Summary of primary prevention implantable cardioverter-defibrillator (ICD) trials

Trial	Enrollment/follow-up	Number of patients	Ischemic/non-ischemic CMP	Entry criteria	Medical therapies?	Outcomes with ICD
Ischemic CMP (late post-MI) trials
MADIT-I	1991 to 1996 Mean follow-up 27 months	196	100%/0%	Prior MI NSVT on ECG monitoring LVEF ≤35% NYHA I/II/III Inducible VT during EPS	BB - 17% ACE/ARB - 58% MRA - NR AAD - 60%	Total mortality: HR 0.46 (95% CI 0.26-0.82) compared with conventional medical therapy alone
MUSTT	1990 to 1996 Mean follow-up 39 months	704	100%/0%	Prior MI NSVT on ECG monitoring LVEF ≤40% NYHA I/II/III Inducible VT during EPS	BB - 40% ACE/ARB - 75% MRA - NR AAD - 45%	SCA or death from arrhythmia: RR 0.24 (95% CI 0.13-0.45) for ICD versus no ICD
CABG-Patch	1993 to 1996 Mean follow-up 32 months	900	100%/0%	<80 years old Scheduled for elective CABG LVEF <36% Abnormal SAECG	BB - 21% ACE-I - 54% MRA - NR AAD - NR	Death from any cause: HR 1.07 (95% CI 0.81-1.42) ICD versus control*
MADIT-II	1997 to 2001 Mean follow-up 20 months	1232	100%/0%	Prior MI LVEF ≤35% NYHA I/II/III^¶	BB - 70% ACE/ARB - 70% MRA - NR AAD - 14%	Total mortality: HR 0.65 (95% CI 0.51-0.93) compared with conventional medical therapy alone
Ischemic CMP (early post-MI) trials
DINAMIT	1998 to 2003 Mean follow-up 30 months	674	100%/0%	6 to 40 days post-MI LVEF ≤35% Impaired autonomic function (depressed HR variability or elevated average 24-hour HR on Holter monitoring)	BB - 87% ACE-I - 95% MRA - NR AAD - 11%	Total mortality: HR 1.08 (95% CI 0.76-1.55), ICD versus control group
IRIS	1999 to 2007 Mean follow-up 37 months	898	100%/0%	5 to 31 days post-MI LVEF ≤40% and HR ≥90 BPM on first ECG or NSVT	BB - 87% ACE-I - 82% MRA - NR AAD - NR	Total mortality: HR 1.04 (95% CI 0.81-1.35) ICD versus control group
Combined ischemic and nonischemic CMP trial
SCD-HeFT	1997 to 2003 Mean follow-up 45 months	2521	52%/48%	HF for ≥3 months LVEF ≤35% NYHA II/III	BB - 69% ACE/ARB - 85% MRA - NR AAD - 34% randomized to amiodarone; additional 7% crossover to amiodarone	Total mortality: HR 0.77 (95% CI 0.62-0.96) compared with conventional medical therapy alone
Nonischemic CMP trials
DEFINITE	1998 to 2003 Mean follow-up 29 months	458	0%/100%	Nonischemic CMP LVEF ≤35% NYHA I/II/III PVCs or NSVT	BB - 85% ACE/ARB - 97% MRA - NR AAD - 5%	Total mortality: HR 0.65 (95% CI 0.4-1.06) compared with conventional medical therapy alone
COMPANION	2000 to 2002 Median follow-up of 16 months	1520	55%/45%	LVEF ≤35% NYHA III/IV requiring hospitalization within prior year	BB - 67% ACE/ARB - 69% MRA - 55% AAD - NR	Combined HF death or HF hospitalization: HR 0.68 (95% CI 0.68-0.95) for CRT versus medical therapy alone
DANISH	2008 to 2014 Mean follow-up 68 months	1114	0%/100%	Nonischemic CMP LVEF ≤35% NYHA II/III (or IV if CRT planned)	BB - 92% ACE/ARB - 97% MRA - 58% CRT - 58% AAD - 6%	Total mortality: HR 0.87 (95% CI 0.68-1.12) compared with conventional HF therapy alone

AAD: antiarrhythmic drugs; ACE-I: angiotensin converting enzyme inhibitor; ARB: angiotensin receptor blocker; BB: beta blocker; BPM: beats per minute; CABG: coronary artery bypass graft surgery; CMP: cardiomyopathy; CRT: cardiac resynchronization therapy; HF: heart failure; ECG: electrocardiogram; EPS: electrophysiologic study; ICD: implantable cardioverter-defibrillator; LVEF: left ventricular ejection fraction; MI: myocardial infarction; MRA: mineralocorticoid receptor antagonist; NR: not reported (likely near zero given early date of trial); NSVT: nonsustained ventricular tachycardia; NYHA: New York Heart Association; PVC: premature ventricular contraction; SAECG: signal averaged electrocardiogram; SCA: sudden cardiac arrest; VT: ventricular tachycardia.
* Epicardial ICDs were predominantly used in the CABG Patch trial, as patients were all undergoing CABG. This is not consistent with contemporary practice.
¶ Some patients with NYHA class IV functional status were enrolled in MADIT-II, but the requirement was to be NYHA class I/II/III at the time of enrollment.

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Summary of primary prevention implantable cardioverter-defibrillator (ICD) trials