ARMYDA-3 Trial: Statin Pretreatment Reduces Post-Cardiac Surgery Arrhythmia Risk

March 22, 2006

March 22, 2006 -- Pretreatment with statin drugs prior to elective cardiac surgery appears to significantly lower patients' risk of developing postoperative atrial fibrillation (AF), according to the results of the Atorvastatin for Reduction of Myocardial Dysrrhythmia After Cardiac Surgery (ARMYDA-3) [1] trial presented at the American College of Cardiology (ACC) 55th Annual Scientific Session.

Germano Di Sciascio, MD, University of Rome, Italy, who presented the study's findings, noted that ARMYDA-3 is the first randomized study to demonstrate that treatment with a statin drug can reduce the incidence of AF after cardiac surgery, and he believes that the results could impact clinical practice for AF prevention.

AF is a common complication following heart surgery, occurring in up to 40% of patients who undergo coronary artery bypass grafting (CABG) and in more than 50% who undergo heart valve operations. Although not immediately life-threatening, it is associated with prolonged ventilatory and inotropic support, increased hospital stay and costs, and significant long-term morbidity. Previous observations have noted a lower incidence of postoperative AF in heart surgery patients on statin drugs, possibly due to the anti-inflammatory effects of the drugs, since AF following heart surgery has been linked with inflammation. ARMYDA-3 was conducted to investigate whether statin drugs could reduce AF risk if given prior to surgery.

Conducted in Italy, ARMYDA-3 was a prospective, double-blind study that randomized 200 elective, open-heart surgery patients to presurgical treatment with either the statin drug atorvastatin (40 mg/day; n = 101) or a placebo (n = 99). Patients currently on statin drugs, those who had previously been treated with statins, and those with a history of AF were excluded from the trial. Drug therapy began 7 days prior to the scheduled operation and continued for 30 days post-procedure. The mean age of patients was 67 years; approximately 40% of all patients had diabetes mellitus, and about 40% of patients had prior myocardial infarction. Patients were evaluated for the incidence of in-hospital postoperative AF, defined as an arrhythmic episode lasting > 5 minutes, registered on continuous telemetry monitoring or on electrocardiogram. The rate of major adverse cardiac and cerebrovascular events (MACCE) was also assessed at 30 days (secondary endpoint).

Investigators found that patients receiving atorvastatin had a significantly lower incidence of postoperative in-hospital AF (35% vs 57%, P = .003), and multivariate analysis demonstrated a 60% reduction in postoperative AF risk in the atorvastatin group (odds ratio 0.39, 95% CI 0.18-0.85; P = .017). Moreover, patients receiving atorvastatin had a significantly shorter duration of hospital stay (6.3 days vs 6.9 days; P = .001).

The researchers also measured postoperative blood levels of the inflammatory marker C-reactive protein (CRP) every 24 hours following the procedure until discharge and found that peak CRP levels were significantly higher in patients in both treatment groups who experienced AF than in those who did not experience an AF episode. "This indicates that higher inflammatory status is correlated with an increased risk of AF," Prof. Di Sciascio said at a press conference held during the meeting. Thirty-day rates of major adverse cardiac and cerebrovascular events (death, stroke, myocardial infarction, repeat surgery) were low and did not differ between the groups. Event-free survival was significantly better in the atorvastatin group than in the placebo group ( P = .003), and the majority of events occurred during the hospital stay.

He and his colleagues concluded that pretreatment with atorvastatin significantly reduces the risk of postoperative AF in cardiac surgery patients, potentially due to the drug's anti-inflammatory effects. "This benefit is also expressed in terms of decreased hospital stay, which is a significant, relevant point," Prof. Di Sciascio observed. "Because of the low cost and low risk of this therapy, these findings may prompt the use of statins before elective cardiac surgery procedures to reduce the incidence of AF," he said. However, he cautioned against drawing definitive conclusions from this small, single-center, unsupported study, and expressed his hope that a larger trial will confirm the findings.

The ARMYDA study also was hailed as a "very important trial" by James H. Stein, MD, of the University of Wisconsin (Madison), who told Medscape in an earlier interview that the results "will bear more quickly on the practice of medicine than a lot of other studies presented this year."

Reference
  1. Patti G, Chello M, Candura D, Pasceri V, Covino E, Di Sciascio G. A randomized trial of Atorvastatin for Reduction of Post-operative Atrial Fibrillation in Patients Undergoing Cardiac Surgery. Results from the ARMYDA-3 (Atorvastatin for Reduction of Myocardial Dysrhythmias After cardiac surgery) study. Program and abstracts from the American College of Cardiology 55th Annual Scientific Session; March 11-14, 2006; Atlanta, Georgia. Abstract 405-6.

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