CORONA
Trial question
What is the role of rosuvastatin in older patients with systolic HF (NYHA class II, III or IV) secondary to ischemic cardiomyopathy?
Study design
Multi-center
Double blinded
RCT
Population
Characteristics of study participants
24.0% female
76.0% male
N = 5011
5011 patients (1180 female, 3831 male)
Inclusion criteria: patients with systolic HF (NYHA class II, III or IV) secondary to ischemic cardiomyopathy
Key exclusion criteria: previous statin-induced myopathy or hypersensitivity reaction; decompensated HF or a need for inotropic therapy; myocardial infarction within the past 6 months; unstable angina or stroke within the past 3 months; PCI, CABG, or the implantation of a cardioverter-defibrillator or biventricular pacemaker within the past 3 months
Interventions
N=2514 rosuvastatin (10 mg PO once daily)
N=2497 placebo (matching placebo once daily)
Primary outcome
Death from cardiovascular causes, nonfatal myocardial infarction or nonfatal stroke
13.8
14.6
14.6 %
10.9 %
7.3 %
3.6 %
0.0 %
Rosuvastatin
Placebo
No significant
difference ↔
No significant difference in death from cardiovascular causes, nonfatal myocardial infarction or nonfatal stroke (13.8% vs. 14.6%; HR 0.92, 95% CI 0.83 to 1.02)
Secondary outcomes
No significant difference in the incidence of death from any cause (11.6/100 py vs. 12.2/100 py; HR 0.95, 95% CI 0.86 to 1.05)
No significant difference in coronary event (9.3 vs. 10 ; HR 0.92, 95% CI 0.82 to 1.04)
Safety outcomes
No significant difference in muscle-related adverse events or other adverse events.
Conclusion
In patients with systolic HF (NYHA class II, III or IV) secondary to ischemic cardiomyopathy, rosuvastatin was not superior to placebo with respect to death from cardiovascular causes, nonfatal myocardial infarction or nonfatal stroke.
Reference
Kjekshus J, Apetrei E, Barrios V et al. Rosuvastatin in older patients with systolic heart failure. N Engl J Med. 2007 Nov 29;357(22):2248-61.
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