Comparative efficacy of sotalol and class I antiarrhythmic agents in patients with ventricular tachycardia or fibrillation: results of the Electrophysiology Study Versus Electrocardiographic Monitoring (ESVEM) Trial.

The ESVEM Trial was a randomized prospective study to compare the predictive accuracy of electrophysiologic testing (EPS) to ambulatory electrocardiographic monitoring (Holter monitoring--HM) for long-term drug therapy of sustained ventricular tachyarrhythmias. 486 patients with documented ventricular tachycardia or resuscitated sudden death were randomized to EPS (n = 242) or HM (n = 244) and underwent serial drug testing with up to six antiarrhythmics; in the EPS limb a drug efficacy prediction was achieved in 108 patients (45%), compared to 188 (77%) in the HM limb (P < 0.001). Efficacy predictions were most frequent with sotalol therapy. During long-term follow-up of the 296 patients discharged on a drug predicted to be effective, there were 151 recurrences of an arrhythmic event; there were no differences in actuarial rates of arrhythmia recurrence between EPS and HM. With multivariate testing of 14 variables, only sotalol therapy and absence of prior antiarrhythmic therapy were associated with a significant reduction in risk of arrhythmia recurrence.