Orly Vardeny1, Brian Claggett2, Jacob A Udell3, Milton Packer4, Michael Zile5, Jean Rouleau6, Karl Swedberg7, Akshay S Desai2, Martin Lefkowitz8, Victor Shi8, John J V McMurray9, Scott D Solomon10. 1. Pharmacy Practice Division, University of Wisconsin School of Pharmacy, Madison, Wisconsin. 2. Cardiovascular Division, Brigham and Women's Hospital, Boston, Massachusetts. 3. Division of Cardiology, Peter Munk Cardiac Centre, Toronto General Hospital and Women's College Hospital, Toronto, Ontario, Canada. 4. Department of Clinical Sciences, University of Texas Southwestern Medical Center, Dallas, Texas. 5. Medical University of South Carolina and Ralph H. Johnston Veterans Administration Medical Center, Charleston, South Carolina. 6. Institut de Cardiologie, Université de Montréal, Montreal, Quebec, Canada. 7. Department of Molecular and Clinical Medicine, University of Gothenburg, Gothenburg, Sweden; National Heart and Lung Institute, Imperial College London, London, England. 8. Novartis Pharmaceuticals Corporation, East Hanover, New Jersey. 9. British Heart Foundation Cardiovascular Research Center, University of Glasgow, Glasgow, Scotland, United Kingdom. 10. Cardiovascular Division, Brigham and Women's Hospital, Boston, Massachusetts. Electronic address: ssolomon@rics.bwh.harvard.edu.
Abstract
OBJECTIVES: This study sought to examine the prevalence and predictors of influenza vaccination among participants in the PARADIGM-HF (Prospective Comparison of ARNI with ACEI to Determine Impact on Global Mortality and Morbidity in Heart Failure) study and investigate associations between receiving influenza vaccine and cardiovascular death or heart failure hospitalizations, all-cause hospitalizations, and cardiopulmonary or influenza-related hospitalizations. BACKGROUND: Influenza is associated with an increased risk for cardiovascular events in patients with heart failure. METHODS: We used data from the PARADIGM-HF trial in which patients with heart failure were randomized to the angiotensin receptor neprilysin inhibitor LCZ696 (sacubitril/valsartan) or enalapril. We assessed predictors of receiving influenza vaccination, and examined the relationship between influenza vaccination and outcomes in a propensity-adjusted model. RESULTS:Of 8,099 study participants, 1,769 (21%) receivedinfluenza vaccination. We observed significant regional variation in vaccination rates, with highest rates in the Netherlands (77.5%), Great Britain (77.2%), and Belgium (67.5%), and lowest rates in Asia (2.6%), with intermediate rates in North America (52.8%). Top predictors of vaccination included enrolling country, white race, implanted defibrillator, older age, lower New York Heart Association functional class, lower heart rate, and a history of diabetes mellitus. Influenza vaccination was associated with a reduced risk for all-cause mortality in propensity-adjusted (hazard ratio: 0.81; 95% confidence interval: 0.67 to 0.97; p = 0.015) models. CONCLUSIONS:Influenza vaccination rates varied widely in patients with heart failure with reduced ejection fraction enrolled in the PARADIGM-HF trial, and vaccination was associated with reduced risk for death, although whether this association was causal cannot be determined.
RCT Entities:
OBJECTIVES: This study sought to examine the prevalence and predictors of influenza vaccination among participants in the PARADIGM-HF (Prospective Comparison of ARNI with ACEI to Determine Impact on Global Mortality and Morbidity in Heart Failure) study and investigate associations between receiving influenza vaccine and cardiovascular death or heart failure hospitalizations, all-cause hospitalizations, and cardiopulmonary or influenza-related hospitalizations. BACKGROUND: Influenza is associated with an increased risk for cardiovascular events in patients with heart failure. METHODS: We used data from the PARADIGM-HF trial in which patients with heart failure were randomized to the angiotensin receptor neprilysin inhibitor LCZ696 (sacubitril/valsartan) or enalapril. We assessed predictors of receiving influenza vaccination, and examined the relationship between influenza vaccination and outcomes in a propensity-adjusted model. RESULTS: Of 8,099 study participants, 1,769 (21%) received influenza vaccination. We observed significant regional variation in vaccination rates, with highest rates in the Netherlands (77.5%), Great Britain (77.2%), and Belgium (67.5%), and lowest rates in Asia (2.6%), with intermediate rates in North America (52.8%). Top predictors of vaccination included enrolling country, white race, implanted defibrillator, older age, lower New York Heart Association functional class, lower heart rate, and a history of diabetes mellitus. Influenza vaccination was associated with a reduced risk for all-cause mortality in propensity-adjusted (hazard ratio: 0.81; 95% confidence interval: 0.67 to 0.97; p = 0.015) models. CONCLUSIONS: Influenza vaccination rates varied widely in patients with heart failure with reduced ejection fraction enrolled in the PARADIGM-HF trial, and vaccination was associated with reduced risk for death, although whether this association was causal cannot be determined.
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