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

John E A Blair, Faiez Zannad, Marvin A. Konstam, Thomas Cook, Brian Traver, John C Jr. Burnett, Liliana Grinfeld, Holly Krasa, Aldo P. Maggioni, Cesare Orlandi, Karl Swedberg, James E. Udelson, Christopher Zimmer, Mihai Gheorghiade

Research output: Contribution to journalArticle

136 Citations (Scopus)

Abstract

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).

Original languageEnglish (US)
Pages (from-to)1640-1648
Number of pages9
JournalJournal of the American College of Cardiology
Volume52
Issue number20
DOIs
StatePublished - Nov 11 2008

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Vasopressins
Heart Failure
Outcome Assessment (Health Care)
North America
Eastern Europe
Mortality
South America
Hospitalization
Confidence Intervals
Stroke Volume
Patient Selection
tolvaptan
Placebos
Clinical Trials

Keywords

  • heart failure
  • outcomes
  • regional differences

ASJC Scopus subject areas

  • Cardiology and Cardiovascular Medicine

Cite this

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. / Blair, John E A; Zannad, Faiez; Konstam, Marvin A.; Cook, Thomas; Traver, Brian; Burnett, John C Jr.; Grinfeld, Liliana; Krasa, Holly; Maggioni, Aldo P.; Orlandi, Cesare; Swedberg, Karl; Udelson, James E.; Zimmer, Christopher; Gheorghiade, Mihai.

In: Journal of the American College of Cardiology, Vol. 52, No. 20, 11.11.2008, p. 1640-1648.

Research output: Contribution to journalArticle

Blair, John E A ; Zannad, Faiez ; Konstam, Marvin A. ; Cook, Thomas ; Traver, Brian ; Burnett, John C Jr. ; Grinfeld, Liliana ; Krasa, Holly ; Maggioni, Aldo P. ; Orlandi, Cesare ; Swedberg, Karl ; Udelson, James E. ; Zimmer, Christopher ; Gheorghiade, Mihai. / 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. In: Journal of the American College of Cardiology. 2008 ; Vol. 52, No. 20. pp. 1640-1648.
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abstract = "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).",
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T2 - 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 Jr.

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

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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).

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