MEDICAL THERAPY IN HEART FAILURE

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1 MEDICAL THERAPY IN HEART FAILURE Dr Lim Choon Pin MBBS, MRCP (UK), MMed (Int Med), FAMS, FESC, FACC Consultant Cardiologist, The Heart and Vascular Centre Heart Failure, Heart Transplant, Mechanical Circulatory Support Devices, Echocardiography Visiting Consultant, National Heart Centre of Singapore Adj Asst Professor, NUS YLL School of Medicine & Duke-NUS

2 TREATMENT OF HF 72 Pages 46 Pages

3 Classification of Heart Failure Based on the LVEF Based on time course Based on the Functional Status The guidelines differ with respect to the LVEF cut-off limits for classification of HF as HFrEF, HFmrEF*, and HFpEF Types ACCF-AHA 2013 ESC 2016 HFSA 2010 NICE 2010 HFrEF 40% <40% <50% Based on Clinical Progression Based on Hemodynamic Status (AHF) HFmrEF % HFpEF 50% 50% 50% 41%-49% (HFpEF, borderline) >40% (HFpEF, improved) - No thresholds of LVEF defined * ESC guidelines has added a new term for patients with HF and a left ventricular ejection fraction (LVEF) that ranges from 40 to 49% HF with midrange EF (HFmrEF) ; HF with reduced ejection fraction (HFrEF), also known as systolic HF/left ventricular systolic dysfunction (LVSD)/HF with dilated left ventricle HF with preserved ejection fraction (HFpEF), also known as diastolic HF/HF with nondilated left ventricle/hf with preserved systolic function (HFPSF) HFrEF, heart failure with reduced ejection fraction; HFpEF, heart failure with preserved ejection fraction; LVEF, left ventricular ejection fraction 3

4 STAGES, PHENOTYPES AND TREATMENT OF HF At Risk for Heart Failure Heart Failure STAGE A At high risk for HF but without structural heart disease or symptoms of HF STAGE B Structural heart disease but without signs or symptoms of HF STAGE C Structural heart disease with prior or current symptoms of HF STAGE D Refractory HF e.g., Patients with: HTN Atherosclerotic disease DM Obesity Metabolic syndrome or Patients Using cardiotoxins With family history of cardiomyopathy Structural heart disease e.g., Patients with: Previous MI LV remodeling including LVH and low EF Asymptomatic valvular disease Development of symptoms of HF e.g., Patients with: Known structural heart disease and HF signs and symptoms Refractory symptoms of HF at rest, despite GDMT e.g., Patients with: Marked HF symptoms at rest Recurrent hospitalizations despite GDMT HFpEF HFrEF THERAPY Goals Heart healthy lifestyle Prevent vascular, coronary disease Prevent LV structural abnormalities Drugs ACEI or ARB in appropriate patients for vascular disease or DM Statins as appropriate THERAPY Goals Prevent HF symptoms Prevent further cardiac remodeling Drugs ACEI or ARB as appropriate Beta blockers as appropriate In selected patients ICD Revascularization or valvular surgery as appropriate THERAPY Goals Control symptoms Improve HRQOL Prevent hospitalization Prevent mortality Strategies Identification of comorbidities Treatment Diuresis to relieve symptoms of congestion Follow guideline driven indications for comorbidities, e.g., HTN, AF, CAD, DM Revascularization or valvular surgery as appropriate THERAPY Goals Control symptoms Patient education Prevent hospitalization Prevent mortality Drugs for routine use Diuretics for fluid retention ACEI or ARB Beta blockers Aldosterone antagonists Drugs for use in selected patients Hydralazine/isosorbide dinitrate ACEI and ARB Digoxin In selected patients CRT ICD Revascularization or valvular surgery as appropriate THERAPY Goals Control symptoms Improve HRQOL Reduce hospital readmissions Establish patient s endof-life goals Options Advanced care measures Heart transplant Chronic inotropes Temporary or permanent MCS Experimental surgery or drugs Palliative care and hospice ICD deactivation

