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Comparing LCZ696 with Enalapril According to Baseline Risk Using the MAGGIC and EMPHASIS-HF Risk Scores An Analysis of Mortality and Morbidity in PARADIGM-HF
Simpson, Joanne Jhund, Pardeep S. Cardoso, Jose Silva Martinez, Felipe Mosterd, Arend Ramires, Felix Rizkala, Adel R. Senni, Michele Squire, Iain Gong, Jianjian
Simpson, Joanne
Jhund, Pardeep S.
Cardoso, Jose Silva
Martinez, Felipe
Mosterd, Arend
Ramires, Felix
Rizkala, Adel R.
Senni, Michele
Squire, Iain
Gong, Jianjian
Author
Simpson, Joanne
Jhund, Pardeep S.
Cardoso, Jose Silva
Martinez, Felipe
Mosterd, Arend
Ramires, Felix
Rizkala, Adel R.
Senni, Michele
Squire, Iain
Gong, Jianjian
Lefkowitz, Martin P.
Shi, Victor C.
Desai, Akshay S.
Rouleau, Jean L.
Swedberg, Karl
Zile, Michael R.
McMurray, John J.V.
Packer, Milton
Solomon, Scott D.
Jhund, Pardeep S.
Cardoso, Jose Silva
Martinez, Felipe
Mosterd, Arend
Ramires, Felix
Rizkala, Adel R.
Senni, Michele
Squire, Iain
Gong, Jianjian
Lefkowitz, Martin P.
Shi, Victor C.
Desai, Akshay S.
Rouleau, Jean L.
Swedberg, Karl
Zile, Michael R.
McMurray, John J.V.
Packer, Milton
Solomon, Scott D.
Abstract
BACKGROUND Although most patients in the PARADIGM-HF (Prospective Comparison of ARNI With ACEI to Determine Impact on Global Mortality and Morbidity in Heart Failure) trial had mild symptoms, there is a poor correlation between reported functional limitation and prognosis in heart failure. OBJECTIVES The aim of this study was to examine the spectrum of risk in PARADIGM-HF and the effect of LCZ696 across that spectrum. METHODS This study analyzed rates of the primary composite outcome of cardiovascular death or heart failure hospitalization, its components, and all-cause mortality using the MAGGIC (Meta-Analysis Global Group in Chronic Heart Failure) and EMPHASIS-HF (Eplerenone in Mild PatientsHospitalization and Survival Study in Heart Failure) risk scores to categorize patients. The authors determined whether risk, on the basis of these scores, modified the treatment effect of LCZ696. RESULTS The complete MAGGIC risk score was available for 8,375 of the 8,399 patients in PARADIGM-HF. The median MAGGIC score was 20 (IQR: 16 to 24). An increase of 1 point was associated with a 6% increased risk for the primary endpoint (p < 0.001) and a 7% increased risk for cardiovascular death (p < 0.001). The benefit of LCZ696 over enalapril for the primary endpoint was similar across the spectrum of risk (p ¼ 0.159). Treating 100 patients for 2 years with LCZ696 instead of enalapril led to 7 fewer patients in the highest quintile of risk experiencing primary outcomes, compared with 3 in the lowest quintile. Analyses using the EMPHASIS-HF risk score gave similar findings. CONCLUSIONS Although most PARADIGM-HF patients had mild symptoms, many were at high risk for adverse outcomes and obtained a large absolute benefit from LCZ696, compared with enalapril, over a relatively short treatment period. LCZ696’s benefit was consistent across the spectrum of risk. (PARADIGM-HF trial [Prospective Comparison of ARNI With ACEI to Determine Impact on Global Mortality and Morbidity in Heart Failure]; NCT01035255) (J Am Coll Cardiol 2015;66:2059–71) © 2015 by the American College of Cardiology Foundation.
Keywords
angiotensin receptor neprilysin inhibitor, prognostic model, risk score, survival
Date
2015
Type
Journal article
Journal
Journal of the American College of Cardiology
Book
Volume
66
Issue
19
Page Range
2059-2071
Article Number
ACU Department
Collections
Relation URI
Source URL
Event URL
Open Access Status
Open access
License
File Access
Controlled