Heart Failure: Results of CORONA trial released

November 5, 2007 By Katherine Ogando [mailto:kogando@perfuse.org]

Orlando, FL: Among older patients with systolic heart failure, rosuvastatin did not reduce the occurrence of myocardial infarction, nonfatal stroke, or death when compared to placebo in the Controlled Rosuvastatin Multinational Trial in Heart Failure (CORONA) study presented today at the American Heart Association’s Scientific Sessions.

Low cholesterol values among patients with heart failure have been assoicated with worse outcomes in the past, and prior statin trials have previously excluded patients with heart failure due to the possible risk associated with statin therapy. The goal of CORONA was to evaluate the possible benefits of statin therapy in patients with ischemic failure, a group of patients who may have a significant atherosclerotic burden.

The CORONA study was a randomized single trial of 5011 patients who were at least 60 years of age who had chronic New York Heart Association (NYHA) class II, III, or IV ischemic systolic heart failure with an ejection fraction less than 40%. Patients in the experimental arm were treated with 10 mg of rosuvastatin. Median follow up was 32.8 months.

Patients in the rosuvastatin group sustained a decrease in low-density lipoprotein (LDL) cholesterol, from 137 mg per deciliter at baseline to 76 mg per deciliter at 3 months, whereas patients in the placebo group maintained a relatively stable LDL at 136 mg per deciliter at baseline vs 138 mg per deciliter after 3 months. The primary endpoint of the study was the composite of cardiovascular-related death, nonfatal myocardial infarction, and nonfatal stroke. Secondary outcomes were death from any cause, number of hospitalizations, any coronary events, and death from cardiovascular causes. In the rosuvastatin group, the primary endpoint was observed in 692 patients, compared to 732 in the placebo arm (hazard ratio 0.92, 95% CI, p=0.31). There were 728 patient deaths in the rovastatin group and 759 deaths in the placebo group (hazard ratio 0.95, 95% CI, p=0.31). CRP levels were significantly reduced in the rosuvastatin group from 3.1 mg/dl to 2.1 mg/dl by 3 months, which was in contrast to the placebo group in which CRP increased (3.0 mg/dl at baseline and 3.3 mg/dl at 3 months; p < 0.001 between groups). There was no excess risk of myositis in the rosuvastatin group.

The authors state that it is not clear why rovastatin had no effect on the primary or secondary endpoints. They speculate that a greater benefit from rosuvastatin might have been observed in a patient population with less advanced disease state, however, more trials would be needed to further explore the effect of rosuvastatin in cardiovascular disease.

The study was supported by AstraZeneca.

References

1. J Kjekshus, E Apetrei, V Barrios, M Bohm, JGF Cleland, JH Cornel. Rosuvastatin in older patients with systolic heart failure. New England Journal of Medicine. 2007 Nov 5; 357.