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Evidence and Guidelines for Cardiovascular Disease Prevention

This article provides evidence and guidelines for current cardiovascular disease prevention, including vaccination, ejection fraction assessment, and the use of aldosterone antagonists. It highlights the importance of these therapies and areas for improvement in cardiovascular care.

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Evidence and Guidelines for Cardiovascular Disease Prevention

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  1. The Evidence for Current Cardiovascular Disease Prevention Guidelines: Other Cardiovascular Therapies and Areas with Room for Improvement American College of Cardiology Best Practice Quality Initiative Subcommittee and Prevention Committee

  2. Classification of Recommendations and Levels of Evidence *Data available from clinical trials or registries about the usefulness/efficacy in different subpopulations, such as gender, age, history of diabetes, history of prior myocardial infarction, history of heart failure, and prior aspirin use. A recommendation with Level of Evidence B or C does not imply that the recommendation is weak. Many important clinical questions addressed in the guidelines do not lend themselves to clinical trials. Even though randomized trials are not available, there may be a very clear clinical consensus that a particular test or therapy is useful or effective. †In 2003, the ACC/AHA Task Force on Practice Guidelines developed a list of suggested phrases to use when writing recommendations. All guideline recommendations have been written in full sentences that express a complete thought, such that a recommendation, even if separated and presented apart from the rest of the document (including headings above sets of recommendations), would still convey the full intent of the recommendation. It is hoped that this will increase readers’ comprehension of the guidelines and will allow queries at the individual recommendation level.

  3. Icons Representing the Classification and Evidence Levels for Recommendations I I I IIa IIb III IIa IIb III IIa IIb III A B C I I I IIa IIb III IIa IIb III IIa IIb III A B C I I I IIa IIb III IIa IIb III IIa IIb III A B C I I I IIa IIb III IIa IIb III IIa IIb III A B C

  4. Evidence for Current Cardiovascular Disease Prevention Guidelines Vaccination Evidence and Guidelines

  5. Influenza Vaccination: Primary Prevention 286,383 community-dwelling members aged >65 years of 3 large managed-care organizations evaluated for 1-2 yrs Influenza vaccination reduces the rate of adverse CV events CV=Cardiovascular Source: Nichol KL et al. NEJM 2003;348:1322-1332

  6. ADA Immunization Recommendations for Patients with Diabetes Mellitus Primary Prevention • An influenza vaccine should be provided to all diabetic patients >6 months of age annually. • A pneumococcal polysaccharide vaccine should be administered to all diabetic patients >2 years of age. A one-time revaccination is recommended for individuals >64 years of age that were previously immunized at <65 years of age, if the vaccine was administered >5 years ago. Other indications for repeat vaccination include nephrotic syndrome, chronic renal disease, and other immunocompromised states, such as after transplantation. ADA=American Diabetes Association Source: American Diabetes Association. Diabetes Care 2010;33:S11-61

  7. I IIa IIb III B Influenza Vaccination Guidelines Secondary Prevention Patients with cardiovascular disease should have an annual influenza vaccination Source: Smith Jr SC et al. JACC 2011;58:2432-2446

  8. Evidence for Current Cardiovascular Disease Prevention Guidelines Ejection Fraction Evidence and Guidelines

  9. Relationship Between Ejection Fraction Post Myocardial Infarction and Mortality 1,181 patients with myocardial infarction treated with fibrinolytic therapy that underwent SPECT and RNA to evaluate LV EF LV EF assessed after MI is predictive of mortality at 6 months LV EF=Left ventricular ejection fraction, MI=Myocardial infarction, RNA=Radionuclide angiography, SPECT=Single photon emission computed tomography Source: Burns RJ et al. JACC 2002;39:30-36

  10. I IIa IIb III C Ejection Fraction Guidelines Secondary Prevention Echocardiography in those following a STEMI to re-evaluate ventricular function when results are used to guide treatment† Echocardiography or radionuclide angiography in those following a NSTE-ACS when results are used to guide treatment‡ NSTE-ACS=Non-ST-segment elevation acute coronary syndrome, STEMI=ST-segment elevation myocardial infarction Sources: †Antman EM et al. JACC 2004;44:671-719 ‡Anderson JL et al. JACC 2007;50:652-726

  11. Evidence for Current Cardiovascular Disease Prevention Guidelines Aldosterone Antagonist Evidence and Guidelines

  12. Aldosterone Antagonist: Mechanisms of Action Aldosterone Sodium and Water Retention Potassium and Magnesium Excretion Collagen deposition Myocardial and Vascular Fibrosis Edema Arrhythmias

