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 I[1]	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-PATCH[2]	EF <35%, abnormal SAECG, elective CABG	900	Conventional therapy	All-cause mortality	No difference in all-cause mortality
MUSTT[3]	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 II[4]	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%
DINAMIT[5]	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-HeFT[6]	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.

References

1. Moss A, Hall W, Cannom D, Daubert J, Higgins S, Klein H, Levine J, Saksena S, Waldo A, Wilber D, Brown M, Heo M; Multicenter Automatic Defibrillator Implantation Trial Investigators. Improved survival with an implanted defibrillator in patients with coronary disease at high risk for ventricular arrhythmia. N Engl J Med. 1996;335:1933–1940.

2. Bigger J; Coronary Artery Bypass Graft (CABG) Patch Trial Investigators. Prophylactic use of implanted cardiac defibrillators in patients at high risk for ventricular arrhythmias after coronary-artery bypass graft surgery. N Engl J Med. 1997;337:1569 –1575.

3. Buxton A, Lee K, DiCarlo L, Gold M, Greer G, Prystowsky E, O’Toole M, Tang A, Fisher J, Coromilas J, Talajic M, Hafley G; Multicenter Unsustained Tachycardia Trial Investigators. Electrophysiologic testing to identify patients with coronary artery disease who are at risk for sudden death. N Engl J Med. 2000;342:1937–1945.

4. Moss A, Zareba W, Hall W, Klein H, Wilber D, Cannom D, Daubert J, Higgins S, Brown M, Andrews M; for the MADIT II Investigators. Prophylactic implantation of a defibrillator in patients with myocardial infarction and reduced ejection fraction. N Engl J Med. 2002;346:877–883.

5. Hohnloser S, Kuck KH, Dorian P, Roberts R, Hampton J, Hatala R, Fain E, Gent M, Connolly S; DINAMIT Investigators. Prophylactic use of an implantable cardioverter-defibrillator after acute myocardial infarction. N Engl J Med. 2004;351:2481–2488.

6. Bardy G, Lee KL, Mark D, Poole J, Packer D, Boineau R, Domanski M, Troutman R, Anderson J, Johnson G, McNulty S, Clapp-Channing N, Davidson-Ray L, Fraulo E, Fishbein D, Luceri R, Ip J. Amiodarone or an implantable cardioverter- defibrillator for congestive heart failure. N Engl J Med. 2005;352:225–237.