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1. Effect of Sacubitril/Valsartan on Cognitive Function in Patients With Heart Failure With Preserved Ejection Fraction: A Prespecified Analysis of PARAGON-HF

Author

Dewan, Pooja, Shen, Li, Pedro Ferreira, João, Jhund, Pardeep S., Anand, Inder S., Chandra, Alvin, Chiang, Lu-May, Claggett, Brian, Desai, Akshay S., Gong, Jianjian, Lam, Carolyn S.P., Lefkowitz, Martin P., Maggioni, Aldo P., Martinez, Felipe, Packer, Milton, Redfield, Margaret M., Rouleau, Jean L., van Veldhuisen, Dirk J., Zannad, Faiez, Zile, Michael R., Solomon, Scott D., and McMurray, John J.V.

Published
2024
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5. Systolic Blood Pressure and Outcomes in Older Patients with HFpEF and Hypertension

Author

Faselis, Charles, Lam, Phillip H, Zile, Michael R, Bhyan, Poonam, Tsimploulis, Apostolos, Arundel, Cherinne, Patel, Samir, Kokkinos, Peter, Deedwania, Prakash, Bhatt, Deepak L, Zeng-Trietler, Qing, Morgan, Charity J, Aronow, Wilbert S, Allman, Richard M, Fonarow, Gregg C, and Ahmed, Ali

Subjects
Biomedical and Clinical Sciences, Cardiovascular Medicine and Haematology, Cardiovascular, Aging, Patient Safety, Clinical Research, Hypertension, Aged, Aged, 80 and over, Blood Pressure, Cohort Studies, Female, Heart Failure, Humans, Inpatients, Male, Medicare, Registries, Treatment Outcome, United States, All-cause mortality, Heart failure with preserved ejection fraction, Readmission, Systolic blood pressure, Heart failure with preserved ejection fraction (HFpEF), Readmission, Medical and Health Sciences, General & Internal Medicine, Biomedical and clinical sciences, Health sciences
Abstract

BackgroundNew hypertension and heart failure guidelines recommend that systolic blood pressure (SBP) in patients with heart failure with preserved ejection fraction (HFpEF) and hypertension be lowered to

Published
2021

7. Right Ventricular Function and Pulmonary Coupling in Patients With Heart Failure and Preserved Ejection Fraction

Author

Inciardi, Riccardo M., Abanda, Martin, Shah, Amil M., Cikes, Maja, Claggett, Brian, Skali, Hicham, Vaduganathan, Muthiah, Prasad, Narayana, Litwin, Sheldon, Merkely, Bela, Kosztin, Annamaria, Nagy, Klaudia Vivien, Shah, Sanjiv J., Mullens, Wilfred, Zile, Michael R., Lam, Carolyn S.P., Pfeffer, Marc A., McMurray, John J.V., and Solomon, Scott D.

Published
2023
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8. Exercise-Induced Left Atrial Hypertension in Heart Failure With Preserved Ejection Fraction

Author

Litwin, Sheldon E., Komtebedde, Jan, Hu, Mo, Burkhoff, Daniel, Hasenfuß, Gerd, Borlaug, Barry A., Solomon, Scott D., Zile, Michael R., Mohan, Rajeev C., Khawash, Rami, Sverdlov, Aaron L., Fail, Peter, Chung, Eugene S., Kaye, David M., Blair, John, Eicher, Jean-Christophe, Hummel, Scott L., Zirlik, Andreas, Westenfeld, Ralf, Hayward, Christopher, Gorter, Thomas M., Demers, Catherine, Shetty, Ranjith, Lewis, Gregory, Starling, Randall C., Patel, Sanjay, Gupta, Deepak K., Morsli, Hakim, Penicka, Martin, Cikes, Maja, Gustafsson, Finn, Silvestry, Frank E., Rowin, Ethan J., Cutlip, Donald E., Leon, Martin B., Kitzman, Dalane W., Kleber, Franz X., and Shah, Sanjiv J.

