The addition of a statin to optimal medical therapy does not improve prognosis for patients with ischemic heart disease and advanced systolic heart failure, according to a late-breaking clinical trial presentation at the annual meeting of the American Heart Association.

“Because patients with symptomatic heart failure were excluded from past placebo-controlled trials with statins, the benefits and risks of statins in the treatment of heart failure remain uncertain,” said Ake Hjalmarson, an investigator in the Sweden-based Controlled Rosuvastatin Multinational Trial in Heart Failure (CORONA). CORONA was designed to clarify the role of statin therapy in treating patients with systolic heart failure.

CORONA was a randomized, double-blind, placebo-controlled study of 5,011 men and women with chronic symptomatic systolic heart failure caused by coronary artery disease. Average patient age was 73 years; 24 percent of participants were women. Among all patients, 37 percent had New York Heart Association (NYHA) class II heart failure and 62 percent had class III failure. Average ejection fraction was 31 percent.

Average total cholesterol among patients was 200 mg/dL. Eligible patients were not already taking a cholesterol-lowering drug. Medical histories included 60 percent with a history of myocardial infarction, 63 percent with hypertension, and 30 percent with diabetes.

“These patients were well-treated for their heart failure,” Hjalmarson said, with 87 percent on loop or thiazide diuretics, 39 percent on aldosterone antagonists, 91 percent taking an angiotensin-converting enzyme inhibitor or angiotensin-I blocker, 75 percent taking a beta-blocker, and 33 percent taking digitalis. In addition, 51 percent were taking aspirin and 36 percent were taking anticoagulants.

Patients were randomized to receive either 10 mg rosuvastatin or placebo along with all other medications. Average follow-up time was 2.5 years.

The primary composite endpoint of CORONA was to determine whether rosuvastatin reduced the number of patients experiencing cardiovascular death, non-fatal myocardial infarction, or non-fatal stroke. The 8 percent reduction with rosuvastatin was not significant. The reduction was primarily due to a decrease in the atherosclerotic-related events of non-fatal myocardial infarction and stroke.

The majority of deaths among study participants were due to sudden death or a non-ischemic cause, outcomes that did not appear to be affected by an added statin. However, significantly fewer hospitalizations occurred in the rosuvastatin group, including non-ischemic and ischemic causes.

“The CORONA results represent a major advancement in medical research and understanding of patients with advanced heart failure, they clearly differ from patients without heart failure in their response to statin treatment” said lead investigator Prof. John Kjekshus, Department of Cardiology, Rikshospitalet University Hospital, Oslo, Norway. “We added a highly effective statin on top of an optimal treatment regimen. Our findings suggest the major cause of death in these patients was likely not to be related to atherosclerotic events, where benefit with statins in non-heart failure patients has been demonstrated, but instead may have been caused by the deterioration of failing heart muscle damaged beyond repair. CORONA underscores the need for early intervention in the progression of atherosclerosis to prevent one of its worst consequences, heart failure.”