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The ABCs of the AHA/ACC Prevention Guidelines Alessandra Calvo-Friedman, Andrew DeFilippis, MD, Ty Gluckman MD, Dominique Ashen, CRNP, PhD, Roger Blumenthal,

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Presentation on theme: "The ABCs of the AHA/ACC Prevention Guidelines Alessandra Calvo-Friedman, Andrew DeFilippis, MD, Ty Gluckman MD, Dominique Ashen, CRNP, PhD, Roger Blumenthal,"— Presentation transcript:

1 The ABCs of the AHA/ACC Prevention Guidelines Alessandra Calvo-Friedman, Andrew DeFilippis, MD, Ty Gluckman MD, Dominique Ashen, CRNP, PhD, Roger Blumenthal, MD, Johns Hopkins Ciccarone Preventive Cardiology Center

2 Definition Primary Prevention: Modification of risk factors or prevent their development to prevent or delay the onset of CHD. Secondary Prevention: Initiation of Rx to reduce recurrent CHD events in patients with CHD. Primary and a Half Prevention*: As individuals with subclinical CHD are identified, the distinction between primary and secondary prevention becomes blurred. *Celermajer DS. JACC 2005;45:1994-6 CHD=Coronary heart disease

3 Aspirin Recommendations Aspirin (75-162 mg daily) in intermediate risk men with a 10 year risk of CHD >10%. Aspirin (75-162 mg daily) in intermediate risk women > 65 yrs with a 10 yr risk of CHD >10% Aspirin in low risk women with a 10 year risk of CHD <10%. Primary Prevention CHD=Coronary heart disease

4 Aspirin Recommendations (Continued) Aspirin (75-325 mg daily) in those with known CHD or carotid artery or leg artery narrowings due to plaque. Aspirin (100-325 mg daily) in those that have undergone CABG surgery*. Secondary Prevention CABG=Coronary artery bypass graft, CHD=Coronary heart disease *To be administered within the first 48 hours after surgery in order to reduce the risk of saphenous vein graft failure. Doses >162 mg/day may be continued for up to one year.

5 Aspirin Evidence: Primary Prevention in Men Physicians Health Study (PHS) 22,071 men randomized to aspirin (325mg every other day) followed for an average of 5 years Aspirin significantly reduces the risk of MI in men Physicians Health Study Research Group. NEJM 1989;321:129-35 CI=Confidence interval, MI=Myocardial infarction

6 Aspirin Evidence: Primary Prevention in Women Womens Health Study (WHS) Cumulative Incidence of MI Placebo Aspirin P=0.83 Ridker P et al. NEJM 2005; 352:1293-204 MI=Myocardial infarction Years 39,876 women randomized to aspirin (100 mg every other day) or placebo for an average of 10 years Aspirin doesnt reduce the risk of MI in women

7 Clopidogrel Evidence: Secondary Prevention Clopidogrel in Unstable Angina to Prevent Recurrent Events (CURE) Trial 369012 Rate of death, myocardial infarction, or stroke P<0.001 Months of Follow Up The CURE Trial Investigators. NEJM. 2001;345:494-502 DAP=Dual antiplatelet therapy, NSTE-ACS=Non ST- segment elevation acute coronary syndrome Aspirin + Clopidogrel Aspirin + Placebo 12,562 patients with a NSTE-ACS randomized to daily aspirin (75-325 mg) or clopidogrel (300 mg load, 75 mg thereafter) plus aspirin for 9 months

8 ACE Inhibitor Recommendations An ACE inhibitor in those following a MI, regardless of EF or in those with CAD* along with hypertension (SBP >120 mmHg), LVSD (EF <0.40), heart failure, DM, or CKD. Optional use of an ACE inhibitor in those with low risk CAD*, well controlled CV risk factors, a normal EF, and successful revascularization. Secondary Prevention *Defined by previous MI or angiographically significant CAD. ACE=Angiotensin converting enzyme, CAD=Coronary artery disease, CKD=Chronic kidney disease, CV=Cardiovascular, DM=Diabetes mellitus, EF=Ejection fraction, LVSD=Left ventricular systolic dysfunction, MI=Myocardial infarction, SBP=Systolic blood pressure

9 Days of Follow-Up CV death, MI, or stroke (%) 22% RRR, P<0.001 0.00 0.05 0.10 0.15 0.20 050010001500 ACE Inhibitor Evidence: Secondary Prevention Placebo Ramipril HOPE Investigators. NEJM 2000;342:145-153 Heart Outcomes Prevention and Evaluation (HOPE) Study ACE-I=Angiotensin converting enzyme inhibitors, DM=Diabetes mellitus, CV=Cardiovascular, HF=Heart failure, LVSD=Left ventricular systolic dysfunction, MI=Myocardial infarction 9,297 patients with DM or vascular disease plus one additional CV risk factor, but without HF or known LVSD randomized to ramipril (10 mg) or placebo for 5 years ACE-I reduce CV events in high-risk individuals

10 Digitalis: Recommendations Digitalis in those with symptomatic HF and LVSD (EF <45%) to reduce hospitalizations for HF*. Digitalis in those with asymptomatic LVSD and normal sinus rhythm. Secondary Prevention EF=Ejection fraction, HF=Heart failure, LVSD=Left ventricular systolic function *Contraindications include significant sinus or atrioventricular block unless a permanent pacemaker is present.