5 HFREF HFPEF 5

6 Clinical status HF is a progressive disease whereby cardiac structure and function continue to deteriorate Increasing frequency of acute events with disease progression leads to high rates of hospitalization and increased risk of mortality 1 7 Compensated Episode of acute decompensation Chronically decompensated Acutely decompensated Adapted from Gheorghiade et al Disease Progression Death 5 HF, heart failure 1. Ahmed et al. Am Heart J 2006;151:444 50; 2. Gheorghiade et al. Am J Cardiol 2005;96:11G 17G; 3. Gheorghiade, Pang. J Am Coll Cardiol 2009;53:557 73; 4. Holland et al. J Card Fail 2010;16:150 6; 5. Muntwyler et al. Eur Heart J 2002;23:1861 6; 6. McCullough et al. J Am Coll Cardiol 2002;39:60 9; 7. McMurray JJ. et al. Eur Heart J. 2012;33(14):

7 Aim of Rx 7

8 Neurohormonal Blockade in HF NP system NPRs NPs Vasodilation Blood pressure Sympathetic tone Natriuresis/diuresis Vasopressin Aldosterone Fibrosis Hypertrophy Neprilysin inhibitors INACTIVE FRAGMENTS HF SYMPTOMS & PROGRESSION Sac/Val SNS Epinephrine Norepinephrine RAAS Ang II α 1, β 1, β 2 receptors Vasoconstriction RAAS activity Vasopressin Heart rate Contractility AT 1 R Vasoconstriction Blood pressure Sympathetic tone Aldosterone Hypertrophy Fibrosis β-blockers RAAS inhibitors (ACEI, ARB, MRA) Sac/Val: enhancement of natriuretic and other vasoactive peptides, with simultaneous RAAS suppression 8 ACEI=angiotensin-converting enzyme inhibitor; Ang=angiotensin; ARB=angiotensin receptor blocker; AT 1 R=angiotensin II type 1 receptor; HF=heart failure; HFrEF=heart failure with reduced ejection fraction; MRA=mineralocorticoid receptor antagonist; NP=natriuretic peptide; NPRs=natriuretic peptide receptors; RAAS=renin-angiotensin-aldosterone system; SNS=sympathetic nervous system 1. McMurray et al. Eur J Heart Fail 2013;15: Figure references: Levin et al. N Engl J Med 1998;339:321 8 Nathisuwan & Talbert. Pharmacotherapy 2002;22:27 42 Kemp & Conte. Cardiovascular Pathology 2012; Schrier & Abraham. N Engl J Med 2009;341:577 85

9 Landmark trials in patients with HFrEF SOLVD-T 1 (1991) 2,569 patients Enalapril (ACEI) vs placebo: 16% all-cause mortality CIBIS-II 8 (1999) 2,647 patients Bisoprolol (BB) vs placebo: 34% all-cause mortality CHARM-Alternative 3 (2003) 2,028 patients Candesartan (ARB) vs placebo: 23% CV mortality or HF hospitalization SHIFT 5 (2010) 6,558 patients Isvabradine (I f inhibitor) vs placebo: 18% CV death or HF hospitalization PARADIGM-HF 7 (2014) 8,442 patients Sacubitril/valsartan (ARNI) vs enalapril: 20% CV mortality or HF hospitalization 1990s 2000s 2010s MERIT-HF 2 (1999) 3991 patients Metorprolol vs placebo: 34% all-cause mortality CHARM-Added 4 (2003) 2,548 patients Candesartan (ARB) vs placebo: 15% CV mortality or HF hospitalization EMPHASIS-HF 6 (2011) 2,737 patients Eplerenone (MRA) vs placebo: 37% CV mortality or HF hospitalization 9 ACEI=angiotensin-converting enzyme inhibitor; ARB=angiotensin receptor blocker; ARNI=angiotensin receptor neprilysin inhibitor; BB=beta blocker; CV=cardiovascular; HF=heart failure; HFrEF=heart failure with reduced ejection fraction; MRA=mineralocorticoid receptor antagonist. See notes for definitions of study names 1. SOLVD Investigators. N Engl J Med 1991;325: MERIT-HF study group, Lancet, 1999, 353: Granger et al. Lancet 2003;362: McMurray et al. Lancet 2003;362: ; 5. Swedberg et al. Lancet 2010;376: Zannad et al. N Engl J Med 2011;364:11 21; 7. McMurray et al. N Engl J Med 2014;371: CIBIS-II Investigators. Lancet 1999;353:9 13