  13. Aldosterone Antagonist: Secondary Prevention Randomized Aldactone Evaluation Study (RALES) 1,663 patients with NYHA Class III or IV HF and LVSD (EF <0.35) randomized to spironolactone (25-50mg) or placebo for 24 months Aldosterone inhibition improves survival in patients with advanced heart failure 1.00 .90 .80 Survival (%) .70 Spironolactone .60 .50 Placebo RR = 0.70, P<0.001 0 0 3 6 9 12 15 18 21 24 27 30 33 36 Months EF=Ejection fraction, HF=Heart failure, LVSD=Left ventricular systolic dysfunction, NYHA=New York Heart Association Source: Pitt B et al. NEJM 1999;341:709-717

  14. Aldosterone Antagonist: Secondary Prevention 25 20 15 10 5 0 0 6 12 18 24 30 36 Eplerenone Post-Acute Myocardial Infarction Heart Failure Efficacy and Survival Study (EPHESUS) 3,313 patients with evidence of HF and LVSD (EF <0.40) after a MI randomized to eplerenone (25-50 mg) or placebo for 16 months Aldosterone inhibition improves survival in patients with post-MI HF and LVSD Placebo Eplerenone All Cause Mortality (%) RR = 0.85, P=0.008 Month EF=Ejection fraction, LVSD=Left ventricular systolic dysfunction, MI=Myocardial infarction, HF=Heart failure Source: Pitt B et al. NEJM 2003;348:1309-1321

  15. Aldosterone Antagonist: Secondary Prevention Eplerenone in Mild Patients Hospitalization and Survival Study in Heart Failure (EMPHASIS-HF) 2737 patients with NYHA Class II HF symptoms and LVSD (mean LV EF 26%) randomized to eplerenone (25-50 mg) or placebo for a median of 21 months* Aldosterone inhibition improves survival in patients with mild HF and LVSD 10 100 Eplerenone % % 5 50 Placebo 25.9 18.3 15.5 12.5 0 0 Primary endpoint** All-cause mortality *The study was stopped prematurely **Composite of CV death or hospitalization for HF CV=Cardiovascular, EF=Ejection fraction, HF=Heart failure, LVSD=Left ventricular systolic dysfunction, NYHA=New York Heart Association Source: Zannad F et al. NEJM 2011;364:11-21

  16. I IIa IIb III A Aldosterone Antagonist Guidelines Secondary Prevention Use of aldosterone blockade in post-MI patients without significant renal dysfunction* or hyperkalemia** is recommended in patients who are already receiving therapeutic doses of an ACE inhibitor and beta-blocker, who have a LV EF <40%, and who have either DM or HF *Estimated creatinine clearance should be >30 ml/min **Potassium should be <5.0 mEq/L ACE=Angiotensin converting enzyme, DM=Diabetes mellitus, EF=Ejection fraction, HF=Heart failure, LV=Left ventricular, MI=Myocardial infarction Source: Smith SC Jr. et al. JACC 2011;58:2432-2446

  17. Evidence for Current Cardiovascular Disease Prevention Guidelines Digoxin Evidence and Guidelines

  18. Digoxin: Mechanism of Action Digoxin Na-K ATPase Na-Ca Exchange Na+ K+ Na+ Ca++ Myofilaments Ca++ K+ Na+ Contractility

  19. Digoxin: Secondary Prevention Digitalis Investigation Group (DIG) Trial 6,800 patients with LV systolic dysfunction (EF <45%) randomized to digitalis (0.25 mg) or placebo for 37 months Digitalis reduces the rate of hospitalization for heart failure* Placebo Digitalis HR=0.75, P<0.001 *28% relative risk reduction (p<0.001) Source: Digitalis Investigation Group. NEJM 1997;336:525-533

  20. I IIa IIb III B I IIa IIb III C Digoxin Guidelines Secondary Prevention Digoxin in those with symptomatic HF and LVSD (EF <45%) to reduce hospitalizations for HF* Digoxin in those with asymptomatic LVSD and normal sinus rhythm *Contraindications include significant sinus or atrioventricular block unless a permanent pacemaker is present EF=Ejection fraction, HF=Heart failure, LVSD=Left ventricular systolic function Source: Hunt SA et al. Circulation 2005;112:e154-235

  21. Evidence for Current Cardiovascular Disease Prevention Guidelines Implantable Cardioverter Defibrillator Evidence and Guidelines

