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CLINICAL STUDIES

Oral d,l sotalol reduces the incidence of postoperative atrial fibrillation in coronary artery bypass surgery patients: a randomized, double-blind, placebo-controlled study

J. Anthony Gomes, MD, FACC^a, John Ip, MD, FACC^*, Francesco Santoni-Rugiu, MD^a, Davendra Mehta, MD, PhD, FACC^a, Arisan Ergin, MD^a, Steven Lansman, MD^a, Elena Pe, RN, NP^a, Teri Takle Newhouse, MS and Sally Chao, BS^a

^a Electrophysiology and Electrocardiography Section, the Zena and Michael Wiener Cardiovascular Institute, Department of Medicine, The Mount Sinai School of Medicine and the Mount Sinai Medical Center, New York, New York, USA
^* Thoracic Cardiovascular Institute, Lansing, Michigan, USA
Biostatistics Department, Medronic, Minneapolis, Minnesota, USA

Manuscript received July 14, 1998; revised manuscript received March 25, 1999, accepted April 21, 1999.

Reprint requests and correspondence: Dr. J. Anthony Gomes, Box 1054, The Mount Sinai Medical Center, 1 Gustave L. Levy Place, New York, New York 10029

OBJECTIVES

The purpose of this prospective, randomized, double-blind, placebo-controlled study was to assess the efficacy of preoperatively and postoperatively administered oral d,l sotalol in preventing the occurrence of postoperative atrial fibrillation (AF).

BACKGROUND

Atrial fibrillation is the most common arrhythmia following coronary artery bypass surgery (CABG). Its etiology, prevention and treatment remain highly controversial. Furthermore, its associated morbidity results in a prolongation of the length of hospital stay post-CABG.

METHODS

A total of 85 patients, of which 73 were to undergo CABG and 12 CABG plus valvular surgery (ejection fraction 28% and absence of clinical heart failure), were randomized to receive either sotalol (40 patients; mean dose = 190 ± 43 mg/day) started 24 to 48 h before open heart surgery and continued for four days postoperatively, or placebo (45 patients, mean dose = 176 ± 32 mg/day).

RESULTS

Atrial fibrillation occurred in a total of 22/85 (26%) patients. The incidence of postoperative AF was significantly (p = 0.008) lower in patients on sotalol (12.5%) as compared with placebo (38%). Significant bradycardia/hypotension, necessitating drug withdrawal, occurred in 2 of 40 (5%) patients on sotalol and none in the placebo group (p = 0.2). None of the patients on sotalol developed Torsade de pointes or sustained ventricular arrhythmias. Postoperative mortality was not significantly different in sotalol versus placebo (0% vs. 2%, p = 1.0). Patients in the sotalol group had a nonsignificantly shorter length of hospital stay as compared with placebo (7 ± 2 days vs. 8 ± 4 days; p = 0.24).

CONCLUSIONS

The administration of sotalol, in dosages ranging from 80 to 120 mg, was associated with a significant decrease (67%) in postoperative AF in patients undergoing CABG without appreciable side effects. Sotalol should be considered for the prevention of postoperative AF in patients undergoing CABG in the absence of heart failure and significant left ventricular dysfunction.

Abbreviations and Acronyms   AF = atrial fibrillation   AV = atrioventricular   CABG = coronary artery bypass surgery   LVEF = left ventricular ejection fraction

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