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.

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  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.

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  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.

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  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.

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  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.

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  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.

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