. 12 Mosca et al. JACC Vol. 57, No. 12, 2011 Guidelines for the Prevention of CVD in Women—2011 Update March 22, 2011:000–000ducted by the AHA librarian. Class III recommendations ever, some cost-effectiveness analyses with Markov or sim-from the 2007 guidelines update were not searched because ulation modeling presented gender-specific or women-onlyof consensus by the expert panel members that data remained data (126 –138).insufficient for modification (ie, menopausal therapy, antiox- Often the cost inputs and methodologies were insufficientlyidants, and folic acid supplementation). Some topics were not described or used resource consumption as a surrogate forincluded in the systematic search if they were covered in cost. On the basis of these analyses, aspirin appears cost-recent guidelines (e.g., treatment of atrial fibrillation for effective in women Ն65 years of age with moderate to severestroke prevention) (10). CVD risk (133–135). Antihypertensive treatments and smok- ing cessation treatments appear cost-effective for womenEvidence Rating and (126 –132). Weight management approaches, including drugRecommendation Procedures therapy and gastric bypass surgery, appear effective forSubcommittees were organized by subtopic and were charged weight loss but add costs, with decision analytic approacheswith preparation of summary evidence tables based on the noting favorable cost-effective ratios in younger and middle-updated literature review. These tables were then reviewed in aged obese women (123,137,138).series of conference calls, after which the subcommittee The expert panel emphasized the need for more cost-modified or retained the current recommendation on the basis effective analyses according to gender. Consistent with aof the discussions. Each recommendation was assigned both recent Institute of Medicine report on women’s health re-a strength of recommendation (Class I, IIa, IIb, or III) and a search, the expert panel recommends adequate participationLevel of Evidence (A, B, or C) as outlined in Table 3. The of women and reporting of gender-stratified analyses inupdated recommendations were voted on by the expert panel health research (139). The panel also emphasized the need forby individual ballot to determine by a majority vote the final reporting of gender-specific analyses for both efficacy andrating of evidence, the strength of the recommendation, and adverse effects of preventative interventions to inform theits wording. Further minor modifications to text and clinical development of future gender-specific guidelines.recommendations were based on peer review comments andcosponsor reviews. The guidelines were then finalized and Acknowledgmentsapproved by the expert panel (Table 4). We are greatly appreciative of Vanessa S. Perez, MLS, librarian at AHA National Center, for her expertise inCost-Effectiveness performing the extensive literature review for all the topicCost-effectiveness analyses reviewed were published between areas and Sheila M. McNallan, MPH, for her assistance2000 and 2010, focusing on randomized controlled trials and with the cost-effectiveness literature review. We are in-observational studies of omega-3 use, dietary intake, debted to Dr. Jose Maria E. Ferrer, AHA Associate␤-blocker and aspirin therapy, and management of obesity, Science and Medicine Advisor, and Dr. Cheryl L. Perkins,smoking, and hypertension in secondary and primary preven- AHA Science and Medicine Advisor, for their support intion of CVD (108 –125). Few of these studies included assisting with responses to peer review and final submis-gender-stratified or gender-specific analyses (119,122); how- sion of the manuscript.Appendix. Specific Dietary Intake Recommendations for Women Nutrient Serving Serving SizeFruits and vegetables Ն4.5 cups/d 1 cup raw leafy vegetable, 1/2 cup cut-up raw or cooked vegetable, 1/2 cup vegetable juice; 1 medium fruit, 1/4 cup dried fruit, 1/2 cup fresh, frozen, or canned fruit, 1/2 cup fruit juiceFish 2/wk 3.5 oz, cooked (preferably oily types of fish)Fiber 30 g/d (1.1 g/10 g carbohydrate) Bran cereal, berries, avocado, etc.Whole grains 3/d 1 slice bread, 1 oz dry cereal, 1/2 cup cooked rice, pasta, or cereal (all whole-grain products)Sugar Յ5/wk (Յ450 kcal/wk from 1 tablespoon sugar, 1 tablespoon jelly or jam, 1/2 cup sorbet, 1 cup lemonade sugar-sweetened beverages)Nuts, legumes, and seeds Ն4/wk 1/3 cup or 1 1/2 oz nuts (avoid macadamia nuts and salted nuts), 2 tablespoons peanut butter, 2 tablespoon or 1/2 oz seeds, 1/2 cup cooked legumes (dry beans and peas)Saturated fat Ͻ7%/total energy intake Found in fried foods, fat on meat or chicken skin, packaged desserts, butter, cheese, sour cream, etc.Cholesterol Ͻ150 mg/d Found in animal meats, organ meats, eggs, etc.Alcohol Յ1/d 4 oz wine, 12 oz beer, 1.5 oz of 80-proof spirits, or 1 oz of 100-proof spiritsSodium Ͻ1,500 mg/dTrans-fatty acids 0 0 Note: The recommended serving amounts are based on a 2,000-kcal diet, and recommendations vary according to individual preference and needs (141). Note for Vitamin D: It is expected that ongoing research regarding the role of vitamin D supplementation in the prevention of cardiovascular disease will shed furtherlight on this issue for future versions of this guideline (142). Downloaded from content.onlinejacc.org by on March 13, 2011
