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CLINICAL RESEARCH: HEART FAILURE

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, MD^_*, Faiez Zannad, MD, Marvin A. Konstam, MD, FACC, Thomas Cook, PhD, Brian Traver, MS, John C. Burnett, Jr, MD^||, Liliana Grinfeld, MD, FACC^¶, Holly Krasa, MS^#, Aldo P. Maggioni, MD^_**, Cesare Orlandi, MD, FACC^#, Karl Swedberg, MD, PhD, FACC, James E. Udelson, MD, FACC, Christopher Zimmer, MD^#, Mihai Gheorghiade, MD, FACC^_*,_* for the EVEREST Investigators

^_* Northwestern University Feinberg School of Medicine, Chicago, Illinois
Institut National de la Santé et de la Recherche Médicale (INSERM), Nancy, France
Tufts-New England Medical Center, Boston, Massachusetts
University of Wisconsin, Madison, Wisconsin
^|| Mayo Clinic, Rochester, Minnesota
^¶ Hospital Italiano, Buenos Aires, Argentina
^# Otsuka Maryland Research Institute, Rockville, Maryland
^_** Associazione Nazionale Medici Cardioligi Ospedalieri Research Center, Florence, Italy
Sahlgrenska University Hospital/Östra, Gothenburg, Sweden

Manuscript received April 15, 2008; revised manuscript received June 27, 2008, accepted July 10, 2008.

^_* Reprint requests and correspondence: Dr. Mihai Gheorghiade, Northwestern University, Feinberg School of Medicine, 201 East Huron Street, Galter 10-240, Chicago, Illinois 60611 (Email: m-gheorghiade{at}northwestern.edu).

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)

Key Words: heart failure • regional differences • outcomes

Abbreviations and Acronyms   AHFS = acute heart failure syndromes   BNP = B-type natriuretic peptide   CI = confidence interval   CV = cardiovascular   HF = heart failure   HR = hazard ratio   ICD = implantable cardioverter-defibrillator

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