Kaufman Elizabeth S, Zimmermann Paul A, Wang Ted, Dennish George W, Barrell Patrick D, Chandler Mary L, Greene H Leon
Heart and Vascular Research Center, Hamann 3rd Floor, MetroHealth Campus, Case Western Reserve University, 2500 MetroHealth Drive, Cleveland, Ohio 44109-1998, USA.
J Am Coll Cardiol. 2004 Sep 15;44(6):1276-82. doi: 10.1016/j.jacc.2004.06.052.
This study examined the risk of proarrhythmic events in patients receiving antiarrhythmic drugs for treatment of atrial fibrillation (AF) according to present-day safety guidelines.
Advances in understanding the proarrhythmic risk of antiarrhythmic drugs has led to development of safety guidelines for these agents. Such guidelines were used in the Atrial Fibrillation Follow-up Investigation of Rhythm Management (AFFIRM) study.
This study was an analysis of the risk of arrhythmic events (arrhythmic death, resuscitated cardiac arrest, sustained ventricular tachycardia (VT), and torsade de pointes VT) in the antiarrhythmic drug arm of the AFFIRM study. Each time an antiarrhythmic drug was begun, it was counted as an exposure to that drug and the risk of an arrhythmic event was calculated.
A total of 2,033 patients received 3,030 exposures to antiarrhythmic drugs. Ninety-six arrhythmic events occurred by six years. Patients with a left ventricular ejection fraction <40% had more arrhythmic events. Twelve documented cases of torsade de pointes VT were noted. The incidence of torsade de pointes was 0.6% at five years (95% confidence interval 0.32 to 1.07).
The overall risk of adverse arrhythmic events upon exposure to antiarrhythmic drugs in the AFFIRM study was reasonably low. Strict criteria for the safe use of antiarrhythmic drugs were successful in minimizing proarrhythmic events.
本研究根据当前的安全指南，调查了接受抗心律失常药物治疗心房颤动（AF）的患者发生心律失常事件的风险。
对抗心律失常药物致心律失常风险认识的进展促使了这些药物安全指南的制定。此类指南在心房颤动节律管理随访研究（AFFIRM）中得到应用。
本研究分析了AFFIRM研究中抗心律失常药物治疗组发生心律失常事件（心律失常性死亡、心脏骤停复苏、持续性室性心动过速（VT）和尖端扭转型室性心动过速）的风险。每次开始使用抗心律失常药物时，计为一次该药物暴露，并计算心律失常事件的风险。
共有2033例患者接受了3030次抗心律失常药物暴露。6年内发生了96次心律失常事件。左心室射血分数<40%的患者发生心律失常事件更多。记录到12例尖端扭转型室性心动过速病例。5年时尖端扭转型室性心动过速的发生率为0.6%（95%置信区间0.32至1.07）。
在AFFIRM研究中，暴露于抗心律失常药物时发生不良心律失常事件的总体风险相当低。严格的抗心律失常药物安全使用标准成功地将心律失常事件降至最低。
