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Atorvastatin for Reduction of Myocardial Dysrhythmias After Cardiac Surgery - ARMYDA-3
Description:
The goal of the trial was to evaluate treatment with atorvastatin compared with placebo on the occurrence of post-operative atrial fibrillation among patients undergoing elective cardiac surgery.
Hypothesis:
Statin therapy will reduce the incidence of post-operative atrial fibrillation due to its anti-inflammatory effects compared with placebo among patients undergoing elective cardiac surgery.
Study Design
Study Design:
Patients Screened: 323
Patients Enrolled: 200
Mean Follow Up: 30 days
Mean Patient Age: Mean age 66 years
Female: 27
Patient Populations:
Scheduled elective cardiac surgery in patients without previous statin treatment and no history of atrial fibrillation.
Exclusions:
Emergency cardiac surgery; history of atrial fibrillation; previous or current treatment with statins; elevated liver enzymes; renal failure with creatinine >3 mg/dL; history of liver or muscle disease; and inflammatory diseases that required therapy with steroids or nonsteroidal anti-inflammatory drugs.
Primary Endpoints:
Post-operative atrial fibrillation lasting >5 minutes through discharge
Drug/Procedures Used:
Patients were randomized to atorvastatin (40 mg/day, n=101) or placebo (n=99) starting 7 days before the scheduled operation. C-reactive protein (CRP) levels were measured prior to surgery and every 24 hours after surgery until discharge.
Principal Findings:
Baseline ejection fraction was 52%, and 97% of patients had multivessel disease. All CABG were performed on-pump.
The primary endpoint of post-operative occurrence of atrial fibrillation occurred less frequently in the atorvastatin group (35%) compared with the placebo group (57%; p=0.003). There was no difference in duration of the arrhythmic episodes (24 hours each, p=0.88) or time of onset from surgery (51 hours in atorvastatin arm vs 50 hours in placebo arm, p=0.59). Duration of hospitalization was shorter in the atorvastatin group (6.3 days vs 6.9 days, p=0.001). Through 30 days, there were 2 deaths in each group, 3 MIs in each group, no repeat revascularizations, and 1 stroke in the placebo group.
Irrespective of the study drug randomization group, peak post-operative CRP levels were significantly lower in patients without atrial fibrillation vs those with atrial fibrillation (p<0.025).
Interpretation:
Among patients undergoing elective cardiac surgery, treatment with atorvastatin was associated with a reduction in the occurrence of post-operative atrial fibrillation compared with placebo.
Statin therapy has been shown to be associated with reductions in ischemic events for secondary prevention following acute coronary syndromes. The present study extends these findings to show a primary prevention effect on atrial fibrillation in the setting of elective CABG. While the findings of the present study are provocative, a larger study would be warranted to confirm these findings. It should be noted that the post-operative atrial fibrillation rate was somewhat high in the placebo arm, likely due to the definition of an event, which required only 5 minutes of atrial fibrillation to meet the endpoint criteria.
References:
Patti G, et al. Randomized Trial of Atorvastatin for Reduction of Postoperative Atrial Fibrillation in Patients Undergoing Cardiac Surgery. Circulation. 2006;114:1455-1461.
Presented by Prof. G. DiSciascio at the March 2006 ACC Annual Scientific Session, Atlanta, GA. Prof DiSciascio has no conflict of interest to report.
Keywords: Pyrroles, Acute Coronary Syndrome, Stroke, C-Reactive Protein, Secondary Prevention, Hydroxymethylglutaryl-CoA Reductase Inhibitors, Coronary Disease, Heptanoic Acids, Cardiac Surgical Procedures, Hospitalization, Primary Prevention
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