Stephen J Greene1, Gregg C Fonarow2, Scott D Solomon3, Haris Subacius1, Aldo P Maggioni4, Michael Böhm5, Eldrin F Lewis3, Faiez Zannad6, Mihai Gheorghiade1. 1. Center for Cardiovascular Innovation, Northwestern University Feinberg School of Medicine, Chicago, IL, USA. 2. Ahmanson-UCLA Cardiomyopathy Center, University of California Los Angeles, Los Angeles, CA, USA. 3. Cardiovascular Division, Brigham and Women's Hospital, Boston, MA, USA. 4. Associazione Nazionale Medici Cardiologi Ospedalieri Research Center, Florence, Italy. 5. Klinik für Innere Medizin III, Universitätsklinikum des Saarlandes, Homburg, Germany. 6. Clinical Investigation Center, INSERM-CHU de Nancy Hôpital Jeanne d'Arc, Dommartin-les Toul Cedex, France.
Abstract
AIMS: This study sought to investigate regional variation in clinical characteristics, therapy utilization, and post-discharge outcomes among patients hospitalized for heart failure (HHF) enrolled in the multinational ASTRONAUT (Aliskiren Trial on Acute Heart Failure Outcomes) trial. METHODS AND RESULTS: The ASTRONAUT trial randomized 1615 HHF patients with ejection fraction ≤40% toaliskiren or placebo. Enrolled patients were from Eastern Europe (n = 495, 30.7%), Asia/Pacific (n = 439, 27.2%), Western Europe (n = 395, 24.5%), Latin America (n = 163, 10.1%), and North America (n = 123, 7.6%). Marked differences were seen across geographic regions in terms of baseline demographics, vital signs, laboratory tests, co-morbidity burden, and use of guideline-recommended therapies. All-cause death at 12 months ranged from 7.3% in North America to 26.7% in Asia/Pacific, with differences largely driven by sudden cardiac death. Rates of repeat HHF at 12 months ranged from 22.7% in Latin America to 43.9% in North America. After adjustment for patient characteristics, region was an independent predictor of death at 12 months, with highest risk in Asia/Pacific (hazard ratio 3.04, 95% confidence interval 1.47-6.29, compared with North America) and lowest risk in North America and Western Europe. There was no association between region and the composite of cardiovascular mortality or HHF. CONCLUSION: For patients enrolled in this HHF trial, baseline characteristics and risk of death differed markedly by geographic region. Rates of death and repeat HHF demonstrated a general inverse relationship. Global differences in patient characteristics and outcomes should be accounted for when designing future HHF clinical trials.
RCT Entities:
AIMS: This study sought to investigate regional variation in clinical characteristics, therapy utilization, and post-discharge outcomes among patients hospitalized for heart failure (HHF) enrolled in the multinational ASTRONAUT (Aliskiren Trial on Acute Heart Failure Outcomes) trial. METHODS AND RESULTS: The ASTRONAUT trial randomized 1615 HHF patients with ejection fraction ≤40% to aliskiren or placebo. Enrolled patients were from Eastern Europe (n = 495, 30.7%), Asia/Pacific (n = 439, 27.2%), Western Europe (n = 395, 24.5%), Latin America (n = 163, 10.1%), and North America (n = 123, 7.6%). Marked differences were seen across geographic regions in terms of baseline demographics, vital signs, laboratory tests, co-morbidity burden, and use of guideline-recommended therapies. All-cause death at 12 months ranged from 7.3% in North America to 26.7% in Asia/Pacific, with differences largely driven by sudden cardiac death. Rates of repeat HHF at 12 months ranged from 22.7% in Latin America to 43.9% in North America. After adjustment for patient characteristics, region was an independent predictor of death at 12 months, with highest risk in Asia/Pacific (hazard ratio 3.04, 95% confidence interval 1.47-6.29, compared with North America) and lowest risk in North America and Western Europe. There was no association between region and the composite of cardiovascular mortality or HHF. CONCLUSION: For patients enrolled in this HHF trial, baseline characteristics and risk of death differed markedly by geographic region. Rates of death and repeat HHF demonstrated a general inverse relationship. Global differences in patient characteristics and outcomes should be accounted for when designing future HHF clinical trials.
Authors: Andrew P Ambrosy; Craig S Parzynski; Daniel J Friedman; Marat Fudim; Adrian F Hernandez; Gregg C Fonarow; Frederick A Masoudi; Sana M Al-Khatib Journal: Circulation Date: 2018-12-11 Impact factor: 29.690
Authors: Robert J Mentz; Lothar Roessig; Barry H Greenberg; Naoki Sato; Kaori Shinagawa; Daniel Yeo; Bernard W K Kwok; Eugenio B Reyes; Henry Krum; Burkert Pieske; Stephen J Greene; Andrew P Ambrosy; Jacob P Kelly; Faiez Zannad; Bertram Pitt; Carolyn S P Lam Journal: JACC Heart Fail Date: 2016-06 Impact factor: 12.035
Authors: Stephen J Greene; Adrian F Hernandez; Jie-Lena Sun; Javed Butler; Paul W Armstrong; Justin A Ezekowitz; Faiez Zannad; João Pedro Ferreira; Adrian Coles; Marco Metra; Adriaan A Voors; Robert M Califf; Christopher M O'Connor; Robert J Mentz Journal: Circ Cardiovasc Qual Outcomes Date: 2018-10