St. George's University of London, United Kingdom.
J Am Coll Cardiol. 2011 Jan 18;57(3):313-21. doi: 10.1016/j.jacc.2010.07.046.
This randomized double-blind study compared the efficacy and safety of intravenous vernakalant and amiodarone for the acute conversion of recent-onset atrial fibrillation (AF).
Intravenous vernakalant has effectively converted recent-onset AF and was well tolerated in placebo-controlled studies.
A total of 254 adult patients with AF (3 to 48 h duration) eligible for cardioversion were enrolled in the study. Patients received either a 10-min infusion of vernakalant (3 mg/kg) followed by a 15-min observation period and a second 10-min infusion (2 mg/kg) if still in AF, plus a sham amiodarone infusion, or a 60-min infusion of amiodarone (5 mg/kg) followed by a maintenance infusion (50 mg) over an additional 60 min, plus a sham vernakalant infusion.
Conversion from AF to sinus rhythm within the first 90 min (primary end point) was achieved in 60 of 116 (51.7%) vernakalant patients compared with 6 of 116 (5.2%) amiodarone patients (p < 0.0001). Vernakalant resulted in rapid conversion (median time of 11 min in responders) and was associated with a higher rate of symptom relief compared with amiodarone (53.4% of vernakalant patients reported no AF symptoms at 90 min compared with 32.8% of amiodarone patients; p = 0.0012). Serious adverse events or events leading to discontinuation of study drug were uncommon. There were no cases of torsades de pointes, ventricular fibrillation, or polymorphic or sustained ventricular tachycardia.
Vernakalant demonstrated efficacy superior to amiodarone for acute conversion of recent-onset AF. Both vernakalant and amiodarone were safe and well tolerated in this study. (A Phase III Superiority Study of Vernakalant vs Amiodarone in Subjects With Recent Onset Atrial Fibrillation [AVRO]; NCT00668759).
这项随机双盲研究比较了静脉用 vernakalant 和胺碘酮治疗近期发作心房颤动（AF）的疗效和安全性。
静脉用 vernakalant 已被证明可有效转换近期发作的 AF，并且在安慰剂对照研究中耐受性良好。
共纳入 254 名适合电复律的成人 AF 患者（持续 3 至 48 小时）。患者接受 vernakalant（3mg/kg）静脉输注 10 分钟，然后观察 15 分钟，如果仍为 AF，则再次输注 vernakalant（2mg/kg），同时给予模拟胺碘酮输注，或胺碘酮（5mg/kg）输注 60 分钟，然后再输注 60 分钟维持剂量（50mg），同时给予模拟 vernakalant 输注。
在 90 分钟内（主要终点）从 AF 转为窦性心律的患者，vernakalant 组为 116 例中的 60 例（51.7%），而胺碘酮组为 116 例中的 6 例（5.2%）（p<0.0001）。vernakalant 可快速转换（反应者的中位数时间为 11 分钟），并且与胺碘酮相比，症状缓解率更高（90 分钟时 vernakalant 组 53.4%的患者报告无 AF 症状，而胺碘酮组为 32.8%；p=0.0012）。少见严重不良事件或导致停止研究药物的事件。无尖端扭转型室性心动过速、心室颤动或多形性或持续性室性心动过速的病例。
vernakalant 对近期发作的 AF 的急性转复疗效优于胺碘酮。在这项研究中，vernakalant 和胺碘酮均安全且耐受良好。（一项 Vernakalant 与胺碘酮治疗近期发作心房颤动患者的 III 期优效性研究 [AVRO]；NCT00668759）。
