The Midlands Trial of Empirical Amiodarone versus Electrophysiology-guided Interventions and Implantable Cardioverter-defibrillators (MAVERIC): a multi-centre prospective randomised clinical trial on the secondary prevention of sudden cardiac death.
OBJECTIVE
MAVERIC was a randomised clinical trial designed to test the possibility of prospectively identifying patients who would benefit most from the implantable cardioverter-defibrillator (ICD) by electrophysiology (EP) study in the context of secondary prevention of sudden cardiac death (SCD) through comparing EP-guided interventions (anti-arrhythmic drugs, coronary revascularization, and ICD) against empirical amiodarone therapy.


METHODS
Two hundred and fourteen survivors of sustained ventricular tachycardia (VT), ventricular fibrillation (VF) or SCD were randomized to either treatment strategy, pre-stratified for haemodynamic status at index event, and followed up for a median of 5 years.


RESULTS
Of the 106 amiodarone arm patients, 89 (84%) received the drug and 5 (5%) received an ICD after crossing over. Of the 108 EP arm patients, 31 (29%) received an ICD, 46 (43%) received anti-arrhythmic drugs only (mainly amiodarone or sotalol) and 18 (17%) received coronary revascularization but no ICD. No significant differences in survival or arrhythmia recurrence existed between the two treatment arms after 6 years. However, ICD recipients had a lower mortality than non-ICD recipients, regardless of allocated treatment (hazard ratio=0.54, p=0.0391).


CONCLUSIONS
Prospective selection of patients to receive the ICD by EP study did not improve survival compared with empirical amiodarone therapy among survivors of VT, VF or SCD, whereas ICD implantation improved survival regardless of allocated treatment. On this basis, routine EP study has no role in the management of such patients, who should be offered empirical ICD therapy according to the results of other secondary prevention ICD trials.
Lau
E W
EW
Queen Elizabeth Hospital, Birmingham B15 2TH, UK.
Griffith
M J
MJ
Pathmanathan
R K
RK
Ng
G A
GA
Clune
M M
MM
Cooper
J
J
Marshall
H J
HJ
Forsey
P R
PR
Stafford
P J
PJ
Gray
R G
RG
Skehan
J D
JD
Garratt
C J
CJ
D000638:Amiodarone / Q000627:therapeutic use*; D000889:Anti-Arrhythmia Agents / Q000627:therapeutic use*; D002985:Clinical Protocols; D016757:Death, Sudden, Cardiac / Q000453:epidemiology / Q000517:prevention & control*; D017147:Defibrillators, Implantable; D015716:Electrocardiography, Ambulatory; D022062:Electrophysiologic Techniques, Cardiac; D006801:Humans; D015999:Multivariate Analysis; D011446:Prospective Studies; D018570:Risk Assessment; D016019:Survival Analysis; D017180:Tachycardia, Ventricular / Q000628:therapy*
D000889:Anti-Arrhythmia Agents; D000638:Amiodarone