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European Journal of Heart Failure 2005 7(6):1059-1069; doi:10.1016/j.ejheart.2005.09.005
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© 2005 European Society of Cardiology

A statin in the treatment of heart failure? Controlled rosuvastatin multinational study in heart failure (CORONA): Study design and baseline characteristics

John Kjekshusa,*, Peter Dunselmanb, Malin Blideskogc, Christina Eskilsonc, Åke Hjalmarsond, John V. McMurraye, Finn Waagsteind, Hans Wedelf, Peter Wessmanc, John Wikstrandc,d and on behalf of the CORONA Study Group1

a Department of Cardiology, Rikshospitalet University Hospital, University of Oslo Sognsvannsveien 20, Oslo 0027, Norway
b Department of Cardiology, Ampia Hospital Breda, The Netherlands
c AstraZeneca R&D Mölndal, Sweden
d Wallenberg Laboratory for Cardiovascular Research, Sahlgrenska University Hospital Göteborg, Sweden
e Department of Cardiology, Western Infirmary Glasgow, UK
f Nordic School of Public Health Göteborg, Sweden

* Corresponding author. Tel.: +47 23073677; fax: +47 23073676. E-mail address: john.kjekshus{at}medisin.uio.no


  Abstract

Background: Previous prospective outcome studies of statins have not provided any guidance on benefit-risk in patients with heart failure.

Aim: The primary objective is to determine whether rosuvastatin (10 mg) reduces the combined endpoint of cardiovascular mortality, non-fatal myocardial infarction or non-fatal stroke (time to first event). The first secondary endpoint is all-cause mortality.

Methods: CORONA is a randomized, double-blind, placebo-controlled trial. Briefly, men and women, aged ≥60 years with chronic symptomatic systolic heart failure of ischemic aetiology and ejection fraction ≤0.40 (NYHA class III and IV) or ≤0.35 (NYHA class II) were eligible if they were not using or in need of cholesterol lowering drugs.

Results: Mean age was 73 years (n=5016; 24% women), with 37% in NYHA II and 62% in NYHA III, ejection fraction 0.31, total cholesterol 5.2 mmol/L. Sixty percent have a history of myocardial infarction, 63% hypertension, and 30% diabetes. Patients are well treated for heart failure with 90% on loop or thiazide diuretics, 42% aldosterone antagonists, 91% ACE inhibitor or AT-I blocker, 75% beta-blockers, and 32% digitalis.

Conclusion: CORONA is important for three main reasons: (1) A positive result is very important because of the high risk of the population studied, the increasing prevalence of elderly patients with chronic symptomatic systolic heart failure in our society, and the health economic issues involved. (2) If negative, new mechanistic questions about heart failure have to be raised. (3) If neutral we can avoid unnecessary polypharmacy.

Key Words: Heart failure • Statins • Ischaemic heart disease • Death

Received June 4, 2005; Revised September 2, 2005; Accepted September 15, 2005

1 For members of the CORONA Study Group, see appendix.


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