  22. Implantable Cardioverter Defibrillator: Secondary Prevention 80 60 40 20 0 MADIT1 MUSTT2 MADIT-II3 Overall death 75% Arrhythmic death 73% 61% 55% 54% % mortality reduction with ICD 31% 27 Months EF <35% 39 Months EF <40% 20 Months EF <30% *Primary prevention of sudden cardiac death Sources: 1Moss AJ et al. NEJM 1996;335:1933-1940 2Buxton AE et al. NEJM 1999;341:1882-1890 3Moss AF et al. NEJM 2002;346:877-883

  23. Implantable Cardioverter Defibrillator: Algorithm in Secondary Prevention Additional Marker of Electrical Instability? No ICD Medical Rx At least one month following MI EF < 30% EF 31-40% EF > 40% No Yes EPS + - EF=Ejection fraction, EPS=Electrophysiology study, ICD=Implantable cardioverter defibrillator, Rx=Treatment Source: DiMarco JP et al. NEJM 2003;349:1836-1847

  24. Implantable Cardioverter Defibrillator Guidelines I I IIa IIb III IIa IIb III A B Secondary Prevention Patients with an ejection fraction of <35% who are at least 40 days post-MI and are in NYHA functional Class II or III Patients with an ejection fraction of <30% who are at least 40 days post-MI and are in NYHA functional Class I Patients with nonsustained VT due to prior MI, an ejection fraction of <40%, and inducible sustained VT or VF at EP study EP=Electrophysiology, MI=Myocardial infarction, NYHA=New York Heart Association, VF=Ventricular fibrillation, VT=Ventricular tachycardia Epstein AE et al. Circulation 2008;117:e350-408

  25. Evidence for Current Cardiovascular Disease Prevention Guidelines Room for Improvement

  26. Utilization of Risk Reducing Medications at Discharge in Acute Coronary Syndromes ACTION Registry/Get With The Guidelines (GWTG) Data 99% 97% 97% 100% 95% 94% 88% 88% 86% 83% 80% 72% 60% NSTEMI STEMI 40% 20% 0% Statins Beta Blockers ACE-1 or ARB ASA Clopidogrel NSTEMI=Non-ST-segment elevation myocardial infarction, STEMI=ST-segment elevation myocardial infarction Source: ACTION Registry-GWTG DATA: January 1, 2010 – December 31, 2010. Courtesy of NCDR 10/21/2011

  27. Self-Reported Medications in Patients with Coronary Artery Disease + Heart Failure Duke Databank for Cardiovascular Disease* *n=31,750 ASA=Aspirin, ACE-I=Angiotensin converting enzyme inhibitor, BB=Beta-blocker, CAD=Coronary artery disease, CHF=Congestive heart failure, HF=Heart failure Source: Newby LK et al. Circulation 2006;113:203-212

  28. Hypertension Awareness, Treatment, and Control in the United States National Health and Nutrition Examination Survey (NHANES) 80 73% 68% 70% Awareness 59% 60 55% 51% Treatment 54% % Adults 40 31% 34% 29% Control 27% 20 10% 0 NHANES II 1976-1980 NHANES III (Phase 2) 1991-1994 NHANES 1999-2000 NHANES III (Phase 1) 1988-1991 Source: Chobanian AV et al. JAMA 2003;289:2560-2572

  29. Antihypertensive Drug Use in the United States National Health and Nutrition Examination Survey (NHANES) ACE=Angiotensin converting enzyme Source: Gu Q et al. Circulation 2006;113:213-221

  30. HMG-CoAReductase Inhibitor: Adherence to Therapy 100 Acute Coronary Syndrome n=22379 80 60 Primary Prevention Coronary Artery Disease n=85020 40 n=36106 20 0 0 3 6 9 12 15 18 21 24 Months Adherence Rate (%) Source: Jackevicius CA et al. JAMA 2002;288:462-467

  31. Cholesterol Treatment Gap in the United States National Health and Nutrition Examination Survey (NHANES)* *Based on 7,399 subjects in NHANES from 1999-2002 Keevil JG et al. Circulation 2007;115:1363-1370

  32. Achievement of Risk Factor Goals Among Diabetics in the United States 100 NHANES III NHANES IV 90 80 70 60 50 40 30 20 10 0 HbA1c<7% BP <130/80 mm Hg TC <200 mg/dL Good Control of all 3 National Health and Nutrition Examination Survey (NHANES) (%) BP=Blood pressure, DM=Diabetes mellitus, HbA1C=Glycosylated hemoglobin, TC=Total cholesterol Saydah S et al. JAMA 2004;291:335-342