Published
2023
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10. Abstract 13828: Aptamer Proteomics for Biomarker Discovery in Heart Failure With Preserved Ejection Fraction: The PARADIGM-HF Proteomic Sub-Study

Author

Patel-Murray, Natasha, Zhang, Luqing, Claggett, Brian, Xu, Dongchu, Serrano-Fernandez, Pablo, Wandel, Simon, Xu, Huilei, Healey, Margaret, Turner, Gordon, Chen, Chien-Wei, Zhao, Faye, CHUTKOW, WILLIAM A, Yates, Denise, ODonnell, Christopher, Prescott, Margaret, Lefkowitz, Martin P, Gimpelewicz, Claudio R, Beste, Michael, Gou, Liangke, Desai, Akshay S, Jhund, Pardeep S, Packer, Milton, Pfeffer, Marc A, Redfield, Margaret M, Rouleau, Jean L, ZANNAD, Faiez, Zile, Michael R, McMurray, John J, Mendelson, Michael, Solomon, Scott D, and Cunningham, Jonathan

Published
2023
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11. Abstract 12470: Sacubitril/Valsartan in Patients With Heart Failure and Deterioration of Kidney Function to Estimated Glomerular Filtration Rate Less Than 30ml/min/1.73m2: Insights From PARAGON-HF and PARADIGM-HF

Author

Chatur, Safia, Vaduganathan, Muthiah, Claggett, Brian L, McCausland, Finnian, Desai, Akshay S, Beldhuis, Iris, Rouleau, Jean L, Zile, Michael R, Packer, Milton, Pfeffer, Marc A, Lefkowitz, Martin P, McMurray, John J, and Solomon, Scott D

Published
2023
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14. Digoxin Initiation and Outcomes in Patients with Heart Failure with Preserved Ejection Fraction.

Author

Lam, Phillip, Packer, Milton, Gill, Gauravpal, Wu, Wen-Chih, Levy, Wayne, Zile, Michael, Brar, Vijaywant, Arundel, Cherinne, Cheng, Yan, Singh, Steven, Allman, Richard, Ahmed, Ali, and Fonarow, Gregg

Subjects
Digoxin, Heart failure with preserved ejection fraction, Mortality, Readmission, Adrenergic beta-Antagonists, Aged, Aged, 80 and over, Angiotensin Receptor Antagonists, Angiotensin-Converting Enzyme Inhibitors, Anti-Arrhythmia Agents, Anticoagulants, Atrial Fibrillation, Cardiotonic Agents, Cause of Death, Digoxin, Female, Heart Failure, Hospitalization, Humans, Hydroxymethylglutaryl-CoA Reductase Inhibitors, Male, Mineralocorticoid Receptor Antagonists, Mortality, Patient Readmission, Platelet Aggregation Inhibitors, Propensity Score, Proportional Hazards Models, Registries, Sodium Potassium Chloride Symporter Inhibitors, Stroke Volume, Warfarin
Abstract

BACKGROUND: Digoxin reduces the risk of heart failure hospitalization in patients with heart failure with reduced ejection fraction. Less is known about this association in patients with heart failure with preserved ejection fraction (HFpEF), the examination of which was the objective of the current study. METHODS: In the Medicare-linked OPTIMIZE-HF registry, 7374 patients hospitalized for HF had ejection fraction ≥50% and were not receiving digoxin prior to admission. Of these, 5675 had a heart rate ≥50 beats per minute, an estimated glomerular filtration rate ≥30 mL/min/1.73 m2 or did not receive inpatient dialysis, and digoxin was initiated in 524 of these patients. Using propensity scores for digoxin initiation, calculated for each of the 5675 patients, we assembled a matched cohort of 513 pairs of patients initiated and not initiated on digoxin, balanced on 58 baseline characteristics (mean age, 80 years; 66% women; 8% African American). Hazard ratios (HRs) and 95% confidence intervals (CIs) for outcomes associated with digoxin initiation were estimated in the matched cohort. RESULTS: Among the 1026 matched patients with HFpEF, 30-day heart failure readmission occurred in 6% and 9% of patients initiated and not initiated on digoxin, respectively (HR 0.70; 95% CI, 0.45-1.10; P = .124). HRs (95% CIs) for 30-day all-cause readmission and all-cause mortality associated with digoxin initiation were 0.95 (0.73-1.23; P = .689) and 0.93 (0.55-1.56; P = .773), respectively. Digoxin initiation had no association with 6-year outcomes. CONCLUSION: Digoxin initiation prior to hospital discharge was not associated with 30-day or 6-year outcomes in older hospitalized patients with HFpEF.

