ICD Primary prevention trials: Difference between revisions

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+{| class="wikitable" border="1"
+|-
+! colspan="6" | Overview of the Major Randomized Controlled Clinical Trials of ICD Therapy for Primary Prevention of SCD in Ischemic Cardiomyopathy<cite>Passman</cite>
+|-
+! Study
+! Inclusion Criteria
+! Number Randomized
+! Control Group
+! Primary Point
+! Main Finding
+|-
+| '''MADIT I'''<cite>35</cite>
+| Prior MI, EF ≤35%, NSVT, inducible and nonsuppressible VT on EPS, NYHA class I–III
+| align="center" | 196
+| Conventional therapy
+| All-cause mortality
+| 54% RRR in all-cause
+mortality with ICD (''P''=0.009); absolute RR 23%
+|-
+| '''CABG-PATCH'''<cite>36</cite>
+| EF <35%, abnormal SAECG, elective CABG
+| align="center" | 900
+| Conventional therapy
+| All-cause mortality
+| No difference in all-cause mortality
+|-
+| '''MUSTT'''<cite>37</cite>
+| Prior MI, EF ≤40%, NSVT, inducible VT on EPS
+| align="center" | 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'''<cite>39</cite>
+| Prior MI≤1 month, EF≤30%, NYHA class I–III
+| align="center" | 1232
+| Conventional therapy
+| All-cause mortality
+| 31% RRR in all-cause mortality with ICD (''P''=0.016); absolute RR 6%
+|-
+| '''DINAMIT'''<cite>38</cite>
+| Recent (6–40 days) MI, EF≤35%, abnormal HRV or elevated average HR on 24-h Holter, NYHA class I–III
+| align="center" | 674
+| Conventional therapy
+| All-cause mortality
+| No difference in all-cause mortality; 58% RRR from arrhythmia with ICD (''P''=0.009)
+|-
+| '''SCD-HeFT'''<cite>34</cite>
+| EF≤35%, (ischemic or nonischemic) NYHA class II–III
+| align="center" | 2521
+| Conventional therapy±amiodarone
+| All-cause mortality
+| 23% RRR in all-cause mortality with ICD (''P''=0.007); absolute RR 7%
+|-
+| colspan="6" | 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==
+<biblio>
+#Passman pmid=17664385
+#34 pmid=15659722
+#35 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.
+#36 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.
+#37 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.
+#38 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.
+#39 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.
+</biblio>