Prevention of supraventricular tachyarrhythmias after open heart operation by low-dose sotalol: a prospective, double-blind, randomized, placebo-controlled study.
BACKGROUND
The aim of this prospective, double-blind, placebo-controlled trial was to assess the preventive effect and safety of low-dose sotalol after heart operation.


METHODS
Two hundred fifty-five consecutive patients referred for elective coronary artery bypass grafting (n = 220) or aortic valve operation (n = 35) were randomized to receive either 80 mg of sotalol twice daily (n = 126) or matching placebo (n = 129) for 3 months, with the first dose given 2 hours before operation.


RESULTS
There were no significant baseline differences between the groups. Overall, supraventricular tachyarrhythmias occurred in 36% of patients (82% atrial fibrillation). Hospital stay was 11.6 +/- 5 days in patients with supraventricular arrhythmias, versus 9.5 +/- 2.4 days in patients without it (p < 0.0001). Low-dose sotalol reduced the rate of supraventricular arrhythmias from 46% (placebo) to 26% (sotalol; p = 0.0012), or by 43%. On the fourth postoperative day, heart rate was lower in the sotalol group (74 +/- 12 beats/min versus 85 +/- 15 beats/min; p < 0.0001) but the QT interval corrected for the heart rate was not prolonged (sotalol group, 0.44 +/- 0.03 second; placebo group, 0.43 +/- 0.03 second; p = not significant). Study medication had to be discontinued because of side effects in 5.6% of sotalol and 3.9% of placebo patients (p = not significant), with one possible proarrhythmic event occurring in a patient receiving sotalol.


CONCLUSIONS
Because more than 90% of supraventricular arrhythmic episodes occurred within 9 days after operation and 70% of all possibly sotalol related side effects occurred after day 9, the findings in this study imply that prophylactic treatment with sotalol may be limited to the first 9 postoperative days.
Pfisterer
M E
ME
Department of Internal Medicine, and Clinic for Cardiothoracic Surgery, University Hospital, Basel, Switzerland. pfisterer@email.ch
Klöter-Weber
U C
UC
Huber
M
M
Osswald
S
S
Buser
P T
PT
Skarvan
K
K
Stulz
P M
PM
D000368:Aged; D000889:Anti-Arrhythmia Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D001021:Aortic Valve / Q000601:surgery; D001026:Coronary Artery Bypass; D004311:Double-Blind Method; D005260:Female; D019918:Heart Valve Prosthesis Implantation; D006801:Humans; D015994:Incidence; D008297:Male; D008875:Middle Aged; D011183:Postoperative Complications / Q000453:epidemiology / Q000517:prevention & control*; D011446:Prospective Studies; D013015:Sotalol / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D013617:Tachycardia, Supraventricular / Q000453:epidemiology / Q000209:etiology / Q000517:prevention & control*
D000889:Anti-Arrhythmia Agents; D013015:Sotalol