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This trial evaluated the effects of atorvastatin on post-operative atrial fibrillation in patients undergoing elective cardiac surgery. Atorvastatin reduced the occurrence of atrial fibrillation and resulted in shorter hospitalization duration. Presented at the ACC 2006.
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ARMYDA-3 Trial Atorvastatin for Reduction of Myocardial Dysrhythmias After Cardiac SurgeryTrial Presented at The American College of Cardiology Scientific Sessions March 2006 Presented by Dr. Giuseppe Patti
ARMYDA-3 Trial: Background • The objective of this trial was to evaluate the effects of treatment with atorvastatin versus placebo on the occurrence of post-operative atrial fibrillation among patients undergoing elective cardiac surgery • Statin therapy has been shown to be associated with reductions in ischemic events following acute coronary syndromes • It is hypothesized that statin therapy will reduce incidences of post-operative atrial fibrillation because of its anti-inflammatory effects Presented at ACC 2006
ARMYDA-3 Trial: Study Design 200 patientsundergoing elective cardiac surgery were randomized to either atorvastatin or placebobeginning 7 days before the operation Placebo-controlled. Randomized. Blinded 31% female, mean age 66 years, mean follow-up 30 days Patients had no previous history of statin treatment or atrial fibrillation Baseline EF was 52%; 97% of patients had multi-vessel disease Atorvastatin 40 mg/day n=101 Placebo n=99 C-reactive protein (CRP) levels measured prior to surgery and every 24 hours until discharge • Primary Endpoint: Post-operative occurrence of atrial fibrillation lasting >5 minutes through discharge Presented at ACC 2006
ARMYDA-3 Trial: Primary Endpoint Post-operative occurrence of atrial fibrillation (%) p=0.003 • Post-operative occurrence of atrial fibrillation occurred less frequently in the atorvastatin group than in the placebo group (35% vs 57%; p=0.003) % occurrence AF Presented at ACC 2006
ARMYDA-3 Trial: Clinical Results Mean Duration of Hospitalization (days) p=0.001 • Duration of hospitalization was shorter in the atorvastatin group than in the placebo group (6.3 vs 6.9 days; p=0.001) Presented at ACC 2006
ARMYDA-3 Trial: Clinical Results Time of onset of atrial fibrillation from surgery (Hours) p=NS Duration of arrhythmic episodes (Hours) p=NS • There was no difference in time of onset of atrial fibrillation from surgery or duration of arrhythmic episodes • 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 Presented at ACC 2006
ARMYDA-3 Trial: Limitations • The rate of post-operative fibrillation was relatively high due to the definition of the event which only required 5 minutes of atrial fibrillation to meet the endpoint criteria • A larger study would be needed to confirm these findings Presented at ACC 2006
ARMYDA-3 Trial: Summary • Treatment with atorvastatin was associated with a reduction in the occurrence of post-operative atrial fibrillation compared with placebo in patients undergoing elective cardiac surgery • Patients in the atorvastatin group had a significantly shorter duration of hospitalization (6.3 days vs 6.9 days, p=0.001) but no difference was seen between the groups in time of onset of atrial fibrillation or duration of arrhythmic episodes • Peak post-operative CRP levels were significantly lower in patients without atrial fibrillation than in patients with atrial fibrillation (p<0.025) regardless of study drug randomization group Presented at ACC 2006