title: A comparison between oral antiarrhythmic drugs in the prevention of atrial fibrillation after cardiac surgery: the pilot study of prevention of postoperative atrial fibrillation (SPPAF), a randomized, placebo-controlled trial.
abstract: BACKGROUND
  Atrial fibrillation (AF) frequently occurs after cardiac surgical procedures, and beta-blockers, sotalol, and amiodarone may reduce the frequency of AF after open heart surgery. This pilot trial was designed to test whether each of the active oral drug regimens is superior to placebo for prevention of postoperative AF and whether there are differences in favor of 1 of the preventive strategies.
  
  
  RESULTS
  We conducted a randomized, double-blinded, placebo-controlled trial in which patients undergoing cardiac surgery in the absence of heart failure and without significant left ventricular dysfunction (n = 253; average age, 65 +/- 11 years) received oral amiodarone plus metoprolol (n = 63), metoprolol alone (n = 62), sotalol (n = 63), or placebo (n = 65). Patients receiving combination therapy (amiodarone plus metoprolol) and those receiving sotalol had a significantly lower frequency of AF (30.2% and 31.7%; absolute difference, 23.6% and 22.1%; odds ratios [OR], 0.37 [95% CI, 0.18 to 0.77, P <.01 vs placebo] and 0.40 [0.19 to 0.82, P =.01 vs placebo]) compared with patients receiving placebo (53.8%). Treatment with metoprolol was associated with a 13.5% absolute reduction of AF (P =.16; OR, 0.58 [0.29 to 1.17]. Treatment effects did not differ significantly between active drug groups. Adverse events including cerebrovascular accident, postoperative ventricular tachycardia, nausea, and dyspepsia, in hospital death, postoperative infections, and hypotension, were similar among the groups. Bradycardia necessitating dose reduction or drug withdrawal occurred in 3.1% (placebo), 3.2% (combined amiodarone and metoprolol; P =.65 vs placebo), 12.7% (sotalol; P <.05 vs placebo), and 16.1% (metoprolol; P <.05 vs placebo). Patients in the placebo group had a nonsignificantly longer length of hospital stay as compared with the active treatment groups (13.1 +/- 8.9 days vs 11.3 +/- 7; P =.10), with no significant difference between the active treatment groups.
  
  
  CONCLUSIONS
  Oral active prophylaxis with either sotalol or amiodarone plus metoprolol may reduce the rate of AF after cardiac surgery in a population at high risk for postoperative AF. Treatment with metoprolol alone resulted in a trend to a lower risk for postoperative AF.
authors.affiliation: Department of Cardiology, General Hospital Wels, Wels, Austria. johann.auer@khwels.net
authors.forename: Johann
authors.initials: J
authors.lastname: Auer
authors.forename: Thomas
authors.initials: T
authors.lastname: Weber
authors.forename: Robert
authors.initials: R
authors.lastname: Berent
authors.forename: Rudolf
authors.initials: R
authors.lastname: Puschmann
authors.forename: Peter
authors.initials: P
authors.lastname: Hartl
authors.forename: Choi-Keung
authors.initials: CK
authors.lastname: Ng
authors.forename: Christian
authors.initials: C
authors.lastname: Schwarz
authors.forename: Ernst
authors.initials: E
authors.lastname: Lehner
authors.forename: Ulrike
authors.initials: U
authors.lastname: Strasser
authors.forename: Elisabeth
authors.initials: E
authors.lastname: Lassnig
authors.forename: Gudrun
authors.initials: G
authors.lastname: Lamm
authors.forename: Bernd
authors.initials: B
authors.lastname: Eber
mesh_terms: D000284:Administration, Oral; D000368:Aged; D000638:Amiodarone / Q000627:therapeutic use*; D000889:Anti-Arrhythmia Agents / Q000627:therapeutic use*; D001281:Atrial Fibrillation / Q000517:prevention & control*; D006348:Cardiac Surgical Procedures; D004311:Double-Blind Method; D004359:Drug Therapy, Combination; D005260:Female; D006801:Humans; D016015:Logistic Models; D008297:Male; D008790:Metoprolol / Q000627:therapeutic use*; D008875:Middle Aged; D010865:Pilot Projects; D011183:Postoperative Complications / Q000517:prevention & control*; D011292:Premedication; D013015:Sotalol / Q000627:therapeutic use*
chemical_list: D000889:Anti-Arrhythmia Agents; D013015:Sotalol; D008790:Metoprolol; D000638:Amiodarone