11 ACE Inhibitor Evidence: Secondary Prevention Prevention of Events with Angiotensin Converting Enzyme Inhibition (PEACE) Trial Primary End Point (%)* 30 25 20 15 10 5 0 0 1 2 3 4 5 6 Years After Randomization Placebo Trandolapril PEACE Trial Investigators. NEJM 2004;351:2058-2068 *Includes death from cardiovascular causes, myocardial infarction, or coronary revascularization 8,290 patients with stable coronary artery disease and normal left ventricular function randomized to trandolapril (4 mg) or placebo for 5 years ACE-I do not reduce CV events in low-risk individuals

12 ACE Inhibitor Evidence: Secondary Prevention Comparison between the HOPE and PEACE trials Patients enrolled in the PEACE trial were at lower risk* MI, Cardiac death, or Stroke (%) Braunwald, E. et al., NEJM 2004;351:2058-68. CHD=Coronary heart disease, MI=Myocardial infarction *Reflects greater blood pressure control, revacularization, and use of other risk-reducing medications (i.e., antiplatelet therapy, -blocker, lipid-lowering medication) Years

13 Probability of Event 0 0.05 0.15 0.2 0.25 0.3 0123 0.35 0.4 4 ACE-I Placebo OR: 0.74 (0.66–0.83) 0.1 Flather MD, et al. Lancet. 2000;355:1575–1581 SAVE Radionuclide EF 40% AIRE Clinical and/or radiographic signs of HF TRACE Echocardiogram EF 35% ACE Inhibitor Evidence: Secondary Prevention ACE-I=Angiotensin converting enzyme inhibitors, LVSD=Left ventricular systolic dysfunction, MI=Myocardial infarction, OR=Odds ratio ACE-I provide substantial benefit in post-MI LVSD

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16 Provides information on response to therapy. May help improve adherence to therapy and evaluate white-coat HTN. Self-measurement Indicated for evaluation of white-coat HTN. Absence of 10–20% BP decrease during sleep may indicate increased CVD risk. Ambulatory BP monitoring Two readings, 5 minutes apart, sitting in chair. Confirm elevated reading in contralateral arm. In-office Brief Description Method JNC VII Guidelines for Measurement of BP BP=Blood pressure, CVD=Cardiovascular disease, HTN=Hypertension Chobanian AV et al. JAMA. 2003;289:2560-2572

17 Percent hypertensive 18-29 National Health and Nutrition Examination Survey (NHANES) III 30-3940-49 50-59 60-6970-7980+ Age 3% 9% 18% JNC-VI. Arch Intern Med. 1997;157:2413-2446 Blood Pressure: Risk Increases with Age 51% 66% 72% 38% Hypertension defined as blood pressure >140/90 mmHg or treatment

18 Prospective Studies Collaboration. Lancet. 2002;360:1903-1913 Usual Diastolic BP (mm Hg)Usual Systolic BP (mm Hg) Ischemic Heart Disease Mortality 50-59 60-69 70-79 80-89 Age at Risk (Y) 40-49 256 128 64 32 16 8 4 2 1 0 120140160180 50-59 60-69 70-79 80-89 Age at Risk (Y) 40-49 256 128 64 32 16 8 4 2 1 0 809010011070 Blood Pressure: Lower is Better Ischemic Heart Disease Mortality BP=Blood pressure

19 JNC VII Causes of Secondary Hypertension Medical Conditions Chronic kidney disease Primary hyperaldosteronism Renovascular disease Chronic steroid therapy Cushings syndrome Pheochromocytoma Aortic coarctation Thyroid or parathyroid disease Sleep apnea Drugs NSAIDS Oral contraceptives Adrenal steroids Sympathomimetics Cyclosporine or tacrolimus Erythropoietin Ephedra, mu huang, bitter orange Cocaine or amphetamines Alcohol Chobanian AV et al. JAMA. 2003;289:2560-2572 NSAIDS=Non-steroidal anti-inflammatory drugs

20 ModificationRecommendationApproximate SBP Reduction Range Weight reductionMaintain normal body weight (BMI=18.5-24.9) 5-20 mmHg/10 kg weight lost Adopt DASH eating plan Diet rich in fruits, vegetables, low fat dairy and reduced in fat 8-14 mmHg Restrict sodium intake <2.4 grams of sodium per day2-8 mmHg Physical activityRegular aerobic exercise for at least 30 minutes on most days of the week 4-9 mmHg Moderate alcohol consumption <2 drinks/day for men and <1 drink/day for women 2-4 mmHg JNC VII Lifestyle Modifications for BP Control Chobanian AV et al. JAMA. 2003;289:2560-2572 BMI=Body mass index, SBP=Systolic blood pressure

21 Two-drug combination for most (usually thiazide-type diuretic and ACEI or ARB or BB or CCB). Yes>100 >160Stage 2 Hypertension Drug(s) for the compelling indications. Other antihypertensive drugs (diuretics, ACEI, ARB, BB, CCB) as needed. Thiazide-type diuretics for most. May consider ACEI, ARB, BB, CCB, or combination. Yes90–99140–159Stage 1 Hypertension Drug(s) for compelling indications. No antihypertensive drug indicated. Yes80–89120–139Prehypertension Encourage<80<120Normal With compelling indications Without compelling indication Initial drug therapy Lifestyle modification DBP* mmHg SBP* mmHg BP classification JNC VII Guidelines for Management and Treatment and or ACEI=Angiotensin converting enzyme inhibitor, ARB=Angiotensin receptor blocker, BB= -blocker, BP=Blood pressure, CCB=Calcium channel blocker, DBP=Diastolic blood pressure, SBP=Systolic blood pressure Chobanian AV et al. JAMA. 2003;289:2560-2572 *Treatment determined by highest blood pressure category. Initial combined therapy should be used cautiously in those at risk for orthostatic hypotension. Treat patients with chronic kidney disease or diabetes mellitus to blood pressure goal of <130/80 mmHg.

