Reiffel J A
Department of Clinical Medicine, Columbia University College of Physicians and Surgeons, New York, New York, USA.
Am J Cardiol. 1996 Aug 29;78(4A):34-40. doi: 10.1016/s0002-9149(96)00451-1.
The Electrophysiologic Study versus Electrocardiographic Monitoring (ESVEM) trial had 2 objectives. The first was to determine the accuracy of noninvasive versus invasive means of predicting the efficacy of drug treatment for ventricular tachycardia/ventricular fibrillation (VT/VF). A second objective was to determine the relative efficacies of 7 antiarrhythmic drugs used in the treatment of ventricular tachyarrhythmias. ESVEM was the first opportunity to compare prospectively the efficacy, safety, and tolerability of a variety of antiarrhythmic drugs in the same patient population. No significant difference was observed between suppression of spontaneous ventricular arrhythmias on Holter monitoring and suppression of inducible ventricular arrhythmias by electrophysiologic study (EPS) in terms of the ability to predict the success of drug therapy. There was also no difference in predictive accuracy if patients in the electrophysiologic limb showed suppression by Holter monitoring in addition to suppression by EPS. Sotalol was more effective than the other 6 antiarrhythmic drugs, all class I agents, in preventing death and recurrence of arrhythmia. Efficacy compared with placebo, however, was not evaluated. In the EPS limb, sotalol was also statistically more likely to achieve an efficacy prediction than any of the sodium channel blocking drugs. Amiodarone was not used in ESVEM. It has been suggested that these conclusions, which differ from those of other, less controlled, invasive and noninvasive studies, might be because of the particular efficacy criteria used in the ESVEM protocol. Retrospective analyses of the ESVEM data were performed using more rigid efficacy criteria than were used in the original ESVEM analysis: a greater degree of ectopy suppression was required for Holter monitoring, and more stringent efficacy definitions were required in the stimulation protocol of the EPS limb. Results from the retrospective analyses and other studies support the initial ESVEM conclusions. In patients with both spontaneous and inducible sustained ventricular tachyarrhythmias as well as frequent spontaneous premature ventricular contractions, therapy with sotalol (guided by either Holter monitoring or EPS) is a reasonable initial strategy because of its superior initial long-term efficacy and better acute and long-term tolerability compared with sodium channel blocking drugs.
电生理研究与心电图监测（ESVEM）试验有两个目标。第一个目标是确定无创与有创方法预测室性心动过速/心室颤动（VT/VF）药物治疗疗效的准确性。第二个目标是确定用于治疗室性快速心律失常的7种抗心律失常药物的相对疗效。ESVEM是首次在同一患者群体中对多种抗心律失常药物的疗效、安全性和耐受性进行前瞻性比较的机会。在预测药物治疗成功的能力方面，动态心电图监测对自发性室性心律失常的抑制与电生理研究（EPS）对诱发性室性心律失常的抑制之间未观察到显著差异。如果电生理组的患者除了被EPS抑制外还被动态心电图监测抑制，预测准确性也没有差异。索他洛尔在预防死亡和心律失常复发方面比其他6种抗心律失常药物（均为I类药物）更有效。然而，未评估与安慰剂相比的疗效。在EPS组中，索他洛尔在统计学上也比任何一种钠通道阻滞剂更有可能实现疗效预测。胺碘酮未在ESVEM中使用。有人认为，这些与其他控制较差的有创和无创研究不同的结论，可能是由于ESVEM方案中使用的特定疗效标准。对ESVEM数据进行了回顾性分析，使用了比原始ESVEM分析更严格的疗效标准：动态心电图监测需要更大程度的异位搏动抑制，EPS组的刺激方案需要更严格的疗效定义。回顾性分析和其他研究的结果支持了ESVEM的初始结论。对于既有自发性又有诱发性持续性室性快速心律失常以及频繁自发性室性早搏的患者，索他洛尔治疗（由动态心电图监测或EPS指导）是一种合理的初始策略，因为与钠通道阻滞剂相比，它具有更好的初始长期疗效以及更好的急性和长期耐受性。
