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Other Risk Reducing Therapies, Guidelines, and Areas for Improvement Andrew P. DeFilippis, Ty J. Gluckman, James Mudd, C

Other Risk Reducing Therapies, Guidelines, and Areas for Improvement Andrew P. DeFilippis, Ty J. Gluckman, James Mudd, Catherine Campbell, Gregg Fonarow & Roger S. Blumenthal. Influenza Evidence and Guidelines. Influenza Vaccination: Primary Prevention.

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Other Risk Reducing Therapies, Guidelines, and Areas for Improvement Andrew P. DeFilippis, Ty J. Gluckman, James Mudd, C

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  1. Other Risk Reducing Therapies, Guidelines, and Areas for Improvement Andrew P. DeFilippis, Ty J. Gluckman, James Mudd, Catherine Campbell, Gregg Fonarow & Roger S. Blumenthal

  2. Influenza Evidence and Guidelines

  3. 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 adverse CV events Nichol KL et al. NEJM 2003;348:1322-32

  4. Influenza Vaccination Patients with cardiovascular disease should receive the influenza vaccination annually

  5. Ejection fraction Evidence and Guidelines

  6. 20 30 40 50 60 70 80 Relationship Between EF* and Mortality 50 <30 40 30 Cardiac Mortality % 31-35 20 36-45 10 46-53 54-60 >60 0 Ejection Fraction (%) EF=Ejection fraction *Post myocardial infarction Brodie B et al. Am J Cardiol 1992;69:1113-9

  7. IIa IIa IIa IIa IIb IIb IIb IIb III III III III I I I IIa IIa IIa IIa IIb IIb IIb IIb III III III III I I I IIa IIa IIa IIa IIb IIb IIb IIb III III III III I I I 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 *Includes use of an aldosterone antagonist, digitalis, and/or an implantable cardioverter defibrillator

  8. Aldosterone Antagonist Evidence and Guidelines

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

  10. 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 reduces death in patients with advanced heart failure 1.00 Spironolactone Placebo .90 .80 Survival (%) .70 .60 .50 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 Pitt B et al. NEJM 1999;341:709-717

  11. 25 20 15 10 5 0 0 6 12 18 24 30 36 Aldosterone Antagonist: Secondary Prevention 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 Eplerenone Placebo All Cause Mortality (%) RR = 0.85, P=0.008 Month EF=Ejection fraction, LVSD=Left ventricular systolic dysfunction, MI=Myocardial infarction, HF=Heart failure Pitt B et al. NEJM 2003;348:1309-21

  12. Aldosterone Antagonist: Guidelines Secondary Prevention Aldosterone antagonist in UA/NSTEMI patients already receiving and ACE-I with LVSD (EF <0.40) and either symptomatic HF or DM Aldosterone antagonist in those with LVSD (EF<0.35) and recent or current NYHA class IV HF symptoms* ACE-I=Angiotensin converting enzyme inhibitor, DM=Diabetes mellitus, EF=Ejection fraction, HF=Heart failure, LVSD=Left ventricular systolic dysfunction, MI=Myocardial infarction, NYHA=New York Heart Association *Contraindications include abnormal renal function (creatinine >2.5 mg/dL in men or >2.0 mg/dL in women) and hyperkalemia (K+ >5.0 meq/L)

  13. Digitalis Evidence and Guidelines

  14. Digitalis: Mechanism of Action Digitalis Na-K ATPase Na-Ca Exchange Na+ K+ Na+ Ca++ Myofilaments K+ Na+ Ca++ Contractility

  15. Digitalis: 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 hospitalization for heart failure* Digitalis Placebo HR=0.75, P<0.001 *28% relative risk reduction (p<0.001) Digitalis Investigation Group. NEJM 1997;336:525-33

  16. IIa IIa IIa IIa IIb IIb IIb IIb III III III III I I I IIa IIa IIa IIa IIb IIb IIb IIb III III III III I I I IIa IIa IIa IIa IIb IIb IIb IIb III III III III I I I B Digitalis: Recommendations Secondary Prevention 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 EF=Ejection fraction, HF=Heart failure, LVSD=Left ventricular systolic function *Contraindications include significant sinus or atrioventricular block unless a permanent pacemaker is present

  17. ICD Evidence and Guidelines

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

  19. Additional Marker of Electrical Instability? No ICD Medical Rx ICD Algorithm 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 DiMarco JP et al. NEJM 2003;349:1836-47

