ICD Primary prevention trials: Difference between revisions
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{| class="wikitable" border="1" | {| class="wikitable" border="1" | ||
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! 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 | ! Study | ||
| Line 10: | Line 10: | ||
! Main Finding | ! Main Finding | ||
|- | |- | ||
| MADIT I< | | '''MADIT I'''<cite>35</cite> | ||
| Prior MI, EF ≤35%, NSVT, inducible and nonsuppressible VT on EPS, NYHA class I–III | | Prior MI, EF ≤35%, NSVT, inducible and nonsuppressible VT on EPS, NYHA class I–III | ||
| align="center" | 196 | | align="center" | 196 | ||
| Line 18: | Line 18: | ||
mortality with ICD (''P''=0.009); absolute RR 23% | mortality with ICD (''P''=0.009); absolute RR 23% | ||
|- | |- | ||
| CABG-PATCH< | | '''CABG-PATCH'''<cite>36</cite> | ||
| EF <35%, abnormal SAECG, elective CABG | | EF <35%, abnormal SAECG, elective CABG | ||
| align="center" | 900 | | align="center" | 900 | ||
| Line 26: | Line 26: | ||
|- | |- | ||
| MUSTT< | | '''MUSTT'''<cite>37</cite> | ||
| Prior MI, EF ≤40%, NSVT, inducible VT on EPS | | Prior MI, EF ≤40%, NSVT, inducible VT on EPS | ||
| align="center" | 704 | | align="center" | 704 | ||
| Line 34: | Line 34: | ||
|- | |- | ||
| MADIT II< | | '''MADIT II'''<cite>39</cite> | ||
| Prior MI≤1 month, EF≤30%, NYHA class I–III | | Prior MI≤1 month, EF≤30%, NYHA class I–III | ||
| align="center" | 1232 | | align="center" | 1232 | ||
| Line 42: | Line 42: | ||
|- | |- | ||
| DINAMIT< | | '''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 | | Recent (6–40 days) MI, EF≤35%, abnormal HRV or elevated average HR on 24-h Holter, NYHA class I–III | ||
| align="center" | 674 | | align="center" | 674 | ||
| Line 50: | Line 50: | ||
|- | |- | ||
| SCD-HeFT< | | '''SCD-HeFT'''<cite>34</cite> | ||
| EF≤35%, (ischemic or nonischemic) NYHA class II–III | | EF≤35%, (ischemic or nonischemic) NYHA class II–III | ||
| align="center" | 2521 | | align="center" | 2521 | ||
| Line 61: | Line 61: | ||
|} | |} | ||
==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> | |||
Latest revision as of 19:30, 15 January 2012
| Overview of the Major Randomized Controlled Clinical Trials of ICD Therapy for Primary Prevention of SCD in Ischemic CardiomyopathyPassman | |||||
|---|---|---|---|---|---|
| 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. | |||||
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>