Reasons for hospitalization and risk of mortality in patients with atrial fibrillation treated with dabigatran or warfarin in the Randomized Evaluation of Long-term Anticoagulation Therapy (RE-LY) trial.

AIMS Hospitalizations are common among patients with atrial fibrillation. This article aimed to analyse the causes and consequences of hospitalizations occurring during the Randomized Evaluation of Long-term Anticoagulation Therapy (RE-LY) trial. METHODS AND RESULTS The RE-LY database was used to evaluate predictors of hospitalization using multivariate regression modelling. The relationship between hospitalization and subsequent major adverse cardiac events was evaluated in a time dependent Cox proportional-hazard modelling. Of the 18 113 patients in RE-LY, 7200 (39.8%) were hospitalized at least once during a mean follow-up of 2 years. First hospitalization rates were 2312 (39.5%) for dabigatran etexilate (DE) 110, 2430 (41.6%) for DE 150, and 42.6% (N = 2458) for warfarin. Hospitalization was associated with post-discharge death [absolute event rate 9.1% vs. 2.2%; adjusted hazard ratio (HR) 3.6, 95% confidence interval (CI) 3.2-4.0, P < 0.0001], vascular death (adjusted HR 2.9, 95% CI 2.5-3.3, P < 0.0001), and sudden cardiac death (adjusted HR 2.3; 95% CI 1.8-2.9, P < 0.0001). Cardiovascular hospitalization was also associated with an increased risk of post-discharge death (adjusted HR 2.8, 95% CI 2.5-3.2, P < 0.0001), vascular death (adjusted HR 2.8, 95% CI 2.4-3.2, P < 0.0001), and sudden cardiac death (adjusted HR 2.1, 95% CI 1.6-2.7, P < 0.0001) compared with patients not hospitalized for any cardiovascular reason. CONCLUSION Hospitalizations are associated an increased risk of with death and cardiovascular death in patients with atrial fibrillation.

[1]  D. Singer,et al.  Hospitalizations in patients with atrial fibrillation: an analysis from ROCKET AF , 2016, Europace : European pacing, arrhythmias, and cardiac electrophysiology : journal of the working groups on cardiac pacing, arrhythmias, and cardiac cellular electrophysiology of the European Society of Cardiology.

[2]  S. Andrieu,et al.  Preventable Iatrogenic Disability in Elderly Patients During Hospitalization. , 2015, Journal of the American Medical Directors Association.

[3]  Vikas Singh,et al.  Contemporary Trends of Hospitalization for Atrial Fibrillation in the United States, 2000 Through 2010: Implications for Healthcare Planning , 2014, Circulation.

[4]  Bernard J. Gersh,et al.  Drivers of hospitalization for patients with atrial fibrillation: Results from the Outcomes Registry for Better Informed Treatment of Atrial Fibrillation (ORBIT-AF). , 2014, American heart journal.

[5]  C. Murray,et al.  Worldwide Epidemiology of Atrial Fibrillation: A Global Burden of Disease 2010 Study , 2014, Circulation.

[6]  S. Yusuf,et al.  The effects of apixaban on hospitalizations in patients with different types of atrial fibrillation: insights from the AVERROES trial. , 2013, European heart journal.

[7]  Harlan M Krumholz,et al.  Post-hospital syndrome--an acquired, transient condition of generalized risk. , 2013, The New England journal of medicine.

[8]  S. Johnston,et al.  Rates and implications for hospitalization of patients ≥65 years of age with atrial fibrillation/flutter. , 2012, The American journal of cardiology.

[9]  S. Yusuf,et al.  Myocardial Ischemic Events in Patients With Atrial Fibrillation Treated With Dabigatran or Warfarin in the RE-LY (Randomized Evaluation of Long-Term Anticoagulation Therapy) Trial , 2012, Circulation.

[10]  Christophe Gaudin,et al.  Impact of dronedarone on hospitalization burden in patients with atrial fibrillation: results from the ATHENA study , 2011, Europace : European pacing, arrhythmias, and cardiac electrophysiology : journal of the working groups on cardiac pacing, arrhythmias, and cardiac cellular electrophysiology of the European Society of Cardiology.

[11]  M. Rosenqvist,et al.  Cardiovascular hospitalization as a surrogate endpoint for mortality in studies of atrial fibrillation: report from the Stockholm Cohort Study of Atrial Fibrillation. , 2011, Europace : European pacing, arrhythmias, and cardiac electrophysiology : journal of the working groups on cardiac pacing, arrhythmias, and cardiac cellular electrophysiology of the European Society of Cardiology.

[12]  S. Yusuf,et al.  Dabigatran versus warfarin in patients with atrial fibrillation. , 2009, The New England journal of medicine.

[13]  S. Connolly,et al.  Effect of dronedarone on cardiovascular events in atrial fibrillation. , 2009, The New England journal of medicine.

[14]  S. Yusuf,et al.  Rationale and design of RE-LY: randomized evaluation of long-term anticoagulant therapy, warfarin, compared with dabigatran. , 2009, American heart journal.

[15]  A. Skanes,et al.  Validation of a New Simple Scale to Measure Symptoms in Atrial Fibrillation: The Canadian Cardiovascular Society Severity in Atrial Fibrillation Scale , 2009, Circulation. Arrhythmia and electrophysiology.

[16]  G. Fonarow,et al.  Incident heart failure hospitalization and subsequent mortality in chronic heart failure: a propensity-matched study. , 2008, Journal of cardiac failure.

[17]  G. Breithardt,et al.  Outcome parameters for trials in atrial fibrillation: recommendations from a consensus conference organized by the German Atrial Fibrillation Competence NETwork and the European Heart Rhythm Association. , 2007, Europace : European pacing, arrhythmias, and cardiac electrophysiology : journal of the working groups on cardiac pacing, arrhythmias, and cardiac cellular electrophysiology of the European Society of Cardiology.

[18]  Karl Swedberg,et al.  Influence of Nonfatal Hospitalization for Heart Failure on Subsequent Mortality in Patients With Chronic Heart Failure , 2007, Circulation.

[19]  Marc A Pfeffer,et al.  Variable Impact of Combining Fatal and Nonfatal End Points in Heart Failure Trials , 2006, Circulation.

[20]  B. Gersh,et al.  Alternative endpoints for mortality in studies of patients with atrial fibrillation: the AFFIRM study experience. , 2004, Heart rhythm.