10 B-BLOCKERS Sympathetic nervous system activated in asymptomatic left ventricular dysfunction, and this activation increases with the severity of heart failure. Experimental data suggest that chronic heightened sympathetic nervous system activation and increased plasma norepinephrine may exacerbate myocyte dysfunction and cell death. Although acute administration of β-adrenergic blockade decreases contractility and heart rate in systolic heart failure, chronic administration improves contractility. Effect becomes apparent in 3 to 6 months. Increase in ejection fraction is positively related to β-blocker dose.

11 11 B-blocker Trials

12 RAAS

13 EFFECTS OF ACE-I Combined arterial and venous vasodilators Reduction in afterload, preload, and wall stress are observed without an increase in heart rate. Augment renal blood flow Reduce production of aldosterone and antidiuretic hormone. Promote excretion of sodium and water. Effects on cellular metabolism independent of their hemodynamic effects Antihypertrophic effects on ventricular and vascular cells are at least partially independent of blood pressure reduction and contribute to their role in the prevention of ventricular remodeling. Blunt progressive dilatation of the ventricle in patients with systolic dysfunction Among the most potent agents for reducing ventricular hypertrophy in patients with hypertension. Demonstrated to reduce ischemic events in patients with systolic dysfunction due to myocardial ischemia.

14 14

15 HF PHARMACOTHERAPY Angiotensin II Receptor Blockers VAL-HEFT, CHARM studies

16 ACEi + ARB Combination in HF No incremental survival benefit but reduced HF Hospitalizations Total Mortality Combined use of ACEi + ARB discouraged. Aim for full doses of either ACEi/ARB instead. HF Hospitalizations ACEi + ARB Combi better ACEi better 16 Lee VC et al., Ann Intern Med. 2004; 141:

17 New Kid on the Block - angiotensin receptor neprilysin inhibitor (ARNI) Natriuretic and other vasoactive peptides* LCZ696 Sacubitril (AHU377; pro-drug) RAAS Angiotensinogen (liver secretion) Ang I Inactive fragments LBQ657 (NEP inhibitor) Valsartan Ang II Enhancing Vasorelaxation Blood pressure Sympathetic tone Aldosterone levels Fibrosis Hypertrophy Natriuresis/diuresis HN O HO O OH O O N O OH N N N NH AT 1 Receptor Inhibiting Vasoconstriction Blood pressure Sympathetic tone Aldosterone Fibrosis Hypertrophy 17 *Neprilysin substrates listed in order of relative affinity for NEP: ANP, CNP, Ang II, Ang I, adrenomedullin, substance P, bradykinin, endothelin-1, BNP Levin et al. N Engl J Med 1998;339:321 8; Nathisuwan & Talbert. Pharmacotherapy 2002;22:27 42; Schrier & Abraham N Engl J Med 2009;341:577 85; Langenickel & Dole. Drug Discov Today: Ther Strateg 2012;9:e131 9; Feng et al. Tetrahedron Letters 2012;53:275 6

18 Cumulative probability Composite primary endpoint Sacubitril/valsartan significantly reduced death from CV causes or first hospitalization for HF* 0.4 Enalapril (N=4,212) Sacubitril/valsartan (N=4,187) % No. at risk Sacubitril/ valsartan Enalapril 0 6 p< HR: 0.80 (95 % CI: ) ARR: 4.7 % Months since randomization 4,187 3,922 3,663 3,018 2,257 1, ,212 3,883 3,579 2,922 2,123 1, RELATIVE RISK REDUCTION OF PRIMARY ENDPOINT *Compared with enalapril, as assessed via time until cardiovascular death or first hospitalization for HF. 1 Enalapril 10 mg 2x daily as comparator vs sacubitril/valsartan 200 mg 2x daily in the PARADIGM-HF study (in addition of standard therapy). 27 months since randomization (median) ACE=angiotensin-converting enzyme; ARR=absolute risk reduction; CI=confidence interval; HF=heart failure; HFrEF=heart failure with reduced ejection fraction; HR=hazard ratio; NNT=number needed to treat McMurray et al. N Engl J Med 2014;371:

