Biomarkers in the Age of Sacubitril/Valsa rten: Has the PARADIGM Changed

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1 Biomarkers in the Age of Sacubitril/Valsa rten: Has the PARADIGM Changed Alan S. Maisel MD FACC Professor of Medicine, University of California, San Diego, Director, CCU and Heart Failure Program San Diego VA Medical Center

2 Sacubitril/Valsartan (LCZ696) Mechanism of Action Buggey et al. Journal of Cardiac Failure, Volume 21, Issue 9, 2015,

3 Aim of the PARADIGM-HF Trial Prospective comparison of ARNI with ACEI to Determine Impact on Global Mortality and morbidity in Heart Failure trial (PARADIGM-HF) Sacubitril/Valsartan 97/103 mg twice daily Enalapril 10 mg twice daily specifically designed to replace current use of ACE inhibitors and angiotensin receptor blockers as the cornerstone of the treatment of heart failure

4 PARADIGM-HF: Effect of Sac/Val vs. Enalapril on the Primary Endpoint and Its Components Sac/Val (n=4187) Enalapril (n=4212) Hazard Ratio (95% CI) p- Value Primary endpoint 914 (21.8%) 1117 (26.5%) 0.80 ( ) <0.001 Cardiovascular death 558 (13.3%) 693 (16.5%) 0.80 ( ) <0.001 Hospitalization for heart failure 537 (12.8%) 658 (15.6%) 0.79 ( ) <0.001 Sac/Val = Sacubitril/Valsartan. McMurray JJV, et al. N Engl J Med. 2014;371:

5 Angiotensin Neprilysin Inhibition with Sac/Val Doubles Effect on CV Death of Current Inhibitors of the RAS 0 Angiotensin Receptor Blocker 1 ACE Inhibitor 2 Angiotensin Neprilysin Inhibition 3 Decrease in Mortality (%) % 18% 20% Granger CB, et al. Lancet. 2003;362: The SOLVD Investigators. N Engl J Med. 1991;325: McMurray JJV, et al. N Engl J Med. 2014;371:

6 2016 ACC/AHA/HFSA Heart Failure Guideline Update Pharmacological Treatment for Stage C HFrEF ARNI = angiotensin receptor blocker and neprilysin inhibitor; COR = class of recommendation; LOE = level of evidence. Reference: Yancy et al. Circulation. 2016;134:[ePub ahead of print].

7 Which peptide with Sacubitril/ Valsartan? NT-proBNP? BNP?

8 Sacubitril / Valsartan Mechanism of Action

9 PARADIGM-HF: NT-proBNP and BNP NT-proBNP pg/ml NT-proBNP BNP Months LCZ696 Enalapril BNP pg/ml

10

11 Single ST2 Cut-point: > ng/ml = RISK

12 ST2 Not Correlated with Renal Function In a cohort of 879 heart failure patients ST2 did not show any correlation with renal function whereas NT-proBNP concentrations increased significantly with decreasing renal function. Bayes-Genis et al JCF

13 Mortality Risk Increases With ST2 Levels One-year mortality exceeded 50% in the highest decile. One Year Mortality (%) P < ST2 Decile Rehman SU, Mueller T, Januzzi JL et al. J Am Coll Cardiol. 2008;52:

14 14 12 ST2 and Admissions Over 6 Months BNP and Admissions Over 6 Months Admissions R² = Admissions R² = ST2 (ng/ml) Wetterson, Maisel AJM BNP (pg/ml) 14

15 Maisel s Frequent-Flyer Index

16 Serial ST2/BNP for Guiding Treatment During Hospitalization? ST2 Courtesy of Damien Logeart.

17 Changes one might consider on the basis of a biomarker prior to discharge Extra hospital time One week follow up Home nursing Telemonitoring More aggressive titration of medicationsincluding Entresto

18 ST2 in Chronic, Ambulatory HF Cohorts HR for risk of death at 1 year, with ST2 >35 ng/ml Univariable Risk-Adjusted Adjusted for age, sex, NYHA class, EF, GFR, diabetes, HTN, and smoking Daniels LB, Future Cardiol 2014

19 ST2 Predicts Response to Treatment: Aldosterone Blockade in STEMI Eplerenone prevents adverse ventricular remodeling ST2 predicts which pts are most at risk AND which pts will benefit most from aldosterone blockade Weir AP, et al. J. Am. Coll. Cardiol. 2010;55; High and low ST2 separated at median. à Eplerenone attenuates remodeling more in pts with higher baseline ST2.

20 Patient: F.S.. 68 y.o; HFpEF Spironolactone: 25mg Carvedilol: 25mg Lasix: 60 mg No Admissions-1 year

21 Patient: K.E. BNP still high but ST2 low-no readmissions in one year

22 Patient: S.V. Rising EF over one year

23

24

25

26 Sacubitril / Valsartan Mechanism of Action

27 HFrEF: New therapeutic approaches after the PARADIGM-HF study? β-blocker ACEI/ARB MRA β-blocker ARNI MRA 27 McMurray JJ et al. Eur Heart J Jul;33(14):

28 Reason for slow uptake?- In the United States it is quite costly It is not always reimbursed Lots of paper-work Even after cost and reimbursement accounted forthousands of patients who qualify are not taking it. Why? 28

29 Think about it. It takes a long time to get a HF patient feeling well without a minimum of medication side effects. You suddenly come in and tell them you want to rearrange their medications so they will feel better and live longer. These patients will not like this approach They will not like the doctor. 29

30

31 Figure 2. Relationships between baseline sst2 concentrations and clinical outcomes 31

32 Primary Care evaluation of ambulatory HF patient Measure ST2 sst2 level > Or less than 35 >35 pg/ml <35 pg/ml what to do Refer to cardiology Echo Increase guideline treatment Stable follow

33 What to do for levels >35 pg/ml >35 pg/ml Other workup: echo, stress test Increase ACE, ARB Increase Spironolactone Start Entresto

34

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