22 Blood Pressure Recommendations Secondary Prevention Initiation or maintenance of lifestyle modification in those with a BP >120/80 mmHg. Use of an ACE inhibitor and/or -blocker in those with a BP >140/90 mmHg*. Other drugs (i.e., thiazide diuretics) should be added in order to achieve the desired BP. ACE=Angiotensin converting enzyme, BP=Blood pressure, CKD=Chronic kidney disease, DM=Diabetes mellitus *A BP >130/80 mmHg should be used for individuals with CKD or DM

23 Blood Pressure Evidence: Primary Prevention 01234567 0.04.08.12.16.20 RR(95% CI)P-value A/C0.98(0.90-1.07)0.65 L/C0.99(0.91-1.08)0.81 Rate of MI or fatal CHD Antihypertensive and Lipid-Lowering Treatment to Prevent Heart Attack Trial (ALLHAT) ALLHAT Investigators. JAMA. 2002;288:2981-97 Years to CHD Event BP=Blood pressure, CHD=Coronary heart disease, HTN=Hypertension, MI=Myocardial infarction Chlrothalidone Amlodipine Lisinopril 33,357 patients with HTN and >1 CHD risk factor randomized to chlorthalidone, amlodipine, or lisinopril for 5 years There is similar efficacy among BP lowering agents

24 0 612182430364248546066 Study Month 4 8 12 16 0 Proportion with CV death, MI, or stroke (%) Blood Pressure Evidence: Primary Prevention Losartan Intervention for Endpoint (LIFE) Reduction in Hypertension Study Dahlöf B et al. Lancet. 2002;359:995-1003. Atenolol Losartan 13% RRR, P=0.021 ARBS=Angiotensin receptor blocker strategy, CV=Cardiovascular, DBP=Diastolic blood presure, LVH=Left ventricular hypertrophy, MI=Myocardial infarction, SBP=Systolic blood pressure *Defined by SBP=160-200 mmHg or DBP=95-115 mmHg 9,193 high-risk hypertensive* patients with LVH randomized to losartan (100 mg) or atenolol (100 mg) for 5 years An ARB provides greater efficacy in patients with LVH

25 Nissen S et al. JAMA 2004;292:2217-26. Blood Pressure Evidence: Secondary Prevention Comparison of Amlodipine vs Enalapril to Limit Occurrences of Thrombosis (CAMELOT) Trial *Includes CV death, MI, cardiac arrest, coronary revascularization, hospitalization for HF or angina pectoris, stroke, TIA, development of PAD CV event rate* 0 0.25 0.20 0.10 0.05 6121824 0.15 0 Placebo Amlodipine Enalapril Months Follow-up BP (mmHg) 125/77 124/77 130/78 BP=Blood pressure, CAD=Coronary artery disease, CV=Cardiovascular, DBP=Diastolic blood pressure, HF=Heart failure, MI=Myocardial infarction, PAD=Peripheral arterial disease, TIA=Transient ischemic attack 1,991 patients with CAD and a DBP <100 mmHg randomized to amloidipine (10 mg), enalapril (20 mg), or placebo for 2 years A BP <130/80 mmHg is associated with fewer CV events

26 A -blocker in all patients following a MI. A beta-blocker in all patients with LVSD. A -blocker in those with other forms of CV disease or DM, unless contraindicated. *Relative contraindications include asthma, chronic obstructive pulmonary disease, insulin dependent diabetes mellitus, severe peripheral arterial disease, and a PR interval >0.24 seconds. CV=Cardiovascular, DM=Diabetes mellitus, LVSD=Left ventricular systolic dysfunction, MI=Myocardial infarction -blocker Recommendations* -blocker Recommendations* Secondary Prevention

27 Phase of Treatment Acute treatment Secondary prevention Overall Total # Patients 28,970 24,298 53,268 0.51.02.0 RR of death -blocker better RR (95% CI) Placebo better 0.87 (0.77-0.98) 0.77 (0.70-0.84) 0.81 (0.75-0.87) -blocker Evidence: Secondary Prevention -blocker Evidence: Secondary Prevention Antman E, Braunwald E. Acute Myocardial Infarction. In: Braunwald E, Zipes DP, Libby P, eds. Heart Disease: A textbook of Cardiovascular Medicine, 6th ed., Philadelphia, PA: W.B. Sanders, 2001, 1168. Summary of Secondary Prevention Trials of -blocker Therapy CI=Confidence interval, RR=Relative risk

28 Secondary Prevention Cholesterol Management Guidelines Restriction of saturated fat (<7% of total calories) and cholesterol (<200 mg/day) in all patients. Promotion of daily physical activity and weight management in all patients. Increase in -3 fatty acid consumption in all patients. LDL-C=Low density lipoprotein cholesterol

29 Secondary Prevention Cholesterol Management Guidelines (Continued) Initiation or intensification of LDL-C lowering drug therapy in those with a baseline or on- treatment LDL-C level >100 mg/dl. Initiation of LDL-C lowering drug therapy in those with a baseline LDL-C level <100 mg/dl based on clinical judgment. LDL-C=Low density lipoprotein cholesterol

30 Cholesterol Management Guidelines (Continued) Goals Recommendations As set forth by the Adult Treatment Panel III (ATP III) National Cholesterol Education Program (NCEP) Obtain a fasting lipid profile in all patients. For those with a myocardial infarction, a fasting lipid profile should be obtained within 24 hrs of admission. Start therapeutic lifestyle changes in all patients, including: Reduced intakes of saturated fats (<7% of total calories) and cholesterol (<200 mg/day) Addition of plant stanols/sterols (2 g/day) and viscous fiber (10-25 g/day) to enhance LDL-C lowering Weight reduction Increased physical activity Expert Panel on Detection, Evaluation, and Treatment of High Blood Cholesterol in Adults. JAMA 2001;285:2486.

