title: Influenza Vaccination in Patients With Chronic Heart Failure: The PARADIGM-HF Trial.
abstract: OBJECTIVE
  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.
authors.affiliation: Pharmacy Practice Division, University of Wisconsin School of Pharmacy, Madison, Wisconsin.
authors.forename: Orly
authors.initials: O
authors.lastname: Vardeny
authors.affiliation: Cardiovascular Division, Brigham and Women's Hospital, Boston, Massachusetts.
authors.forename: Brian
authors.initials: B
authors.lastname: Claggett
authors.affiliation: Division of Cardiology, Peter Munk Cardiac Centre, Toronto General Hospital and Women's College Hospital, Toronto, Ontario, Canada.
authors.forename: Jacob A
authors.initials: JA
authors.lastname: Udell
authors.affiliation: Department of Clinical Sciences, University of Texas Southwestern Medical Center, Dallas, Texas.
authors.forename: Milton
authors.initials: M
authors.lastname: Packer
authors.affiliation: Medical University of South Carolina and Ralph H. Johnston Veterans Administration Medical Center, Charleston, South Carolina.
authors.forename: Michael
authors.initials: M
authors.lastname: Zile
authors.affiliation: Institut de Cardiologie, Université de Montréal, Montreal, Quebec, Canada.
authors.forename: Jean
authors.initials: J
authors.lastname: Rouleau
authors.affiliation: Department of Molecular and Clinical Medicine, University of Gothenburg, Gothenburg, Sweden; National Heart and Lung Institute, Imperial College London, London, England.
authors.forename: Karl
authors.initials: K
authors.lastname: Swedberg
authors.affiliation: Cardiovascular Division, Brigham and Women's Hospital, Boston, Massachusetts.
authors.forename: Akshay S
authors.initials: AS
authors.lastname: Desai
authors.affiliation: Novartis Pharmaceuticals Corporation, East Hanover, New Jersey.
authors.forename: Martin
authors.initials: M
authors.lastname: Lefkowitz
authors.affiliation: Novartis Pharmaceuticals Corporation, East Hanover, New Jersey.
authors.forename: Victor
authors.initials: V
authors.lastname: Shi
authors.affiliation: British Heart Foundation Cardiovascular Research Center, University of Glasgow, Glasgow, Scotland, United Kingdom.
authors.forename: John J V
authors.initials: JJV
authors.lastname: McMurray
authors.affiliation: Cardiovascular Division, Brigham and Women's Hospital, Boston, Massachusetts. Electronic address: ssolomon@rics.bwh.harvard.edu.
authors.forename: Scott D
authors.initials: SD
authors.lastname: Solomon
mesh_terms: D000368:Aged; D004311:Double-Blind Method; D005060:Europe / Q000453:epidemiology; D005260:Female; D006333:Heart Failure / Q000150:complications / Q000188:drug therapy* / Q000401:mortality; D006801:Humans; D009980:Influenza A virus / Q000276:immunology*; D007252:Influenza Vaccines / Q000008:administration & dosage*; D007251:Influenza, Human / Q000150:complications / Q000517:prevention & control*; D008297:Male; D008875:Middle Aged; D011379:Prognosis; D011446:Prospective Studies; D012307:Risk Factors; D015996:Survival Rate / Q000639:trends; D014481:United States / Q000453:epidemiology; D014611:Vaccination / Q000379:methods*
chemical_list: D007252:Influenza Vaccines
keywords: chronic heart failure; clinical trial; influenza vaccination