Published
2020

16. Loop Diuretic Prescription and 30-Day Outcomes in Older Patients With Heart Failure

Author

Faselis, Charles, Arundel, Cherinne, Patel, Samir, Lam, Phillip H, Gottlieb, Stephen S, Zile, Michael R, Deedwania, Prakash, Filippatos, Gerasimos, Sheriff, Helen M, Zeng, Qing, Morgan, Charity J, Wopperer, Samuel, Nguyen, Tran, Allman, Richard M, Fonarow, Gregg C, and Ahmed, Ali

Subjects
Biomedical and Clinical Sciences, Clinical Sciences, Aging, Cardiovascular, Clinical Research, Heart Disease, Aged, Aged, 80 and over, Cohort Studies, Female, Heart Failure, Humans, Male, Sodium Potassium Chloride Symporter Inhibitors, Time Factors, Treatment Outcome, heart failure, loop diuretics, outcomes, Cardiorespiratory Medicine and Haematology, Public Health and Health Services, Cardiovascular System & Hematology, Cardiovascular medicine and haematology
Abstract

BackgroundHeart failure (HF) is a major source of morbidity and mortality. Fluid retention and shortness of breath are its cardinal manifestations for which loop diuretics are used. Although their usefulness is well accepted, less is known about their role in improving clinical outcomes.ObjectivesThe purpose of this study was to determine the relationship between loop diuretics and clinical outcomes in patients with HF.MethodsOf the 25,345 older patients hospitalized for HF in the Medicare-linked OPTIMIZE-HF (Organized Program to Initiate Lifesaving Treatment in Hospitalized Patients with Heart Failure) registry, 9,866 (39%) received no pre-admission diuretics. The study excluded 1,083 patients receiving dialysis and 847 discharged on thiazide diuretics. Of the remaining 7,936 patients, 5,568 (70%) were prescribed loop diuretics at discharge. Using propensity scores for receipt of loop diuretics estimated for each of the 7,936 patients, a matched cohort of 2,191 pairs of patients was assembled balanced on 74 baseline characteristics. Hazard ratios (HRs) and 95% confidence intervals (CIs) for outcomes were estimated in the matched cohort.ResultsMatched patients (n = 4,382) had a mean age of 78 years, 54% were women, and 11% were African American. The 30-day all-cause mortality occurred in 4.9% (107 of 2,191) and 6.6% (144 of 2,191) of patients in the loop diuretic and no loop diuretic groups, respectively (HR when the use of loop diuretics was compared with nonuse: 0.73; 95% CI: 0.57 to 0.94; p = 0.016). Patients in the loop diuretic group had a significantly lower risk of 30-day HF readmission (HR: 0.79; 95% CI: 0.63 to 0.99; p = 0.037) but not of 30-day all-cause readmission (HR: 0.89; 95% CI: 0.79 to 1.01; p = 0.081). None of the associations was statistically significant during 60 days of follow-up.ConclusionsHospitalized older patients not taking diuretics prior to hospitalization for HF decompensation who received a discharge prescription for loop diuretics had significantly better 30-day clinical outcomes than those not discharged on loop diuretics. These findings provide new information about short-term clinical benefits associated with loop diuretic use in HF.

Published
2020

22. Sacubitril/Valsartan in Patients With Heart Failure and Deterioration in eGFR to <30 mL/min/1.73 m2

Author

Chatur, Safia, primary, Beldhuis, Iris E., additional, Claggett, Brian L., additional, McCausland, Finnian R., additional, Neuen, Brendon L., additional, Desai, Akshay S., additional, Rouleau, Jean L., additional, Zile, Michael R., additional, Packer, Milton, additional, Pfeffer, Marc A., additional, Lefkowitz, Martin P., additional, McMurray, John J.V., additional, Solomon, Scott D., additional, and Vaduganathan, Muthiah, additional