31 Cholesterol Management Guidelines (Continued) Goals Recommendations As set forth by the Adult Treatment Panel III (ATP III) National Cholesterol Education Program (NCEP) For primary and secondary prevention, HMG-coA reductase inhibitors (statins) should be first-line in order to achieve the LDL-C goal. For those that remain above the LDL-C goal, statin therapy should be intensified along with the addition of a second LDL-C lowering agent if needed. If the TG level is >150 mg/dl or HDL-C level is <40 mg/dl, emphasize weight management, physical activity, and smoking cessation. If the TG level is 200-499 mg/dl after initiation of LDL-C lowering therapy, consider adding nicotinic acid or a fibrate. If the TG level is >500 mg/dl, consider adding nicotinic acid or a fibrate before LDL-C lowering therapy. Expert Panel on Detection, Evaluation, and Treatment of High Blood Cholesterol in Adults. JAMA 2001;285:2486. TG=Triglyceride

32 01020 2 RFs 0-1 RF CAD or Risk Equivalent** Risk Profile Assessment for LDL-C Lowering A risk assessment tool* is needed for individuals with >2 RFs Expert Panel on Detection, Evaluation, and Treatment of High Blood Cholesterol in Adults. JAMA 2001;285:2486. CAD=Coronary artery disease, CHD=Coronary heart disease, DM=Diabetes mellitus, RF=Risk factor **Includes DM, non-coronary atherosclerotic vascular disease, and >20% 10-year CHD risk by the FRS *Such as the Framingham Risk Score (FRS) 10-year CHD Risk

33 Passed torch: President and Mrs. Clinton exit McDonalds after his symbolic passage of leadership.

34 YearsPoints 20-34-9 35-39-4 40-440 45-493 50-546 55-598 60-6410 65-6911 70-7412 75-7913 Step 1: Age Points TC (mg/dl) Age 20-39 Age 40-49 Age 50-59 Age 60-69 Age 70-79 <16000000 160-19943210 200-23975310 240-27996421 >280118531 Framingham Risk Score: Men Step 2: Total Cholesterol Points HDL-C (mg/dl)Points >60 50-590 40-491 <402 Step 3: HDL-C Points SBP (mmHg) If untreat ed If treated <12000 120-12901 130-13912 140-15912 >16023 Step 4: SBP Points Age 20-39 Age 40-49 Age 50-59 Age 60-69 Age 70-79 Nonsmoker00000 Smoker85311 Step 5: Smoking Status Points Age Total Cholesterol HDL-C Systolic Blood Pressure Smoking Status Point Total Step 6: Sum of Points Point Total 10-year Risk Point Total 10-year Risk Point Total 10-year Risk <0<1%62%1312% 01%73%1416% 11%84%1520% 21%95%1625% 31%106%>17>30% 41%118% 52%1210% Step 7: 10-year CHD Risk

35 YearsPoints 20-34-7 35-39-3 40-440 45-493 50-546 55-598 60-6410 65-6912 70-7414 75-7916 Step 1: Age Points TC (mg/dl) Age 20-39 Age 40-49 Age 50-59 Age 60-69 Age 70-79 <16000000 160-19943211 200-23986421 240-279118532 >2801310742 Framingham Risk Score: Women Step 2: Total Cholesterol Points HDL-C (mg/dl)Points >60 50-590 40-491 <402 Step 3: HDL-C Points SBP (mmHg) If untreat ed If treated <12000 120-12913 130-13924 140-15935 >16046 Step 4: SBP Points Age 20-39 Age 40-49 Age 50-59 Age 60-69 Age 70-79 Nonsmoker00000 Smoker97421 Step 5: Smoking Status Points Age Total Cholesterol HDL-C Systolic Blood Pressure Smoking Status Point Total Step 6: Sum of Points Point Total 10-year Risk Point Total 10-year Risk Point Total 10-year Risk <9<1%153%2217% 91%164%2322% 101%175%2427% 111%186%>25>30% 121%198% 132%2011% 142%2114% Step 7: 10-year CHD Risk

36 Risk CategoryLDL-C GoalInitiate TLC Consider Drug Therapy High risk: CHD or CHD risk equivalents (10-year risk >20%) <100 mg/dL (optional goal: <70 mg/dL) 100 mg/dL >100 mg/dL (<100 mg/dL: consider drug options) Moderately high risk: 2+ risk factors* (10-year risk 10% to 20%) <130 mg/dL (optional goal: <100 mg/dL) 130 mg/dL >130 mg/dL (100-129 mg/dL: consider drug options) Moderate risk: 2+ risk factors* (10 year risk <10%) <130 mg/dL 130 mg/dL >160 mg/dL Lower risk: 0-1 risk factor* <160 mg/dL 160 mg/dL >190 mg/dL (160-189 mg/dL: LDL- lowering drug optional) Grundy, S. et al. Circulation 2004;110:227-39. ATP III LDL-C Goals and Cut-points for Drug Therapy ATP=Adult Treatment Panel, CHD=Coronary heart disease, LDL-C=Low-density lipoprotein cholesterol, TLC=Therapeutic lifestyle changes *Risk factors for cardiovascular disease include: cigarettes smoking, hypertension (blood pressure >140/90 mmHg or on antihypertensive medication, HDL-C 60 mg/dl is a negative risk factor), family history of premature CHD, age >45 years in men or >55 years in women.

37 Primary Therapies to Lower LDL-C ClassDrug(s) 3-Hydroxy-3-Methylglutaryl Coenzyme A (HMG-CoA) reductase inhibitors [Statins] Atorvastatin (Lipitor) Fluvastatin (Lescol XL) Lovastatin (generic and Mevacor) Pravastatin (Pravachol) Rosuvastatin (Crestor) Simvastatin (Zocor) Bile acid sequestrantsCholestyramine (generic and Questran) Colesevelam (Welchol) Colestipol (Colestid) Cholesterol absorption inhibitorEzetimibe (Zetia) Dietary AdjunctsSoluble fiber Soy protein Stanol esters

38 Illingworth DR. Med Clin North Am. 2000;84:23- 42. HMG-CoA Reductase Inhibitor: Dose-Dependent Effect The Rule of 6s Each doubling of the statin dose produces an additional 6% reduction in the LDL-C level

