Circulation, Vol 79, 1354-1360, Copyright © 1989 by American Heart Association
ESVEM (Electrophysiologic Study Versus Electrocardiographic Monitoring) is
an ongoing multicenter trial supported by the National Heart, Lung, and
Blood Institute that began enrollment of patients on October 1, 1985. We
describe here the methodology of the trial and data regarding enrollment of
patients in the trial. The purpose of the trial is to determine whether
electrophysiologic study or electrocardiographic Holter monitoring more
accurately predicts antiarrhythmic drug efficacy in patients with aborted
sudden death or sustained ventricular tachyarrhythmias. Consenting patients
with inducible, sustained ventricular tachyarrhythmias and at least 480
premature ventricular contractions during 48 hours are randomized to
undergo antiarrhythmic drug selection either by electrophysiologic study or
by Holter monitoring. Up to six drugs (mexiletine, pirmenol, procainamide,
propafenone, quinidine, and sotalol) are assessed in random order until one
is predicted effective. An efficacy prediction is achieved in the
electrophysiology limb if ventricular tachyarrhythmias are no longer
inducible and in the Holter limb if ventricular ectopy is largely
suppressed. Patients in whom a drug is predicted effective are followed
while they are taking that drug to detect one of the three primary
endpoints: arrhythmia recurrence, sudden death, or unmonitored syncope. In
the first 37 months, 967 patients satisfied inclusion and exclusion
criteria to undergo baseline studies. Two hundred eighty-six were eligible
for and consented to randomization. In total, approximately 500 patients
will be randomized and 285 subjects will be followed while receiving drugs
that are predicted effective in this trial. Approximately 70 patients are
expected to attain a primary end-point during a mean follow-up ot 3
years.(ABSTRACT TRUNCATED AT 250 WORDS)
ARTICLES
The ESVEM trial. Electrophysiologic Study Versus Electrocardiographic Monitoring for selection of antiarrhythmic therapy of ventricular tachyarrhythmias. The ESVEM Investigators
This article has been cited by other articles:
 |
|
 |
|
  M. P. Anstadt and J. E. Lowe Cardiopulmonary Resuscitation Card. Surg. Adult, January 1, 2003; 2(2003): 471 - 494. [Full Text]
|
|
|
|
 |
|
 V. Shusterman, B. Aysin, V. Gottipaty, R. Weiss, S. Brode, D. Schwartzman, K. P. Anderson, and for the ESVEM Investigators Autonomic nervous system activity and the spontaneous initiation of ventricular tachycardia J. Am. Coll. Cardiol., December 1, 1998; 32(7): 1891 - 1899. [Abstract] [Full Text] [PDF]
|
|
|
|
 |
|
 P. P. Sharma, P. Ott, V. Hartz, J. W. Mason, and F. I. Marcus Risk Factors for Tachycardia Events Caused by Antiarrhythmic Drugs: Experience From the ESVEM Trial Journal of Cardiovascular Pharmacology and Therapeutics, January 1, 1998; 3(4): 269 - 274. [Abstract] [PDF]
|
|
|
|
 |
|
 A. C. Caruso, F. I. Marcus, E. A. Hahn, V. L. Hartz, and J. W. Mason Predictors of Arrhythmic Death and Cardiac Arrest in the ESVEM Trial Circulation, September 16, 1997; 96(6): 1888 - 1892. [Abstract] [Full Text]
|
|
|
|
|
|
S. Saksena and I. Giorgberidze The Multicenter Automatic Defibrillator Implantation Trial: MADIT Provides the Basis for Developing Therapeutic Strategy for Patients With Severely Depressed Ventricular Ejection Fraction With Nonsustained Ventricular Tachycardia Journal of Cardiovascular Pharmacology and Therapeutics, January 1, 1997; 2(3): 229 - 234. [PDF]
|
|
|
|
|
|
M. J. Reiter, D. E. Mann, J. E. Reiffel, E. Hahn, and V. Hartz Significance and Incidence of Concordance of Drug Efficacy Predictions by Holter Monitoring and Electrophysiological Study in the ESVEM Trial Circulation, April 1, 1995; 91(7): 1988 - 1995. [Abstract] [Full Text]
|
|
|
|
|
|
N. A. Omoigui, F. I. Marcus, J. W. Mason, E. A. Hahn, V. L. Hartz, and M. A. Hlatky Cost of Initial Therapy in the Electrophysiological Study Versus ECG Monitoring Trial (ESVEM) Circulation, February 15, 1995; 91(4): 1070 - 1076. [Abstract] [Full Text]
|
|
|
|
 |
|
 R. S. Damle, F. A. Ehlert, S. L. Winters, D. Rubinstein, J. A. Gomes, J. W. Mason, and The ESVEM Investigators The Treatment of Ventricular Tachyarrhythmias N. Engl. J. Med., January 27, 1994; 330(4): 286 - 288. [Full Text]
|
|
|
|
|
|
J. W. Mason and The Electrophysiologic Study versus Electrocardiog A Comparison of Electrophysiologic Testing with Holter Monitoring to Predict Antiarrhythmic-Drug Efficacy for Ventricular Tachyarrhythmias N. Engl. J. Med., August 12, 1993; 329(7): 445 - 451. [Abstract] [Full Text]
|
|
|
|
|
|
J. W. Mason and The Electrophysiologic Study versus Electrocardiog A Comparison of Seven Antiarrhythmic Drugs in Patients with Ventricular Tachyarrhythmias N. Engl. J. Med., August 12, 1993; 329(7): 452 - 458. [Abstract] [Full Text]
|
|
|
|
|
|
D. E. Ward and A. J. Camm Dangerous Ventricular Arrhythmias -- Can We Predict Drug Efficacy? N. Engl. J. Med., August 12, 1993; 329(7): 498 - 499. [Full Text]
|
|
|
|
|
|
P. T. Vaitkus, M. A. Capeless, M. S. Stanton, B. I. Gersh, S. C. Hammill, G. Steinbeck, and D. Andresen Electrophysiologically Guided Antiarrhythmic Therapy versus Beta-Blocker Therapy in Patients with Ventricular Tachyarrhythmias N. Engl. J. Med., February 4, 1993; 328(5): 357 - 358. [Full Text]
|
|
|
|
 |
|
 A. E. Buxton Antiarrhythmic Drugs: Good for Premature Ventricular Complexes but Bad for Patients? Ann Intern Med, March 1, 1992; 116(5): 420 - 422. [Abstract] [PDF]
|
|
|
|
|
|
J. N. Weiss, K. Nademanee, W. G. Stevenson, and B. Singh Ventricular Arrhythmias in Ischemic Heart Disease Ann Intern Med, May 1, 1991; 114(9): 784 - 797. [Abstract] [PDF]
|
|