ICD Primary prevention trials

Overview of the Major Randomized Controlled Clinical Trials of ICD Therapy for Primary Prevention of SCD in Ischemic Cardiomyopathy[1]
Study	Inclusion Criteria	Number Randomized	Control Group	Primary Point	Main Finding
MADIT I[2]	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[3]	EF <35%, abnormal SAECG, elective CABG	900	Conventional therapy	All-cause mortality	No difference in all-cause mortality
MUSTT[4]	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[5]	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[6]	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[7]	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. Passman R and Kadish A. Sudden death prevention with implantable devices. Circulation. 2007 Jul 31;116(5):561-71. DOI:10.1161/CIRCULATIONAHA.106.655704 |

2. 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.

3. 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.

4. 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.

5. 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.

6. 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.

7. Bardy GH, Lee KL, Mark DB, Poole JE, Packer DL, Boineau R, Domanski M, Troutman C, Anderson J, Johnson G, McNulty SE, Clapp-Channing N, Davidson-Ray LD, Fraulo ES, Fishbein DP, Luceri RM, Ip JH, and Sudden Cardiac Death in Heart Failure Trial (SCD-HeFT) Investigators. Amiodarone or an implantable cardioverter-defibrillator for congestive heart failure. N Engl J Med. 2005 Jan 20;352(3):225-37. DOI:10.1056/NEJMoa043399 |