39 HMG-CoA Reductase Inhibitor: Primary Prevention West of Scotland Coronary Prevention Study (WOSCOPS) CHD=Coronary heart disease, MI=Myocardial infarction, RRR=Relative risk reduction Shepherd J et al. NEJM 1995;333:1301-1307 Placebo 7.5 Pravastatin 9 6 3 0 5.3 P<0.001 31% RRR Rate of MI or CHD death (%) 6,595 men with moderate hypercholesterolemia randomized to pravastatin (40 mg) or placebo for 5 years Statins provide significant benefit in those with average cholesterol levels

40 Rate of MI, unstable angina, or SCD (%) Placebo 5.5 Lovastatin 6 4 2 0 3.5 HMG-CoA Reductase Inhibitor: Primary Prevention Air Force/Texas Coronary Atherosclerosis Prevention Study (AFCAPS/TexCAPS) P<0.001 37% RRR MI=Myocardial infarction, RRR=Relative risk reduction, SCD=Sudden cardiac death Downs JR et al. JAMA 1998;279(20):1615–1622 6,605 patients with average LDL-C levels randomized to lovastatin (20-40 mg) or placebo for 5.2 years Statins provide significant benefit in those with average LDL-C levels

41 Anglo-Scandinavian Cardiac Outcomes TrialLipid Lowering Arm (ASCOT-LLA) Sever PS et al. Lancet. 2003;361:1149-1158 0 1 2 3 4 0.00.51.01.52.02.53.03.5 Atorvastatin 90 mg/dl* Placebo 126 mg/dl* P=0.0005 Cumulative incidence of MI and fatal CHD (%) Follow-up (yr) 36% RRR *Post-treatment LDL-C level 10,305 patients with hypertension randomized to atorvastatin (10 mg) or placebo for 5 years Statins provide significant benefit in moderate- to high-risk individuals by lowering LDL-C levels below current goals CHD=Coronary heart disease, RR=Relative risk HMG-CoA Reductase Inhibitor: Primary Prevention

42 0 5 10 15 Myocardial Ischemia Reduction with Aggressive Cholesterol Lowering Trial (MIRACL) HMG-CoA Reductase Inhibitor: Secondary Prevention 17.4% 14.8% RR=0.84, P=0.048 Combined cardiovascular event rate (%)* Weeks *Includes death, myocardial infarction, resuscitated cardiac arrest, recurrent symptomatic myocardial ischemia requiring emergency rehospitalization. 4812160 Atorvastatin Placebo Schwartz GG et al. JAMA 2001;285:1711-1718 4,162 patients with an ACS randomized to atorvastatin (80 mg) or pravastatin (40 mg) for 24 months Acute intensive therapy significantly reduces the event rate

43 Follow-up (months) 3 6 9 1215 182124 27 30 30 25 20 15 10 5 0 P =0.005 Recurrent MI or Cardiac Death 16% RRR Pravastatin or Atorvastatin Evaluation and Infection Therapy (PROVE-IT)TIMI 22 Study Atorvastatin Pravastatin ACS=Acute coronary syndrome, CV=Cardiovascular, MI=Myocardial infarction, RRR=Relative risk reduction Cannon CP et al. NEJM 2004;350:1495-1504 HMG-CoA Reductase Inhibitor: Secondary Prevention 4,162 patients with an ACS randomized to atorvastatin (80 mg) or pravastatin (40 mg) for 24 months Acute intensive therapy significantly reduces the event rate

44 HMG-CoA Reductase Inhibitor: Secondary Prevention Scandinavian Simvastatin Survival Study (4S) Mortality (%) Placebo 11.5 Simvastatin 12 8 4 0 8.2 P<0.001 30% RRR 4S Group. Lancet 1994;344:1383–1389 MI=Myocardial infarction, RRR=Relative risk reduction 4,444 patients with angina pectoris or previous MI randomized to simvastatin (20-40 mg) or placebo for 5.4 years Statins provide significant benefit in those with average LDL-C levels

45 HMG-CoA Reductase Inhibitor: Secondary Prevention Cholesterol and Recurrent Events (CARE) Study Placebo 13.2 Pravastatin 15 10 5 0 10.2 P=0.003 24% RRR Rate of MI or CHD death (%) Sacks FM et al. NEJM 1996;335:1001–1009 CHD=Coronary heart disease, MI=Myocardial infarction, RRR=Relative risk reduction 4,159 patients with a history of MI randomized to pravastatin (40 mg) or placebo for 5 years Statins provide significant benefit in those with average cholesterol levels

46 Baseline LDL-C (mg/dL) Statin (n = 10,269) Placebo (n = 10,267) <100282 (16.4%)358 (21.0%) 100–129668 (18.9%)871 (24.7%) 130 1083 (21.6%)1356 (26.9%) All patients2033 (19.8%)2585 (25.2%) Event Rate Ratio (95% CI) Statin BetterStatin Worse 0.40.60.81.01.21.4 0.76 (0.72–0.81) P<0.0001 Heart Protection Study (HPS) HMG-CoA Reductase Inhibitor: Secondary Prevention 20,536 patients with CAD, other occlusive arterial disease, or DM randomized to simvastatin (40 mg) or placebo for 5.5 years Statins provide significant benefit across a broad range of LDL-C levels CAD=Coronary artery disease, CI=Confidence interval, DM=Diabetes mellitus, HPS Collaborative Group. Lancet 2002;360:7-22

47 Illingworth DR. Med Clin North Am. 2000;84:23- 42. HMG-CoA Reductase Inhibitor: Dose-Dependent Effect The Rule of 6s Each doubling of the statin dose produces an additional 6% reduction in the LDL-C level

48 HMG-CoA Reductase Inhibitor: Primary Prevention West of Scotland Coronary Prevention Study (WOSCOPS) CHD=Coronary heart disease, MI=Myocardial infarction, RRR=Relative risk reduction Shepherd J et al. NEJM 1995;333:1301-1307 Placebo 7.5 Pravastatin 9 6 3 0 5.3 P<0.001 31% RRR Rate of MI or CHD death (%) 6,595 men with moderate hypercholesterolemia randomized to pravastatin (40 mg) or placebo for 5 years Statins provide significant benefit in those with average cholesterol levels