Published
2024
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23. In vivo fluid dynamics of the Ventura interatrial shunt device in patients with heart failure

Author

Pfeiffer, Michael, primary, Boehmer, John, additional, Gorcsan, John, additional, Eguchi, Shunsuke, additional, Orihara, Yoshiyuki, additional, Perl, Michal Laufer, additional, Eigler, Neal, additional, Abraham, William T., additional, Villota, Julio Nuñez, additional, Lee, Elizabeth, additional, Bayés‐Genís, Antoni, additional, Moravsky, Gil, additional, Kar, Saibal, additional, Zile, Michael R., additional, Holcomb, Richard, additional, Anker, Stefan D., additional, Stone, Gregg W., additional, Rodés‐Cabau, Josep, additional, Lindenfeld, JoAnn, additional, and Bax, Jeroen J., additional

Published
2024
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24. Cardiovascular-Kidney-Metabolic Overlap in Heart Failure with Mildly Reduced or Preserved Ejection Fraction: A Trial-Level Analysis

Author

Ostrominski, John W., primary, Claggett, Brian L., additional, Miao, Zi Michael, additional, Mc Causland, Finnian R., additional, Anand, Inder S., additional, Desai, Akshay S., additional, Jhund, Pardeep S., additional, Lam, Carolyn S.P., additional, Pfeffer, Marc A., additional, Pitt, Bertram, additional, Zannad, Faiez, additional, Zile, Michael R., additional, Bomfim Wirtz, Antonieta, additional, Lay-Flurrie, James, additional, Viswanathan, Prabhakar, additional, McMurray, John J.V., additional, Solomon, Scott D., additional, and Vaduganathan, Muthiah, additional

Published
2024
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26. Interatrial shunt therapy in advanced heart failure: Outcomes from the open‐label cohort of the RELIEVE‐HF trial

Author

Rodés‐Cabau, Josep, primary, Lindenfeld, JoAnn, additional, Abraham, William T., additional, Zile, Michael R., additional, Kar, Saibal, additional, Bayés‐Genís, Antoni, additional, Eigler, Neal, additional, Holcomb, Richard, additional, Núñez, Julio, additional, Lee, Elizabeth, additional, Perl, Michal Laufer, additional, Moravsky, Gil, additional, Pfeiffer, Michael, additional, Boehmer, John, additional, Gorcsan, John, additional, Bax, Jeroen J., additional, Anker, Stefan, additional, and Stone, Gregg W., additional

Published
2024
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29. Role of High-Dose Beta-Blockers in Patients with Heart Failure with Preserved Ejection Fraction and Elevated Heart Rate.

Author

Lam, Phillip, Gupta, Neha, Dooley, Daniel, Singh, Steven, Ahmed, Ali, Zile, Michael, Bhatt, Deepak, Morgan, Charity, Pitt, Bertram, Fonarow, Gregg, and Deedwania, Prakash

Subjects
All-cause mortality, Heart failure with preserved ejection fraction, Heart rate, High-dose beta-blocker, Adrenergic beta-Antagonists, Aged, Aged, 80 and over, Dose-Response Relationship, Drug, Heart Failure, Heart Rate, Humans, Logistic Models, Propensity Score, Stroke Volume
Abstract

