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European Journal of Heart Failure 2003 5(4):537-544; doi:10.1016/S1388-9842(03)00112-0
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© 2003 European Society of Cardiology

VALsartan In Acute myocardial iNfarcTion (VALIANT) trial: baseline characteristics in context

Eric J. Velazqueza,*, Marc A. Pfefferb, John V. McMurrayc, Aldo P. Maggionid, Jean-Lucien Rouleaue, Frans Van de Werff, Lars Koberg, Harvey D. Whiteh, Karl Swedbergi, Jeffrey D. Leimbergera, Paul Galloj, Mary Ann Sellersa, Susan Edwardsj, Marc Henisj, Robert M. Califfa and for the VALIANT Investigators

a Division of Cardiology, Department of Medicine, Duke University Medical Center and the Duke Clinical Research Institute 2400 Pratt Street, Durham, NC 27715, USA
b Cardiovascular Division Brigham and Women's Hospital, Boston, MA, USA
c Clinical Research Initiative in Heart Failure University of Glasgow, Glasgow, Scotland, UK
d ANMCO Research Center Florence, Italy
e Division of Cardiology University of Toronto, Toronto, ON, Canada
f Leuven Coordinating Center Leuven, Belgium
g Rigshospitalet, Copenhagen Denmark
h Green Lane Hospital Auckland, New Zealand
i Sahlgrenska Hospital Göteborg, Sweden
j Novartis Pharmaceutical Corporation East Hanover, NJ, USA

* Corresponding author. Tel.: +1-919-668-8041; fax: +1-919-668-7058 velaz002{at}mc.duke.edu


   Abstract

Background: The VALsartan In Acute myocardial iNfarcTion (VALIANT) trial compared outcomes with: (1) angiotensin-converting enzyme inhibition (ACEI) with the reference agent captopril; (2) angiotensin-receptor blockade (ARB) with valsartan; or (3) both in patients with heart failure (HF) and/or left ventricular systolic dysfunction (LVSD) after myocardial infarction (MI).

Aims: A goal of this active-control trial was to simulate conditions that would lead current practitioners to use ACEIs. Thus, we compared characteristics of VALIANT patients with those of patients in placebo-controlled trials that established ACEIs as standard treatment.

Methods and Results: We collected demographic, clinical, medication and imaging information from 14703 patients in 24 countries. This high-risk population was a median 65.8 years old, and 31.1% were female. Most (51.8%) showed imaging evidence of LVSD at enrollment. Most (72%) had Killip class≥II HF. Patients received evidence-based therapies at rates similar to those of contemporary MI trials and at an improved rate compared with prior placebo-controlled ACEI trials.

Conclusion: VALIANT represents the largest globally representative cohort enrolled with HF and/or LVSD after MI. Patients were similar to those in placebo-controlled ACEI trials while reflecting improvements in evidence-based care. With enrollment complete, VALIANT is poised to define the optimal strategy for renin–angiotensin system blockade after MI to improve cardiovascular outcomes.

Key Words: Angiotensin-converting enzyme • Angiotensin receptor blocker • Myocardial infarction • Left ventricular dysfunction • Heart failure • Prognosis

Received March 18, 2003; Revised July 2, 2003; Accepted July 3, 2003


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