49 Rate of MI, unstable angina, or SCD (%) Placebo 5.5 Lovastatin 6 4 2 0 3.5 HMG-CoA Reductase Inhibitor: Primary Prevention Air Force/Texas Coronary Atherosclerosis Prevention Study (AFCAPS/TexCAPS) P<0.001 37% RRR MI=Myocardial infarction, RRR=Relative risk reduction, SCD=Sudden cardiac death Downs JR et al. JAMA 1998;279(20):1615–1622 6,605 patients with average LDL-C levels randomized to lovastatin (20-40 mg) or placebo for 5.2 years Statins provide significant benefit in those with average LDL-C levels

50 Anglo-Scandinavian Cardiac Outcomes TrialLipid Lowering Arm (ASCOT-LLA) Sever PS et al. Lancet. 2003;361:1149-1158 0 1 2 3 4 0.00.51.01.52.02.53.03.5 Atorvastatin 90 mg/dl* Placebo 126 mg/dl* P=0.0005 Cumulative incidence of MI and fatal CHD (%) Follow-up (yr) 36% RRR *Post-treatment LDL-C level 10,305 patients with hypertension randomized to atorvastatin (10 mg) or placebo for 5 years Statins provide significant benefit in moderate- to high-risk individuals by lowering LDL-C levels below current goals CHD=Coronary heart disease, RR=Relative risk HMG-CoA Reductase Inhibitor: Primary Prevention

51 0 5 10 15 Myocardial Ischemia Reduction with Aggressive Cholesterol Lowering Trial (MIRACL) HMG-CoA Reductase Inhibitor: Secondary Prevention 17.4% 14.8% RR=0.84, P=0.048 Combined cardiovascular event rate (%)* Weeks *Includes death, myocardial infarction, resuscitated cardiac arrest, recurrent symptomatic myocardial ischemia requiring emergency rehospitalization. 4812160 Atorvastatin Placebo Schwartz GG et al. JAMA 2001;285:1711-1718 4,162 patients with an ACS randomized to atorvastatin (80 mg) or pravastatin (40 mg) for 24 months Acute intensive therapy significantly reduces the event rate

52 Follow-up (months) 3 6 9 1215 182124 27 30 30 25 20 15 10 5 0 P =0.005 Recurrent MI or Cardiac Death 16% RRR Pravastatin or Atorvastatin Evaluation and Infection Therapy (PROVE-IT)TIMI 22 Study Atorvastatin Pravastatin ACS=Acute coronary syndrome, CV=Cardiovascular, MI=Myocardial infarction, RRR=Relative risk reduction Cannon CP et al. NEJM 2004;350:1495-1504 HMG-CoA Reductase Inhibitor: Secondary Prevention 4,162 patients with an ACS randomized to atorvastatin (80 mg) or pravastatin (40 mg) for 24 months Acute intensive therapy significantly reduces the event rate

53 HMG-CoA Reductase Inhibitor: Secondary Prevention Scandinavian Simvastatin Survival Study (4S) Mortality (%) Placebo 11.5 Simvastatin 12 8 4 0 8.2 P<0.001 30% RRR 4S Group. Lancet 1994;344:1383–1389 MI=Myocardial infarction, RRR=Relative risk reduction 4,444 patients with angina pectoris or previous MI randomized to simvastatin (20-40 mg) or placebo for 5.4 years Statins provide significant benefit in those with average LDL-C levels

54 HMG-CoA Reductase Inhibitor: Secondary Prevention Cholesterol and Recurrent Events (CARE) Study Placebo 13.2 Pravastatin 15 10 5 0 10.2 P=0.003 24% RRR Rate of MI or CHD death (%) Sacks FM et al. NEJM 1996;335:1001–1009 CHD=Coronary heart disease, MI=Myocardial infarction, RRR=Relative risk reduction 4,159 patients with a history of MI randomized to pravastatin (40 mg) or placebo for 5 years Statins provide significant benefit in those with average cholesterol levels

55 Baseline LDL-C (mg/dL) Statin (n = 10,269) Placebo (n = 10,267) <100282 (16.4%)358 (21.0%) 100–129668 (18.9%)871 (24.7%) 130 1083 (21.6%)1356 (26.9%) All patients2033 (19.8%)2585 (25.2%) Event Rate Ratio (95% CI) Statin BetterStatin Worse 0.40.60.81.01.21.4 0.76 (0.72–0.81) P<0.0001 Heart Protection Study (HPS) HMG-CoA Reductase Inhibitor: Secondary Prevention 20,536 patients with CAD, other occlusive arterial disease, or DM randomized to simvastatin (40 mg) or placebo for 5.5 years Statins provide significant benefit across a broad range of LDL-C levels CAD=Coronary artery disease, CI=Confidence interval, DM=Diabetes mellitus, HPS Collaborative Group. Lancet 2002;360:7-22

56 Change from Baseline Goldberg A et al. Am J Cardiol 2000;85:1100-1105 500 HDL-C LDL-C TG –9% –14% –22% –21% –17% 30% 26% 22% 15% 10% –28% –35% –44% –39% –11% –5% Nicotinic Acid: Efficacy at Raising HDL-C 1000150020002500Dose (mg)3000

57 Frick MH et al. NEJM 1987;317:1237-1245 Manninen V et al. Circulation 1992;85:37-45 BIP Study Group. Circulation 2000;102:21-27 Rubins HB et al. NEJM 1999;341:410-418 *Post hoc analysis of subgroup with TG >200 mg/dL and HDL-C <42 mg/dL. **Post hoc analysis of subgroup with TG 200 mg/dL and HDL-C <35 mg/dL. ***Difference between placebo and Rx for primary endpoint was statistically significant (p < 0.05). % CHD Death/Nonfatal MI Rx Placebo 2.7 4.1*** 4.1*** 2.7 8.0 13.6 15.0 13.0 22.3 17.3 17.3 21.7*** 66% 34% 9% 42% 22% 22% PRIMARY PREVENTIONSECONDARY PREVENTION HHSHHS*BIP BIP** VA-HIT Fibrate: Primary and Secondary Prevention

58 Complete cessation No environmental tobacco smoke exposure Cigarette Smoking Cessation Guidelines Goals Recommendations Ask about tobacco use at every visit. In a clear, strong, and personalized manner, advise the patient to stop smoking. Urge avoidance of exposure to secondhand smoke at work and home. Assess the patients willingness to quit smoking. Develop a plan for smoking cessation and arrange follow-up. Provide counseling, pharmacologic therapy, and referral to formal smoking cessation programs as indicated.

