A summary and assessment of the findings and conclusions of the ESVEM trial

The Electrophysiologic Study Versus Electrocardiographic Monitoring (ESVEM) trial was completed in 1992 and the primary results were reported in 1993. Since then, considerable discussion about this trial has taken place and new trial results have been reported. Trial analysis has yielded seven principal findings to date concerning treatment of patients with ventricular tachyarrhythmias, ie: (1) similar accuracy of electrophysiologic study (EPS), Holter monitoring (HM), and EPS combined with HM for predicting antiarrhythmic drug efficacy; (2) greater efficiency and lower cost of HM; (3) improved survival associated with predicted drug efficacy; (4) predictors of response to EPS and HM; (5) greater efficacy and lower cost of therapy with sotalol compared with drugs with class-I effects; (6) lack of a relationship between presenting and recurring arrhythmia; and (7) preponderance of nonarrhythmic deaths in trial participants. A number of additional specific findings of the trial are reviewed in this symposium. Several criticisms of the trial's enrollment, methods, and efficacy criteria are reviewed and discussed. Some criticisms are valid. Many are related to misunderstandings of ESVEM trial methodology and to bias of the individual critics. Some are simply incorrect. The importance of the ESVEM trial in the present day may be limited by the growing use of implanted devices rather than drugs for treatment of ventricular tachyarrhythmias. If clinical trials ultimately prove devices to be no more effective than drugs, the findings of the ESVEM investigators will grow in importance.