TY - JOUR
T1 - Continental Differences in Clinical Characteristics, Management, and Outcomes in Patients Hospitalized With Worsening Heart Failure. Results From the EVEREST (Efficacy of Vasopressin Antagonism in Heart Failure: Outcome Study with Tolvaptan) Program
AU - Blair, John E.A.
AU - Zannad, Faiez
AU - Konstam, Marvin A.
AU - Cook, Thomas
AU - Traver, Brian
AU - Burnett, John C.
AU - Grinfeld, Liliana
AU - Krasa, Holly
AU - Maggioni, Aldo P.
AU - Orlandi, Cesare
AU - Swedberg, Karl
AU - Udelson, James E.
AU - Zimmer, Christopher
AU - Gheorghiade, Mihai
PY - 2008/11/11
Y1 - 2008/11/11
N2 - Objectives: Our aim was to examine continental and regional differences in baseline characteristics and post-discharge clinical outcomes in the EVEREST (Efficacy of Vasopressin Antagonism in Heart Failure: Outcome Study with Tolvaptan) trial. Background: Continental and regional differences in clinical trials of acute heart failure syndromes (AHFS) have not been well studied. Methods: We analyzed data from the EVEREST trial, which randomized 4,133 patients hospitalized for worsening (HF) and left ventricular ejection fraction ≤40% to oral tolvaptan, a vasopressin antagonist, or placebo and followed for a median of 9.9 months. Baseline characteristics, mortality, and outcomes were analyzed across North America (n = 1,251), South America (n = 688), Western Europe (564 patients), and Eastern Europe (n = 1,619). Results: There were major differences between the 4 groups in the severity, etiology, and management of HF. Unadjusted 1-year mortality and cardiovascular mortality/HF hospitalization were 30.4% and 52.5% in North America, 27.2% and 41.6% in South America, 27.1% and 47.3% in Western Europe, and 20.5% and 35.3% in Eastern Europe. After adjustment, South American patients had the highest overall mortality (hazard ratio: 1.42, 95% confidence interval: 1.15 to 1.76), while Eastern European patients had the lowest cardiovascular death and HF hospitalization rate (hazard ratio: 0.84, 95% confidence interval: 0.73 to 0.97), compared with patients in North America. Conclusions: Major continental and regional differences in HF severity, etiology, and management exist among AHFS patients, resulting in varied post-discharge outcomes, despite pre-defined selection criteria. These differences should be taken into account when planning global trials in AHFS. (Efficacy of Vasopressin Antagonism in Heart Failure: Outcome Study with Tolvaptan [EVEREST]; NCT00071331).
AB - Objectives: Our aim was to examine continental and regional differences in baseline characteristics and post-discharge clinical outcomes in the EVEREST (Efficacy of Vasopressin Antagonism in Heart Failure: Outcome Study with Tolvaptan) trial. Background: Continental and regional differences in clinical trials of acute heart failure syndromes (AHFS) have not been well studied. Methods: We analyzed data from the EVEREST trial, which randomized 4,133 patients hospitalized for worsening (HF) and left ventricular ejection fraction ≤40% to oral tolvaptan, a vasopressin antagonist, or placebo and followed for a median of 9.9 months. Baseline characteristics, mortality, and outcomes were analyzed across North America (n = 1,251), South America (n = 688), Western Europe (564 patients), and Eastern Europe (n = 1,619). Results: There were major differences between the 4 groups in the severity, etiology, and management of HF. Unadjusted 1-year mortality and cardiovascular mortality/HF hospitalization were 30.4% and 52.5% in North America, 27.2% and 41.6% in South America, 27.1% and 47.3% in Western Europe, and 20.5% and 35.3% in Eastern Europe. After adjustment, South American patients had the highest overall mortality (hazard ratio: 1.42, 95% confidence interval: 1.15 to 1.76), while Eastern European patients had the lowest cardiovascular death and HF hospitalization rate (hazard ratio: 0.84, 95% confidence interval: 0.73 to 0.97), compared with patients in North America. Conclusions: Major continental and regional differences in HF severity, etiology, and management exist among AHFS patients, resulting in varied post-discharge outcomes, despite pre-defined selection criteria. These differences should be taken into account when planning global trials in AHFS. (Efficacy of Vasopressin Antagonism in Heart Failure: Outcome Study with Tolvaptan [EVEREST]; NCT00071331).
KW - heart failure
KW - outcomes
KW - regional differences
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U2 - 10.1016/j.jacc.2008.07.056
DO - 10.1016/j.jacc.2008.07.056
M3 - Article
C2 - 18992654
AN - SCOPUS:55049127403
SN - 0735-1097
VL - 52
SP - 1640
EP - 1648
JO - Journal of the American College of Cardiology
JF - Journal of the American College of Cardiology
IS - 20
ER -