ICD Primary prevention trials
From TextbookOfCardiology
| 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
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- 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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- 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.
- 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.
- 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, and Ip JH. 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 pmid:15659722.