  20. IIa IIa IIa IIa IIb IIb IIb IIb III III III III I I I IIa IIa IIa IIa IIb IIb IIb IIb III III III III I I I IIa IIa IIa IIa IIb IIb IIb IIb III III III III I I I B ICD Guidelines Patients with an ejection fraction of <30% at least 1 month after a MI and 3 months after CABG Patients with nonsustained VT, CAD, prior MI, LV dysfunction, and inducible sustained VT of VF at electrophysiology study CABG=Coronary artery bypass graft surgery, CAD=Coronary artery disease, LV=Left ventricular, MI=Myocardial infarction, VF=Ventricular fibrillation, VT=Ventricular tachycardia

  21. Room for Improvement

  22. Discharge Medications in Patients Post-MI + HF National Registry of Myocardial Infarction (NRMI) 77 80 HF Absent HF on Presentation 60 60 55 HF After Presentation 48 Patients Treated (%) 36 40 35 32 32 30 26 27 26 24 22 20 12 0 Aspirin Beta-Blocker ACE-I Lipid-Lowering Digoxin Treatment Discharge Medications ACE-I=Angiotensin converting enzyme inhibtor, HF=Heart failure, MI=Myocardial infarction Spencer FA et al. Circulation 2002;105:2605-2610

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

  24. U.S. Hypertension Awareness, Treatment, and Control National Health and Nutrition Examination Survey (NHANES) 73% 70% 68% Awareness 59% 55% 54% 51% Treatment 34% 31% % Adults 29% 27% Control 10% NHANES II 1976-1980 NHANES III (Phase 2) 1991-1994 NHANES 1999-2000 NHANES III (Phase 1) 1988-1991 Chobanian AV et al. JAMA 2003;289:2560-2572

  25. Antihypertensive Drug Use among U.S. Adults National Health and Nutrition Examination Survey (NHANES) ACE=Angiotensin converting enzyme Gu Q et al. Circulation 2006;113:213-221

  26. Percent of U.S. Adults Achieving LDL-C Goal National Health and Nutrition Examination Survey (NHANES) and Lipid Treatment Assessment Project (L-TAP) 100 NHANES III 82 83 L-TAP 80 63 60 % not at LDL-C target 55 40 20 0 2 RF (LDL <130 mg/dl) CHD (LDL <100 mg/dl) Risk profile National Center for Health Statistics. National Health and Nutrition Examination Survey (III); 1994. (Data collected 1991-1994) Pearson TA et al. Arch Intern Med 2000;160:459-467

  27. 24-26 million 25 11-18 million Recommended for drug therapy 20 Gap Rx treated Rx Eligible Americans (Millions) 15 Gap 10 9-11 million 5 3-5 million Moderate RiskPrimary Prevention High RiskSecondary Prevention/CHD Risk Equivalents 0 U.S. Treatment Gap in Lipid Lowering National Health and Nutrition Examination Survey (NHANES) NHANES 1994, IMS 2003, Ingenix Treatment Gap Data 2003

  28. Adherence Rates to HMG-coA Reductase Inhibitors Adherence Rate (%) Jackevicius CA et al. JAMA 2002;288:462-467

  29. U.S. Adults with DM Achieving Risk Factor Goals National Health and Nutrition Examination Survey (NHANES) (%) HbA1c <7% BP <130/80 mm Hg TC <200 mg/dL Good Control of all 3 BP=Blood pressure, DM=Diabetes mellitus, HbA1C=Glycosylated hemoglobin, TC=Total cholesterol Saydah S et al. JAMA 2004;291:335-342

  30. Discharge Medications Following a NSTE-ACS* CRUSADE Initiative **LVEF <40%, CHF, DM, HTN#Known hyperlipidemia, TC, LDL Mehta RH et al. Arch Intern Med 2006;166:2027-2034

  31. Quality Improvement Initiatives

  32. Strategies for Initiating and Optimizing CV 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

  33. Utilization of Risk Reducing Therapies in CAD Get With the Guidelines-Coronary Artery Disease (GWTG-CAD) * * * * * * * * * * * * * * 123 U.S. Hospitals, n=27,825 *P<0.05 compared to baseline LaBresh KA et al. Circulation 2003;108:IV-722

  34. Improved 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 Lee JK et al. JAMA 2006;296:2563-2571

  35. 1-Year Post-Intervention Outcomes After NSTE-ACS CHAMP Study 15 Pre-CHAMP Event Rate, % *P<0.05 Post-CHAMP 8 7.6* 7.0 4.7 3* 3* 2.6 Recurrent MI Heart Failure Hospitalization Total Mortality MI=Myocardial infarction, NSTE-ACS=Non-ST-segment elevation acute coronary syndrome Fonarow GC et al. Am J Cardiol 2001;87:819-822

  36. Post Intervention Mortality After Acute MI 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

  37. In-Hospital Post-Intervention Mortality Outcomes CRUSADE Initiative 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 CRUSADE = Can Rapid Risk Stratification of Unstable Angina Patients Suppress Adverse Outcomes With Early Implementation of the ACC/AHA Guidelines. 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

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