Table 2.
Early ICD implantation trials for primary prevention of SCD after acute MI.
| Trial Name | DINAMIT | BEST+ † | IRIS | DAPA † |
|---|---|---|---|---|
| Year of publication | 2004 | 2005 | 2009 | 2020 |
| Year of enrollment | 1998–2002 | 1998–2003 | 1999–2007 | 2004–2013 |
| Inclusion criteria | Recent MI (6–40 days), LVEF ≤35% and one of the following: - RR intervals variability ≤70 ms on continuous ECG monitoring - Mean heart rate >80 beats per minute on continuous ECG monitoring |
Recent MI (5–30 days), LVEF ≤35% and one or more of the following: - PVCs >= 10/h; - reduced HRV - positive SAECG + tolerance to metoprolol–at least 25 mg/day |
Recent MI (5–31 days), LVEF ≤ 40% and one of the following: - HR ≥ 90 on ECG; - NSVT on continuous ECG monitoring |
Recent MI (30–60 days)–Primary PCI for STEMI and ≥1 high risk factor: - LVEF <30% within 4 days - TIMI flow <3 after PCI - Primary VF - Killip class ≥2 |
| No. of patients enrolled | 674 | 138 | 898 | 262 |
| No. of patients in ICD group/control group | 332/342 | 79 (24)/59 * | 445/453 | 129/133 |
| Follow-up, mean | 30 months +/− 13 months | 540 days +/− 403 days | 37 months (range 0–106) | 36 months |
| ICD programming | VT: 175–200 bpm 16 intervals to detect (4 ATP sequences–burst) VF zone ≥200 bpm (18/24) VVI pacing mode 40 to 55 bpm |
N/A | VT: 150–200 bpm (32 intervals to detect, no ATP) VF zone ≥200 bpm VVI pacing mode 40 bpm |
Fast VT or VF ≥190 bpm (ATP burst during charging) VVI pacing mode/DDI mode with a long AV interval |
| DFT Testing | Yes | N/A | Yes | Yes |
| Reperfusion Therapy | 66.5% | 16.3% | 86.8% | 97% |
| All-cause mortality | 62 in the ICD group 58 in the control group |
13 in EPS/ICD group 13 in control group |
116 in the ICD group 117 in the control group |
40 patients (15%) 5% in the ICD group 13% in the control group |
| SCD | 12 in the ICD group 29 in the control group |
4 in EPS/ICD group 5 in the control group |
27 in the ICD group 60 in the control group |
3.1% in the ICD group 5.9% in the control group |
| Cardiac non-SCD | 34 in the ICD group 20 in the control group |
9 in EPS/ICD and control group | 68 in the ICD group 39 in the control group |
7.9% in the ICD group 16.1% in the control group |
| Total cardiac death | 46 in the ICD group 49 in the control group |
18 in EPS/ICD and control group | 95 in the ICD group 99 in the control group |
11% in the ICD group 22% in the control group |
* In BEST+ 79 patients were randomized to EPS guided/ICD strategy, with only 24 inducible patients with ICD implantation; † BEST+ and DAPA trials were prematurely terminated because of a slow enrollment rate; AV = atrioventricular; DFT = defibrillation threshold; EPS = electrophysiological study; HR = heart rate; HRV = heart rate variability; ICD = implantable cardiac defibrillator; LVEF = left ventricular ejection fraction; MI = myocardial infarction; N/A = not available; NSVT = non-sustained ventricular tachycardia; PCI = percutaneous coronary intervention; PVCs = premature ventricular contractions; SAECG = signal-averaged electrocardiogram; SCD = sudden cardiac death; STEMI = ST-elevation myocardial infarction; VT = ventricular tachycardia; VF = ventricular fibrillation.