59 Smoking Cessation Pharmacotherapy* AgentCautionSide Effects DosageDurationInstructions Bupropion SR (Zyban®) Seizure disorder Eating disorder Taking MAO inhibitor Pregnancy Insomnia Dry mouth 150 mg QAM then 150 mg BID 3 days Maintenance (8 weeks, but may be used up to 6 months) Start 1-2 weeks before quit date. Take second dose in early afternoon or decrease to 150 mg QAM for insomnia. Transdermal Nicotine Patch** Within 2 weeks of a MI Unstable angina Arrhythmias Decompensated heart failure Skin reaction Insomnia 21 mg QAM 14 mg QAM 7 mg QAM or 15 mg QAM 4 weeks 2 weeks 8 weeks Apply to different hairless site daily. Remove before bed for insomnia. Start at <15 mg for <10 cigs/day *Pharmacotherapy combined with behavioral support provides the best success rate **Other nicotine replacement therapy options include: nicotine gum, lozenge, inhaler, nasal spray

60 Jorenby DE et al. NEJM 1999;340:685-91 Cigarette Smoking Cessation: Primary Prevention Placebo (n=160) NRT (n=244) Bupropion (n=244) Nicotine patch and Bupropion (n=245) Abstinence rate at 6 months 18.8%21.3%34.8% a,b 38.8% a,c,d Abstinence rate at 12 months 15.6%16.4%30.3% a,c 35.5% a,c,e a p<0.001 when compared to placebo b p=0.001 when compared to NRT c p<0.001 when compared to NRT d p=0.37 when compared to buproprion e p=0.22 when compared to buproprion NRT=Nicotine replacement therapy 893 smokers randomized to 9 weeks of buproprion (150 mg a day for 3 days and then 150 mg twice daily), NRT (21 mg patch weeks 2-7, 14 mg patch week 8, and 7 mg patch week 9), bupropion and NRT, or placebo Bupropion with or without NRT provides the greatest benefit

61 JAMA 2006:296:47-55 and JAMA 2006;296:56-63 Smoking Cessation Pharmacotherapy: Varenicline Two trials compared treatment with varenicline, a nicotine acetylcholine receptor agonist, to treatment with buproprion or placebo. These trials included a total of almost 700 participants. The mean duration of smoking was 25 years. Varenicline yielded higher rates of smoking cessation than buproprion or placebo. Study 1p<0.001 for V vs Bp<0.001 for V vs PStudy 1p<0.001 for V vs Bp<0.001 for V vs P Study 2p<0.001 for V vs Bp<0.001 for V vs PStudy 2p<0.001 for V vs Bp<0.001 for V vs P

62 Goals Recommendations Calculate BMI* and measure waist circumference as part of evaluation. Monitor response of BMI and waist circumference to therapy. BMI 18.5 to 24.9 kg/m 2 Women: <35 inches Men: <40 inches Weight Management Guidelines Start weight management and physical activity as appropriate. If BMI and/or waist circumference is above goal, initiate caloric restriction, measures to increase caloric expenditure, and treatment strategies for the metabolic syndrome. BMI=Body mass index *BMI is calculated as the weight in kilograms divided by the body surface area in meters 2. Overweight state is defined by BMI=25-30 kg/m2. Obesity is defined by a BMI >30 kg/m2. 10% weight reduction within the first year of therapy

63 Prevalence of Obesity in U.S. Adults 1991 1996 2003 % State Population No Data <10% 10%–14% 15%–19% 20%–24% 25% Source: CDC Overweight and Obesity

64 Mhurchu N et al. Int J Epidemiol 2004;33:751-758 0.5 1.0 2.0 4.0 162024283236 Body Mass Index (kg/m 2 )* Hazard Ratio 0.5 1.0 2.0 4.0 162024283236 0.5 1.0 2.0 4.0 162024283236 Hemorrhagic Stroke Ischemic Stroke Ischemic Heart Disease CV Risk Increases with Body Mass Index CV=Cardiovascular Body mass index is calculated as the weight in kilograms divided by the body surface area in meters 2.

65 Goals Recommendations Diabetes Mellitus Guidelines Goal HbA1C <7% Intensive lifestyle modification to prevent the development of DM (especially in those with the metabolic syndrome) Aggressive management of CV risk factors (i.e., tobacco use, hypertension, dyslipidemia, physical inactivity, and overweight and obese states) Hypoglycemic therapy to achieve normal to near normal fasting plasma glucose as defined by the HbA1C (<7%) Weight reduction and exercise Oral hypoglycemic agents Insulin therapy Coordination of diabetic care with the patients primary physician and/or endocrinologist. CV=Cardiovascular, DM=Diabetes mellitus, HbA1C=Glycosylated hemoglobin

66 Consists of a constellation of major risk factors, life- habit risk factors, and emerging risk factors Over-represented among populations with cardiovascular disease Often occurs in individuals with a distinctive body-type including an increased abdominal circumference The Metabolic Syndrome