BACKGROUND: Beta-blockers in high target doses are recommended for heart failure with reduced ejection fraction (HFrEF) but not for preserved ejection fraction (HFpEF). Treatment benefits are often more pronounced in high-risk subgroups, and patients with HFpEF with heart rate ≥70 beats per minute have emerged as such a high-risk subgroup. We examined the associations of high-dose beta-blocker use with outcomes in these patients. METHODS: Of the 8462 hospitalized patients with heart failure with ejection fraction ≥50% in the Medicare-linked Organized Program to Initiate Lifesaving Treatment in Hospitalized Patients with Heart Failure (OPTIMIZE-HF) registry, 5422 had a discharge heart rate ≥70 beats per minute. Of these, 4537 had no contraindications to beta-blocker use, of which 2797 (2592 with dose data) received prescriptions for beta-blockers. Of the 2592, 730 received high-dose beta-blockers, defined as atenolol ≥100 mg/day, carvedilol ≥50 mg/day, metoprolol tartrate or succinate ≥200 mg/day, or bisoprolol ≥10 mg/day, and 1740 received no beta-blockers. Using propensity scores for the receipt of high-dose beta-blockers, we assembled a matched cohort of 1280 patients, balanced on 58 characteristics. RESULTS: All-cause mortality occurred in 63% and 68% of matched patients receiving high-dose beta-blocker vs no beta-blocker, respectively, during 6 years (median, 2.8) of follow-up (hazard ratio, 0.86; 95% confidence interval, 0.75-0.98; P = .027). The hazard ratios (95% confidence intervals) for all-cause readmission and the combined endpoint of all-cause readmission or all-cause mortality associated with high-dose beta-blocker use were 0.90 (0.81-1.02) and 0.89 (0.80-1.00), respectively. CONCLUSIONS: In patients with HFpEF and heart rate ≥70 beats per minute, high-dose beta-blocker use was associated with a significantly lower risk of death. Future randomized controlled trials are needed to examine this association.

Published
2018

30. Sacubitril/Valsartan and Frailty in Patients With Heart Failure and Preserved Ejection Fraction

Author

Butt, Jawad H., Dewan, Pooja, Jhund, Pardeep S., Anand, Inder S., Atar, Dan, Ge, Junbo, Desai, Akshay S., Echeverria, Luis E., Køber, Lars, Lam, Carolyn S.P., Maggioni, Aldo P., Martinez, Felipe, Packer, Milton, Rouleau, Jean L., Sim, David, Van Veldhuisen, Dirk J., Vrtovec, Bojan, Zannad, Faiez, Zile, Michael R., Gong, Jianjian, Lefkowitz, Martin P., Rizkala, Adel R., Solomon, Scott D., and McMurray, John J.V.

Published
2022
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35. Cardiovascular‐kidney‐metabolic overlap in heart failure with preserved ejection fraction: Cardiac structure and function, clinical outcomes, and response to sacubitril/valsartan in PARAGON‐HF.

Author

Lassen, Mats C.H., Ostrominski, John W., Claggett, Brian L., Packer, Milton, Zile, Michael, Desai, Akshay S., Shah, Amil M., Cikes, Maja, Merkely, Bela, Gori, Mauro, Wang, Xiaowen, Hegde, Sheila M., Pfeffer, Marc A., Lefkowitz, Martin, McMurray, John J.V., Solomon, Scott D., and Vaduganathan, Muthiah

Subjects
GLOBAL longitudinal strain, HEART failure, TYPE 2 diabetes, GLOMERULAR filtration rate, CHRONIC kidney failure, ENTRESTO
Abstract

Aims: Cardiovascular‐kidney‐metabolic (CKM) multimorbidity is prevalent among individuals with heart failure (HF), but whether cardiac structure and function, clinical outcomes, and treatment response to sacubitril/valsartan vary in relation to CKM status is unknown. Methods and results: In this PARAGON‐HF post‐hoc analysis, we evaluated the impact of CKM multimorbidity (atherosclerotic cardiovascular [CV] disease, chronic kidney disease, and type 2 diabetes) on cardiac structure and function, clinical outcomes, and treatment effects of sacubitril/valsartan versus valsartan. The primary outcome was a composite of total HF hospitalizations and CV death. Secondary outcomes included the individual components of the primary outcome and a composite kidney outcome (sustained estimated glomerular filtration rate reduction of ≥50%, end‐stage kidney disease, or kidney‐related death). At baseline, 35.2% had one CKM condition, 33.3% had two, 15.9% had three, and only 15.6% had HF alone. CKM multimorbidity was associated with higher septal and posterior wall thickness, lower global longitudinal strain, higher E/e', and worse right ventricular function. Total HF hospitalizations or CV death increased with greater CKM multimorbidity, with the highest relative risk observed with three CKM conditions (rate ratio 3.06, 95% confidence interval 2.33–4.03), compared with HF alone. Treatment effects of sacubitril/valsartan were consistent irrespective of the number of CKM conditions for the primary endpoint (pinteraction = 0.75), CV death (pinteraction = 0.82), total HF hospitalizations (pinteraction = 0.67), and the composite kidney endpoint (pinteraction = 0.99). Conclusions: Cardiovascular‐kidney‐metabolic multimorbidity was common in PARAGON‐HF and associated with adverse changes in cardiac structure and function and with a stepwise increase in risk of clinical outcomes. Treatment effects of sacubitril/valsartan were consistent irrespective of CKM burden. Clinical Trial Registration: ClinicalTrials.gov NCT01920711. [ABSTRACT FROM AUTHOR]

