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Appendix: Clinical Guidelines VBWG
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I Intervention is useful and effective III Intervention is not useful or effective and may be harmful A Data derived from multiple randomized clinical trials BData derived from a single RCT or nonrandomized studies CConsensus opinion of experts ClassesLevels of evidence Gibbons RJ et al. J Am Coll Cardiol. 2003;41:159-68. IIB Evidence conflicts / opinions differ, but leans against efficacy IIA Evidence conflicts / opinions differ, but leans toward efficacy Updated guidelines: Classes of Recommendations and levels of evidence VBWG
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ACC/AHA: Update for management of chronic stable angina—asymptomatic patients Gibbons RJ et al. J Am Coll Cardiol. 2003;41:159-68. Aspirin in patients with prior MI Class I interventions Level of evidence A B A A Beta-blockers in patients with prior MI Lipid-lowering therapy in patients with CAD and LDL-C >130 mg/dL with target LDL <100 mg/dL ACEI in patients with CAD who have diabetes and/or systolic dysfunction VBWG
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ACC/AHA guidelines: Discharge therapy after unstable angina/NSTEMI–Class I interventions Braunwald E et al. J Am Coll Cardiol. 2002;40:1366-74. A ACEI for patients with CHF, LV dysfunction (EF <40%), hypertension, or diabetes A C Lipid-lowering agents + diet if LDL >130 mg/dL, Lipid-lowering agents if LDL-C after diet is >100 mg/dL B Beta-blockade for all patients A B Aspirin 75 – 325 mg/d Clopidogrel 75 mg/d if aspirin is contraindicated Level of evidence VBWG
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ACC/AHA: Discharge medical therapy after STEMI–Class I interventions Antman EM et al. Circulation. 2004;110:588-636. RAAS modulation A B A ACEI for all patients ARB for ACEI-intolerant patients with HF or LVEF <40% Aldosterone blocker for patients on ACEI with LVEF <40% and HF or diabetes Lipid lowering A B Statins in patients with LDL-C >100 mg/dL LDL-C <100 mg/dL Beta-blockadeABeta-blockers for all patients except those with normal/near-normal ventricular function, successful reperfusion, absence of ventricular arrhythmias AntiplateletAAspirin 75–162 mg for all patients Level of evidence VBWG
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RALES and EPHESUS: Aldosterone blockade in HF and post-MI LV dysfunction RALES N = 1633 with NYHA class III/IV HF Randomized to placebo or spironolactone 25 mg Treatment in addition to ACE inhibitor and loop diuretic; most patients also received digoxin EPHESUS N = 6632 with post-MI LV dysfunction and HF Randomized to placebo or eplerenone 50 mg Treatment in addition to ACEI or ARB, -blockers, diuretics, aspirin RALES = Randomized ALdactone Evaluation Study EPHESUS = Eplerenone Post-Acute Myocardial Infarction Heart Failure Efficacy and SUrvival Study Pitt B et al. N Engl J Med. 1999;341:709-17. Pitt B et al. N Engl J Med. 2003;348:1309-21. VBWG
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Aldosterone blockade and AT 1 receptor blockade: Trials in post-MI LV dysfunction and HF Pitt B et al. N Eng J Med. 1999;341:709-17. Pitt B et al. N Eng J Med. 2003;348:1309-21. RALES 0.75 0.60 1.00 0 Placebo Spironolactone 25 mg Months Probability of survival 24366 30% Risk reduction RR 0.70 (0.60–0.82) P < 0.001 30 0.00 1218 0.90 0.45 EPHESUS 22 10 2 624300 Eplerenone 50 mg Months 18 14 6 3612 15% Risk reduction RR 0.85 (0.75–0.96) P = 0.008 Cumulative incidence (%) Placebo 0 18 VBWG
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ESC Guidelines: ACEI in secondary prevention and to prevent sudden death Setting/indicationClassLevel Secondary prevention High-risk patients (CVD or diabetes + 1 other risk factor) 1 A Sudden death Patients with heart failure Patients with previous MI Patients with dilated cardiomyopathy 1 A B López-Sendón J et al. Eur Heart J. 2004;25:1454-70. VBWG
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