67 Expert Panel on Detection, Evaluation, and Treatment of High Blood Cholesterol in Adults. JAMA 2001;285:2486-2497 Risk FactorDefining Level Waist circumference (abdominal obesity)>40 in (>102 cm) in men >35 in (>88 cm) in women Triglyceride level>150 mg/dl HDL-C level<40 mg/dl in men <50 mg/dl in women Blood pressure>130/>85 mmHg Fasting glucose>100 mg/dl ATP III Definition of the Metabolic Syndrome Defined by presence of >3 risk factors HDL-C=High-density lipoprotein cholesterol

68 Tuomilehto J et al. NEJM 2001;344:1343-1350 Intervention Control 11% 23% % with Diabetes Mellitus Metabolic Syndrome: Risk of Developing DM Finnish Diabetes Prevention Study Defined as a glucose >140 mg/dl 2 hours after an oral glucose challenge 522 overweight (mean BMI=31 kg/m 2 ) patients with impaired fasting glucose randomized to intervention or usual care for 3.2 years Lifestyle modification reduces the risk of developing DM Aimed at reducing weight (>5%), total intake of fat ( 15 g/1000 cal); and physical activity (moderate at least 30 min/day)

69 Metabolic Syndrome: Risk of Developing DM Diabetes Prevention Program (DPP) Knowler WC et al. NEJM 2002;346:393-403 *Includes 7% weight loss and at least 150 minutes of physical activity per week Placebo Metformin Lifestyle modification Incidence of DM (%) 0 20 30 10 40 0 0 1423 Years 3,234 patients with elevated fasting and post-load glucose levels randomized to placebo, metformin (850 mg twice daily), or lifestyle modification* for 2.8 years Lifestyle modification reduces the risk of developing DM

70 Assess risk, preferably with exercise test, to guide prescription. Encourage aerobic activity (e.g., walking, jogging, cycling) supplemented by an increase in daily activities (e.g., walking breaks at work, gardening, household work). Encourage resistance training (e.g., weight machines, free weights) 2 days a week (Class IIb, Level C) Encourage cardiac rehabilitation for patients with chronic stable angina, recent myocardial infarction, left ventricular systolic dysfunction, or recent coronary artery bypass graft surgery. Minimum: 30 minutes, 5 days per week Optimal: 30 minutes daily Goals Recommendations Exercise Guidelines

71 Ejection Fraction Guidelines Echocardiography in those following a STEMI to re-evaluate ventricular function when results are used to guide therapy*. Echocardiography or radionuclide angiography in those following a NSTE-ACS when results are used to guide therapy*. *Includes use of an aldosterone antagonist, digitalis, and/or an implantable cardioverter defibrillator NSTE-ACS=Non-ST-segment elevation acute coronary syndrome, STEMI=ST-segment elevation myocardial infarction Secondary Prevention

72 Digitalis: Recommendations Digitalis in those with symptomatic HF and LVSD (EF <45%) to reduce hospitalizations for HF*. Digitalis in those with asymptomatic LVSD and normal sinus rhythm. Secondary Prevention EF=Ejection fraction, HF=Heart failure, LVSD=Left ventricular systolic function *Contraindications include significant sinus or atrioventricular block unless a permanent pacemaker is present.

73 80706050403020 54-60 >60 50 40 30 20 10 0 <30 31-35 36-45 46-53 Cardiac Mortality % Brodie B et al. Am J Cardiol 1992;69:1113 Relationship Between EF* and Mortality Ejection Fraction (%) *Post myocardial infarction EF=Ejection fraction

74 Pitt B et al. NEJM 1999;341:709-717 RR = 0.70, P<0.001 Months Survival (%) 3633302724211815129630 1.00.90.80.70.60.50 0 Aldosterone Antagonist: Secondary Prevention Randomized Aldactone Evaluation Study (RALES) EF=Ejection fraction, HF=Heart failure, LVSD=Left ventricular systolic dysfunction, NYHA=New York Heart Association Spironolactone Placebo 1,663 patients with NYHA Class III or IV HF and LVSD (EF <0.35) randomized to spironolactone (25 mg) or placebo (50 mg) for 24 months Aldosterone inhibition provides significant benefit in patients with advanced heart failure

75 RR = 0.85, P=0.008 61218243036 0 5 10 15 20 25 0 All Cause Mortality (%) Month Aldosterone Antagonist: Secondary Prevention Eplerenone Poct-Acute Myocardial Infarction Heart Failure Efficacy and Survival Study (EPHESUS) Eplerenone Placebo 3,313 patients with evidence of heart failure and LVSD (EF <0.40) after a MI randomized to eplerenone (50 mg) or placebo for 16 months Aldosterone inhibition provides significant benefit in patients with post-MI heart failure and LVSD Pitt B et al. NEJM 2003;348:1309-21 EF=Ejection fraction, LVSD=Left ventricular systolic dysfunction, MI=Myocardial infarction

76 ICD Algorithm EF < 30% EPS Yes + NEJM 349:1836,2003 EF 31-40% No No ICD. Medical Rx EF > 40% - Additional Marker of Electrical Instability? At least one month following a myocardial infarction EF=Ejection fraction, EPS=Electrophysiology study, ICD=Implantable cardioverter defibrillator, Rx=Treatment, SCD=Sudden cardiac death,

77 1 Moss AJ. N Engl J Med. 1996;335:1933-1940 2 Buxton AE. N Engl J Med. 1999;341:1882-1890 3 Moss AF. N Engl J Med. 2002;346:877-883 1 2 3 54% 75% 55% 73% 31% 61% 27 Months 39 Months 20 Months % Mortality Reduction w/ ICD Rx ICD: Secondary Prevention* *Primary prevention of sudden cardiac death Overall death Arrhythmic death EF <35%EF <40%EF <30%

78 Prevention Pyramid Physical activity Healthy eating Ideal weight Psychosocial factors Familial predisposition Lipids Hypertension Smoking cessation Diabetes +Primordial ASA ACE-I Rehab β-blockers +Primary ACE-1 = angiotensin converting enzyme inhibitor; ASA = aspirin Secondary Primary Primordial


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