  33. Utilization of Risk Reducing Interventions at Discharge in Acute Coronary Syndromes ACTION Registry/Get With The Guidelines (GWTG) Data 100% 80% 60% NSTEMI 40% STEMI 20% 0% Exercise Counseling Dietary Modification Cardiac Rehab Referral Smoking Cessation NSTEMI=Non-ST-segment elevation myocardial infarction, STEMI=ST-segment elevation myocardial infarction ACTION Registry-GWTG DATA: January 1, 2010 – December 31, 2010. Courtesy of NCDR 10/21/2011

  34. Evidence for Current Cardiovascular Disease Prevention Guidelines Quality Improvement Initiatives

  35. Strategies for Initiating and Optimizing Cardiovascular Therapies • Hospital based performance improvement systems • In-hospital initiation of CV protective therapies • Pay for performance/financial incentives • Nurse or pharmacist managed outpatient CV prevention programs • Preventive cardiology and cardiac rehabilitation centers • Virtual prevention clinics using electronic medical record systems • Combination of CV protective medications CV=Cardiovascular

  36. Composite performance measure adherence by age and gender Utilization of Risk Reducing Therapies in Coronary Artery Disease Get With the Guidelines-Coronary Artery Disease (GWTG-CAD) Quarters of participation Percent adherence Lewis WR et al. Circ Cardiovasc Qual Outcomes 2009;2:633-641

  37. Utilization of Risk Reducing Therapies After Acute Myocardial Infarction Guidelines Applied in Practice (GAP) Initiative 45 P=0.004 Baseline 40 Post-GAP 35 30 P=0.001 25 Mortality (%) 20 P=0.017 15 10 5 0 In-hospital Mortality 30-day Mortality 1-yr Mortality MI=Myocardial infarction Eagle KA et al. JACC 2005;46:1242-1248

  38. Registry of 4,608 patients with a ST-segment elevation myocardial infarction Utilization of Risk Reducing Therapies After ST-Segment Elevation Myocardial Infarction Global Registry of Acute Coronary Events (GRACE) % Patients Fox KAA et al. JAMA 2007;297:1892-1900

  39. Utilization of Risk Reducing Therapies After Non-ST-Segment Elevation ACS 15 10 5 0 Cardiac Hospital Atherosclerosis Management Program (CHAMP) 14.8 Pre-CHAMP* Event Rate, % Post-CHAMP* 7.8 7.6† 7.0 4.7 3.1† 3.3† 2.6 Recurrent MI Heart Failure Hospitalization Total Mortality *1 year outcomes †P<0.05 ACS=Acute coronary syndrome, MI=Myocardial infarction Fonarow GC et al. Am J Cardiol 2001;87:819-822

  40. Utilization of Risk Reducing Therapies After Non-ST-Segment Elevation ACS Can Rapid Risk Stratification of Unstable Angina Patients Suppress Adverse Outcomes with Early Implementation of the ACC/AHA Guidelines (CRUSADE) Registry NSTE-ACS NSTE-MI 8 8 7 7 6 6 5 5 In-Hospital Mortality, % In-Hospital Mortality, % 4 4 3 3 2 2 1 1 0 0 1 2 3 4 1 2 3 4 Hospital Composite Guideline Adherence Quartiles Hospital Composite Guideline Adherence Quartiles NSTE-ACS=Non-ST-segment elevation acute coronary syndrome, NSTE-MI=Non-ST segment elevation myocardial infarction Peterson ED et al. JAMA 2006;295:1912-1920

  41. Registry of 8,375 patients with a non-ST-segment elevation ACS Utilization of Risk Reducing Therapies After Non-ST-Segment Elevation ACS Global Registry of Acute Coronary Events (GRACE) ACS=Acute coronary syndrome Fox KAA et al. JAMA 2007;297:1892-1900

  42. Pharmacy Intervention to Improve Utilization of Risk Reducing Therapies Federal Study of Adherence to Medications in the Elderly (FAME) 200 patients with CV risk factors randomized to pharmacy intervention* or usual care for 6 months An intervention program significantly improves adherence *Includes standardized medication education, regular follow-up by pharmacists, and medications dispensed in time-specific blister packs CV=Cardiovascular Lee JK et al. JAMA 2006;296:2563-2571

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