Published
2024
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37. Heart Rate and Outcomes in Hospitalized Patients With Heart Failure With Preserved Ejection Fraction

Author

Lam, Phillip H, Dooley, Daniel J, Deedwania, Prakash, Singh, Steven N, Bhatt, Deepak L, Morgan, Charity J, Butler, Javed, Mohammed, Selma F, Wu, Wen-Chih, Panjrath, Gurusher, Zile, Michael R, White, Michel, Arundel, Cherinne, Love, Thomas E, Blackman, Marc R, Allman, Richard M, Aronow, Wilbert S, Anker, Stefan D, Fonarow, Gregg C, and Ahmed, Ali

Subjects
Biomedical and Clinical Sciences, Cardiovascular Medicine and Haematology, Heart Disease, Cardiovascular, Aging, Clinical Research, Adrenergic beta-Antagonists, Aged, Aged, 80 and over, Female, Follow-Up Studies, Heart Failure, Heart Rate, Hospitalization, Humans, Male, Medicare, Mortality, Outcome and Process Assessment, Health Care, Patient Acuity, Patient Discharge, Patient Readmission, Proportional Hazards Models, Registries, Risk Assessment, Stroke Volume, United States, all-cause mortality, all-cause readmission, atrial fibrillation, beta-blockers, propensity score, Cardiorespiratory Medicine and Haematology, Public Health and Health Services, Cardiovascular System & Hematology, Cardiovascular medicine and haematology
Abstract

BackgroundA lower heart rate is associated with better outcomes in patients with heart failure (HF) with reduced ejection fraction (EF). Less is known about this association in patients with HF with preserved ejection fraction (HFpEF).ObjectivesThe aims of this study were to examine associations of discharge heart rate with outcomes in hospitalized patients with HFpEF.MethodsOf the 8,873 hospitalized patients with HFpEF (EF ≥50%) in the Medicare-linked OPTIMIZE-HF (Organized Program to Initiate Lifesaving Treatment in Hospitalized Patients with Heart Failure) registry, 6,286 had a stable heart rate, defined as ≤20 beats/min variation between admission and discharge. Of these, 2,369 (38%) had a discharge heart rate of

Published
2017

39. Clinical implications of subclinical left ventricular dysfunction in heart failure with preserved ejection fraction: The PARAGON‐HF study

Author

Minamisawa, Masatoshi, primary, Inciardi, Riccardo M., additional, Claggett, Brian, additional, Cikes, Maja, additional, Liu, Li, additional, Prasad, Narayana, additional, Biering‐Sørensen, Tor, additional, Lam, Carolyn S.P., additional, Shah, Sanjiv J., additional, Zile, Michael R., additional, O'Meara, Eileen, additional, Redfield, Margaret M., additional, McMurray, John J.V., additional, Solomon, Scott D., additional, and Shah, Amil M., additional

Published
2024
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42. Implantable Hemodynamic Monitors Improve Survival in Patients With Heart Failure and Reduced Ejection Fraction

Author

Lindenfeld, JoAnn, primary, Costanzo, Maria Rosa, additional, Zile, Michael R., additional, Ducharme, Anique, additional, Troughton, Richard, additional, Maisel, Alan, additional, Mehra, Mandeep R., additional, Paul, Sara, additional, Sears, Samuel F., additional, Smart, Frank, additional, Johnson, Nessa, additional, Henderson, John, additional, Adamson, Philip B., additional, Desai, Akshay S., additional, and Abraham, William T., additional

Published
2024
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43. Haemodynamic-guided management of heart failure (GUIDE-HF): a randomised controlled trial