19 Summary of results efficacy Primary outcome 20% reduction in CV death or HF hospitalization with LCZ696 compared with enalapril 20% reduction in CV mortality 21% reduction in HF hospitalization Secondary outcomes 16% reduction in all-cause mortality with LCZ696 vs enalapril LCZ696 superior to enalapril in reducing symptoms and physical limitations of HF (indicated by KCCQ score) No significant difference in incidence of new onset atrial fibrillation between treatment groups No significant difference in protocol-defined decline in renal function between treatment groups McMurray, et al. N Engl J Med 2014; epub ahead of print: DOI: /NEJMoa

20 Aldosterone Antagonist In patients with HFrEF (EF<35%) and NYHA III-IV symptoms, spironolactone led to a 30% reduction in all-cause mortality.

21 Aldosterone Antagonist 2737 patients NYHA II heart failure and LVEF 35% Eplerenone (up to 50 mg daily) vs placebo, in addition to recommended therapy Primary outcome was a composite of death from cardiovascular causes or hospitalization for heart failure.

22 Ivabradine NYHA II-IV, LVEF 35% with hospitalization for heart failure within the preceding year on contemporary medical therapy with resting heart rate 70bpm, the addition of ivabradine resulted in a 5% absolute reduction in heart failure mortality or hospitalization at 2 years. The benefit of ivabradine was driven both by a 5% absolute reduction in heart failure hospitalization as well as a 2% absolute reduction in heart failure mortality.

23 23 Hydralazine + Nitrate 43% all-cause mortality reduction in Afro-Americans with HFREF NYHA III to IV

24 DIGOXIN RADIANCE study. Kaplan-Meier analysis of cumulative probability of worsening heart failure in patients continuing to receive digoxin (n=85) and those with treatment switched to placebo (n=93). Patients in the placebo group had a higher risk of worsening heart failure throughout the 12-week study (relative risk, 5.9; 95% confidence interval, 2.1 to 17.2; P<0.001).

25 Iron therapy: FAIR-HF Trial design: Patients with chronic heart failure and iron deficiency (with or without anemia) were randomized to intravenous iron (ferric carboxymaltose) (n = 304) vs. placebo (n = 155) for 24 weeks. 60 % (p < 0.001) (p < 0.001) 50 Much or moderately improved patient assessment Intravenous iron NYHA class I or II Placebo Results Primary outcome, Patient Global Assessment at 24 weeks: Much or moderately improved in 50% of the intravenous iron group vs. 28% of the placebo group (p < 0.001) New York Heart Association (NYHA) class I or II at 24 weeks: 47% vs. 30% (p < 0.001) Death: 3.4% vs. 5.5% (p = 0.47) Hospitalization for any cardiovascular cause: 10.4% vs. 20.0% (p = 0.08) Conclusions Among patients with chronic heart failure and iron deficiency, the use of intravenous iron for 24 weeks was beneficial This therapy resulted in improved symptoms and functional capacity Intravenous iron appeared to be safe Anker SD, et al. N Engl J Med 2009;Nov 17:[Epub]

26 DIURETICS Loop diuretics Frusemide Bumetinide Better bioavailability and higher potency Thiazide diuretics If resistant to loop diuretics Hydrochlorothiazide, Metolazone Potent diuresis, monitor electrolytes 26

