ICD Primary prevention trials

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TABLE 1. Overview of the Major Randomized Controlled Clinical Trials of ICD Therapy for Primary Prevention of Sudden Cardiac Death in Ischemic Cardiomyopathy
Study	Inclusion Criteria	Number Randomized	Control Group	Primary Point	Main Finding
MADIT I35	Prior MI, EF ≤35%, NSVT, inducible and nonsuppressible VT on EPS, NYHA class I–III	196	Conventional therapy	All-cause mortality	54% RRR in all-cause mortality with ICD (P=0.009); absolute RR 23%
CABG-PATCH36	EF <35%, abnormal SAECG, elective CABG	900	Conventional therapy	All-cause mortality	No difference in all-cause mortality
MUSTT37	Prior MI, EF ≤40%, NSVT, inducible VT on EPS	704	EP-guided antiarrhythmic therapy or conventional therapy	Cardiac arrest or death due to arrhythmia	60% RRR in all-cause mortality with ICD (P=0.001); absolute RR 31%
MADIT II39	Prior MI≤1 month, EF≤30%, NYHA class I–III	1232	Conventional therapy	All-cause mortality	31% RRR in all-cause mortality with ICD (P=0.016); absolute RR 6%
DINAMIT38	Recent (6–40 days) MI, EF≤35%, abnormal HRV or elevated average HR on 24-h Holter, NYHA class I–III	674	Conventional therapy	All-cause mortality	No difference in all-cause mortality; 58% RRR from arrhythmia with ICD (P=0.009)
SCD-HeFT34	EF≤35%, (ischemic or nonischemic) NYHA class II–III	2521	Conventional therapy±amiodarone	All-cause mortality	23% RRR in all-cause mortality with ICD (P=0.007); absolute RR 7%
EF indicates ejection fraction; NSVT, nonsustained VT; EPS, electrophysiological study; NYHA, New York Heart Association; RRR, relative risk reduction; RR, risk reduction; CABG, coronary artery bypass grafting; SAECG, signal-averaged ECG; HRV, heart rate variability; and HR, heart rate.