Author

Lindenfeld, JoAnn, Zile, Michael R, Desai, Akshay S, Bhatt, Kunjan, Ducharme, Anique, Horstmanshof, Douglas, Krim, Selim R, Maisel, Alan, Mehra, Mandeep R, Paul, Sara, Sears, Samuel F, Sauer, Andrew J, Smart, Frank, Zughaib, Marcel, Castaneda, Paige, Kelly, Jean, Johnson, Nessa, Sood, Poornima, Ginn, Greg, Henderson, John, Adamson, Philip B, and Costanzo, Maria Rosa

Published
2021
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48. Incidence and Outcomes of Pneumonia in Patients With Heart Failure

Author

Shen, Li, Jhund, Pardeep S., Anand, Inder S., Bhatt, Ankeet S., Desai, Akshay S., Maggioni, Aldo P., Martinez, Felipe A., Pfeffer, Marc A., Rizkala, Adel R., Rouleau, Jean L., Swedberg, Karl, Vaduganathan, Muthiah, Vardeny, Orly, van Veldhuisen, Dirk J., Zannad, Faiez, Zile, Michael R., Packer, Milton, Solomon, Scott D., and McMurray, John J.V.

Published
2021
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50. Efficacy of sacubitril/valsartan vs. enalapril at lower than target doses in heart failure with reduced ejection fraction: the PARADIGM‐HF trial

Author

Vardeny, Orly, Claggett, Brian, Packer, Milton, Zile, Michael R, Rouleau, Jean, Swedberg, Karl, Teerlink, John R, Desai, Akshay S, Lefkowitz, Martin, Shi, Victor, McMurray, John JV, Solomon, Scott D, and Investigators, for the Prospective Comparison of ARNI with ACEI to Determine Impact on Global Mortality and Morbidity in Heart Failure

Subjects
Clinical Trials and Supportive Activities, Clinical Research, Cardiovascular, 6.1 Pharmaceuticals, Evaluation of treatments and therapeutic interventions, Good Health and Well Being, Aged, Aminobutyrates, Angiotensin Receptor Antagonists, Biphenyl Compounds, Dose-Response Relationship, Drug, Double-Blind Method, Drug Combinations, Enalapril, Female, Heart Failure, Humans, Male, Middle Aged, Stroke Volume, Tetrazoles, Valsartan, Chronic heart failure, Neprilysin inhibitor, Clinical trial, Sacubitril, Prospective Comparison of ARNI with ACEI to Determine Impact on Global Mortality and Morbidity in Heart Failure (PARADIGM-HF) Investigators, Cardiorespiratory Medicine and Haematology, Cardiovascular System & Hematology
Abstract

AimsIn this analysis, we utilized data from PARADIGM-HF to test the hypothesis that participants who exhibited any dose reduction during the trial would have similar benefits from lower doses of sacubitril/valsartan relative to lower doses of enalapril.Methods and resultsIn a post-hoc analysis from PARADIGM-HF, we characterized patients by whether they received the maximal dose (200 mg sacubitril/valsartan or 10 mg enalapril twice daily) throughout the trial or had any dose reduction to lower doses (100/50/0 mg sacubitril/valsartan or 5/2.5/0 mg enalapril twice daily). The treatment effect for the primary outcome was estimated, stratified by dose level using time-updated Cox regression models. In the two treatment arms, participants with a dose reduction (43% of those randomized to enalapril and 42% of those randomized to sacubitril/valsartan) had similar baseline characteristics and similar baseline predictors of the need for dose reduction. In a time-updated analysis, any dose reduction was associated with a higher subsequent risk of the primary event [hazard ratio (HR) 2.5, 95% confidence interval (CI) 2.2-2.7]. However, the treatment benefit of sacubitril/valsartan over enalapril following a dose reduction was similar (HR 0.80, 95% CI 0.70-0.93, P < 0.001) to that observed in patients who had not experienced any dose reduction (HR 0.79, 95% CI 0.71-0.88, P < 0.001).ConclusionsIn PARADIGM-HF, study medication dose reduction identified patients at higher risk of a major cardiovascular event. The magnitude of benefit for patients on lower doses of sacubitril/valsartan relative to those on lower doses of enalapril was similar to that of patients who remained on target doses of both drugs.

Published
2016

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