27 27

28 Reduction in relative risk of all-cause mortality Effects of drugs are Additive ACEIs* vs Placebo ARBs* vs Placebo -Blockers* + ACEI/ARB vs. ACEI/ARB alone MRAs* + ACEI/ARB + -blockers vs. ACEI/ARB + -blockers ARNIs ARNI + -blockers + MRA vs. ACEI/ARB + -blockers + MRA 16% (4.5% ARR; mean follow up of 41.4 months) 17% (3.0% ARR; median follow up of 33.7 months) SOLVD 1,2 CHARM- 34% Alternative 3 (3.8% ARR; mean follow up of 1 year) MERIT-HF 4 24% (7.6% ARR; mean follow up of 21 months) EMPHASIS- HF 1,5 16% (2.8% ARR; median follow up of 27 months) PARADIGM -HF 6 *On top of standard therapy at the time of study, except in CHARM-Alternative where patients were intolerant to ACEI: On top of standard therapy and as a replacement for ACE!s (enalapril) Patient populations varied between trials and as such relative risk reductions cannot be directly compared 28 ACEI=angiotensin-converting-enzyme inhibitor; ARB=angiotensin receptor blocker; HF=heart failure; ARR=absolute risk reduction; HFrEF=heart failure with reduced ejection fraction; LVEF=left ventricular ejection fraction; MRA=mineralocorticoid receptor antagonist 1. McMurray et al. Eur Heart J 2012;33: ; 2. SOLVD Investigators. N Engl J Med 1991;325: ; 3. Granger et al. Lancet 2003;362:772 66; 4. MERIT-HF study group. Lancet 1999;353: Pitt et al. N Engl J Med 1999;341:709-17; 6. McMurray et al.,n. Eng. J Med. 2014, 371:

29 ABCS OF PHARMACOTHERAPY IN HF A ACE-inhibitors/ARBs/ARNI, (antiplatelets, anticoagulation) B Beta blockers C (Cholesterol meds) D Diuretics, dilators (hydralazine/nitrates), digoxin E Eplerenone (MRA), spironolactone F If channel blocker (Ivabradine), IV Ferrinject (Iron)

30 Diuretics to relieve symptoms and signs of congestion If LVEF 35% despite OMT or a history of symptomatic VT/VF, implant ICD THE TREATMENT OF PATIENTS WITH SYMPTOMATIC HFREF Patient with symptomatic a HFrEF b Therapy with ACEI c and beta-blocker (up-titrate to maximum tolerated evidence-based doses) Still symptomatic and LVEF 35% Yes Add MR antagonist d,e (up-titrate to maximum tolerated evidence-based doses) Yes Still symptomatic and LVEF 35% Yes No No Able to tolerate ACEI (or ARB) f,g Sinus rhythm, QRS duration 130 msec Sinus rhythm, h HR 70 bpm ARNI to replace ACEI Evaluateneed for CRT i,j Ivabradine These above treatments may be combined if indicated Class I Class IIa Yes Consider digoxin or H-ISDN or LVAD, or heart transplantation Resistant symptoms Green indicates a class I recommendation; yellow indicates a class IIa recommendation. a. Symptomatic = NYHA Class II IV; b. HFrEF = LVEF <40%; c. If ACE inhibitor not tolerated/contra-indicated, use ARB; d. If MR antagonist not tolerated/contra-indicated, use ARB; e. With a hospital admission for HF within the last 6 months or with elevated natriuretic peptides (BNP > 250 pg/ml or NTproBNP > 500 pg/ml in men and 750 pg/ml in women); f. With an elevated plasma natriuretic peptide level (BNP 150 pg/ml or plasma NT-proBNP 600 pg/ml, or if HF hospitalization within recent 12 months plasma BNP 100 pg/ml or plasma NT-proBNP 400 pg/ml); g. In doses equivalent to enalapril 10 mg b.i.d; h. With a hospital admission for HF within the previous year; i. CRT is recommended if QRS 130 msec and 30 LBBB (in sinus rhythm); j. CRT should/may be considered if QRS 130 msec with non-lbbb (in a sinus rhythm) or for patients in AF provided a strategy to ensure bi-ventricular capture in place (individualised decision) Ponikowski et al. Eur Heart J 2016;37: No No further action required Consider reducing diuretic dose

31 DOSE MATTERS High Dose vs Low Dose ACEi / ARB: Mortality & HF Hospitalizations

32 OPTIMAL DOSE

33 TREATMENT IN CHRONIC HF Treat the underlying aetiology/ precipitating factor Non-pharmacologic treatment Pharmacologic treatment Reduce mortality and morbidity Beta-blocker, ACE-I/ ARB/ ARNI, Aldosterone-inhibitor, ivabradine, hydralazine+nitrate Symptomatic relief Diuretics, digoxin, GTN IV iron Device therapy Advanced HF therapies

34 THANK YOU! me at:

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