Division of Cardiovascular Disease, Lankenau Hospital and Institute of Medical Research, Wynnewood, PA 19096, USA.
Circ Arrhythm Electrophysiol. 2009 Dec;2(6):652-9. doi: 10.1161/CIRCEP.109.870204.
Postoperative atrial arrhythmias are common and are associated with considerable morbidity. This study was designed to evaluate the efficacy and safety of vernakalant for the conversion of atrial fibrillation (AF) or atrial flutter (AFL) after cardiac surgery.
This was a prospective, randomized, double-blind, placebo-controlled trial of vernakalant for the conversion of AF or AFL after coronary artery bypass graft, valvular surgery, or both. Patients were randomly assigned 2:1 to receive a 10-minute infusion of 3 mg/kg vernakalant or placebo. If AF or AFL was present after a 15-minute observation period, then a second 10-minute infusion of 2 mg/kg vernakalant or placebo was given. The primary end point was the conversion of postcardiac surgery AF or AFL to sinus rhythm within 90 minutes of dosing. In patients with AF, 47 of 100 (47%) who received vernakalant converted to SR compared with 7 of 50 (14%) patients who received placebo (P<0.001). The median time to conversion was 12 minutes. Vernakalant was not effective in converting postoperative AFL to sinus rhythm. Two serious adverse events occurred within 24 hours of vernakalant administration (hypotension and complete atrioventricular block). There were no cases of torsades de pointes, sustained ventricular tachycardia, or ventricular fibrillation. There were no deaths.
Vernakalant was safe and effective in the rapid conversion of AF to sinus rhythm in patients who had AF after cardiac surgery.
clinicaltrials.gov. Identifier: NCT00125320.
术后房性心律失常很常见，且与相当大的发病率有关。本研究旨在评估维纳卡兰在心脏手术后转复心房颤动（AF）或心房扑动（AFL）的疗效和安全性。
这是一项前瞻性、随机、双盲、安慰剂对照的维纳卡兰治疗冠状动脉旁路移植术、瓣膜手术或两者术后 AF 或 AFL 转复的试验。患者随机以 2:1 的比例接受 3mg/kg 维纳卡兰或安慰剂 10 分钟输注。如果在 15 分钟观察期后仍存在 AF 或 AFL，则给予第二次 10 分钟 2mg/kg 维纳卡兰或安慰剂输注。主要终点是在给药后 90 分钟内将心脏手术后的 AF 或 AFL 转复为窦性心律。在 AF 患者中，接受维纳卡兰治疗的 100 例患者中有 47 例（47%）转复为 SR，而接受安慰剂的 50 例患者中有 7 例（14%）（P<0.001）。转复中位时间为 12 分钟。维纳卡兰对转复术后 AFL 为窦性心律无效。维纳卡兰给药后 24 小时内发生 2 例严重不良事件（低血压和完全性房室传导阻滞）。无尖端扭转型室速、持续性室性心动过速或心室颤动。无死亡。
维纳卡兰在心脏手术后发生 AF 的患者中，快速转复 AF 为窦性心律安全且有效。
clinicaltrials.gov。标识符：NCT00125320。
