Gomes J A, Ip J, Santoni-Rugiu F, Mehta D, Ergin A, Lansman S, Pe E, Newhouse T T, Chao S
Department of Medicine, The Mount Sinai School of Medicine and the Mount Sinai Medical Center, New York, New York 10029, USA.
J Am Coll Cardiol. 1999 Aug;34(2):334-9. doi: 10.1016/s0735-1097(99)00213-2.
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).
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.
A total of 85 patients, of which 73 were to undergo CABG and 12 CABG plus valvular surgery (ejection fraction > or = 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).
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).
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.
本前瞻性、随机、双盲、安慰剂对照研究旨在评估术前及术后口服d,l索他洛尔预防冠状动脉搭桥术(CABG)后房颤(AF)发生的疗效。
房颤是冠状动脉搭桥术后最常见的心律失常。其病因、预防和治疗仍存在很大争议。此外,其相关的发病率导致冠状动脉搭桥术后住院时间延长。
总共85例患者,其中73例将接受冠状动脉搭桥术,12例接受冠状动脉搭桥术加瓣膜手术(射血分数≥28%且无临床心力衰竭),随机分为接受索他洛尔组(40例患者;平均剂量=190±43mg/天),在心脏直视手术前24至48小时开始给药,并在术后持续四天,或安慰剂组(45例患者,平均剂量=176±32mg/天)。
总共22/85(26%)例患者发生房颤。与安慰剂组(38%)相比,索他洛尔组患者术后房颤的发生率显著降低(p=0.008)(12.5%)。40例接受索他洛尔治疗的患者中有2例(5%)发生显著心动过缓/低血压,需要停药,而安慰剂组无一例发生(p=0.2)。接受索他洛尔治疗的患者均未发生尖端扭转型室速或持续性室性心律失常。索他洛尔组与安慰剂组的术后死亡率无显著差异(0%对2%,p=1.0)。与安慰剂组相比,索他洛尔组患者的住院时间缩短,但差异无统计学意义(7±2天对8±4天;p=0.24)。
在接受冠状动脉搭桥术的患者中,给予剂量为80至120mg的索他洛尔可使术后房颤显著减少(67%),且无明显副作用。对于无心力衰竭和严重左心室功能障碍的冠状动脉搭桥术患者,应考虑使用索他洛尔预防术后房颤。