  • 14. JACC Vol. 57, No. 12, 2011 Mosca et al. 13March 22, 2011:000–000 Guidelines for the Prevention of CVD in Women—2011 Update DisclosuresWriting Group DisclosuresWriting Group Other Research Speakers’ Bureau/ Ownership Consultant/Member Employment Research Grant Support Honoraria Expert Witness Interest Advisory Board OtherLori Mosca Columbia University None None None None None None NoneEmelia J. Boston University Itamar Medical†; None None None None None NoneBenjamin Schools of Medicine NIH: NHLBI/NIA† and Public HealthKathy Berra Stanford University None None Boehringer-Ingelheim*; None None Aspirin Task Force None Novartis*; Pfizer* (Partnership for Prevention)*Judy L. American Heart None None None None None None NoneBezanson AssociationRowena J. Duke University AHRQ†; NIH† None None None None None NoneDolorDonald M. Northwestern University None None Pfizer* None None None NoneLloyd-JonesL. Kristin Duke University Amgen†; None None None None None NoneNewby Medical Center Amylin*; AstraZeneca*; diaDexus†; GlaxoSmithKline† Merck & Company†; Schering Plough (now owned by Merck)†Ileana L. Piña Case Western Reserve NIH* None AstraZeneca*; Boehringer None None FDA;* None University Ingelheim*; Innovia*; GE Healthcare† Merck*; Otuska*; Sanofi- Aventis*; Solvay*Véronique L. Mayo Clinic Rochester None None None None None None NoneRogerLeslee J. Emory University Bracco None None None None None NoneShaw Diagnostics;† GE Healthcare†Dong Zhao Capital Medical None None Presented ЉWomen’s None None None None University/Beijing HealthЉ to a group of Anzhen Hospital/Beijing female cardiologists from Institute of Heart, Lung, Ϸ20 hospitals in Beijing. and Blood Vessel This lecture was Diseases organized by Woman Physician Association but sponsored by Novartis*Theresa M. University of South None None None None None None NoneBeckie FloridaCheryl Wake Forest University NIH Bristol-Myers None None None None NoneBushnell Health Sciences KO2NS058760, Squibb, co-PI PI, Sex for AVAIL Differences in Registry† Markers of Vascular Risk†Jeanine Columbia University None None None None None None NoneD’ArmientoPenny M. Pennsylvania State None USDA, PI on None None None WomenHeart NoneKris-Etherton University “Development, Advisory Board Implementation, Member* and Testing Educational programs to Track Weight Loss using the 2005 Dietary GLs in Premenopausal Women”† (Continued) Downloaded from content.onlinejacc.org by on March 13, 2011
  • 15. 14 Mosca et al. JACC Vol. 57, No. 12, 2011 Guidelines for the Prevention of CVD in Women—2011 Update March 22, 2011:000–000Writing Group Disclosures, ContinuedWriting Group Other Research Speakers’ Bureau/ Ownership Consultant/Member Employment Research Grant Support Honoraria Expert Witness Interest Advisory Board OtherJing Fang CDC None None None None None None NoneTheodore G. UCSD Amgen*; NIH* None None Witness for None American NoneGaniats plaintiff in Academy of case about Family Physicians; failure to give American College DVT of Cardiology*; prophylaxis* American Heart Association*Antoinette S. UCLA School of None None None None None None NoneGomes MedicineClarisa R. University of None None None None None None NoneGracia PennsylvaniaConstance K. University of Florida None None None None None None NoneHaan College of Medicine– JacksonvilleElizabeth A. University of Michigan NIH†; University None ACC*; McKesson*; None None ACC*; McKesson*; NoneJackson Health System of Michigan PriMed* PriMed* Cardiovascular Center†Debra R. Cardiovascular Medical None None None Expert on None None NoneJudelson Group of Southern Seroquel for California AstraZeneca (no case, deposition or trial)†; expert on fentanyl for ALZA/Johnson & Johnson (no case, deposition, or trial)†; addendum: deposition fentanyl case: Auburn vs Johnson & Johnson et al., no trial)†; addendum: expert on OrthoEvra for Johnson & Johnson et al., deposition Crespin v. Johnson & Johnson et al., no trial)Ellie Drexel University None None Genzyme Corp* None None Genzyme Corp* NoneKelepouris College of MedicineCarl J. Lavie Ochsner Health System None None Abbott Laboratories†; None None None None GlaxoSmithKline†; Pfizer†Anne Moore Vanderbilt School of None None Bayer*; Teva None None Bayer*; Teva None Nursing Pharmaceuticals* Pharmaceuticals*Nancy A. SUNY Upstate Medical Conmed*; Nonin* None Schering Plough* None None Novo Nordisk*; NoneNussmeier University Schering Plough*Elizabeth Ofili Morehouse School of Bristol Myers None Novartis† None None Merck & Co*; None Medicine Squibb†; NIH† Novartis*; Sanofi AventisSuzanne University of Alabama None None None None None None NoneOparil at BirminghamPamela Johns Hopkins Bristol-Myers None None None None Society of NoneOuyang University Squibb†; NIH† Women’s Health Research, ISIS Fund CVD Network* (Continued) Downloaded from content.onlinejacc.org by on March 13, 2011

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